BioNTech and Autolus Announce Strategic CAR-T Cell Therapy
Collaboration to Advance Pipeline and Expand Late-Stage
Programs
- Strategic alliance leverages manufacturing and commercial
infrastructure as well as technology with the aim to advance both
companies’ autologous CAR-T programs towards market, pending market
authorization
- BioNTech secures the right to utilize Autolus’ manufacturing
capacity in a cost-efficient set-up to accelerate the development
of BNT211 into pivotal trials in CLDN6+ tumors
- BioNTech to support launch and expansion of development
program of Autolus’ lead cell therapy candidate obe-cel and will
receive a royalty on net sales
- BioNTech has co-commercialization options for Autolus’
AUTO1/22 and AUTO6NG programs
- BioNTech has the option to access a suite of Autolus target
binders and cell programming technologies to support BioNTech’s
development of in vivo cell therapy and antibody-drug conjugate
candidates
- BioNTech agrees to invest $200 million in
Autolus
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, CEO 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:
- BioNTech is eligible to receive an up to mid-single digit
royalty on obe-cel net sales. Autolus will retain full rights to
and control of the development and commercialization of
obe-cel.
- BioNTech has the option to access Autolus’ commercial and
clinical site network, manufacturing capacities in the United
Kingdom and commercial supply infrastructure in a cost-efficient
set-up in order to accelerate the development of BNT211 in
additional CLDN6+ tumor types. BioNTech plans to have 10 or more
ongoing potentially registrational clinical trials in the pipeline
by the end of 2024, including its fully owned CLDN6 CAR-T program
BNT211 in relapsed or refractory germ cell tumors.
- Autolus will lead the development and commercialization for
AUTO1/22 and AUTO6NG in any oncology indication with BioNTech
having an option to support certain development activities and
co-commercialize both candidates in certain territories. If
BioNTech exercises an option, it will receive a profit share with
respect to such exercised product candidate worldwide while Autolus
will be eligible to receive an option exercise fee, milestone
payments and co-funding of development expenses.
- Autolus granted BioNTech an exclusive license to develop and
commercialize therapeutics incorporating certain of Autolus’
proprietary binders along with options to license binders and cell
programming technology for use in BioNTech’s in vivo cell
therapy development programs and investigational antibody-drug
conjugates. If BioNTech exercises an option, Autolus will be
eligible to receive exercise fees and milestones payments, with
low-single digit royalties on net sales of the licensed
products.
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 a 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.
About BioNTech
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 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 forward-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.
You should review 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.
About Autolus
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
This press release 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.
CONTACTS
BioNTech
Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Autolus
Olivia Manser
+44 (0) 7780 471
o.manser@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
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