Syncona Limited
BioNTech and Autolus announce Strategic
Collaboration
08 February 2024
Syncona Ltd, a leading life science investor focused
on creating, building and scaling global leaders in life science,
notes that its portfolio company, Autolus Therapeutics plc
("Autolus"), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announced a
strategic collaboration with BioNTech SE ("BioNTech"), a
next-generation immunotherapy company pioneering novel therapies
for cancer and other serious diseases. The strategic collaboration
is aimed at advancing both companies' autologous CAR-T programs
towards commercialisation, pending regulatory authorisations. In
connection with the strategic collaboration, the companies entered
into a license and option agreement and a securities purchase
agreement.
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 commercialisation 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+ tumour 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 tumours.
· Autolus will lead
the development and commercialisation for AUTO1/22 and AUTO6NG in
any oncology indication with BioNTech having an option to support
certain development activities and co-commercialise 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 commercialise
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.
The announcement can be accessed on Autolus' investor
website at https://www.autolus.com/investor-relations/news/
and the full text of the announcement from Autolus is contained
below.
[ENDS]
Enquiries
Syncona Ltd
Annabel Clark / Fergus
Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins
/ Tim Stamper
Tel: +44 (0) 20 3727 1000
About
Syncona
Syncona's purpose is to invest to
extend and enhance human life. We do this by creating and building
companies to deliver transformational treatments to patients in
areas of high unmet need.
Our strategy is to create, build and
scale companies around exceptional science to create a diversified
portfolio of 20-25 globally leading healthcare businesses, across
development stage and therapeutic areas, for the benefit of all our
stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and
management teams. Our balance sheet underpins our strategy enabling
us to take a long-term view as we look to improve the lives of
patients with no or poor treatment options, build sustainable life
science companies and deliver strong risk-adjusted returns to
shareholders.
Syncona Limited seeks to
achieve returns over the long term. Investors should seek to ensure
they understand the risks and opportunities of an investment
in Syncona Limited, including the information in our published
documentation, before investing.
About
Autolus
Autolus is a clinical-stage biopharmaceutical company
developing next-generation, programmed T cell therapies for the
treatment of cancer. 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 cancer 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 and solid tumors. For more information,
please visit www.autolus.com.
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, 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:
·
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.
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.
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