Pet Stem Cell Therapy

Meat-Tech Agrees to Acquire Cultured Fat Pioneer ‘Peace of Meat’ – PRNewswire

December 8, 2020 admin Pet Stem Cell Therapy

NESSZIONA,Israel, Dec. 8, 2020 /PRNewswire/ -- Meat-Tech 3D Ltd. (TASE: MEAT), today announced that it has signed an agreement to acquire 100% of the share capital of Peace of Meat PV, a pioneering Belgian producer of cultured avian products, for EUR 15 million in a combination of cash and Meat-Tech ordinary shares. The Company believes that it will be able to leverage Peace of Meat's technologies, including through novel hybrid food products, to expedite market entry while Meat-Tech develops an industrial process for cultivating and producing real meat using 3D bioprinting technology, without harming animals. The acquisition is expected to close in the coming weeks, subject to customary closing conditions.

Peace of Meat has developed a proprietary, stem-cell-based bioreactor technology for cultivating animal fats from chicken and ducks, without harming animals. It has conducted a number of taste tests, demonstrating the potential that its cultured fat has to enhance the taste of plant-based protein products. The technology's first expected application is in hybrid food products, combining plant-based protein with cultured animal fat, designed to provide meat analogues with qualities of "meatiness" (taste and texture) closer to that of conventional meat products. Meat-Tech estimates that the first hybrid products based on Peace of Meat technology could hit the market as early as 2022.

Pursuant to the acquisition agreement, Meat-Tech will pay half of the consideration immediately, with the payment of the balance subject to Peace of Meat complying with preset technological milestones over a period of two years, that were designed to scale up cultured fat production capabilities in preparation for market entry. To that end, it was agreed that Peace of Meat's management will continue in place to lead the development process.

This acquisition is consistent with Meat-Tech's growth strategy, aiming to streamline development processes and expand the Company's product range to penetrate cultured meat technology markets as quickly as possible. Meat-Tech is working to create synergy and added value for food manufacturers in the advanced production of cultured meat, while sustaining animal welfare and meeting the growing global demand for meat.

Sharon Fima, Meat-Tech's CEO: "Meat-Tech's novel technology for producing meat using 3D printing is gaining increasing international recognition. Boosted by our acquisition strategy, we believe we can turn Meat-Tech into a leading global center and home for innovative and groundbreaking cell-based food solutions that are both healthy and environmentally friendly. The combination of Peace of Meat's human capital and technology make this acquisition a significant step in that direction. I am pleased that both management teams share a common vision and strategy, and can join forces to advance the development of cultured food products with the potential to create real alternatives in the global meat market."

David Brandes and Dirk von Heinrichshorst, Co-Founders of Peace of Meat:"In an industry that is working towards a kinder, more sustainable planet, joining forces makes us stronger together. Peace of Meat has developed a powerful system for upscaled cultured biomass production and together with Meat-Tech we intend to accelerate product development toward commercialization.

"While Peace of Meat's core activity remains focused on the production of tasty, cultured fat as a B2B ingredient for meat alternatives, we see tremendous opportunity in jointly building a leading food-tech enterprise with Meat-Tech, based on a cellular platform.

"As entrepreneurs, we are excited about this acquisition as it poses a novel way of building and growing a company while significantly increasing the prospects of launching our product into the market."

About Peace of Meat:

Peace of Meat was established in Belgium in 2019 and is developing cultured chicken fat directly from animal cells without the need to grow or kill animals. The company believes that its innovative technology has the potential to support an industrial process for the production of cultured chicken fat. Peace Of Meat has entered into a number of scientific and commercial collaborations, in the process of positioning itself as a future B2B provider, with the potential to cover the entire value chain and to accelerate research and production processes in the industry, and has conducted taste tests for hybrid products it has developed.

About Meat-Tech:

Meat-Tech is developing a novel biological printing process designed to create living, edible meat tissue using cellular agriculture. Meat-Tech is developing technologies, processes and machines for cultivating, producing, and printing cultured meat. The company believes that it was the first in the world to use edible biological inks to 3D-print living tissue made up of various cells of bovine origin. The Company has the technology, knowledge and experience in applying tissue engineering practices for producing fat and muscle tissue for food consumption, as well as the ability to print, using a 3D bioprinter, a combination of live animal cells, growth factors and biological materials to produce living tissues that mimic the characteristics of natural tissue.

Forward-Looking Statements:

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the Company's development of the next generation of cultured meat food products by leveraging 3D digital printing technology, Peace of Meat's development of cultured fat products, the expected closing of the Company's acquisition of Peace of Meat and the expected post-closing synergies of the combined companies. These forward-looking statements include information about possible or assumed future results of the Company's business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management's current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Actual results could differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.

COMPANY / INVESTOR CONTACT:Eran Gabay, Partner, Director of Strategy Gelbart-Kahana Investor Relations: [emailprotected]

SOURCE Meat-Tech 3D Ltd.

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Meat-Tech Agrees to Acquire Cultured Fat Pioneer 'Peace of Meat' - PRNewswire

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Data Evaluating Tafasitamab with and without Lenalidomide in Combination with R-CHOP in Patients with DLBCL Presented at ASH 2020 – Business Wire

December 8, 2020 admin Pet Stem Cell Therapy

WILMINGTON, Del. & PLANEGG/MUNICH, Germany--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) announce that preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of tafasitamab or tafasitamab plus lenalidomide in addition to R-CHOP for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Additionally, a long-term subgroup analysis of the L-MIND study investigating tafasitamab combined with lenalidomide in patients with relapsed or refractory DLBCL was also presented at ASH.

The preliminary results of firstMIND indicate that tafasitamab plus lenalidomide in addition to R-CHOP shows an acceptable tolerability profile. Toxicities appear to be similar to what is expected with R-CHOP alone or in combination with lenalidomide. Serious or severe neutropenia and thrombocytopenia events (grade 3 or higher) were more frequent in the tafasitamab plus lenalidomide arm. The incidence of febrile neutropenia was comparable between both arms and the average relative dose intensity of R-CHOP was maintained in both arms. Interim response assessments after three cycles were available for 45 patients. In both arms combined, 41/45 (91.1%) of patients had an objective response as per Lugano 20141.

The preliminary data from this ongoing study in first-line DLBCL warrant further investigation. To that end, MorphoSys and Incyte plan to initiate frontMIND, a Phase 3 trial evaluating tafasitamab plus lenalidomide in combination with R-CHOP compared to R-CHOP alone as first-line treatment for patients with newly diagnosed DLBCL.

The initial results of the firstMIND study, shared today at ASH, as well as the long-term analyses from L-MIND, underscore the potential of tafasitamab as a combination therapeutic for patients with DLBCL, where there remains a significant unmet need. Along with our partners at MorphoSys, we are pleased to be moving forward with the initiation of a Phase 3 study in 2021, said Steven Stein, M.D., Chief Medical Officer at Incyte.

The preliminary firstMIND study results mark another important step as we explore the potential of tafasitamab as a backbone therapy, said Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. Given the data available to date, including data from the L-MIND study, we believe that the mechanism of action, efficacy and safety profile of tafasitamab have the potential to make it a preferred combination partner as we seek to transform the standard of care in DLBCL. We are committed to developing innovative therapies to battle this aggressive disease for the benefit of patients with DLBCL, and look forward to beginning the planned frontMIND in the first half of 2021.

In addition to the firstMIND data presented today, the long-term L-MIND analyses showed that treatment with tafasitamab plus lenalidomide resulted in durable responses after 2 years of follow-up. At the time of analysis, patients with complete responses (CR) continued to experience durable treatment responses, including long duration of response (DoR) and overall survival (OS). The data also showed that tafasitamab plus lenalidomide taken for 12 cycles, followed by tafasitamab until progression, did not result in any unexpected safety signals2.

In July 2020, the FDA approved Monjuvi (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)3.

The FDA decision represented the first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.

About Diffuse Large B-cell Lymphoma (DLBCL)

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide4, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter5. In the United States each year, approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT)6,7,8.

About firstMIND

The firstMIND (NCT04134936) trial is a Phase 1b, randomized study of tafasitamab + R-CHOP (Arm A) or tafasitamab + lenalidomide + R-CHOP (Arm B) in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study includes a safety run-in phase and a main phase. In the safety run-in phase, 24 patients were enrolled. The primary objective is to assess safety; secondary objectives include objective response rate, PET negative complete response (PET-CR) rate at end of treatment, progression-free survival, event-free survival, long-term safety, pharmacokinetics and immunogenicity of tafasitamab.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.

XmAb is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

The most common side effects of MONJUVI include:

These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

About MorphoSys

MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys proprietary product Monjuvi (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com or http://www.morphosys-us.com.

Monjuvi is a registered trademark of MorphoSys AG.

Tremfya is a registered trademark of Janssen Biotech, Inc.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release - including statements about: plans to initiate frontMIND, a Phase 3 trial evaluating tafasitamab plus lenalidomide in combination with R-CHOP compared to R-CHOP alone as first-line treatment for patients with newly diagnosed DLBC; whether the mechanism of action, efficacy and safety profile of tafasitamab have the potential to make it a preferred or ideal combination partner in the treatment of DLBCL and, whether it will change or become the standard of care for the treatment of DLBCL; whether and when, if ever, confirmatory trials of tafasitamab will result in the conditional FDA approval of tafasitamab in the conditionally approved indication described above becoming a final approval; whether and when, if ever, the EMA will approve the filed MAA for tafasitamab; and additional development of tafasitamab, including in B-cell malignancies - contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Incytes current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA or the EMA; clinical and commercial supply of products in development or being commercialized; Incytes dependence on its relationships with its collaboration partners; the efficacy or safety of Incytes products and the products of its collaboration partners; the acceptance of Incytes products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in Incytes reports filed with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2020. Incyte disclaims any intent or obligation to update these forward-looking statements.

MorphoSys Forward-Looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvis ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words anticipate, believe, estimate, expect, intend, may, plan, predict, project, would, could, potential, possible, hope and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

1 Belada D, M.D., Ph.D., et al. A Phase 1b, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-In Phase. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #3028.

2 Maddocks KJ, M.D., et al. Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #3021.

3 Monjuvi (tafasitamab-cxix) Prescribing Information. Boston, MA, MorphoSys.

4 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:20916. doi.org/10.1016/j.beha.2018.07.014.

5 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253265. doi.org/10.3747/co.26.5421.

6 DRG Epidemiology data.

7 Kantar Market Research (TPP testing 2018).

8 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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Data Evaluating Tafasitamab with and without Lenalidomide in Combination with R-CHOP in Patients with DLBCL Presented at ASH 2020 - Business Wire

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Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma | DNA RNA and Cells…

December 7, 2020 admin Pet Stem Cell Therapy

DetailsCategory: DNA RNA and CellsPublished on Monday, 07 December 2020 09:38Hits: 33

3 of 4 Patients Evaluable for Efficacy in Dose Escalation Cohorts 2 and 3 Show Objective Response, with 2 Patients Achieving Complete Response

No Observed Events of Any Grade of Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, or Graft-vs-Host Disease

Six Doses of FT516 were Well-tolerated with No FT516-related Grade 3 or Greater Adverse Events Reported by Investigators

SAN DIEGO, CA, USA I December 04, 2020 I Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced positive interim data from the Companys dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is the Companys universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

We are highly encouraged by these Phase 1 data, which clearly demonstrate that off-the-shelf, iPSC-derived NK cells can drive complete responses for cancer patients and that our proprietary hnCD16 Fc receptor can effectively synergize with and enhance the mechanism of action of tumor-targeted antibodies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Importantly, the safety profile of FT516 continues to suggest multiple doses of iPSC-derived NK cells can be administered in the outpatient setting, and supports potential use across multiple lines of therapy, including as part of early-line CD20-targeted monoclonal antibody regimens, for the treatment of B-cell lymphoma.

As of a November 16, 2020 data cutoff, three patients in the second dose cohort of 90 million cells per dose and one patient in the third dose cohort of 300 million cells per dose were available for assessment of safety and efficacy. All four patients were heavily pre-treated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles, with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support, and rituximab.

Safety DataAll four relapsed / refractory patients were administered FT516 in an outpatient setting with no requirement for inpatient monitoring. No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose, two-cycle treatment regimen was well-tolerated with no FT516-related grade 3 or greater adverse events reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting without patient matching. All grade 3 or greater treatment emergent adverse events were not related to FT516 and were consistent with lympho-conditioning chemotherapy and underlying disease.

Activity DataThree of four relapsed / refractory patients achieved an objective response, including two complete responses (CR), following the second FT516 treatment cycle as assessed by PET-CT scan per Lugano 2014 criteria. A CR was achieved in one patient with diffuse large B-cell lymphoma (DLBCL) who was most recently refractory to a rituximab-containing treatment regimen, and a CR was achieved in one patient with follicular lymphoma (FL) who had previously been treated with four rituximab-containing treatment regimens. Notably, in one patient for which an interim tumor assessment showed a partial response following the first FT516 treatment cycle, the response deepened to a CR following administration of the second FT516 treatment cycle, suggesting that additional FT516 treatment cycles can confer clinical benefit.

M = million; CR = Complete Response; PR = Partial Response; PD = Progressive DiseaseAs of November 16, 2020 database entry. Data subject to cleaning and source document verification.1 Day 29 of the second FT516 treatment cycle as assessed per Lugano 2014 criteria

Dose escalation is continuing in the current dose cohort of 300 million cells per dose in combination with rituximab, and a fourth dose cohort of 900 million cells per dose in combination with rituximab is planned. The Company previously reported that two patients treated in the first dose cohort of 30 million cells per dose in combination with rituximab showed a protocol-defined response assessment of progressive disease. No events of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease were observed in either patient.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About FT516FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Scientists from the Company have shown in a peer-reviewed publication (Blood. 2020;135(6):399-410) that hnCD16 iPSC-derived NK cells, compared to peripheral blood NK cells, elicit a more durable anti-tumor response and extend survival in combination with anti-CD20 monoclonal antibodies in an in vivo xenograft mouse model of human lymphoma. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

SOURCE: Fate Therapeutics

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Canine Stem Cell Therapy Market Key Trends, Drivers, Challenges And Standardization To 2020-2025 – The Haitian-Caribbean News Network

December 5, 2020 admin Pet Stem Cell Therapy

Canine Stem Cell Therapy Marketreport examines Product Specification, Major Segments in Focus, Geographic Focus, Production Capacity, Production, Sales Performance of key players in market which gives you deep understanding of competitive scenario of Canine Stem Cell Therapy market. Canine Stem Cell Therapy industry research report enables reader to dive into consumers mind.

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Canine Stem Cell Therapy market competition by top manufacturers, with production, price, and revenue (value) and market share for each manufacturer; the top players including:VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, VetbiologicsVetMatrix, Magellan Stem Cells

Goal Audience of Canine Stem Cell Therapy Market 2019 Forecast to 2026 Market:Raw material suppliers->>Distributors/traders/wholesalers/suppliers->>Regulatory bodies, including government agencies and NGO->>Commercial research & development (R&D) institutions->>Importers and exporters->>Government organizations, research organizations, and consulting firms->>Trade associations and Canine Stem Cell Therapy industry bodies->>End-use industries

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Based on Product Type, Canine Stem Cell Therapy market report displays the manufacture, profits, value, and market segment and growth rate of each type, covers:

Allogeneic Stem CellsAutologous Stem cells

Based on end users/applications, Canine Stem Cell Therapy market report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate for each application, this can be divided into:

Veterinary HospitalsVeterinary ClinicsVeterinary Research Institutes

Canine Stem Cell Therapy Market 2019 forecast to 2026 Market Segment by Regions, regional analysis covers North America (USA, Canada and Mexico) Europe (Germany, France, UK, Russia and Italy) Asia-Pacific (China, Japan, Korea, India and Southeast Asia) South America (Brazil, Argentina, Columbia etc.) Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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Some of the important topics in Canine Stem Cell Therapy Market Research Report:

1. Canine Stem Cell Therapy Market Manufacturing Cost Analysis: Price Trend of Key Raw Materials, Key Raw Materials, Canine Stem Cell Therapy Market Concentration Rate of Raw Materials, Key Suppliers of Raw Materials, Proportion of Manufacturing Cost Structure, Raw Materials, Labor Cost, Manufacturing Expenses, Manufacturing Process Analysis of Canine Stem Cell Therapy market.2. Industrial Chain, Sourcing Strategy and Downstream Buyers: Canine Stem Cell Therapy Industrial Chain Analysis, Upstream Raw Materials Sourcing, Raw Materials Sources of Canine Stem Cell Therapy market Major Manufacturers in 2019, Downstream Buyers.3. Marketing Strategy Analysis, Distributors/Traders: Marketing Channel, Direct Marketing, Indirect Marketing, Marketing Channel Development Trend, Canine Stem Cell Therapy Market Positioning, Pricing Strategy, Brand Strategy, Target Client, Distributors/Traders List.4. Canine Stem Cell Therapy Market Effect Factors Analysis: Technology Progress/Risk, Substitutes Threat, Technology Progress in Related Industry, Consumer Needs/Customer Preference Change, Economic/Political Environmental Change.

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Canine Stem Cell Therapy Market Key Trends, Drivers, Challenges And Standardization To 2020-2025 - The Haitian-Caribbean News Network

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Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma – GlobeNewswire

December 5, 2020 admin Pet Stem Cell Therapy

3 of 4 Patients Evaluable for Efficacy in Dose Escalation Cohorts 2 and 3 Show Objective Response, with 2 Patients Achieving Complete Response

No Observed Events of Any Grade of Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, or Graft-vs-Host Disease

Six Doses of FT516 were Well-tolerated with No FT516-related Grade 3 or Greater Adverse Events Reported by Investigators

Management to Host Virtual Event Entitled The Power of hnCD16 Today at 4:30 PM Eastern Time

SAN DIEGO, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced positive interim data from the Companys dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is the Companys universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the safety and therapeutic potential of the Companys iPSC-derived NK cell product candidates, including FT516, its ongoing and planned clinical studies, and the expected clinical development plans for FT516. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties or delays in subject enrollment in current and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

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Study: Covid cases traced to December 2019 in US – ETHealthworld.com

December 2, 2020 admin Pet Stem Cell Therapy

Testing has found Covid-19 infections in the US in December 2019, according to a study, providing further evidence indicating the coronavirus was spreading globally weeks before the first cases were reported in China.

The study published on Monday identified 106 infections from 7,389 blood samples collected from donors in nine US states between December 13 and January 17. The samples, collected by the American Red Cross, were sent to the US Centers for Disease Control and Prevention for testing to detect if there were antibodies against the virus. The findings of this report suggest that SARS-CoV-2 infections may have been present in the US in December 2019, earlier than previously recognised, the paper said.

Reports of a mysterious pneumonia spreading in Wuhan, China, first emerged in late December 2019. The first US case was reported on January 19. The revelations in the paper by researchers from the CDC reinforce the growing understanding that the coronavirus was silently circulating worldwide earlier than known, and could re-ignite debate over the origins of the pandemic. Its not the first evidence showing the virus could have existed outside China before 2020. A patient in France was found to have contracted the virus at the end of December.

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Study: Covid cases traced to December 2019 in US - ETHealthworld.com

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US Oncology Research Announces Schedule of Presentations at the Virtual 2020 American Society of Hematology Annual Meeting and Exposition – Business…

December 2, 2020 admin Pet Stem Cell Therapy

THE WOODLANDS, Texas--(BUSINESS WIRE)--During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, principal investigators from The US Oncology Network (The Network) and US Oncology Research will share detailed results from 30 studies covering topics that include Hodgkin lymphoma, multiple myeloma and the effects of cancers on older patient populations. The ASH Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will be taking place virtually from Dec. 5-8, 2020.

In this landscape impacted by COVID-19, real-world evidence shows that our collective fight against cancer must include advancing clinical research and empowering patients through timely health screenings, said Robert L. Coleman, MD, chief scientific officer, US Oncology Research. At this years ASH virtual meeting, we are looking forward to sharing the latest advances from investigators in The Network and to exploring ways we can continue working together to navigate the unprecedented challenges and risks that patients with cancer are facing today.

Christopher A. Yasenchak, MD, associate chair of hematology research for US Oncology Research and a hematologist with Willamette Valley Cancer Institute and Research Center, will present an oral abstract titled, Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients, on Sunday, Dec. 6, at 2:15 p.m. ET.

Older patients with Hodgkin lymphoma often have poorer outcomes than younger patients due to comorbidities and the toxicity of conventional first-line chemotherapy, said Dr. Yasenchak. Brentuximab vedotin, as monotherapy and in combination with other agents, shows high response rates and clinically meaningful improvements in progression-free survival and tolerability compared to conventional combination chemotherapy. The study, SGN35-015, presents compelling evidence underscoring the growing interest and urgency in research to advance cancer treatment and care for older populations.

In addition, Robert Rifkin, MD, FACP, medical director of biosimilars for McKesson, associate chair of hematology research and myeloma disease lead for US Oncology Research and a hematologist with Rocky Mountain Cancer Centers, a practice in The Network, co-authored The Phase 3 TOURMALINE-MM2 Trial: Oral Ixazomib, Lenalidomide, and Dexamethasone (IRd) Vs Placebo-Rd for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (NDMM). The oral presentation will take place on Monday, Dec. 7, at 7:45 a.m. ET.

Patients who are newly diagnosed with multiple myeloma and not eligible for autologous stem cell transplants need additional treatment options, said Dr. Rifkin. We believe the findings from TOURMALINE-MM2 emphasize the need for all-oral, proteasome inhibitor-based treatment options and will help pave the way for future innovation on behalf of the multiple myeloma community.

Dr. Rifkin will also present a trial-in-progress poster, DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) With Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM), on Monday, Dec. 7, from 7:00 a.m.3:30 p.m. ET.

Another oral abstract, Subgroup Analyses of Elderly Patients Aged 70 Years in MAGNIFY: A Phase IIIb Interim Analysis of Induction R2 Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma, was co-authored by David Andorsky, MD, a hematologist with Rocky Mountain Cancer Centers. The presentation will take place on Sunday, Dec. 6, at 10:30 a.m. ET.

Results from MAGNIFY indicate an important option for older, high-risk patients with non-Hodgkin lymphoma who have relapsed or did not respond to previous treatment with chemotherapy, said Dr. Andorsky. In this patient population, lenalidomide combined with rituximabwith close attention to dose reductiondemonstrated encouraging efficacy and a tolerable safety profile.

Mitul Gandhi, MD, a medical oncologist with Virginia Cancer Specialists, a practice in The Network, co-authored the poster, Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma. The presentation will take place on Sunday, Dec. 6, from 7:00 a.m.3:30 p.m. ET.

Options are critically needed to improve outcomes for patients with diffuse large B-cell lymphoma who did not respond to previous therapy, are unsuitable for autologous stem cell transplantation or relapsed shortly after a transplantation, said Dr. Gandhi. I am looking forward to presenting findings that indicate the potential to meet the needs of more patients with this aggressive form of lymphoma.

Furthermore, Houston Holmes, MD, a medical oncologist and hematologist at Texas Oncology, a practice in The Network, co-authored the oral abstract Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients With Previously Untreated Diffuse Large BCell Lymphoma. The presentation will take place on Sunday, Dec. 6, at 12:15 p.m. ET.

Among patients with diffuse large B-cell lymphoma, approximately 30% over age 75 do not receive standard chemotherapy as a first-line treatment due to concerns about frailty and comorbidities, said Dr. Holmes. Based on early clinical data, single-agent mosunetuzumab could offer a promising chemotherapy-free regimen for these patients who otherwise have limited options.

Researchers with McKesson Data, Evidence and Insights also worked with US Oncology Research and The US Oncology Network physicians on studies advancing the applications of real-world evidence, which will be presented this year.

Dr. Yasenchak will present a real-world evidence study titled, Real-World Adherence to National Comprehensive Cancer Network (NCCN) Guidelines Regarding the Usage of PET/CT and Reported Deauville Scores in Advanced Stage Classical Hodgkin Lymphoma: A Community Oncology Practice Perspective. The poster presentation will take place on Sunday, Dec. 6, from 7:00 a.m.3:30 p.m. ET.

Providers may not always have the comprehensive information needed to optimize treatment modifications for patients with Hodgkin lymphoma, added Dr. Yasenchak. Based on our findings, there is an opportunity to educate oncologists and radiologists about the importance of consistently reporting PET/CT Deauville scores in the initial staging and assessment of treatment response for these patients.

An additional real-world evidence poster, NHL Patients and Nurses in the US Prefer Subcutaneous Rituximab Injection Versus Intravenous Rituximab Infusion: A Real-World Study, will be presented by Dr. Gandhi on Saturday, Dec. 5 from 7:00 a.m.3:30 p.m. ET.

As the COVID-19 pandemic adds new barriers to our health systems and the completion of clinical trials, real-world evidence is pivotal in providing insights into how we can improve outcomes, said Nicholas J. Robert, MD, medical director, McKesson Data, Evidence and Insights. By leveraging data from our electronic medical records, healthcare providers and researchers are making an impact and optimizing care for patients managing cancer.

The full schedule of affiliated data presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or Claire.Crye@usoncology.com or Edie DeVine at 209.814.9564 or Edie.DeVine@gcihealth.com.

About US Oncology Research

US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves approximately 60 research sites and more than 165 locations, managing about 400 active trials at any given time. For the past 20 years, physicians in the research network have enrolled more than 82,000 patients in over 1,600 trials and have played a role in more than 100 FDA-approved cancer therapies. US Oncology Research is supported by McKesson Corporation.

About The US Oncology Network

Every day, The US Oncology Network (The Network) helps more than 1,380 independent physicians deliver value-based, integrated care to patients close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network provides practices with access to coordinated resources, best business practices, and the experience, infrastructure and support of McKesson Corporation. This collaboration allows the providers in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. The Network is committed to the success of independent practices, everywhere.

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US Oncology Research Announces Schedule of Presentations at the Virtual 2020 American Society of Hematology Annual Meeting and Exposition - Business...

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Positron Emission Tomography (PET) Market To 2026: Growth Analysis By Manufacturers, Regions, Types And Applications – Murphy’s Hockey Law

December 1, 2020 admin Pet Stem Cell Therapy

A new research study has been presented by Industrygrowthinsights.com offering a comprehensive analysis on the Global Positron Emission Tomography (PET) Market where user can benefit from the complete market research report with all the required useful information about this market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. The report discusses all major market aspects with expert opinion on current market status along with historic data. This market report is a detailed study on the growth, investment opportunities, market statistics, growing competition analysis, major key players, industry facts, important figures, sales, prices, revenues, gross margins, market shares, business strategies, top regions, demand, and developments.

The Positron Emission Tomography (PET) Market report provides a detailed analysis of the global market size, regional and country-level market size, segment growth, market share, competitive landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunity analysis, strategic market growth analysis, product launches, and technological innovations.

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Major Players Covered in this Report are: GESiemens HealthcarePhilips HealthcareToshibaHitachiNeusoftTopgrade HealthCareUnited Imaging

Global Positron Emission Tomography (PET) Market SegmentationThis market has been divided into Types, Applications, and Regions. The growth of each segment provides an accurate calculation and forecast of sales by Types and Applications, in terms of volume and value for the period between 2020 and 2026. This analysis can help you expand your business by targeting qualified niche markets. Market share data is available on the global and regional level. Regions covered in the report are North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America. Research analysts understand the competitive strengths and provide competitive analysis for each competitor separately.

By Types:PET-CTPET-MROther

By Applications:OncologyCardiologyNeurologyOther

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Global Positron Emission Tomography (PET) Market Regions and Countries Level AnalysisRegional analysis is a highly comprehensive part of this report. This segmentation sheds light on the sales of the Positron Emission Tomography (PET) on regional- and country-level. This data provides a detailed and accurate country-wise volume analysis and region-wise market size analysis of the global market.

The report offers an in-depth assessment of the growth and other aspects of the market in key countries including the US, Canada, Mexico, Germany, France, the UK, Russia, Italy, China, Japan, South Korea, India, Australia, Brazil, and Saudi Arabia. The competitive landscape chapter of the global market report provides key information about market players such as company overview, total revenue (financials), market potential, global presence, Positron Emission Tomography (PET) sales and revenue generated, market share, prices, production sites and facilities, products offered, and strategies adopted. This study provides Positron Emission Tomography (PET) sales, revenue, and market share for each player covered in this report for a period between 2016 and 2020.

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Table of Contents1. Executive Summary2. Assumptions and Acronyms Used3. Research Methodology4. Market Overview5. Global Market Analysis and Forecast, by Types6. Global Market Analysis and Forecast, by Applications7. Global Market Analysis and Forecast, by Regions8. North America Market Analysis and Forecast9. Latin America Market Analysis and Forecast10. Europe Market Analysis and Forecast11. Asia Pacific Market Analysis and Forecast12. Middle East & Africa Market Analysis and Forecast13. Competition Landscape

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Animal Stem Cell Therapy Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By Industry Growth…

November 30, 2020 admin Pet Stem Cell Therapy

IndustryGrowthInsights (IGI), one of the worlds prominent market research firms has released a new report on Global Animal Stem Cell Therapy Market. The report contains crucial insights on the market which will support the clients to make the right business decisions. This research will help both existing and new aspirants for Animal Stem Cell Therapy market to figure out and study market needs, market size, and competition. The report talks about the supply and demand situation, the competitive scenario, and the challenges for market growth, market opportunities, and the threats faced by key players.

The report also includes the impact of ongoing global crisis i.e. COVID-19 on the Animal Stem Cell Therapy market and what the future holds for it. The published report is designed using a vigorous and thorough research methodology and IndustryGrowthInsights (IGI) is also known for its data accuracy and granular market reports.

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A complete analysis of the competitive scenario of the Animal Stem Cell Therapy market is depicted by the report. The report has a vast amount of data about the recent product and technological developments in the markets. It has a wide spectrum of analysis regarding the impact of these advancements on the markets future growth, wide-range of analysis of these extensions on the markets future growth.

Animal Stem Cell Therapy market report tracks the data since 2015 and is one of the most detailed reports. It also contains data varying according to region and country. The insights in the report are easy to understand and include pictorial representations. These insights are also applicable in real-time scenarios.

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Components such as market drivers, restraints, challenges, and opportunities for Animal Stem Cell Therapy are explained in detail. Since the research team is tracking the data for the market from 2015, therefore any additional data requirement can be easily fulfilled.

Some of the prominent companies that are covered in this report:

Medivet Biologics LLCVETSTEM BIOPHARMAJ-ARMU.S. Stem Cell, IncVetCell TherapeuticsCelavet Inc.Magellan Stem CellsKintaro Cells PowerAnimal Stem CareAnimal Cell TherapiesCell Therapy SciencesAnimacel

*Note: Additional companies can be included on request

The industry looks to be fairly competitive. To analyze any market with simplicity the market is fragmented into segments, such as its product type, application, technology, end-use industry, etc. Segmenting the market into smaller components helps in understanding the dynamics of the market with more clarity. Data is represented with the help of tables and figures that consist of a graphical representation of the numbers in the form of histograms, bar graphs, pie charts, etc. Another key component that is included in the report is the regional analysis to assess the global presence of the Animal Stem Cell Therapy market.

Following is the gist of segmentation:

By Application:

Veterinary HospitalsResearch Organizations

By Type:

DogsHorsesOthers

By Geographical Regions

Asia Pacific: China, Japan, India, and Rest of Asia PacificEurope: Germany, the UK, France, and Rest of EuropeNorth America: The US, Mexico, and CanadaLatin America: Brazil and Rest of Latin AmericaMiddle East & Africa: GCC Countries and Rest of Middle East & Africa

You can also go for a yearly subscription of all the updates on the Animal Stem Cell Therapy market.

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Below is the TOC of the report:

Executive Summary

Assumptions and Acronyms Used

Research Methodology

Animal Stem Cell Therapy Market Overview

Animal Stem Cell Therapy Supply Chain Analysis

Animal Stem Cell Therapy Pricing Analysis

Global Animal Stem Cell Therapy Market Analysis and Forecast by Type

Global Animal Stem Cell Therapy Market Analysis and Forecast by Application

Global Animal Stem Cell Therapy Market Analysis and Forecast by Sales Channel

Global Animal Stem Cell Therapy Market Analysis and Forecast by Region

North America Animal Stem Cell Therapy Market Analysis and Forecast

Latin America Animal Stem Cell Therapy Market Analysis and Forecast

Europe Animal Stem Cell Therapy Market Analysis and Forecast

Asia Pacific Animal Stem Cell Therapy Market Analysis and Forecast

Middle East & Africa Animal Stem Cell Therapy Market Analysis and Forecast

Competition Landscape

If you have any questions on this report, please reach out to us @ https://industrygrowthinsights.com/enquiry-before-buying/?reportId=171131

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G1 Therapeutics: Depressed Price Before Catalyst, No Apparent Reason – Seeking Alpha

November 28, 2020 admin Pet Stem Cell Therapy

We were discussing G1 Therapeutics (GTHX) in our TPT member chat yesterday. It has been a depressed stock for over a year now, and even today, despite having a PDUFA date in less than 3 months, the stock shows little sign of improvement. Lead drug candidate trilaciclib is a myelopreservation agent supporting chemo regimens that have shown enough data in phase 2 trials that the FDA has allowed GTHX to proceed to an NDA directly from there without requiring a phase 3 trial. Rintodestrant, their second asset, is in early stages of developing but targeting a larger opportunity in breast cancer and is going to announce a major update on December 9; and yet, the stock shows no sign of improvement.

Their current pipeline looks like this:

Source

I covered trilaciclib a year ago. There is not a lot to be added to that except that their NDA was accepted by the FDA on August 17 with a PDUFA date for February 15, 2021. The NDA was accepted under an accelerated review program, which is why PDUFA is occurring in 6 months instead of the regular 10. The Priority Review is based on positive data from three randomized clinical trials showing robust myelopreservation benefits for the drug.

There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur, said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.

Trilaciclib also has a Breakthrough Therapy Designation - meaning preliminary clinical evidence for trilaciclib shows a clear advantage over available therapy. In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for the drug.

While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations, said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, NC. Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.

Myelosuppression, caused by damage to bone marrow stem cells, occurs due to chemotherapy and can cause symptoms like anemia, neutropenia or thrombocytopenia. In clinical trials, trilaciclib has demonstrated strong reduction of chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Another important development is trilaciclibs expanded access program, which means the company is making the drug available to patients while it undergoes the approval process. The EAP usually means the drug is so beneficial that it is unethical to make patients wait even a few months to get it. This is an important development because it shows the value of trilaciclib.

In June, G1 Therapeutics entered into a 3-year US/Puerto Rico co-promotion agreement with Boehringer Engelheim, which has a lot of experience in oncology asset commercialization. GTHX will book revenue and retain full commercialization rights, and will pay Boehringer a promotional fee based on net sales. G1 will pay a promotion fee of a mid-twenties percentage of net sales in the first year of commercialization, which decreases to a low double-digit/high single-digit percentage in the second and third years of commercialization, respectively.

As for the total addressable market or TAM, over 25,000 people in the U.S. and Puerto Rico are diagnosed with SCLC every year. Approximately 90% of SCLC patients receive first-line chemotherapy treatment, and approximately 60% of those patients receive subsequent second-line chemotherapy treatment. That means, there are 22,500 patients in the 1st line setting who will benefit from trilaciclib, and another 13,500 patients in the 2nd line setting. That is a total of 36,000 patients. From research available last year, cost of chemotherapy treatment for SCLC patients was around $60,000. If we assume a 10% cost for trilaciclib, then we have $6000 per patient. So, every year, they are looking at a TAM of $216mn in this one indication in the US. With Boehringers involvement, we can safely assume a 10% penetration within the first two years of approval, especially given the breakthrough designation. So, that is $22mn from the US; similar figure for Europe, and another such figure from the RoW will give us $60mn in about 3 years, with increasing penetration of the market.

This is a conservative estimate. As I wrote in my earlier coverage:

According to a 2027 estimate by Decision Resources Group, trilaciclib has the potential to benefit a significant number of patients beyond SCLC. There were approximately 1 million chemo treated patients including adjuvant/1L CRC, 1L NSCLC, and adjuvant/1L BC in the U.S., Europe, and Japan in 2018. Chemotherapy treated patients include:

68,000 - ES-SCLC (1st Line - 3rd Line)

68,000 - 1st Line BC

126,000 - 1st Line NSCLC

356,000 - Adjuvant & 1st Line CRC

354,000 - Adjuvant BC

This vast cohort of patients can benefit from trilaciclib in combination with chemotherapy. The company estimates the target market to be at $3bn.

Trilaciclib is a first-in-class drug and doesn't have real competition. It could replace current rescue growth factor support treatments, "including Neulasta (pegfigrastim), Neupogen (filgrastim), Procrit (epoeitin alpha), and Aranesp (darbepoetin alfa)."

Trilaciclib is also being evaluated in other cancers. From their press release:

In a randomized trial of women with metastatic triple-negative breast cancer, preliminary data showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to present final overall survival data from this trial in the fourth quarter of 2020.

On November 18, the company announced that final overall survival data from the mTNBC trial was consistent with the above preliminary findings announced last year, and showed that trilaciclib significantly improved median OS for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin.

They will initiate a pivotal trial in mTNBC in 2021 with OS as the primary endpoint.

Trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL, and the company expects to initiate a Phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.

In the same press release quoted above, GTHX also announced that it will provide an update on Rintodestrant at the 2020 San Antonio Breast Cancer Symposium (SABCS) to be held virtually on December 9, 2020. Specifically, they said The company will also present updated monotherapy findings from the Phase 1 portion of its ongoing clinical trial of rintodestrant, a potential best-in-class oral selective estrogen receptor degrader (SERD) in development for treatment of ER+, HER2- breast cancer.

It seems they will provide pk/pd and mtd (maximum tolerated dose) data, with probable comments on early signs of efficacy. Primary outcomes are dose limiting toxicity and phase 2 dose determination. secondary outcomes are about efficacy, specifically tumor response with RECIST, and pk/pd. Before competitor fulvestrant went generic last year, it had $541mn annual sales. This indicates the potential for Rintodestrant.

I am providing below the entire abstract on Rintodestrant - there will be three of these but this is the critical one.

Background: Rintodestrant (G1T48) is a potent oral selective estrogen receptor degrader (SERD) that competitively binds to the estrogen receptor (ER) and blocks ER signaling in tumors resistant to other endocrine therapies. Preliminary results from Part 1 dose escalation showed robust target engagement on 18F-fluoroestradiol positron emission tomography (FES-PET), a favorable safety profile, and encouraging antitumor activity in patients with heavily pretreated ER+/HER2- advanced breast cancer (ABC), including those with ESR1 mutations (Dees et al., ESMO 2019 [abstract #3587]). Here, we present updated results from dose escalation and expansion (Parts 1 and 2). Methods: This Phase 1, first-in-human, open-label study evaluated rintodestrant monotherapy in women with ER+/HER2- ABC after progression on endocrine therapy. Part 1 was a 3+3 dose escalation (200- 1000 mg once daily [QD]); Part 2 expanded 600 and 1000 mg QD; and Part 3 was added to assess rintodestrant with palbociclib in patients in earlier lines in the advanced setting. Primary objectives included dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), safety, and recommended Phase 2 dose. Secondary objectives included pharmacokinetics and antitumor activity (RECIST v1.1). Exploratory objectives included pharmacodynamic inhibition of ER target engagement (FES-PET), mutation profiling (cell-free DNA [cfDNA]), and change in ER expression from baseline to on-treatment tumor biopsies. Results: As of May 13, 2020, 67 patients (Part 1: n = 26; Part 2: n = 41) were treated, with a median age of 61 years (range 34-83) and ECOG PS of 0 (49%) or 1 (51%). Median number of prior lines in the advanced setting was 2 (range 0-9), including prior fulvestrant (64%), CDK4/6 inhibitor (69%), mTOR inhibitor (22%), and/or chemotherapy (46%). Median number of prior lines of endocrine therapy in the advanced setting was 2 (range 0-5), with 61% of patients having received 2 lines. Treatment-related adverse events (TRAEs) were reported in 70% of patients. The most common TRAEs in 10% of patients included hot flush (24%), fatigue (21%), nausea (19%), diarrhea (18%), and vomiting (10%), mostly grade 1 or 2. No DLTs were reported and MTD was not reached. Dose reduction due to TRAEs occurred in 1 patient (1%), with elevated transaminases (grade 3 ALT and grade 2 AST) at 600 mg. Serious TRAEs occurred in 2 patients at 1000 mg (grade 5 cerebral hemorrhage in the setting of low molecular weight heparin and grade 2 upper abdominal pain). Two patients (3%) discontinued treatment due to TRAEs. Overall, the frequency of patients with TRAEs at 800 mg was comparable with that at 600 mg (57% vs 63%) and less than that at 1000 mg (81%). Of 67 patients, 16 were on study treatment for 24 weeks and 3 (n = 1 at 600 mg; n = 2 at 1000 mg, including 1 with ESR1 mutation) had a confirmed partial response (clinical benefit rate [CBR]: 28%). FES-PET standard uptake values decreased at week 4 with a mean reduction of 87% (8%) at doses 600 mg. Of 59 patients tested for baseline cfDNA, 41% harbored 1 ESR1 mutation, with a similar CBR in both groups (33% in ESR1 mutant and 29% in ESR1 wild-type). Seven of 9 patients had a decrease in ER immunohistochemistry H-score at both 600 and 1000 mg (median [range]: -27.8% [-33.8%, - 3.4%]), irrespective of ESR1 mutation status. Based on safety, efficacy, and ER degradation, 800 mg was selected as the optimal dose for further study. Conclusions: Rintodestrant continues to demonstrate an excellent safety/tolerability profile across all doses, with promising antitumor activity in patients with heavily pretreated ER+/HER2- ABC, including those with tumors harboring ESR1 mutations. Part 3 of this study, evaluating rintodestrant 800 mg QD with palbociclib in a more endocrine-sensitive population, is ongoing (NCT03455270).

There is not a lot to comment here. 800 mg seems to be the optimal dose, and that one patient with grade 5 cerebral hemorrhaging may be an outlier, especially with heparin in the mix, but that is something to keep an eye out for. Effect on an endocrine-sensitive population is preliminary but encouraging, and although a partial response, at this late stage in the game, that is not a bad deal. A larger trial developing the ESR1 scenario more fully is going to be interesting to watch.

According to latest reports, the company has $200-205mn in cash and cash equivalents as of the latest quarter. Burn was around $90mn last year, so with the Boehringer deal, that is not going to increase substantially, putting them in a comfortable position with a 2-year cash runway. The company recently changed CEOs, which seems to be in anticipation of approval, and nothing else.

For whatever reasons I cannot fathom, the stock remains depressed. They have a major catalyst 3 months down the line, and if past performance in trials is anything to go by, theres considerable chance of approval. Post approval scenario, both in terms of revenue stream and label expansions/other indications, looks good. I think this is a good candidate to accumulate at this time.

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G1 Therapeutics: Depressed Price Before Catalyst, No Apparent Reason - Seeking Alpha

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