REG - Syncona Limited - Autolus announces Strategic Collaboration

SynconaAnnouncement

08/02/2024 11:00

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RNS Number : 5094C  Syncona Limited  08 February 2024

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/
(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 (http://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
(https://www.globenewswire.com/Tracker?data=q2wGZcYD0l-O9m5hy7RkMaVgWVEuep6g42UlX21sjF93vzsvDBNypN1YgTgS8M6gDzFb7Z5QDLShW2Sq-Ef3IGDi9IN9W94DO1QKBRh05CM=)
 (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
(https://www.globenewswire.com/Tracker?data=m6296T6ZTewI0tDHCCDtZjOSy6bGCIoPCBaBSnxnRuhgCVcw5mwfotZxHd6hIQOZhIt4TANdChllO0C-oRd8-P4vcjU3d1dFrVTXL1zouOcele7Ra1NVxZTGHw-zSL6a7cwZPEgGqvhEJMT97ogLr8XcKiz1gErJCFWzf8-VRM8RSqzYEhw76x5HDudCi8AUB_xpks6rXe7QsX2BUEg7TpU7xq_4lyWAttBFmK3l0VUozLlK65kUWiCH4XAlNnpvabAmr-jNgX0cu5UmLOtJxg==)
.

 

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 (mailto:o.manser@autolus.com)

 

Julia Wilson

+44 (0) 7818 430877

j.wilson@autolus.com (mailto:j.wilson@autolus.com)

 

Susan A. Noonan

S.A. Noonan Communications

+1-917-513-5303

susan@sanoonan.com (mailto:susan@sanoonan.com)

 

 

 

 

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