Category Archives: Cell Therapy

The open-label, randomized BRUIN trial will compare LOXO-305 to investigators choice of either ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa). Approximately 500 patients will be enrolled in the study.

"MCL patients who have been treated with a covalent BTK inhibitor have very few therapeutic options, and outcomes are extremely poor. LOXO-305 has demonstrated a promising efficacy profile in these patients, a setting where we urgently need new therapies," said Michael Wang, MD, Puddin Clarke Endowed professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, in a press release.

The primary end point of BRUIN is progression-free survival (PFS), and the secondary end points include event-free survival, time to treatment failure, time to worsening of MCL-related symptoms, comparative tolerability, overall response rate (ORR), duration of response, and overall survival.

A confirmed diagnosis of MCL is required for inclusion in the study as well as being previously treated with at least 1 prior line of systemic therapy for MCL, having measurable disease per Lugano criteria, having an ECOG performance status of 0 to 2, and having adequate laboratory values at baseline.

In the case of prior treatment with an FDA-approved or investigational BTK inhibitor, patients are ineligible to enroll in the study. According to the criteria, patients are also excluded if they have a history of bleeding diathesis, stroke, or intracranial hemorrhage within 6 months of randomization, and prior allogeneic stem cell transplant (ASCT) or chimeric antigen receptor (CAR) T-cell therapy within 60 days of randomization. In addition, patients with significant cardiovascular disease, and other comorbidities that may interfere with study treatment are not eligible to enroll.

Treatment with LOXO-305 has already shown promise for the treatment of 323 patients with previously treated B-cell malignancies. In the phase 1/2 BRUIN study, the use of the agent was investigated in patients with MCL, chronic lymphocytic leukemia/small lymphocytic leukemia, Waldenstroms macroglobulinemia (WM), and other B-cell malignancies. The patients were pretreated with a BTK inhibitor (95%), anti-CD20 antibody (98%), chemotherapy (92%), lenalidomide (Revlimid; 20%), autologous transplant (25%), CAR T-cell therapy (5%), and ASCT.3

According to data presented during the 2020 American Society of Hematology Annual Meeting, the ORR observed with LOXO-305 in 59 efficacy-evaluable patients from the MCL cohort was 52% (95% CI, 38%-65%), which included 14 complete and 15 partial responses. The median time to the first response in these patients was 1.8 months.

In the WM cohort of 19 efficacy-evaluable patients, the ORR observed was 68% (95% CI, 44%-87)%, which notably was similar in patients who were previously treated with a BTK inhibitor (69%; 95% CI, 39%-91%). Further, 4 out of 8 patients with follicular lymphoma had a response to LOXO-305, in addition to 75% of the evaluable Richter's transformation cohort, and 8 out of 35 patients with other B-cell malignancies, including diffuse large B-cell lymphoma and marginal zone lymphoma.

The most commonly reported adverse events (AEs) with LOXO-305 in the phase 1/2 BRUIN study were fatigue (20%), diarrhea (17%), and contusion (13%). Eight percent of patients had dose interruptions due to AEs, while 2.2% had dose reduction, and 1.5% permanently discontinued treatment with LOXO-305.

LOXO-305 was designed to overcome some of the limitations seen with current BTK therapies and we believe the promising efficacy and tolerability data demonstrate its potential to be an important new treatment option for MCL patients, said David Hyman, MD, chief medical officer of Loxo Oncology at Lilly, in a press release.

References:

1. Mato AR, Pagel JM, Coombs CC, et al. 542LOXO-305, a next generation, highly selective, non-covalent BTK inhibitor in previously treated CLL/SLL: results from the phase 1/2 bruin study. . Presented at: 2020 ASH Annual Meeting and Exposition. December 4-8, 2020; Virtual. Abstract 542.

2. Study of BTK inhibitor LOXO-305 versus approved BTK inhibitor drugs in patients withmantle cell lymphoma(MCL) (BRUIN-MCL-321). Clnicaltrials.gov. Accessed August 17, 2021. https://bit.ly/3CXTgu4

3. Loxo Oncology at Lilly announces updated data from the phase 1/2 BRUIN Clinical Trial for LOXO-305 in mantle cell lymphoma and non-Hodgkin lymphomas at the American Society of Hematology (ASH) Annual Meeting. News release. Loxo Oncology at Lilly. December 5, 2020. accessed August 17, 2021. https://prn.to/37QNw7a

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Head-To-Head Phase 3 Trial To Evaluate BTK Inhibitors in MCL - Targeted Oncology

For patients with amyotrophic lateral sclerosis (ALS), the prognosis is dire. According to National Institutes of Health statistics, most people succumb to the neurogenerative disease within three to five years of receiving the diagnosisand while there are therapies that may help the symptoms, to date there is no treatment for the disease itself.

Coya Therapeutics, a clinical-stage biotechnology firm that focuses on the discovery and development of treatments for neurogenerative diseases, believes it might have come upon a treatment that offers hope for ALS sufferers.

Coya Therapeutics CEO Howard Berman spoke with Outsourcing-Pharma about the companys innovative research around regulatory T-cells (Tregs), how research has progressed, and what it might mean for patients with ALS.

OSP: Could you please share a little bit of perspective about why ALS is especially worthy of researchers attention?

HB: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. This results in the deterioration of muscle, loss of movement, and eventual paralysis.

There are an estimated 30,000 people living with ALS in the US at any given time. Every 90 minutes, someone is diagnosed with ALS. About 90% of all ALS cases are sporadic with no known history of the disease in a family. The remaining 10% of cases are known as familial ALS.

This is a horrendous and progressive disease that some patients describe as being buried alive, as the disease progressively destroys muscle controlling motor neurons, eventually paralyzing the individual and ultimately the muscles used to breathe. All while the patients mind, personality, intelligence, or memory remains intact.

There are no meaningful treatments that are available and the ones approved measure success by only slightly reducing deterioration, and the clinical trial landscape has been littered with many failures due to the complexity of the disease process and inability to control the underlying progenitor that leads to the decline of the patient, which is runaway inflammation. Our goal at Coya is to go beyond incremental improvements in care; rather, we aim to exponentially challenge the current treatment paradigm and transform the disease to a long term chronic

OSP: Please talk about the progress (or more accurately, the lack thereof) in the search for ALS treatments.

HB: The treatment landscape is littered with many failures and this is due to a number of reasons, including misleading preclinical data in mice models, poor clinical trial design and methodological issues, phenotypic heterogeneity of ALS patients, and insensitive biomarkers to stratify patients. Moreover, we now know that inflammation drives the disease decline and prior treatments targeting inflammatory processes have focused on one immune pathway or cytokine, but we know that the immune system is complex, and single pathway blockade will be insufficient to dampen the runaway inflammation.

This is why we are so excited about our Treg cell therapy, as it introduces a highly immunosuppressive cell type that is upstream of the majority of immune pathways.

OSP: Could you please discuss the pioneering ALS research involving Tregs, and why this is especially important/promising?

HB: We have learned a tremendous amount in the past 20 years, but the most significant is that the spread and decline of the disease is really a consequence of how cells around the nerves (macrophages and microglial cells, which are important cells of the immune system) respond to the dying motor neurons. Its once this inflammatory process is triggered that the disease becomes debilitating and the patients decline starts to rapidly increase.

Much of the seminal work which mapped out the role of the immune system in ALS decline and deterioration was done in the laboratory and clinic of the head of our scientific advisory board Stan Appel. He discovered that regardless of the mutation or underlying cause of the disease, peripheral inflammation was directly tied to the patients survival and rate of decline and was driven by the dysfunction of a critical immune cell called the regulatory T cell or Treg.

Tregs have the ability to regulate the activity of other immune cells, such as the pro-inflammatory macrophages and microglial cells, acting as a stop sign when the system is overreactive. Because these cells can infiltrate the brain and spinal cord, they hold the potential to reduce the inflammation characteristic of ALS.

When you measure the blood of a patient with fast progressing ALS, you find increased levels of M1 pro-inflammatory macrophages, pro-inflammatory T cells, and cytokines. But the most significant finding is the decreased function and number of Tregs.

Coya has learned how to remove the dysfunctional Tregs from the patient from an apheresis and repair these cells back to a functional status as well as expand the new, highly suppressive Tregs into billions of cells for reinfusion back to the patient to stop the runaway inflammation and aim to stop ALS progression.

We have revolutionized Treg cell therapy and Treg exosome manufacturing steps with cryopreservation techniques that allow for an industrialized supply chain management process--single manufacturing run once per year produces enough patient doses or a full years supply that can be stored, shipped, rethawed, and infused at remote, outpatient facilities

Our Treg cell therapy platform aims to slow and halt the progression of not only ALS but other neurodegenerative diseases. These other diseases include Alzheimers Disease, Frontotemporal Dementia, Parkinson's Disease, various autoimmune conditions, in addition to ALS.

OSP: Your Treg cell therapy is in the final stages of its Phase IIa trialcould you please offer detail about the clinical progress to date, when data might be available, etc.?

HB: This is an exciting time for our team at Coya. We had completed a Phase I trial and recently completed our Phase IIa trial, and the data is now in review by our team, Mass General, and other notable scientists. We are expecting to publish the data at the end of summer and look forward to sharing this with you and your readership.

We have learned a tremendous amount from our Phase I and IIa trials. Our Phase I trial showed that regulatory T cell infusions can stop progression and stabilize patients and are safe to infuse. Stopping disease progression is rarely seen in ALS trials. Our goal in our Phase IIa trial is to show that in the majority of cases, that we can replicate what we saw in our phase 1 study, specifically halting the progression of disease with maintenance monthly infusions and an excellent safety profile.

Moreover, we are taking additional steps to ensure that our next series of trials (post Phase IIa) are successful by implementing and leveraging correlative markers and biomarkers which are linked to efficacy signals. By personalizing a trial through biomarker-driven analysis, as is done regularly in Oncology, one significantly enriches for the correct patient population. Prior ALS trials have not been successful in this approach. By collecting a vast amount of proteomics data, immune-based profiling, and RNA expression correlations, we are aiming to be able to better stratify responders vs. nonresponders.

OSP: Can you talk about any challenges ALS trials might face that are unique to research centered on the condition? Please feel free to talk about challenges experienced by trial staff, as well as patients obstacles.

HB: ALS trials have been limited by misleading preclinical data in mice models, poor clinical trial design and methodological issues, phenotypic heterogeneity of ALS patients, and insensitive biomarkers to stratify patients. Learning from these past failures and these limitations will enable Coya to design a trial that leverages the strength of the Treg mechanism of action for the right patient population who will benefit the most.

OSP: Then, how might this research impact other diseases (you mention Alzheimers and other neurodegenerative diseases)?

HB: Our Treg cell therapy is in development aiming to treat ALS, frontotemporal dementia, scleroderma, and other neurodegenerative diseases. We strongly believe that our platform will greatly benefit patients suffering from several other neurogenerative diseases. These and multiple diseases are driven by dysfunctional Tregs and these conditions are ripe for leveraging our therapy.

Moreover, we are developing Treg-derived exosome therapeutics which have the potential to be given an allogeneic manner, which will enable a more scalable solution. We have shown that our exosomes are significantly more neuroprotective and immunosuppressive than mesenchymal and platelet-derived exosomes (that are currently the standard in other company approaches) and we plan to bring this therapy to the clinic in 2022.

OSP: Is there anything youd like to addabout your company, this research, ALS, etc?

HB: We recently were granted orphan drug status for ALS001 and are working to make a true impact in the ALS community.

We are developing disruptive, first-in-class, autologous regulatory Treg and allogeneic exosome therapies - leveraging the seminal discoveries from the laboratory of Stanley Appel M.D., in which dysfunctional Tregs modulate neurodegenerative and autoimmune diseases. Dr. Appel has been a major advocate in the fight against ALS and other neurodegenerative diseases. With his knowledge, our strong management team, leading board of directors, and scientific advisory boards expertise, we are in a position to change how the world looks at these diseases.

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Treg cell therapy showing promise in ALS trials: Coya Therapeutics - OutSourcing-Pharma.com

MAINZ, Germany & SANTA MONICA, Calif.--(BUSINESS WIRE)--BioNTech SE (Nasdaq: BNTX, BioNTech) and Kite, a Gilead Company (Nasdaq: GILD, Kite) today announced the closing of the acquisition of the solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facilitys assets and leases in Gaithersburg, MD, from Kite. The transaction was announced on July 19, 2021.

The acquisition strengthens BioNTechs cell therapy pipeline by accelerating the individualized solid tumor Neoantigen TCR cell therapy research and development program. It also expands the Companys cell therapy capabilities and manufacturing footprint in North America, building on its acquisition of Neon Therapeutics in 2020. With three acquisitions completed in the last 14 months, BioNTech confirms its strategy of complementing organic growth through targeted acquisitions that expand its capabilities and accelerate development of its broad immunotherapy pipeline.

All Kite employees at the Gaithersburg facility were offered employment with BioNTech prior to closing. The plant will be fully integrated into BioNTechs US-operations and the global manufacturing network.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer. For more information, please visit http://www.BioNTech.de.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead and Kite Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

BioNTech Forward-Looking Statements

This press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding the expected impact of the acquisition on BioNTechs business; the creation of long-term value for BioNTech shareholders; potential synergies between BioNTech and the acquired Kite assets; and BioNTechs global expansion strategy. Any forward-looking statements in this press release are based on BioNTech managements current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the reaction of third parties to the proposed merger, the retention of employees at the acquired sites, BioNTechs plans with respect to the acquired assets, the future growth of BioNTechs business and the possibility that integration following the proposed acquisition may be more difficult than expected, uncertainties related to the initiation, timing and conduct of studies and other development requirements for the acquired TCR product candidates; the risk that any one or more of the acquired product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future studies or trials; and risks related to BioNTechs ability to protect and maintain the acquired intellectual property position.

For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SECs website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Kite, the Kite logo and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the companys website at http://www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

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BioNTech Completes Acquisition of Kite's Neoantigen TCR Cell Therapy R&D Platform and Manufacturing Facility in Gaithersburg, Maryland - Business Wire

August 2021 marks the fourth year since the U.S. Food and Drug Administration approved cellular therapy implementing specialized chimeric antigen receptor T-cells for cancer treatment.

These CAR T-cells (as theyre known colloquially) form a type of protein with genetically-modified T-cells that are engineered to replicate an artificial T-cell receptor used clinically within immunotherapy. Unlike pre-existing, naturally-formed T-cells, these CAR T-cells are able to target certain proteins, specifically cancerous cells invading the body.

In efforts to improve cancer immunotherapy and commercialize the treatment introduced by CAR T-cells, the University of Pennsylvania alongside the Childrens Hospital of Philadelphia established Kymriah with Novartis and the Lymphoma Research Foundation for the CAR T-cell therapy.

Specifically, research and clinical trials at Penns Perelman School of Medicine and CHOP worked in collaboration with facilities from Novartis to gain FDA approval.

This breakthrough was especially positive for youngpatients who sought treatment for various forms of blood cancer. With CAR T-cells, patients could battle the cancer from within.

The new treatment would alter patients own T-cells within the immune system.

Then, at a Novartis manufacturing facility, the cells would be collected and modified to create CAR T-cells.

Finally, these potential CAR T-cells would distinguish cancerous cells from healthy ones, eventually destroying the invading leukemia cells. The specific protein they target in leukemia patients is known as CD19.

The CAR T-cells also act similarly to any immune system cells inside the body, and multiply at rapid rates with even 10,000 new cells originating from one new CAR T-cell.

As a result of the successful cell engineering, leukemia patients have experienced high remission rates.

Initially, the treatment was created for patients suffering from B-cell precursor acute lymphoblastic leukemia (ALL) in refractory, second stages, or relapse.

In 2017, these patients could also be up to 25 years of age, but as the CAR T technology underwent numerous clinical trials, the ages of patients expanded.

At one trial at UPenn and CHOP implementing huCART19 in diagnosed B-ALL patients, the ages eligible for examination ranged from 1 to 29 years. However, the primary application of these CAR T-cells appeared to be within pediatric care.

The first pediatric patient in the world, six-year-old Emily Whitehead, was able to have treatment injecting the engineered CAR T-cells after searching for alternative care options for her leukemia.

Following close examination, Whiteheads cancer appeared to be in remission, similar to the outcomes found in larger clinical trials.

Penns Abramson Cancer Center reported that after four years of FDA approval and five years after the initial treatment of Kymriah and CAR T-cells, non-Hodgkin lymphoma patients continue on their paths of remission.

Senior author Stephen J. Schuster, MD, the director of the Lymphoma Program at the Abramson Cancer Center, and assistant professor in Hematology-Oncology at the Perelman School of Medicine Marco Ruella, MD worked in CAR T-cell research to discover the outcomes of this FDA-approved cellular therapy.

According to Penn Medicines news journal, after examining 24 patients with an aggressive form of lymphoma who had treatment after their cancers, came back following standard care

Forty-six percent achieved complete remission and 31% achieved progression-free survival at five years, read the Penn Medicine report.

Also, following a separate 14 patients with another form of non-Hodgkins lymphoma, 71% achieved complete remission and 43% achieved progression-free survival at five years.

This specific research underscores the most extended follow-up care relating to CAR T-cell therapy.

With official published data and an FDA approval, this form of immunotherapy is proving to be effective within both pediatric and adult patients with relapsed or refractory large B-cell (aggressive) lymphomas.

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Where does CAR T-cell cancer therapy stand after its FDA approval? - AL DIA News

This article was originally published here

Blood Adv. 2021 Aug 10;5(15):2982-2986. doi: 10.1182/bloodadvances.2021004554.

ABSTRACT

Chimeric antigen receptor (CAR) T-cells have emerged as an efficacious modality in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). Clonal hematopoiesis of indeterminate potential (CHIP), a state in which mutations in hematopoietic cells give rise to a clonal population of cells, is more common in patients exposed to cytotoxic therapies, has been shown to influence inflammatory immune programs, and is associated with an adverse prognosis in patients with NHL and MM receiving autologous transplantation. We therefore hypothesized that CHIP could influence clinical outcomes in patients receiving CAR T-cell therapy. In a cohort of 154 patients with NHL or MM receiving CAR T-cells, we found that CHIP was present in 48% of patients and associated with increased rates of complete response and cytokine release syndrome severity, but only in patients younger than age 60 years. Despite these differences, CHIP was not associated with a difference in progression-free or overall survival, regardless of age. Our data suggest that CHIP can influence CAR T-cell biology and clinical outcomes, but, in contrast to autologous transplantation, CHIP was not associated with worse survival and should not be a reason to exclude individuals from receiving this potentially life-prolonging treatment.

PMID:34342642 | DOI:10.1182/bloodadvances.2021004554

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Clonal hematopoiesis in patients receiving chimeric antigen receptor T-cell therapy - DocWire News

Jae H. Park, MD, discusses emerging CAR T-cell therapies in hematologic malignancies.

Jae H. Park, MD, hematologic oncologist, Memorial Sloan Kettering Cancer Center, discusses emerging CAR T-cell therapies in hematologic malignancies.

Allogeneic CAR T-cell therapies are emerging for use in hematologic malignancies, such as leukemia, lymphoma, and multiple myeloma, as a potential strategy to shorten manufacturing time and increase accessibility to immune effector cell therapy, Park says. Further data are needed to determine if the off-the-shelf approach will yield similar rates of durable remission compared with autologous CAR T-cell therapies, Park adds. Additionally, some allogeneic products are utilizing modified or unmodified natural killer cells rather than T cells, Park explains.

Another emerging strategy is with dual-targeting CAR T-cell therapy, Park says. Particularly in leukemia, antigen escape has been observed as a driver of treatment resistance, Park explains. Dual-targeting therapies have the potential to overcome antigen escape, Park adds.

In acute myeloid leukemia (AML), cellular therapy has not demonstrated significant success because myeloid and leukemic cells do not express an exclusive target, Park says. As such, dual-targeted or armored CAR T-cell therapies could overcome tumor microenvironment resistance and effectively treat AML, other hematologic malignancies, and some solid tumors, Park concludes.

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Dr. Park on Emerging CAR T-Cell Therapies in Hematologic Malignancies - OncLive

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Wednesday, August 11, 2021, at 8:00 a.m. ET to review its second quarter 2021 financial results and provide an update on the company.

Management will discuss the companys progress during the quarter, including advances in the development of omidubicel, which has the potential to be the first approved cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant, following the planned BLA submission in the fourth quarter of 2021. Gamida Cell will also provide an update on its pipeline of NAM-enabled natural killer (NK) cell therapies, including GDA-201 and genetically-modified NK cell constructs. The Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.

The webcast will be available on the Investors & Media section of the Gamida Cell website at http://www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 9949715. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the anticipated submission of a BLA for omidubicel and an IND for GDA-201, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to Gamida Cells ability to prepare regulatory filings and the review process therefor; complications in Gamida Cells ability to manufacture its products; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended on March 22, 2021, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

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Gamida Cell Announces the Date of Its Second Quarter 2021 Financial Results and Webcast - Business Wire

Tycel Jovelle Phillips, MD, discusses the future of CAR T-cell therapy in mantle cell lymphoma patients.

Tycel Jovelle Phillips, MD, clinical associate professor, Division of Hematology and Oncology, Department of Internal Medicine, Rogel Cancer Center, Michigan Medicine, discusses the future of CAR T-cell therapy in mantle cell lymphoma (MCL) patients.

Based on published data, CAR T-cell therapy appears to be agnostic to some of the high-risk features that distinguish frontline treatment outcomes in patients with MCL, Phillips says. As such, this modality may have clinical utility as up-front treatment to improve outcomes in patients with high-risk disease, Phillips explains. However, developing improved toxicity management, particularly with regard to CAR T-cell therapyrelated neurotoxicity, is important in MCL, Phillips adds.

Increased exposure to using CAR T-cell therapy will increase provider comfortability with the modality and improve toxicity-management strategies, Phillips continues. With additional data emerging, FDA approvals of novel CAR T-cell therapies in MCL could be on the horizon to provide more options to patients, Phillips concludes.

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Dr. Phillips on the Future of CAR T-Cell Therapy in MCL - OncLive

The powerhouse of the cellis powering a new collaboration pact between Astellas Pharma and Minovia Therapeutics, with the latter receiving $20 million upfront for the joint work on cell therapies.

The Japanese Big Pharma will also pay the U.S.-Israel biotechup to $420 million in biobucks for each cell therapy commercialized for diseases caused by mitochondrial dysfunction, under the terms of the deal revealed Friday.

Mitochondrial dysfunction occurs when the mitochondria, which produce much of a cell's energy, don't work as well as they should due to another disease or condition. Many conditions can lead to secondary mitochondrial dysfunction and affect other diseases, including Alzheimer's disease, muscular dystrophy, Lou Gehrig's disease, diabetes and cancer.

The collab license pact focuses specifically on allogeneic mitochondrial cell therapies. Astellas will contribute cells from its genetically-engineered, induced pluripotent stem cells. Minovia meanwhile will hand forth its mitochondrial augmentation therapy platform. The biotech is currently testing the MAT platform in a phase 1 study of Pearson Syndrome, a childhood bone marrow disease.

RELATED:Mitochondrial biotech Minovia Therapeutics nabs biopharma veteran Jacobs as new chief medical officer

"We, at Astellas, have positioned mitochondrial biology as one of the Primary Focuses of our research and development strategy to develop therapies for patients with unmet medical needs. One of the aspirations of this Primary Focus is to establish a mitochondrial cell therapy platform," saidAstellas Chief Financial Officer Naoki Okamura in a statement.

The goal is to treat diseases by transferring healthy mitochondria to restore patients' tissues. This involves isolating a patient's own cells, providing them with healthy mitochondria from a donor and then re-infusing back into the patient.

The mitochondrial biology pact with Minovia follows Astellas' deals in the space in recent years. The Big Pharma acquiredMitobridge in late 2017 and, more recently, Nanna Therapeutics in April 2020.

The Mitobridge deal appears to have produced three clinical-stage assets for the Astellas pipeline. Mitobridge is listed as a partner on Astellas'mitochondria biology primary focus areas in a July 30 pipeline update, with a phase 2 acute kidney injury small molecule, a phase 2 primary mitochondrial myopathy small molecule and a phase 1 Duchenne muscular dystrophy treatment hopeful.

RELATED:Astellas buys DMD drug in $450M mitochondrial takeover

"We share with Astellas both their passion for mitochondrial science and their commitment to patients in need of new therapies," said Natalie Yivgi-Ohana, Ph.D., Minovias CEO and co-founder, in a statement.

Editor's note: This article has been updated to delete an inaccurate reference to a collaboration between Takeda and PeptiDream.

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Astellas to pay Minovia $20M upfront, with $420M on the table per product, for mitochondrial cell therapies - FierceBiotech

MAINZ, Germany & Santa Monica, USA, August 4, 2021 -- https://www.globenewswire.com/Tracker?data=rd-GqRgZzMAvrqdXdlZCZtWIr-1HWyTArNNvmD50nTmy38yKOl694yPgCc1EUzlDcRwLvaSZZ4fDi_mgCtCcJHiWNl88xlgxSPnv7IbOjjdeab0WzFWQKlkR5EzJDzicbrsnGiyKImvL-HFAKL7CGwmGLHJXTKW7ZvKM4rA9sRBshh27SsRpJTPn8ZFQ9mHnC2si1RVdrYRU2P6aVAtM0VY2r5t4-AalziVQxO5lq6c= BioNTech SE (Nasdaq: BNTX, "BioNTech") and https://www.globenewswire.com/Tracker?data=H4C-hcf0HQdKBoPKhwSfI4dvQNZwKgjelS-XFyvXgYZRzf9yCeu4jV8cdqdaf7EVB8oISc0ioLW8qxctEjXrVQ== Kite, a Gilead Company (Nasdaq: GILD, "Kite") today announced the closing of the acquisition of the solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility's assets and leases in Gaithersburg, MD, from Kite. The transaction was https://www.globenewswire.com/Tracker?data=CtfxPETleqKZM8FjmNb2p9VDNQ4MG3ZK6vmaRnxQ3pgf0UeqRarcrzirdVO3a2EY7kIq1yRgO0Ekv6qJ86ZCKTaSJwZAkvIn7l2EXxmRfhq8rm7TRzW5qtOC9Kkvxsz_PbRdNy01WcUUEuJtqg7qEMkuqbswaA55I44kcWX52X6xqtFQTuoqDOq5d4s3RkQ0mVEF99kdYR5kBf3wLPuW9w== announced on July 19, 2021.

The acquisition strengthens BioNTech's cell therapy pipeline by accelerating the individualized solid tumor Neoantigen TCR cell therapy research and development program. It also expands the Company's cell therapy capabilities and manufacturing footprint in North America, building on its https://www.globenewswire.com/Tracker?data=VdCDxXoP-JoGhXT3wCAyucc4Lk9MyzwgAaIOz2VimsXf8opXSPOGA3ASQ1yCdSh1dokBArMCqzmyLMofB2u2YL4Flw5Y-VI613GHw5ARdG9rGuNJ0i5sKnxnz5Jq-gq7mFbZBuIIhM7aN2hx3XE2XB1qaYXfFR-baRhDJCm56nV6Z_7foaUzGn36eWoDNFcFkwL58FTs4cIVuT6D4FHfSoaXEFc0b_1Zi3TIH0oHDb61D3mk92r8SUNKZPBOB57q acquisition of Neon Therapeutics in 2020. With three acquisitions completed in the last 14 months, BioNTech confirms its strategy of complementing organic growth through targeted acquisitions that expand its capabilities and accelerate development of its broad immunotherapy pipeline.

All Kite employees at the Gaithersburg facility were offered employment with BioNTech prior to closing. The plant will be fully integrated into BioNTech's US-operations and the global manufacturing network.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer. For more information, please visit http://www.BioNTech.de.

BioNTech Forward-Looking Statements

This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding the expected impact of the acquisition on BioNTech's business; the creation of long-term value for BioNTech shareholders; potential synergies between BioNTech and the acquired Kite assets; and BioNTech's global expansion strategy. Any forward-looking statements in this press release are based on BioNTech management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the reaction of third parties to the proposed merger, the retention of employees at the acquired sites, BioNTech's plans with respect to the acquired assets, the future growth of BioNTech's business and the possibility that integration following the proposed acquisition may be more difficult than expected, uncertainties related to the initiation, timing and conduct of studies and other development requirements for the acquired TCR product candidates; the risk that any one or more of the acquired product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future studies or trials; and risks related to BioNTech's ability to protect and maintain the acquired intellectual property position.

For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Kite, the Kite logo and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company's website at https://www.globenewswire.com/Tracker?data=Vx9hjgANMsd296jYISCp9j5WTYOgbp1nUaGrtGdY-XwKsS7q8Xbas0WOSSPaMevMAi3MH0WpwnrbcpP4m0_tvro9p6_0zCOeoQMoEQTwGSU= http://www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter https://www.globenewswire.com/Tracker?data=iFWoF7pnp6Sh28S8ykqkp00YZ8BkMxqeqTTN_f3GN6cKOqpAwF6R_rBzCXTp0ou8Ljvs_HYgoCeh_F5CL_DGrBR3uS3BoS-KKJVmcoIPTdI= (@KitePharma) and https://www.globenewswire.com/Tracker?data=3NXdf6zn8By3dflg7qXH5uT4yrCKpqWnXKZIDQG92uIXhw6KVuzYROc6TJiexbaWoeod6tPERXdEsroV6DXYhpiDebAF6jhGuRnoNNYHMgk_rh3okHpNqqIoK_9hEfL_ LinkedIn.

Gilead and Kite Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

BioNTech Contacts

Media Relations

Jasmina Alatovic

+49 (0)6131 9084 1513

https://www.globenewswire.com/Tracker?data=KEBimuH0_CJMJ1VDrSmGIqQl36hj4NgfZLmgx5dRIEYrKtZv9IAHKXGMauCxl4QUTBrPsVDBJ-x6XX05uCPzmV0BYGO_1W8FRga6VJ_2zpM= Media@biontech.de

Investor Relations

Sylke Maas, Ph.D.

+49 (0)6131 9084 1074

https://www.globenewswire.com/Tracker?data=53GtOCMcD2Wk9MPdvRd9a7ASxpHVRZy1tzs2F2VGIq1XoVe-SaHY0jXnpmNnrBmR06o2It-0ipxmYHFL3sG64sV8FcG7YcFN2_Or8X6xB8Q= Investors@biontech.de

Kite Contacts

Mary Lynn Carver, Media

+1 (410) 443-1853

Jacquie Ross, Investors

+1 (650) 358-1054

(END) Dow Jones Newswires

August 04, 2021 07:00 ET (11:00 GMT)

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Press Release : BioNTech Completes Acquisition of Kite's Neoantigen TCR Cell Therapy R&D Platform and Manufacturing Facility in Gaithersburg, Maryland...