\nBioNTech SE (Nasdaq: BNTX, \u201cBioNTech\u201d) and Kite, a Gilead Company (Nasdaq: GILD, \u201cKite\u201d) today announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite\u2019s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD. The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech\u2019s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech\u2019s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.\n<\/p>\n
This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20210719005385\/en\/<\/a><\/p>\n \n\u201cThe development of individualized cancer therapies is at the core of our work at BioNTech. The acquisition of the Kite facility and its individualized TCR platform allows us to accelerate the clinical development of our cell therapies in the U.S. and advance at the forefront of individualized cell therapies,\u201d said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. \u201cIt also strengthens our presence in the U.S., building on our successful integration of adoptive T-cell and neoantigen TCR therapies as part of our acquisition of Neon Therapeutics last year.\u201d\n<\/p>\n \nAll Kite employees at the Gaithersburg facility will be offered employment with BioNTech prior to the date of closing. To support its growing cell therapy pipeline, BioNTech plans to further invest in the site including hiring additional personnel. Under the terms of the agreement, Kite will receive a one-time upfront payment from BioNTech to purchase Kite\u2019s individualized solid tumor neoantigen TCR discovery platform as well as the Gaithersburg R&D and clinical manufacturing facility. Financial terms were not disclosed. Kite\u2019s new manufacturing facility in Frederick, MD for commercial production of CAR T-cell therapy is not part of the purchase agreement.\n<\/p>\n \n\u201cIn order to serve more patients that need cell therapy today, Kite is rapidly growing both through global expansion and seeking new indications for our existing approved CAR T-cell therapies. This transaction will enable us to focus our energies and investment on accelerating the reach of our current CAR T-cell therapies and midterm pipeline,\u201d said Christi Shaw, Chief Executive Officer of Kite. \u201cAs a company solely focused on cell therapy for over a decade, our approach to solid tumors and allogeneic cell therapy will progress through a combination of both internal research and external partnerships as we are an excellent partner for likeminded companies that share our vision of the power of CAR T-cell therapy to create better outcomes for patients.\u201d\n<\/p>\n \nTCR therapy is a type of cellular immunotherapy designed to redirect the patient\u2019s immune system in order to recognize and target tumors. In contrast to CARs that recognize antigens on the cell surface, TCR therapy involves engineering an individual\u2019s T cells to express TCRs that can recognize peptide fragments from both intracellular and extracelluar antigens. As a result, complex TCR therapies may be more effective in the treatment of solid tumors. Neoantigens are immune targets derived from somatic mutations displayed by cancer cells offering the potential for more targeted anti-tumor activity. Kite\u2019s neoantigen TCR platform enables the development of individualized TCR therapies that are custom designed to target individual neoantigens on a patient\u2019s tumor. This program builds and further extends BioNTech\u2019s leadership in individualized neoantigen targeting programs such as BNT122 (iNeST) and BNT221 (NEOSTIM).\n<\/p>\n \nCowen & Company LLC acted as financial advisor to Kite for this transaction.\n<\/p>\n About BioNTech \nFor more information, please visit www.BioNTech.de<\/a><\/p>\n About Kite About Gilead Sciences Gilead Forward-Looking Statements BioNTech Forward-Looking Statements \nFor a discussion of these and other risks and uncertainties, see BioNTech\u2019s 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\u2019s website at www.sec.gov<\/a>. 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.\n<\/p>\n Kite, the Kite logo and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.<\/i><\/p>\n For more information on Kite, please visit the company\u2019s website at www.kitepharma.com<\/a> or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma<\/a>) and LinkedIn<\/a>.<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210719005385\/en\/<\/a><\/span><\/p>\n BIONTECH CONTACTS: Jasmina Alatovic, Media KITE CONTACTS: Mary Lynn Carver, Media KEYWORDS:<\/b> Germany Europe United States North America California Maryland<\/p>\n INDUSTRY KEYWORDS:<\/b> Research Hospitals Chemicals\/Plastics Manufacturing Biotechnology Health Pharmaceutical Other Science Science<\/p>\n
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<\/span><\/b>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.\n<\/p>\n
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<\/span><\/b>Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite\u2019s 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 www.kitepharma.com<\/a>.\n<\/p>\n
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<\/span><\/b>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.\n<\/p>\n
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<\/span><\/b>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, including the risk that Kite and BioNTech may not realize the potential benefits of the purchase agreement. These and other risks, uncertainties and other factors are described in detail in Gilead\u2019s 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.\n<\/p>\n
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<\/span><\/b>This press release contains \u201cforward-looking statements\u201d 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 this proposed acquisition on BioNTech\u2019s business; the timing and likelihood of the closing of the proposed acquisition; the creation of long-term value for BioNTech shareholders; potential synergies between BioNTech and the Kite assets proposed to be acquired; and BioNTech\u2019s global expansion strategy. Any forward-looking statements in this press release are based on BioNTech management\u2019s 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 possibility that the proposed merger may not close, the reaction of third parties to the proposed merger, the retention of employees at the acquired sites, BioNTech\u2019s plans with respect to the acquired assets, the future growth of BioNTech\u2019s 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\u2019s ability to protect and maintain the acquired intellectual property position.\n<\/p>\n<\/p>\n
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Sylke Maas, Ph.D., Investors
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+49 (0)6131 9084 1074
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Investors@biontech.de
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+49 (0)6131 9084 1513
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Media@biontech.de
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Jacquie Ross, Investors
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(650) 358-1054<\/p>\n
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(410) 443-1853\n<\/p>\n
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