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

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

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

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

A new technology for cellular immunotherapy developed by Abramson Cancer Center researchers at Penn Medicine showed promising anti-tumor activity in the lab against hard-to-treat cancers driven by the once-considered undruggable KRAS mutation, including lung, colorectal, and pancreatic.

The study, published in Nature Communications, successfully demonstrates using human cells that a T-cell receptor, or TCR, therapy could be designed to mobilize an immune system attack on mutated KRAS solid tumors and shrink them. The preclinical work has laid the groundwork for the first-in-human clinical trial now in the planning stages for the treatment of advanced pancreatic cancer in patients whose tumors harbor specific KRAS mutations and express a specific type of human leukocyte antigen, or HLA, the therapy is built to recognize.

Weve shown that targeting mutant KRAS immunologically is feasible and potentially generalizable for a group of patients with lung, colorectal, and pancreatic tumors, says senior author Beatriz M. Carreno, an associate professor of pathology and laboratory medicine in the Perelman School of Medicine and a member of the Center for Cellular Immunotherapies, the Abramson Cancer Center, and Parker Institute for Cancer Immunotherapy at Penn. We look forward to taking this research to the next level and closer to clinical study.

Read more at Penn Medicine News.

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New cell therapy shows potential against solid tumors with KRAS mutations | Penn Today - Penn Today

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

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Investor Relations

Sylke Maas, Ph.D.

+49 (0)6131 9084 1074

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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...

Bijal Shah, MD, MS, discusses the results of treatment with the chimeric antigen receptor T-cell therapy brexucabtagne autoleucel in the ZUMA-3 trial in patients with acute lymphoblastic leukemia.

Bijal Shah, MD, MS, an associate member in the Department of Malignant Hematology at Moffitt Cancer Center, discusses the results of treatment with the chimeric antigen receptor (CAR) T-cell therapy brexucabtagne autoleucel (Tecartus) in the ZUMA-3 trial (NCT02614066) in patients with acute lymphoblastic leukemia (ALL).

Shah hopes that he and his fellow investigators have done enough to show the FDA that this treatment is safe option to treat patients with ALL. Patients in the ZUMA-3 trial had a 71% complete remission (CR) rate with CAR T-cell therapy, which Shah says is unheard of in this population. These patients had progressed on previous therapies or after transplant. Patients achieved deep remissions and most had minimal residual disease negativity after treatment. These were real remissions, as opposed to cosmetic remissions, according to Shah.

This efficacy translated into pronounced benefits in relapse-free survival, duration of remission, and overall survival. Patients who achieved CR did not reach a median overall survival with CAR T. Shah feels that this is incredible for this patient population. CAR T-cell therapy was expected to be a meaningful treatment in ALL, and now the data show it can be used safely.

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ZUMA-3 Trial of CAR T Results in Impressive Efficacy for Patients With ALL - Targeted Oncology