Georgina Ellison-Hughes, Professor of Kings College London, found stem cells can control many parts of the immune system and even rein it in where theres a danger of it overreacting to Covid infections

Image: Getty Images/Westend61)

We have come a long way in discovering new weapons against Covid. But people who require ventilation have been especially difficult to treat since the pandemic took hold.

Well, an international team of researchers has got together and come up with a new approach using stem cells to treat seriously ill patients with Covid-19.

Georgina Ellison-Hughes, Professor of Kings College London, a member of the International Society on Aging and Disease, found stem cells (MSC) can control many parts of the immune system and even rein it in where theres a danger of it overreacting to Covid infections.

These MSC stem cells are unique and powerful in modulating the immune system, which make them an excellent candidate for treating Covid.

In February 2020, the professor and her team had shown that an injection of MSC into seven Covid-19 pneumonia patients improved symptoms and recovery time, compared to three placebo-treated patients.

Image:

In its latest study, the team completed a trial of MSC infused intravenously. The results showed the MSC treatment was effective, rapidly and substantially relieving symptoms and improving the prognosis of severe and critically ill patients.

Follow-up chest scans showed a greater improvement in patients with critical bronchial and lung disease in the MSC treatment group compared with the placebo group. Importantly, the treatment also led to a shorter hospital stay 11 days versus 15 days. This fact has always proved popular with patients and their families and will, of itself, promote MSC therapy.

Professor Ellison-Hughes is positive.

These findings advance MSC transplantation as a safe and effective therapeutic for treating those critically ill patients with Covid-19, she says.

Our findings show MSC therapy has multiple modes of action in how it can effectively treat Covid-19.

During the trial, markers of Covid disease were tracked and MSC treatment improved them all, especially the markers for severe inflammation, and resulted in prolonged persistence of Covid-19 antibodies.

MSC infusion also reduced the frequency of thrombosis, which is a complication of Covid infection. MSC really seems to improve many aspects of the infection and counteract its ill effects.

Overall, patients in the MSC group tolerated the treatment well and were discharged from hospital without any adverse reactions. The death rate was zero in the MSC group and 6.9% in the placebo group.

In line with previous clinical studies, it indicates it is a safe therapeutic approach for use in patients with Covid and effective in treating it.

Wow, Im impressed. Another weapon in our locker against Covid.

Read More

Read More

See the original post:
'The injection of stem cells helps dangerously ill ...

Regardless of which combination of rehabilitation techniques you and your veterinarian ultimately select to manage injuries, generally your goal is to facilitate return to performance. This requires working closely with your horses rehab team to know which modality to use at what point during the recovery process.

To garner the most benefit from rehabilitation, the first step is to pinpoint the underlying injury, says Fortier. Only once a firm diagnosis has been achieved can a rehabilitation plan be mapped out.

When to use which rehabilitation technique depends on the exact nature of the injury, whether the goal at that point is pain reduction, restoring range of motion, contributing to tissue healing, and/or strengthening healing tissues. Even the veterinarians experience with biologics greatly impacts how each horse is treated.

As excited as you might be about the prospect of having stem cell technology at your fingertips, know that its not a magic bullet. Researchers recently reviewed the plights associated with obtaining, processing, transporting, and administering stem cells to horses so you can get the maximum bang for your buck (Barrachina et al., 2018). Here are some of the many factors your veterinarian considers when planning your horses biologic needs:

MSC therapy is expensive. To use autologous stem cells, which are collected from your horse, processed, and used to treat his own injury, your veterinarian must sedate the horse and collect and process bone marrow (or fat) according to rigid guidelines using specialized equipment and laboratories. The cost of the equipment, supplies, and time adds up.

The process of using bone-marrow-derived autologous stem cells is time-consuming. This method requires several weeks of culture to acquire a sufficient number of stem cells for administration. It is possible, however, to inject a subset of concentrated bone marrow cells immediately after collecting the marrow, while the remainder of the sample is sent for culture. Further, veterinarians can use PRP in the interim so the horse is at least receiving some form of biologic therapy while awaiting the delivery of the cultured cells.

Another way to circumvent delayed treatment times is to use allogeneic stem cells. These are stem cells collected from a different horse ready to inject into the patient. The main concern with allogeneic stem cell usage, our sources say, is that the patients immune system will view them as nonself, similar to bacteria and viruses, and attack and destroy them. However, many horses with underlying medical conditions, such as pituitary pars intermedia dysfunction (equine Cushings disease), equine metabolic syndrome, or insulin dysregulation, cannot use their own stem cells because those cells arent considered healthy. Thus, veterinarians must rely on allogeneic cells instead (e.g., for managing laminitis).

As Barrachina et al. noted in their review of stem cell pros and cons, Although MSCs may be a promising treatment for equine musculoskeletal injuries, it is important to highlight that their actual therapeutic potential still remains unclear and that there are still several gaps in the knowledge to be investigated.

For example, some veterinarians use combinations of stem cells, PRP, and other rehabilitation modalities. Because of this wide array of treatment plans and because equine veterinarians implement and adapt their own protocols to best help each patient, collecting clear data and creating a recipe book for biologic therapy is challenging to say the least.

Continued here:
Stem Cell Therapy for Sport Horses The Horse - TheHorse.com

La Crosse, WI (KROC AM News ) - Be careful when heading out Thursday morning.

The National Weather Service is advising motorists in Olmsted, Wabasha, Winona Counties to be prepared for slippery conditions.

The Weather Service says a band of light freezing rain is expected to move across the area. Expect the light freezing rain to move out of the area by 8 a.m.

CO killed Minnesota family

To prepare yourself for a potential incident, always keep your vet's phone number handy, along with an after-hours clinic you can call in an emergency. The ASPCA Animal Poison Control Center also has a hotline you can call at (888) 426-4435 for advice.

Even with all of these resources, however, the best cure for food poisoning is preventing it in the first place. To give you an idea of what human foods can be dangerous, Stacker has put together a slideshow of 30 common foods to avoid. Take a look to see if there are any that surprise you.

Originally posted here:
Possible Slick Roads In Parts Of Southeast Minnesota - KROC-AM

For the 13 patients treated at the recommended phase 2 dose (RP2D) the response rate after one cycle of treatment remains at 100% with a 38.5% complete response (CR) rate; one additional patient completed cycle 1 at the RP2D and was assessed with a partial response (PR)Three of 3 patients treated with two cycles in the dose escalation part of the study at the RP2D remain in CR at 6 months after start of treatmentSide effect profile shows only five instances of transient infusion-related reactions (IRR) in more than 100 AFM13 infusions with no episodes of neurotoxicity, CRS or GvHD

HEIDELBERG, Germany, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer will host today a financial community call to discuss recent findings from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center investigating the treatment of CD30-positive lymphoma patients with its innate cell engager (ICE) AFM13, pre-complexed with cord blood-derived natural killer (cbNK) cells (AFM13-104).

A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1106, three patients with 1107 and 13 patients with 1108 AFM13-pre-complexed cbNK cells per kg body weight.

Response Assessment

A total of 19 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (17 and 2 patients, respectively) have been treated to date across three dose cohorts. According to investigator assessment, 17 of 19 patients had achieved an objective response (ORR 89.5%) to the treatment, with seven complete responses (CR 36.8%) and ten partial responses (PR 52.6%).

In patients treated at the RP2D level of 1x108 cbNK cells per kg, 12 of 13 had classical Hodgkin lymphoma and 1 patient had CD30-positive NHL. In this cohort, 100% of patients responded after the first cycle of treatment with five CRs (38.5%) and seven PRs (61.5%). All patients treated at the RP2D have now received a second cycle of therapy. Response evaluation after cycle 2 will be reported at a future scientific conference.

Initial Durability of Response Observations

Nine patients treated in the dose escalation phase of the study had follow-up at 6 months. Of note, the three patients treated at the RP2D remain in remission at 6 months after start of treatment, two without additional treatment and one on anti-PD-1 antibody maintenance.

In the four responders out of six treated at the two lower dose levels, one patient, who started treatment in September 2020, remains in remission after consolidation autologous stem cell transplant, and three relapsed at 3.4, 4.8 and 6.3 months after start of therapy.

Safety

Five reported cases of transient infusion related reactions were reported after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

Conference Call/Webcast Information

The event today will include a review of Affimeds approach to activating the innate immune system in the fight against cancer, preclinical data supporting the combination of Affimeds ICE molecules with adoptive NK cell transfer, a review of the treatment challenges and clinical opportunities for CD30+ lymphomas, and review of the interim data from AFM13-104 by the studys principal investigator, Yago L. Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at of The University of Texas MD Anderson Cancer Center.

Affimed will host a conference call and webcast today, December 9th, 2021, at 8:30 a.m. EST. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at https://www.affimed.com/webcasts/investor-day/ or https://edge.media-server.com/mmc/p/zzwismtq. A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1106 NK cells/kg in Cohort 1; 1107 NK cells/kg in Cohort 2; and 1108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28. MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at http://www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimeds most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at http://www.clinicaltrials.gov (NCT04101331).

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The companys proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the companys people, pipeline and partners, please visit: http://www.affimed.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, and our other product candidates, the value of our ROCK platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact Alexander Fudukidis Director, Head of Investor Relations E-Mail: a.fudukidis@affimed.com Tel.: +1 (917) 436-8102

Media Relations Contact Mary Beth Sandin Vice President, Marketing and Communications E-Mail: m.sandin@affimed.com Tel.: +1 (484) 888-8195

Original post:
Affimed to Host Virtual Investor Call Today to Discuss Treatment of CD30-positive Lymphoma ... - KULR-TV

For most adults before owning a pet they realize this is going to be a forever family member. This isn't just for a few months as the puppy is growing but as soon as they tear up a pillow it's time to say goodbye. It's really unfortunate to see so many dogs and cats that are dumped here in East Texas. In Dallas, there is a ban being considered that would make it illegal to see puppies and kittens in stores and I think this is something that should be implemented across the whole state of Texas.

There are lots of free pet pages all over social media and that should be another reason why you never even think about purchasing a new pet, you should always adopt one that is already in a tough situation. I'm not trying to shame stores that sell adorable puppies and kittens but I think we can all agree these animals deserve more room to play than they get in those small containers.

Could you imagine living in a place that you believe to be your home and next thing you know you are in a brand new place and the person who has always taken care of you is nowhere to be found? The pets that are up for adoption have already dealt with so much, they deserve to find a loving forever family to enjoy for the rest of their life.

There are lots of amazing places and organizations across East Texas that has animals waiting for their forever home. There is Pets Fur People & SPCA of East Texas both I highly suggest and even if you just want to foster an animal you can do that too. Please remember to adopt don't shop, and know they are with you until they cross that rainbow bridge.

Just thinking about the animals and what's best for them, that is why I want to see it illegal for puppies and kittens to be sold in stores across the whole state of Texas.

More and more, East Texans want restaurants where they can share a meal and hang out on a cool patio with their best furry friends. Here are TEN great spots in Tyler to do just that!

To prepare yourself for a potential incident, always keep your vet's phone number handy, along with an after-hours clinic you can call in an emergency. The ASPCA Animal Poison Control Center also has a hotline you can call at (888) 426-4435 for advice.

Even with all of these resources, however, the best cure for food poisoning is preventing it in the first place. To give you an idea of what human foods can be dangerous, Stacker has put together a slideshow of 30 common foods to avoid. Take a look to see if there are any that surprise you.

Prairie dogs might as well be the official animal of Lubbock. Here are some fun facts about the plump little critters.

The rest is here:
Puppies and Kittens Should NOT Be Sold in Stores in Tyler, TX - knue.com

Nothing is worst than a dog owner leaving their dog's poop in the grass. The number of times I have stepped in dog poop in my apartment complex is ungodly. It's as if people don't have any respect for others nowadays.

My apartment complex in Bensalem, Pennsylvania makes it so easy for dog owners to clean up after their pets. There are stations set up outside throughout the complex that provide doggy bags and trash bins for the poop. But yet, it seems as if no one wants to take the extra step to help keep a shared area clean.

It's not just in my apartment complex, this happens everywhere. Some people either forget bags when walking their dogs or simply don't feel like bending down andpicking it up. According to Protect My Paws, experts say that we are in the middle of a dog poop epidemic. There is an abnormal amount of dog poop being left in the street and people are stepping all in it. And even worse, some kids are getting sick from it.

Actually, the city that is considered to be the Dog Poop capital of America is right here in Pennsylvania. Pittsburgh has been dubbed as "Poopsburgh" if you didn't know. The reason the state is full of so much poop is that it is considered to be a great place for tourists to travel to with their pets, according to Protect My Paws. More dogs in the area, the more poop there is going to be.

If you have a dog, please be considerate of other people and our shoes and pick up their poop.

To prepare yourself for a potential incident, always keep your vet's phone number handy, along with an after-hours clinic you can call in an emergency. The ASPCA Animal Poison Control Center also has a hotline you can call at (888) 426-4435 for advice.

Even with all of these resources, however, the best cure for food poisoning is preventing it in the first place. To give you an idea of what human foods can be dangerous, Stacker has put together a slideshow of 30 common foods to avoid. Take a look to see if there are any that surprise you.

Follow this link:
This Pennsylvania City is the Poopiest City In America - 94.5 PST

For the 13 patients treated at the recommended phase 2 dose (RP2D) the response rate after one cycle of treatment remains at 100% with a 38.5% complete response (CR) rate; one additional patient completed cycle 1 at the RP2D and was assessed with a partial response (PR)Three of 3 patients treated with two cycles in the dose escalation part of the study at the RP2D remain in CR at 6 months after start of treatmentSide effect profile shows only five instances of transient infusion-related reactions (IRR) in more than 100 AFM13 infusions with no episodes of neurotoxicity, CRS or GvHD

HEIDELBERG, Germany, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer will host today a financial community call to discuss recent findings from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center investigating the treatment of CD30-positive lymphoma patients with its innate cell engager (ICE) AFM13, pre-complexed with cord blood-derived natural killer (cbNK) cells (AFM13-104).

A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1106, three patients with 1107 and 13 patients with 1108 AFM13-pre-complexed cbNK cells per kg body weight.

Response Assessment

A total of 19 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (17 and 2 patients, respectively) have been treated to date across three dose cohorts. According to investigator assessment, 17 of 19 patients had achieved an objective response (ORR 89.5%) to the treatment, with seven complete responses (CR 36.8%) and ten partial responses (PR 52.6%).

In patients treated at the RP2D level of 1x108 cbNK cells per kg, 12 of 13 had classical Hodgkin lymphoma and 1 patient had CD30-positive NHL. In this cohort, 100% of patients responded after the first cycle of treatment with five CRs (38.5%) and seven PRs (61.5%). All patients treated at the RP2D have now received a second cycle of therapy. Response evaluation after cycle 2 will be reported at a future scientific conference.

Initial Durability of Response Observations

Nine patients treated in the dose escalation phase of the study had follow-up at 6 months. Of note, the three patients treated at the RP2D remain in remission at 6 months after start of treatment, two without additional treatment and one on anti-PD-1 antibody maintenance.

In the four responders out of six treated at the two lower dose levels, one patient, who started treatment in September 2020, remains in remission after consolidation autologous stem cell transplant, and three relapsed at 3.4, 4.8 and 6.3 months after start of therapy.

Safety

Five reported cases of transient infusion related reactions were reported after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

Conference Call/Webcast Information

The event today will include a review of Affimeds approach to activating the innate immune system in the fight against cancer, preclinical data supporting the combination of Affimeds ICE molecules with adoptive NK cell transfer, a review of the treatment challenges and clinical opportunities for CD30+ lymphomas, and review of the interim data from AFM13-104 by the studys principal investigator, Yago L. Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at of The University of Texas MD Anderson Cancer Center.

Affimed will host a conference call and webcast today, December 9th, 2021, at 8:30 a.m. EST. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at https://www.affimed.com/webcasts/investor-day/ or https://edge.media-server.com/mmc/p/zzwismtq. A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1106 NK cells/kg in Cohort 1; 1107 NK cells/kg in Cohort 2; and 1108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28. MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at http://www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimeds most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at http://www.clinicaltrials.gov (NCT04101331).

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The companys proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the companys people, pipeline and partners, please visit: http://www.affimed.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, and our other product candidates, the value of our ROCK platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact Alexander Fudukidis Director, Head of Investor Relations E-Mail: a.fudukidis@affimed.com Tel.: +1 (917) 436-8102

Media Relations Contact Mary Beth Sandin Vice President, Marketing and Communications E-Mail: m.sandin@affimed.com Tel.: +1 (484) 888-8195

Read the original:
Affimed to Host Virtual Investor Call Today to Discuss Treatment of CD30-positive Lymphoma ... - The Bakersfield Californian

For patients with previously untreated Richters transformation (RT), treatment with venetoclax, obinutuzumab, and atezolizumab led to high rates of remission, according to results presented at the 2021 American Society of Hematology Annual Meeting.

In previous studies, BCL2 inhibitor venetoclax and CD20 monoclonal antibody obinutuzumab have shown clinical activity in patients with diffuse large B-cell lymphoma (DLBCL) and RT. PD-L1 checkpoint inhibitor atezolizumab has been approved by the FDA for the treatment of melanoma, lung cancer, and other solid tumors.

From March 2020 to June 2021, researchers led by Nitin Jain, MD, of MD Anderson Cancer Center, enrolled eight patients with DLBCL RT in a phase II trial. Eligible patients with either previously untreated (n = 7) or relapsed/refractory (n = 1) RT were at least 18 years of age, had adequate organ function, and had not undergone prior treatment with venetoclax.

The median age of patients in the study was 70 years (range = 52-80). Patients had previously been treated for CLL with ibrutinib (n = 4), chlorambucil plus obinutuzumab followed by acalabrutinib (n = 1), bendamustine-rituximab (n = 1). All six patients for whom CLL IGHV mutation status was available were IGHV-mutated. Three patients had complex karyotype, three had a TPS53 mutation, and two had a NOTCH1 mutation. CLL FISH panel found the following:

Treatment consisted of the following:

Responses were evaluated using PET imaging and bone marrow aspirate/biopsy with measurable residual disease (MRD) assessment at the end of cycles 1, 4, 9, and 26. All seven patients achieved a response, including five complete metabolic responses and two partial metabolic responses. All but one of the responses occurred after the introduction of venetoclax in cycle 2. The remaining patient achieved complete metabolic response and bone marrow undetectable MRD after cycle 1.

Three patients underwent allogeneic stem cell transplant (alloSCT) in complete metabolic remission after 4.1, 4.2, and 6.6 months. Bone marrow undetectable MRD remission was also achieved in these three patients. One of the three has since relapsed and is currently receiving salvage therapy, the authors noted.

One patient who achieved partial metabolic remission relapsed prior to a planned alloSCT in cycle 8, but after treatment with a non-covalent BTK inhibitor, is now in remission, they added. Three patients continue to receive treatment on the trial in cycle 2, cycle 5, and cycle 12.

The patient with relapsed/refractory RT was a 58-year-old male with previously untreated CLL (unmutated IGHV, del17p, TPS53 mutation, and NOTCH1 mutation). Prior to enrollment in the trial, this patient received R-CHOP for three cycles but had no response.

No deaths were observed during follow-up. One patient developed pancreatitis associated with checkpoint inhibitor treatment and diabetes mellitus. Another patient required the venetoclax dose to be reduced to 400 mg daily.

Although this study is limited by its small sample size, these results are encouraging in relation to combined ibrutinib plus nivolumab in previously untreated RT, Dr. Jain wrote.

Read the original here:
Evaluating Venetoclax, Obinutuzumab, and Atezolizumab in Patients With Richters Transformation - DocWire News

HEIDELBERG, Germany, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimeds innate cell engager (ICE) AFM13.

As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1x106, three patients with 1x107 and 12 patients with 1x108 AFM13-pre-complexed cbNK cells per kg body weight.

As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses (CR) and nine partial responses (PR). Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

The patients enrolled in this study were all heavily pre-treated with a median of 6 lines of prior therapy and had progressive disease after their previous line of therapy, said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. We are encouraged by the response rates that we continue to observe in these difficult to treat patients. The data are in line with data presented at AACR earlier this year. We also continue to see a very good safety profile of the combination, which is important as many of these patients have been very heavily pretreated and cannot tolerate aggressive therapies. Combining our ICE molecules with NK cells is an integral part of our strategy to bring innovative therapies to patients in need. We believe these preliminary data provide further validation of this approach.

Conference Call/Webcast Information

Affimed will host a conference call and webcast on December 9th, 2021, at 8:30 a.m. EST to review the data. Affimeds management will discuss the results to date, the current treatment landscape for CD30+ lymphomas, and next steps for the study. Dr. Yago L. Nieto, M.D., Ph.D, Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine from M.D Anderson Cancer Center will also be available during the call.

To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/ or https://edge.media-server.com/mmc/p/zzwismtq. A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1106 NK cells/kg in Cohort 1; 1107 NK cells/kg in Cohort 2; and 1108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1x108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28.

MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.

Additional information about the study can be found at http://www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimeds most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at http://www.clinicaltrials.gov (NCT04101331).

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The companys proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the companys people, pipeline and partners, please visit: http://www.affimed.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, and our other product candidates, the value of our ROCK platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102

Media Contact

Mary Beth SandinVice President, Marketing and CommunicationsE-Mail: m.sandin@affimed.comTel.: +1 (484) 888-8195

View original post here:
Affimed Announces 100% Objective Response Rate at Highest Dose in Phase 1-2 Study of Cord Blood-derived Natural Killer Cells Pre-complexed with Innate...

The time to start planning for your pet's care during the busy holiday season is now and meet Bailey, a young girl looking for her forever family.

Halloween is over and that means the busy holiday season is now upon us. While many of us make plans for those, one thing that can slip through the cracks is getting a holiday pet plan in place.

The staff at the Humane Society of South Central Michigan (HSSCM) say if you are planning on leaving town over the holidays, now would be the time to make arrangements for your furry family member while you are away.

Another helpful tip is having a quiet place away from your family gathering where your pet can escape the noise and overstimulation. Along with that, make sure your pet is secured as groups come and go from your home and packages are being carried in and out.

Food is another thing to be aware of. There are many foods we eat during the holidays that should not be shared with cats and dogs. Find a list below of common foods that are poisonous to dogs and clickhere for a list of foods that should not be given to cats.

Miss Bailey is just shy of 5 months old. She is an Australian Shepherd mixedwith some possible Hound. But there are no breed guarantees. One thing for sure is Baily is a very sweet and beautiful girl. She can be a bit on the timid side but with some patience and encouragement, her confidence is sure to grow.

Bailey enjoys playing but also loves to snuggle once she's had time to get to know you. Due to her breed, a physically fenced-in yard is a must. Bailey loves to run and play outside. She may do well in a home with another dog, pending an approved application and meet and greet. She has not been tested with cats at this time. Bailey would do best in a home with children 8 years and older.

Would you like to makeBailey a forever part of your family?Click here to find an application (click the Adoption tab on the top left) to fill out and return to HSSCM.

Want to add a furry family member but maybe Bailey isn't the right fit? Click here to see other cats and dogs waiting for their forever home.

To prepare yourself for a potential incident, always keep your vet's phone number handy, along with an after-hours clinic you can call in an emergency. The ASPCA Animal Poison Control Center also has a hotline you can call at (888) 426-4435 for advice.

Even with all of these resources, however, the best cure for food poisoning is preventing it in the first place. To give you an idea of what human foods can be dangerous, Stacker has put together a slideshow of 30 common foods to avoid. Take a look to see if there are any that surprise you.

See original here:
Holiday Pet Safety Tips and Bailey the Featured Pet of the Week - wbckfm.com