-- Deal Strengthens BioNTech’s Cell Therapy
Pipeline By Accelerating Individualized Solid Tumor Neoantigen TCR
Cell Therapy Research and Development Program and Adding
Manufacturing Footprint in North America --
-- Kite Remains Focused on Rapid Advancement
of Current CAR T-Cell Therapies to Reach More Patients and Further
Optimize Therapeutic Potential of Cell Therapy --
-- Transaction Expected to Close By End of
July 2021 --
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Kite, a Gilead
Company (Nasdaq: GILD, “Kite”) today announced the two companies
have entered into a purchase agreement for BioNTech to acquire
Kite’s 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’s existing cell therapy manufacturing facility in
Idar-Oberstein, Germany. The facility will support the development
of BioNTech’s 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.
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“The 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,” said Ugur
Sahin, M.D., CEO and Co-founder of BioNTech. “It 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.”
All 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’s individualized solid tumor neoantigen
TCR discovery platform as well as the Gaithersburg R&D and
clinical manufacturing facility. Financial terms were not
disclosed. Kite’s new manufacturing facility in Frederick, MD for
commercial production of CAR T-cell therapy is not part of the
purchase agreement.
“In 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,” said Christi Shaw, Chief Executive
Officer of Kite. “As 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.”
TCR therapy is a type of cellular immunotherapy designed to
redirect the patient’s 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’s 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’s neoantigen TCR platform
enables the development of individualized TCR therapies that are
custom designed to target individual neoantigens on a patient’s
tumor. This program builds and further extends BioNTech’s
leadership in individualized neoantigen targeting programs such as
BNT122 (iNeST) and BNT221 (NEOSTIM).
Cowen & Company LLC acted as financial advisor to Kite for
this transaction.
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 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. 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
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 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, 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’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 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 this proposed
acquisition on BioNTech’s 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’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 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’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 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
company’s website at 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210719005385/en/
BIONTECH CONTACTS: Sylke Maas, Ph.D., Investors +49
(0)6131 9084 1074 Investors@biontech.de Jasmina Alatovic, Media +49
(0)6131 9084 1513 Media@biontech.de KITE CONTACTS: Jacquie
Ross, Investors (650) 358-1054 Mary Lynn Carver, Media (410)
443-1853
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