Category Archives: Cell Therapy

As vaccine effectiveness has been found to wane over time, an Israeli clinical-stage biotech company is optimistic about the authorization of its experimental cell-based drug therapy to treat pneumonia and respiratory distress suffered by severe COVID-19 patients, hoping to keep them out of hospitals.

The more vaccinated people we will have the less COVID we will have. Nevertheless, vaccination effectiveness reduces so dramatically after four or five months, even after second vaccination, and the third one is not the end of the story which allowed us to understand that COVID is not going anywhere, Shai Meretzki, founder and CEO of Bonus Biogroup told The Algemeiner. The ability to have a therapy which specifically heals severe COVID-19 patients and gets them out of hospitals is amazing, because it means that we can live with the virus.

Bonus Biogroup, which focuses on the development of biomedical tissue engineering and cell therapy products, announced this month that it has concluded a Phase II clinical trial to assess the safety and efficacy of its MesenCure therapy in 50 severe COVID-19 patients who suffer from acute respiratory distress syndrome (ARDS) and other life-threatening lung diseases, and have a mortality rate of 35 percent.

The Haifa, Israel-based company expects to publish results from the trial in November.

Meretzki is hopeful that results from the Phase II trial will be good enough to get marketing approval for the therapy from Israeli regulators without the need to conduct a Phase III trial. But he acknowledged that in the US, the Food and Drug Administration (FDA) will demand a late-stage trial.

We hope we can get emergency approval to take care of everyone globally with a regular treatment as soon as possible to get the majority of severe COVID-19 patients out of hospitals, Meretzki said.

He described the companys novel method for growing live, active human tissue outside the human body, which it started tested by growing bone.

When COVID broke out we understood very quickly that what is killing many severely infected patients is not the virus. Its a process called cytokine storm, in which the virus gets into the human cells, the immune system of the patient attacks the infected cells very strongly and blocks the lungs by billions of immune cells, he explained. When the lung is filling with immune cells you dont breathe anymore.

With that in mind, Bonus Biogroup started to do more research into mesenchymal stromal cells (MSCs), which they use on a day-to-day basis and derive from the patients own tissue to create bone tissue. It found that the natural activity of MSCs had anti-inflammatory potential by regulating the overshooting of the immune system.

We decided to try and use our MSCs to try and relax the overreaction a bit, and as a result patients will be cured as the virus itself doesnt kill them, Meretzki said. We are a year after this point and we have the first product in the world, MesenCure, that has the ability to reduce, not to shut down, the overactivity of the immune system. We have the only therapy for the treatment of hundreds of thousands if not billions of severe COVID-19 patients suffering from life-threatening inflammatory diseases.

MesenCure is an allogeneic, cell-based experimental drug, consisting of primed mesenchymal cells, which are isolated from the fat tissue of healthy donors. Technologies developed by Bonus BioGroup were used to obtain a higher number of cells from a donor; once isolated, the company enhanced the cells therapeutic efficacy.

The drug is administered via injection of mesenchymal cells. After injection into the patients body, the cells travel to the inflamed lungs and depress the cytokine storm caused by the coronavirus which in turn promotes the relief of symptoms and the healing process of the respiratory system and other internal organs. With one sample of cells, 45,000 patients can be treated, according to Meretzki.

The results of the therapys early-stage clinical trial conducted earlier this year in 10 severe COVID-19 patients aged 45 to 75 showed significant decrease in inflammation of the lungs. The patients were discharged from the hospital within a median of one day following treatment requiring no respiratory support. As a result, the stay of severe COVID-19 patients in the hospital was reduced by an average of 10 days, the company said.

Chest X-rays of the patients demonstrated a reduction in inflammation from about 55% of the lung area before treatment, to about 15%, five days after starting the treatment, and up to around 1%, about a month after treatment initiation.

The treatment results with MesenCure, thus far, are very impressive and are significantly better compared to the results achieved with other therapies. All patients treated with MesenCure were in a severe condition, suffering from acute respiratory distress, diffuse pneumonia as per chest radiographs, and blood parameters indicative of a cytokine storm, said Dr. Shadi Hamoud, the clinical trials lead researcher and deputy director of Haifas Rambam hospital department of internal medicine. Moreover, about 90% of the trial participants suffered from co-morbidities known as risk factors for increased disease severity, complications, and mortality.

We hope to treat a large number of patients with this cell therapy, and we will strive to extend its use to other indications as well, Hamoud added.

Bonus Biogroup believes MesenCure may be used for the treatment of other indications, including lower respiratory tract infections, asthma, and chronic obstructive pulmonary disease caused by viral or bacterial infection which together represent a global market that is expected to exceed $43 billion per year, by 2026, not including the COVID-19 effect.

According to Meretzki, a major drawback of most cell-based therapies for the treatment of COVID-19 patients is that that they were not developed for lung diseases, and have therefore failed to show clinical efficacy.

Going forward, should MesenCure receive necessary regulatory approval for general use, its maker will face logistical issues in how to best fit production with the drugs short shelf life of seven days

Meretzki also disclosed that the company is in talks with a number of countries about the potential use of MesenCure.

Israel was vaccinated about six months before the rest of the world and is just coming out of the fourth COVID wave, which other countries like the UK, Romania, Italy, and Germany are now dealing with, he said. Our goal is to help as many severe COVID patients survive as possible globally.

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High Hopes for Israeli Cell Therapy for Hospitalized COVID-19 Patients, Aiming to Help 'Live With the Virus' - Algemeiner

Published: Oct. 27, 2021 at 8:56 AM CDT|Updated: 16 hours ago

RALEIGH, N.C., Oct. 27, 2021 /PRNewswire/ -- Inceptor Bio ("Inceptor"), today announced an agreement with Arranta Bio ("Arranta") for the acquisition of a 29,000 ft2 process development and GMP clinical manufacturing facility and the transfer of a core operating team to establish cell therapy processes and clinical supply for Inceptor Bio's planned oncology clinical trials.

Inceptor Bio Announces Agreement to Acquire Gainesville, FL GMP Facility And Transfer Operating Team From Arranta Bio

Inceptor Bio's Advanced Manufacturing Platform (AMP+) will be based at the new facility in Gainesville, FL, that will be developed as a state-of-the-art cell and gene therapy GMP facility to deliver Inceptor Bio's programs.

"We are thrilled to welcome the experienced, talented operating team from Arranta and look forward to establishing cell therapy GMP clinical manufacturing as a key strategic capability. This acquisition accelerates Inceptor Bio's path to the clinic for our CAR-T, CAR-M and CAR-NK programs with our lead CAR-T candidate scheduled for IND in early 2023," said Shailesh Maingi, Founder and CEO of Inceptor Bio.

Inceptor Bio is developing multiple next-generation cell therapy platforms to address difficult-to-treat cancers with a focus on novel mechanisms to enhance immune cell performance in the tumor microenvironment (TME). Inceptor Bio currently has three cell therapy technologies: a CAR-T platform with a novel co-stimulatory technology, a CAR-M platform using macrophages with enhanced phagocytic capabilities, and a CAR-NK platform.

Arranta is a leading contract development and manufacturing organization (CDMO) supporting advanced therapy pioneers. Arranta has invested in building the capabilities at the Gainesville, FL site and expanded the team over the last two years. "After conducting a strategic review, we concluded that the early clinical supply for clients from our Gainesville facility could be supported by our experienced team and accommodated in the over 200,000 ft2 of facilities that Arranta has in Massachusetts" said Mark Bamforth, Executive Chair and CEO at Arranta. "We are delighted that some of the technical team will transfer to Massachusetts, leaving a highly capable GMP operating team in place for Inceptor. We wish them every success in their critical mission."

About Inceptor Bio Founded in 2020, Inceptor Bio is a biotechnology company developing multiple next-generation cell and gene therapy platforms to deliver cures for underserved and difficult-to-treat cancers. By partnering with universities, medical centers, and industry leaders, Inceptor Bio advances cell and gene therapy programs from discovery-phase technologies into Phase I and II clinical assets. An experienced management team, Scientific Advisory Board, Directors and strategic advisors offer industry-leading expertise to partnerships. Inceptor Bio is investing in an Advanced Manufacturing Platform (AMP+) to provide fit-for-purpose, capital efficient, scalable shared infrastructure to support advancement of a diversified portfolio of cell therapy platforms across multiple cell types, including CAR-T, CAR-M, and CAR-NK/NKT. Additional information about Inceptor Bio is availableatwww.inceptor.bio.

About Arranta Bio Founded in 2019, Arranta Bio is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled expertise are crucial for advancing products from development to commercial launch. Arranta Bio continues to expand capacity and development and manufacturing services across multiple sites with three distinct technology platforms designed to meet the evolving demands of our clients and partners. Additional information about Arranta Bio is available at http://www.arrantabio.com

Inceptor Bio media contact: Mary Pat Joyce T: 978-835-9768 E: marypat.joyce@inceptor.bio

Arranta Bio media contact: Nathan Archibald T: 321-271-0777 E: nathan.archibald@arrantabio.com

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Inceptor Bio Announces Agreement to Acquire Gainesville, FL GMP Facility And Transfer Operating Team From Arranta Bio To Accelerate Cell Therapies To...

WATERTOWN, Mass.--(BUSINESS WIRE)--SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced that the independent Data and Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 has recommended that the trial advance into the combination stage with checkpoint inhibitors. In June, the company presented initial results from the first three monotherapy cohorts at the American Society of Clinical Oncology annual meeting demonstrating that the investigational cell therapy is safe and well-tolerated and can stimulate immune responses in certain patients with advanced or metastatic human papillomavirus positive (HPV16+) tumors. Data from the highest dose monotherapy cohort has been accepted for oral presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress being held December 8-11, 2021.

We are encouraged by our initial SQZ-PBMC-HPV-101 Phase 1/2 trial data and pleased to advance the highest dose of our SQZ APC clinical candidate into the combination stage of the trial, said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. Based on our preclinical studies and available clinical trial data, we believe SQZ APCs could work synergistically with checkpoint inhibitors to provide additional clinical benefit to patients. Our clinical team and trial sites are ready to begin this important phase of the study.

The combination stage of the trial is now open for enrollment and will include checkpoint inhibitors targeting the PD-(L)1 and CTLA-4 pathways. In parallel, the company plans to continue to enroll in the highest dose monotherapy cohort.

The DSMB recommendation and initiation of the combination cohorts will trigger a Roche collaboration agreement milestone payment. The companys most recently reported cash runway projections anticipated these proceeds.

New data from the monotherapy portion of the SQZ-PBMC-HPV-101 trial will be part of an oral presentation at ESMO-IO on December 9 in Geneva, Switzerland. Full presentation details can be found below.

ESMO-IO Presentation Details

Abstract Title: SQZ-PBMC-HPV-101: Preliminary results of a first-in-human, dose-escalation study of a cell-based vaccine in HLA-A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors

Lead Author: Jong Chul Park, MD, Massachusetts General Hospital; Developmental Therapeutics Member, Dana-Farber/Harvard Cancer Center

ESMO-IO will publish full abstracts on their website on Thursday, December 2 at 12:00 pm CET. SQZ will post its oral presentation on the company website on December 9 at 11:00 am CET.

SQZ-PBMC-HPV-101 Trial Design

SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The studys primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and the definition of a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

About SQZ Biotechnologies

SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients around the world and has active programs in Oncology, Autoimmune and Infectious Diseases, as well as additional exploratory initiatives to support future pipeline growth. The companys proprietary Cell Squeeze technology offers the unique ability to deliver multiple biological materials into many cell types to engineer what we believe can be a broad range of potential therapeutics. With demonstrated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could significantly broaden the therapeutic range and accessibility of cell therapies. The companys first therapeutic applications seek to generate target-specific immune responses, both in activation for the treatment of solid tumors and infectious diseases, and in immune tolerance for the treatment of autoimmune diseases. For more information, please visit http://www.sqzbiotech.com.

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 that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements relating to our platform development, manufacturing capabilities, product candidates, preclinical and clinical activities, progress and outcomes, development plans, clinical efficacy, therapeutic impact, strategic partnerships and market opportunities. These forward-looking statements are based on management's current expectations. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors and strategic partners; and protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date and SQZ undertakes no duty to update these forward-looking statements, whether as a result of new information, the occurrence of current events, or otherwise, unless required by law.

Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources.

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SQZ Biotechnologies Announces Independent DSMB Recommendation to Advance Lead Cell Therapy Candidate Into Combination With Checkpoint Inhibitors -...

LONDON and BOSTON, Oct. 27, 2021 /PRNewswire/ -- Quell Therapeutics Ltd ("Quell"), the world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announces that its Clinical Trial Application (CTA) for the first clinical trial of its lead Treg cell therapy candidate QEL-001 has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This approval paves the way for the first ever clinical trial of a multi-modular engineered CAR-Treg cell therapy and patient recruitment is expected to begin before the end of the year, with first patient dosed expected in Q1 2022.

QEL-001 is a first-in-class antigen-specific CAR-Treg cell therapy candidate designed using Quell's unique multi-modular engineered Treg platform and engineered with three proprietary modules: a chimeric antigen receptor (CAR) for tissue targeting, the Foxp3 phenotype lock module, and a safety switch. The QEL-001 CAR is specific for HLA-A2, which localizes the activity of the CAR-Tregs to the site of the transplanted organ in HLA-A2 mismatch liver transplant patients (i.e. HLA-A2 negative recipients who received an HLA-A2 positive donor liver).

Dr Dominik Hartl, Chief Medical Officer,said: "We are very pleased to receive approval to advance QEL-001 into clinical studies in this important and underserved indication. While liver transplant today is a life-saving procedure, recipients still face the prospect of lifelong systemic immunosuppression, which comes with significant risk of serious complications, including increased rates of certain malignancies and infections, diabetes, cardiovascular disease and irreparable kidney damage requiring dialysis and further transplant. As a result, the ten-year survival rate for liver transplant patients is poor and similar to that for common cancers.

"Our new clinical trial with QEL-001 is called 'LIBERATE' because our goal is to show that this novel engineered CAR-Treg candidate can establish and maintain immune tolerance to the transplanted organ, and to 'liberate' patients entirely from their immunosuppressive regimens to reduce the associated complications and economic burden on health care systems."

The Phase 1/2 clinical trial ('LIBERATE') will investigate the safety and efficacy of QEL-001, in approximately 18 HLA-A2 mismatched liver transplant patients at multiple clinical sites in the UK. The study is designed to wean patients fully off their immunosuppressive therapy after QEL-001 infusion, and to assess the induction and durability of operational tolerance (i.e. prevent a host vs graft immune response that could lead to organ rejection) by QEL-001 treatment. In addition, the study will provide the opportunity for deep translational learnings to monitor the localization, phenotype, persistence and function of the CAR-Tregs in the liver tissue and periphery, and to assess how they modulate the allo-immune response in liver transplant patients.

Iain McGill, CEO,added "This is a significant milestone for Quell as we take QEL-001 into our first clinical trial and also into the first ever clinical trial of a multi-modular engineered CAR-Treg cell therapy. The LIBERATE trial in liver transplant patients offers an ideal setting to investigate and provide proof-of-concept for our novel approach to engineering Tregs to deliver truly life-changing, effective and durable, and even potentially curative treatments for patients with serious immune diseases. We are very excited about what this trial with QEL-001 will show and what information it will yield to feedback into and enhance the development of our broader engineered Treg pipeline targeting transplantation, as well as serious neuroinflammatory and autoimmune diseases."

About Liver Transplantation

Approximately 15,000 patients receive new liver transplants in the US and EU5 each year and nearly one quarter of these individuals receives an HLA-A2 mismatched liver, i.e. one that does not match their own immunological profile and is therefore prone to a serious host vs graft immune response that leads to organ rejection.

The standard of care for liver transplant patients is to receive systemic immunosuppression for the rest of their lives. There have been no significant improvements in therapy options since the 1990s.

Current treatments, such as calcineurin inhibitors, cause significant non-liver comorbidities resulting in poor post-transplant survival with the 10-year survival outcome of liver transplant patients being around 60% and comparable to that of common malignancies, such as colon cancer, cancer of the uterus or Non-Hodgkin's lymphoma. Further, long-term immunosuppressive therapy is nephrotoxic, leading to progressive and irreparable kidney damage that eventually requires dialysis and transplant.

About Quell Therapeutics

Quell Therapeutics is the world leader in developing engineered T-regulatory (Treg) cell therapies that aim to harness, direct and optimize their immune suppressive properties to address serious medical conditions driven by the immune system.

The Company is leveraging its pioneering phenotype lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches.

Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in neuroinflammatory and autoimmune diseases. http://www.quell-tx.com.

Contacts

Investors: Christina TartagliaStern Investor Relations, Inc.+1 212 362 1200[emailprotected]

Media: Mark Swallow, Frazer HallMEDiSTRAVA Consulting+44 207 638 9571[emailprotected]

SOURCE Quell Therapeutics

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Quell Therapeutics Granted CTA Approval to Begin First Clinical Trial with a Multi-modular Engineered Treg Cell Therapy - PRNewswire

DUBLIN--(BUSINESS WIRE)--The "Global Cell Therapy Market Size, Share & Trends Analysis Report by Use-type, by Therapy Type (Autologous, Allogenic), by Region (North America, Europe, Asia Pacific, Latin America, MEA), and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The global cell therapy market size is expected to reach USD 23.0 billion by 2028 and is expected to expand at a CAGR of 14.5% from 2021 to 2028.

The emergence of new technologies to support the development of advanced cellular therapies has aided in market growth. Companies are leveraging new technologies not only for the expansion of their product portfolio but also for establishing out-licensing or co-development agreements with other entities to support their product development programs.

Cell-based therapies hold great potential for replacing, repairing, restoring, or regenerating damaged tissues, and organs. Researchers are making huge investments in the development of such effective and safe treatments as an alternative to conventional treatment strategies which can be further attributed to the market growth.

Out of all therapeutic areas, oncology has the highest number of ongoing clinical trials. T cells, CD34+ and/or CD133+ stem cells, mesenchymal stem/stromal cells are predominantly employed for clinical investigation.

The majority of biopharmaceutical entities have been affected by the COVID-19 pandemic, while several cellular therapy development companies have witnessed a strongly negative impact, which can be attributed to complications in logistics as well as the manufacturing models employed in this industry. In addition, substantial and stable funding is imperative to ensure successful commercial translation of cell-based therapeutics, a factor that was negatively affected in 2020, further affecting the market growth.

A survey conducted recently among executives of more than 15 European and U.S. cellular therapy companies indicated that disruption caused by the pandemic was significant, which demanded market entities to create strategies to sustain themselves and plan the next wave of innovative therapies.

Key issues faced by companies operating in the market include on-time delivery of therapies to patients at required clinical sites. In addition, the administration of these therapeutics poses several post-pandemic challenges. Hospitals are hesitant in offering services, owing to concerns over transmission of SARS-CoV-2, particularly to vulnerable individuals. Moreover, patients have not been able to visit cellular therapy centers either, owing to the lockdowns and travel bans.

Cell Therapy Market Report Highlights

Market Dynamics

Market driver analysis

Market restraint analysis

Market opportunity analysis

COVID-19 Impact Analysis

Challenges analysis

Opportunities analysis

Challenges in manufacturing cell therapies against COVID-19

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/n1u89x

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Global Cell Therapy Market Research Report 2021: Opportunities with the Approval of Kymriah and Yescarta Across Various Countries -...

Published: Oct. 27, 2021 at 4:30 AM EDT|Updated: 22 hours ago

FRANKFURT, Germany, Oct. 27, 2021 /PRNewswire/ European Wellness Academy (EWA), the educational arm of European Wellness Biomedical Group (EWG), has signed an agreement to carry out joint scientific research on the efficacy of peptides, cell therapy, exosomes and cell reprogramming for rejuvenation in premature murine aging models.

EWA was represented by its Group Chairman, Prof. Dr. Mike Chan, while Heidelberg University was represented by its Commercial Managing Director, Katrin Erk and its Head of Institute of Anatomy and Cell Biology III, Prof. Dr. Thomas Skutella.

The cutting-edge therapeutics used for the studies include precursor (progenitor) stem cells (PSC), precursor cells (Frozen Organo Crygenics (FOC)), Mito Organelle (MO), Nano Organo Peptides (NOP) and exosomes.

Their studies include in vitro experiments concentrating on the effects of the products on the aging of somatic cells and cellular senescence, which is known to contribute to disease onset and progression. Investigated exosomes include neuronal stem cells (NSCs), mesenchymal stem cells (MSCs), cardiomyocytes, kidney progenitors and hepatocytes.

EWA and Heidelberg University will also conduct in vivo experiments to demonstrate both safety and efficacy of the therapeutics, whereby the proof of effectivity will be recorded in the life span, histopathological and molecular criteria of neurodegeneration including Alzheimer/dementia, and system degeneration disorders including those affecting the immune system, skin, cardio, lung, kidney, liver, stomach/intestine/gut, eye, and muscular dystrophy.

Other criteria included are cartilage/joint/bone regeneration including knees/joints/hips, cervical, thoracic, lumbar, pelvic and musculoskeletal disorder, as well as endocrine disorders like endocrinal dysfunction due to over and underproduction of hormones and other activity pattern under the sleep wake cycle.

The ongoing specially designed studies are coordinated and designed by Prof. Dr. Thomas Skutella of Heidelberg University, a world-renowned research university and one of Germany's Top 3, Prof. Dr.Mike Chan and scientists of EWG.

European Wellness Academy

Located in Germany, Switzerland, Greece and Malaysia, EWA is a UK CPD authorised body with a premium training and development wing that revolves around cutting-edge Bio-Regenerative Medicine modalities for practitioners and researchers. The Academy has extensive years of combined clinical experience and a core academic team comprising of qualified clinicians and scientists with multiple international affiliations and accreditations.

https://ewacademy.euhttps://european-wellness.eu/

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European Wellness Collaborates with Heidelberg University Germany to Conduct Efficacy Studies of Peptides and Cell Therapy Research - WSAZ-TV

Welcome to OncLive On Air! Im your host today, Kristi Rosa.

OncLive On Air is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In todays episode, we had the pleasure of speaking with Muhammad Bilal Abid, MD, MRCP, an assistant professor of medicine in the Divisions of Hematology/Oncology & Infections Diseases at the Medical College of Wisconsin, about his recent review paper outlining what is known about the risk of infections with CAR T-cell therapy and determinants of SARS-CoV-2 responses.

CAR T-cell therapies have demonstrated unprecedented response rates in patients with relapsed or refractory hematologic malignancies. However, this modality also has been found to have distinctive short- and long-term toxicities and infection risks in those who receive it after several prior treatments, such as transplant.

Toxicities can include cytokine release syndrome and immune effector cellassociated neurotoxicity syndrome. Other adverse effects like long-term B-cell depletion, hypogammaglobulinemia, and cytopenia can predispose patients to severe infections and impact remission success.

Risk of such infections depend upon certain patient- and disease-related factors, including lymphodepletion chemotherapy regimen, the interval between cell collection and infusion, bridging therapy, CAR T-cell dose, signaling and costimulatory domains, and target antigen. Moreover, certain CAR T constructs may confer a higher risk or more frequent CRS than others, resulting in a higher incidence of infections.

Early observational findings suggested that patients with hematologic malignancies might not achieve an acceptable response to SARS-CoV-2 vaccination. In our exclusive interview, Abid discussed immune-compromising factors that are indigenous to CAR T recipients, the immunogenic potential of different vaccines, determinants of vaccine responses, and the potential need for booster vaccine dosing in this population.

Thank you for listening to this episode of OncLive On Air. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field. For more updates in oncology, be sure to visit http://www.OncLive.com and sign up for our e-newsletters.

OncLive is also on social media. On Twitter, follow us at @OncLive and @OncLiveSOSS. On Facebook, like us at OncLive and OncLive State of the Science Summit and follow our OncLive page on LinkedIn.

If you liked todays episode of OncLive On Air, please consider subscribing to our podcast on Apple Podcasts, Spotify, Google Podcasts, Amazon Music, and many of your other favorite podcast platforms,* so you get a notification every time a new episode is posted. While you are there, please take a moment to rate us!

Thanks again for listening to OncLive On Air.

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Abid on Optimizing COVID-19 Vaccines in CAR T-Cell Therapy Recipients - OncLive

A significant proportion of patients worldwide live disease-free for a decade or longer following first-line therapy, with various approaches suggesting that there may be pathways to develop approaches for a cure for at least a subset of patients

Follicular lymphoma (FL) and other forms of indolent non-Hodgkin lymphoma (iNHL) are commonly considered incurable diseases with continual risk of relapse over time, shorter durations of response with each subsequent line of therapy, and a risk of transformation to a more aggressive B-cell lymphoma. Although these lymphomas are characterized as indolent, one of the most common causes of death for these patients is lymphoma.1 On the other hand, a significant proportion of patients worldwide live disease-free for a decade or longer following first-line therapy, with various approaches suggesting that there may be pathways to develop approaches for a cure for at least a subset of patients.1-5 In the Indolent B-Cell Lymphoma session during the Society of Hematologic Oncology 2021 Annual Meeting, 4 presentations were explored: Molecular Pathogenesis of Follicular Lymphoma and Its Relevance to Clinical Practice, Sequencing Therapy in Follicular Lymphoma, Novel Therapies in Indolent Lymphoma, and CAR T-Cell Therapy in Indolent Lymphoma in lectures by world-class experts Jessica Okosun, MA, MB BChir, MRCP, FRCPath, PhD, Peter Martin, MD, Loretta Nastoupil, MD, and Caron Jacobson, MD, MMSc.

Next-generation sequencing studies, led by Michael R. Green, PhD, Dr Okosun, and others, have described the panoply of genomic events involved in FL and have aided in identifying candidate genetic drivers.6-9 This work clarified the diverse genomic landscape and the temporal clonal dynamics of FL. Common genomic events that occur with t(14;18) include high frequencies of mutations affecting epigenetic regulation, disruptions in pathways such as those involved in immune recognition (eg, TNFRSF14), NF-KB (eg, CARD11), and JAK/STAT signaling (eg, STAT6).9,10 Next-generation sequencing also has been used to examine factors associated with progression of FL, transformation of iNHL to more aggressive lymphomas, and spatial heterogeneity in FL. Recent studies have explored the subclonal diversity and spatial heterogeneity observed among patients with FL that have potential clinical implications for the development of prognostic and predictive biomarkers and targeted treatment strategies. For instance, exome sequencing of FL tumors and paired germline have identified nonsynonymous somatic variants corresponding to missense (81%), indels (10%), nonsense (7%), and splice site (2%) changes.6 This work revealed spatially discordant mutations in genes such as EZH2 and EP300. One attractive treatment paradigm emerging from this work involves specifically targeting highly recurrent and truncal gene mutations that have roles in FL pathogenesis. Other studies did not identify a single compelling genetic event responsible for transformation, but instead suggest that the acquisition of certain genetic alterations may result in aggressive transformation.7,9,11 Exploration of the FL genomics in this session can clarify stratified treatment approaches targeting specific early genetic lesions identified in FL and may eventually provide strategies to eradicate these cell populations and provide pathways to cure FL.

In the past decade, many new agents have been introduced for the management of FL, and therapeutic strategies have evolved over time. Recently, my co-chair in this session, Nathan Fowler, MD, and I reviewed data from trials addressing the safety and efficacy of lenalidomide alone and in combination with rituximab as a first-line therapy and as a treatment of patients with relapsed/refractory FL.12 However, since that review other agents have received FDA approval for patients with relapsed FL. There is considerable variation in response rates for recently approved therapies ranging from objective response rates of 40% to 60% for PI3K inhibitors, 35% to 65% for EZH2 inhibitors, and greater than 70% for autologous stem cell transplantation, and CD19-directed chimeric antigen receptor (CAR) T-cell therapy.13-18 Recently approved therapies in relapsed FL have commonly been based on response rate and duration of response (DOR) demonstrated in phase 2 studies. However, despite numerous trials performed in the field, there is no single standard of care for patients with iNHL who are undergoing second-line treatment or beyond.

As a result of the patterns of relapse and transformation associated with iNHL, the clinical treatment of patients with FL and other iNHLs often requires multiple lines of therapy using various regimens with different mechanisms of action.19-22 The clinical benefits and adverse effects associated with the treatments available at relapse vary and are influenced by patient and disease characteristics at the time of progression, the duration of the interval from last treatment, and the toxicity and responses associated with the treatments previously administered. This results in a marked heterogeneity of clinical situations encountered during the treatment of these patients. Some patients with iNHL will remain well treated using available treatments, whereas others will develop disease refractory to conventional approaches and become candidates for novel treatments and clinical trials. Additional real-world data regarding patient characteristics at relapse, patterns of care, expectations of response rates and duration, and survival outcomes are lacking in the setting of relapsed and refractory iNHL. To help inform treatment decisions by health care providers treating patients with iNHL in this complex and evolving treatment landscape, Dr Martin will describe approaches for sequencing therapies. To optimally individualize treatment strategies for patients with previously untreated and relapsed iNHL, the risks and benefits of the available options should be well known. This lecture will enable providers to effectively discuss the goals of therapy with the patient at each intervention, which is also critical in providing an optimal sequence of therapy.

Although many patients with FL experience long or possibly near-normal life expectancies, there remains persistent variability in patient outcomes.19-22 Patients who relapse within 2 years of first-line chemoimmunotherapy or with histologic transformation are at risk for early mortality and are high-priority candidates for novel treatment strategies evaluated in clinical trials.23-25 Prior studies have demonstrated diminishing DOR by line of therapy.26,27

However, variability of iNHL disease biology, treatment options, and treatment patterns complicate outcome assessments based on line of therapy alone. Several novel and targeted therapies are being developed and evaluated in patients with relapsed iNHL, including cereblon inhibitors, antiCD20-CD3 bispecific antibodies, and additional anti-CD19 CAR T-cell therapies. Dr Nastoupil will provide key insights on the novel therapies available for patients in clinical trials and those that are establishing pathways toward applications in clinical settings.

CAR therapy targeting CD19 is one promising treatment for patients with relapsed or refractory FL and CD19+ iNHLs. Patients who are candidates for CAR T-cell therapy often have symptomatic disease that could be fatal if left untreated. Dr Jacobson will discuss strategies for bridging therapy, which may include chemotherapy, targeted therapy, or radiation therapy; approved and experimental CAR T-cell approaches for FL and iNHLs; and describe traditional and novel adverse events and outcomes from clinical trials involving CAR T-cell therapy.

REFERENCES:

1. Sarkozy C, Maurer MJ, Link BK, et al. Cause of death in follicular lymphoma in the first decade of the rituximab era: a pooled analysis of French and US cohorts. J Clin Oncol. 2019;37(2):144-152. doi:10.1200/JCO.18.00400

2. Bachy E, Seymour JF, Feugier P, et al. Sustained progression-free survival benefit of rituximab maintenance in patients with follicular lymphoma: long-term results of the PRIMA study. J Clin Oncol. 2019;37(31):2815-2824. doi:10.1200/JCO.19.01073.

3. Becnel MR, Nastoupil LJ, Samaniego F, et al. Lenalidomide plus rituximab (R 2 ) in previously untreated marginal zone lymphoma: subgroup analysis and long-term follow-up of an open-label phase 2 trial. Br J Haematol. 2019;185(5):874-882. doi:10.1111/bjh.15843

4. Strati P, Jain P, Johnson RJ, et al. Long-term follow-up of lenalidomide and rituximab as initial treatment of follicular lymphoma. Blood. 2021;137(8):1124-1129. doi:10.1182/blood.2020007994

5. Watanabe T, Tobinai K, Wakabayashi M, et al; JCOG0203 Collaborators. Outcomes after R-CHOP in patients with newly diagnosed advanced follicular lymphoma: a 10-year follow-up analysis of the JCOG0203 trial. Lancet Haematol. 2018;5(11):e520-e531. doi:10.1016/S2352-3026(18)30155-8

6. Araf S, Wang J, Korfi K, et al. Genomic profiling reveals spatial intra-tumor heterogeneity in follicular lymphoma [published correction appears in Leukemia. 2019;33(6):1540]. Leukemia. 2018;32(5):1261-1265. doi:10.1038/s41375-018-0043-y

7. Green MR, Gentles AJ, Nair RV, et al. Hierarchy in somatic mutations arising during genomic evolution and progression of follicular lymphoma. Blood. 2013;121(9):1604-1611. doi:10.1182/blood-2012-09-457283

8. Green MR, Kihira S, Liu CL, et al. Mutations in early follicular lymphoma progenitors are associated with suppressed antigen presentation. Proc Natl Acad Sci U S A. 2015;112(10):E1116-E1125. doi:10.1073/pnas.1501199112

9. Okosun J, Bdr C, Wang J, et al. Integrated genomic analysis identifies recurrent mutations and evolution patterns driving the initiation and progression of follicular lymphoma. Nat Genet. 2014;46(2):176-181. doi:10.1038/ng.2856

10. Kumar E, Pickard L, Okosun J. Pathogenesis of follicular lymphoma: genetics to the microenvironment to clinical translation. Br J Haematol. Published online March 10, 2021. doi:10.1111/bjh.17383

11. Okosun J, Montoto S, Fitzgibbon J. The routes for transformation of follicular lymphoma. Curr Opin Hematol. 2016;23(4):385-391. doi:10.1097/MOH.0000000000000255

12. Flowers CR, Leonard JP, Fowler NH. Lenalidomide in follicular lymphoma. Blood. 2020;135(24):2133-2136. doi:10.1182/blood.2019001751

13. Dreyling M, Santoro A, Mollica L, et al. Phosphatidylinositol 3-kinase inhibition by copanlisib in relapsed or refractory indolent lymphoma. J Clin Oncol. 2017;35(35):3898-3905. doi:10.1200/JCO.2017.75.4648

14. Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: a phase II study of duvelisib (IPI-145) in patients with refractory indolent non-Hodgkin lymphoma. J Clin Oncol. 2019;37(11):912-922. doi:10.1200/JCO.18.00915

15. Gopal AK, Kahl BS, de Vos S, et al. PI3K inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-1018. doi:10.1056/NEJMoa1314583

16. Jacobson C, Chavez JC, Sehgal AR, et al. Primary analysis of zuma-5: a phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood. 2020;136(suppl 1):40-41. doi:10.1182/blood-2020-136834

17. Metzner B, Pott C, Mller TH, et al. Long-term clinical and molecular remissions in patients with follicular lymphoma following high-dose therapy and autologous stem cell transplantation. Ann Oncol. 2013;24(6):1609-1615. doi:10.1093/annonc/mds657

18. Morschhauser F, Tilly H, Chaidos A, et al. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020;21(11):1433-1442. doi:10.1016/S1470-2045(20)30441-1

19. Flowers CR, Leonard JP, Nastoupil LJ. Novel immunotherapy approaches to follicular lymphoma. Hematology Am Soc Hematol Educ Program. 2018;2018(1):194-199. doi:10.1182/asheducation-2018.1.194

20. Leonard JP, Nastoupil LJ, Flowers CR. Where to start? Upfront therapy for follicular lymphoma in 2018. Hematology Am Soc Hematol Educ Program. 2018;2018(1):185-188. doi:10.1182/asheducation-2018.1.185

21. Nastoupil LJ, Flowers CR, Leonard JP. Sequencing of therapies in relapsed follicular lymphoma. Hematology Am Soc Hematol Educ Program. 2018;2018(1):189-193. doi:10.1182/asheducation-2018.1.189

22. Salles G. How do I sequence therapy for follicular lymphoma? Hematology Am Soc Hematol Educ Program. 2020;2020(1):287-294. doi:10.1182/hematology.2020000156

23. Casulo C, Byrtek M, Dawson KL, et al. Early relapse of follicular lymphoma after rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone defines patients at high risk for death: an analysis from the National LymphoCare Study. J Clin Oncol. 2015;33(23):2516-2522. doi:10.1200/JCO.2014.59.7534

24. Casulo C, Friedberg JW, Ahn KW, et al. Autologous transplantation in follicular lymphoma with early therapy failure: a National LymphoCare Study and Center for International Blood and Marrow Transplant Research analysis. Biol Blood Marrow Transplant. 2018;24(6):1163-1171. doi:10.1016/j.bbmt.2017.12.771

25. Casulo C, Nastoupil L, Fowler NH, Friedberg JW, Flowers CR. Unmet needs in the first-line treatment of follicular lymphoma. Ann Oncol. 2017;28(9):2094-2106. doi:10.1093/annonc/mdx189

26. Batlevi CL, Sha F, Alperovich A, et al. Follicular lymphoma in the modern era: survival, treatment outcomes, and identification of high-risk subgroups. Blood Cancer J. 2020;10(7):74. doi:10.1038/s41408-020-00340-z

27. Link BK, Day BM, Zhou X, et al. Second-line and subsequent therapy and outcomes for follicular lymphoma in the United States: data from the observational National LymphoCare Study. Br J Haematol. 2019;184(4):660-663. doi:10.1111/bjh.15149

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Pursuing Optimal Therapy Remains a Challenge in Indolent B-Cell Lymphoma - Targeted Oncology

Immusoft CEO Sean Ainsworth. (Immusoft Photo)

Seattle-based cell therapy startup Immusoft will collaborate with pharma giant Takeda to develop treatments targeted to the central nervous system in a deal worth potentially more than $900 million.

Immusofts technology involves engineering a patients B cells to mass produce therapeutic proteins. These immune cells are good at pumping out large amounts of proteins, such as an enzyme missing in a particular condition.

This advances our leadership position in B cells as biofactories for therapeutic protein delivery, said Immusoft CEO Sean Ainsworth in a statement.

The new partnership will focus on delivering protein therapeutics across the blood-brain barrier to treat rare neurometabolic conditions. Under the agreement, Takeda has options to exclusively license programs at the preclinical stage and will take products to the clinic and through commercialization. Immusoft will receive research funding support and an undisclosed upfront payment, with total value of option fees and milestone payments of potentially more than $900 million.

Immusofts most advanced therapeutic program is designed to treat a rare enzyme deficiency disorder, Hurler syndrome. The company aims to file an investigational new drug application for the condition with the U.S. Food and Drug Administration by the end of the year, according to its website, a key step toward a clinical trial.

Ainsworth, a veteran biotech exec, has led the company since 2018 when he replaced Matthew Scholz, who founded the company in 2009 and is now CEO of Oisn Biotechnologies. Ainsworth previously founded gene therapy company RetroSense Therapeutics, which sold to Allergan in 2016 in a deal worth up to $555 million.

Immusoft closed a $33 million Series B round last year, noted FierceBiotech.

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Cell therapy startup Immusoft lands deal with Takeda worth potentially more than $900M - GeekWire

NEW YORK Treadwell Therapeutics said on Friday that it has acquired the firm TCRyption, bringing its T-cell receptor (TCR)-based autologous therapies into its pipeline.

With the acquisition of TCRyption, a TIO Bioventures portfolio company, Treadwell also gains access to TCRyption's platform for developing cancer therapies, which is designed to identify TCRs that can recognize epitopes regardless of their haplotype. In the past, autologous TCR-based cell therapies for cancer have been limited to TCRs that recognize epitopes with specific haplotypes namely HLA-A2. According to Treadwell, the HLA-A2 restricted epitopes, most notably NY-ESO-1, are well represented in Caucasian patient populations, and therapies against these targets can lead to durable remissions in these cases, but the restriction can limit patient eligibilityas well as commercial opportunity.

Using TCRyption's platform, Treadwell hopes to identify TCRs beyond the HLA-A2 restriction, including class I and II alleles prevalent in Asian patient populations.

"We believe that the TCRypt platform will allow us to move beyond the narrow focus on HLA-A2 restricted epitopes, and greatly expand the patient populations that can be addressed by this approach," Michael Tusche, Treadwell Therapeutics' co-CEO, said in a statement, adding that the firm hopes to bring several of these TCR therapies into clinical studies for multiple tumor types beginning in early 2023.

Beyond its TCR-based autologous cell therapy programs, New York City-based Treadwell Therapeutics is also focused on developing several targeted agents in its pipeline, including its PLK4 kinase inhibitor, CFI-400945, and its TTK inhibitor, CFI-402257, as treatments for various cancer types including prostate and breast cancers.

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Treadwell Therapeutics Acquires T Cell Therapy Firm TCRyption - Precision Oncology News