Full Press Release Details
BioNTech and Autolus Announce Strategic CAR-T Cell Therapy
Collaboration to Advance Pipeline and Expand Late-Stage Programs
MAINZ, Germany and LONDON, United Kingdom, February 8, 2024 BioNTech SE (Nasdaq: BNTX, BioNTech ), a next-generation
immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, Autolus ), a clinical-stage biopharmaceutical company developing next-generation programmed T cell
therapies, today announced a strategic collaboration aimed at advancing both companies autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the
strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.
The collaboration with
Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way. Autolus
state-of-the-art manufacturing facilities set-up for clinical and commercial supply
will enhance our own capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland, said Prof. Ugur Sahin, M.D., CEO and Co-Founder of
BioNTech. Furthermore, this collaboration grants us access to Autolus precise cell targeting tools to further support BioNTech s development of in vivo cell therapy and antibody-drug conjugate candidates.
We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities
beyond autologous cell therapies, said Dr. Christian Itin, Chief Executive Officer of Autolus. We look forward to investing a portion of the capital raised on delivering on
obe-cel s path in adult acute lymphoblastic leukaemia, potentially offering another treatment option for patients where there is still an unmet medical need. This collaboration creates a path for
accelerating our respective oncology pipeline programs and broadening the use of Autolus technology outside of autologous cell therapy applications.
BioNTech has agreed to purchase $200 million of Autolus American Depositary Shares in a private
placement. BioNTech will have a right to appoint a director to the Board of Autolus.
Under the terms of the license and option agreement, BioNTech will
make a cash payment of $50 million and is granted the following rights in exchange:
Evercore, goetzpartners and Cooley LLP acted as advisors to Autolus.
About BioNTech s cell and gene therapy portfolio
BioNTech has been active in the development of cell and gene therapies since 2009. Today, it is one core platform technology in BioNTech s pipeline.
BioNTech is investing in multiple platform technologies with the aim to lead in the field. BioNTech s engineered cell therapy portfolio features both chimeric antigen receptor (CAR) and T-cell receptor
(TCRs) or individualized T-cell receptor therapeutic drug candidates.
BNT211 is BioNTech s most advanced
cell therapy development program. BNT211 is an autologous Claudin-6 (CLDN6)-targeting CAR-T cell therapy candidate that is being tested alone and in combination with a CAR-T cell Amplifying RNA Vaccine ( CARVac ), encoding CLDN6. The CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity. CARVac
is intended to support in vivo expansion of CAR-T cells to increase their persistence and efficacy. CLDN6 is expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. BioNTech plans
to initiate its first pivotal Phase 2 trial evaluating BNT211 in 2L+ germ cell tumors in 2024 and is continuing to assess additional indications for further development.
BioNTech is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech 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 (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and
antibody-drug conjugate (ADC) therapeutics, as well as 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 Duality
Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer.
For more information, please
visit www.BioNTech.com.
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, as
amended. These forward-looking statements include, but are not limited to, statements concerning: the collaboration between BioNTech and Autolus to advance both companies autologous CAR-T programs
towards commercialization, pending regulatory authorizations, including BNT211 in CLDN6+ tumors, obe-cel in adult acute lymphoblastic leukemia, and AUTO1/22 and AUTO6NG in any oncology indication; the expected
impact of the collaboration on BioNTech s business, including any potential benefits to BioNTech and Autolus resulting from the collaboration; BioNTech s access to or option to access Autolus target binders and cell programming
technologies to support development of in vivo cell therapy and ADC candidates; BioNTech s co-commercialization options for Autolus AUTO1/22 and AUTO6NG programs; BioNTech s option to
enter into a future agreement to access Autolus commercial and clinical site network, manufacturing capacities and commercial supply infrastructure; BioNTech s plans regarding the timing, characterization and number of potentially
registrational trials, including BNT211 in relapsed or refractory germ cell tumors; BioNTech s agreement to make an equity investment in Autolus, including BioNTech s director appointment right; the parties ability to receive certain
milestone, royalty, revenue sharing, and/or profit-sharing payments; the planned next steps in BioNTech s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or
submission for and receipt of product approvals with respect to BioNTech s product candidates; the ability of BioNTech s mRNA technology to demonstrate clinical efficacy outside of BioNTech s infectious disease platform; the potential
safety and efficacy of BioNTech s product candidates; and BioNTech s anticipated market opportunity and size for its product candidates. Any forward-looking statements in this press release are based on BioNTech 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
looking statements. In some cases, forward-looking statements can be identified by terminology such as will, may, should, expects,
intends, plans, aims, anticipates, believes, estimates, predicts, potential, continue, or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking
statements. These risks and uncertainties include, but are not limited to: the risk that the proposed transactions may not close, in whole or in part; the compliance of the proposed transactions with applicable securities laws with respect to the
purchase and sale of Autolus securities, including the availability of exemptions from registration and/or the future registration of purchased securities; the reaction of third parties, including competitors, to the transactions, including
BioNTech s planned equity investment in Autolus; each party s ability to protect and maintain its intellectual property position; Autolus ability to maintain its manufacturing and supply infrastructure; the uncertainties inherent in
research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated
with preclinical and clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing data; the nature of the clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; the timing of and BioNTech s ability to obtain and maintain regulatory approval for its product candidates; BioNTech s and its counterparties ability to manage and source necessary energy resources,
capital requirements, the use of capital and unexpected expenditures; BioNTech s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech s third-party
collaborators to continue research and development activities relating to BioNTech s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and
product candidates developed or manufactured by BioNTech; BioNTech s and its collaborators ability to commercialize and market, if approved, its product candidates; BioNTech s ability to manage its development and expansion;
regulatory developments in the United States and other countries; BioNTech s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and
markets; BioNTech s ability to create long-term value for its shareholders; and other factors not known to BioNTech at this time.
the risks and uncertainties described under the heading Risk Factors in BioNTech s Report on Form 6-K for the period ended September 30, 2023, and in subsequent filings made by BioNTech
with the SEC, which are available on the SEC s website at www.sec.gov. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech s current expectations and speak only as of the date hereof.
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune
disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their
defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.
Autolus Forward-Looking Statements
contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can
be identified by terms such as may, will, could, expects, plans, anticipates, and believes. These statements include, but are not limited to, statements regarding
Autolus development of its product candidates, including the obe-cel program; the profile and potential application of obe-cel in additional disease settings; the
future clinical development, efficacy, safety and therapeutic potential of Autolus product candidates, including progress, expectations as to the reporting of data, conduct and timing and potential future clinical and preclinical activity and
milestones; expectations regarding the initiation, design and reporting of data from clinical trials and preclinical studies; expectations regarding the regulatory approval process for any product candidates; the benefits of the collaboration
between Autolus and BioNTech, including the potential and timing to receive equity investments, milestone payments, profit share payments, and/or royalties under the terms of the strategic collaboration; Autolus current and future
manufacturing capabilities; and the completion and timing of the proposed private placement . Any forward-looking statements are based on management s current views and assumptions and involve risks and uncertainties that could cause actual
results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus preclinical or clinical programs do not advance or
result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not
become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of
which could cause Autolus actual results to differ from those contained in the forward-looking statements, see the section titled Risk Factors in Autolus Annual Report on Form 20-F
filed with the Securities and Exchange Commission, or the SEC, on March 7, 2023 and in Autolus Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9,
2023, as well as discussions of potential risks, uncertainties, and other important factors in Autolus subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and
Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as
representing Autolus views as of any date subsequent to the date of this press release.
Victoria Meissner, M.D.
+49 (0)6131 9084 1513
S.A. Noonan Communications