Focus will be on Development of Allogeneic
Universal CAR T-Cell Therapies for Immuno-oncology and Autoimmune
Diseases
- Blackstone Life Sciences Commits to an Active Role and a $250
Million Financing as Sole Founding Investor
- Cellex to Contribute Switchable Universal CAR-T Technology
Developed by GEMoaB GmbH and Manufacturing Expertise
- Intellia Contributes Best-in-Class CRISPR/Cas9 Genome Editing
Technology that Creates an Allogeneic Universal CAR-T Platform
- Intellia to Host Conference Call Today, June 22 at 8:00 a.m.
ET
Blackstone (NYSE: BX) announced today that funds managed by
Blackstone Life Sciences have committed $250 million towards the
launch of a new autologous and allogeneic universal chimeric
antigen receptor (CAR) T-cell therapy company, along with Intellia
Therapeutics, Inc. (NASDAQ: NTLA) and Cellex Cell Professionals
GmbH (“Cellex”), the parent company of GEMoaB GmbH (“GEMoaB”), a
clinical-stage cell therapy company. The new company will combine
GEMoaB’s world-leading clinical-stage universal CAR-T platforms
with Intellia’s differentiated allogeneic cell platform and CRISPR
cell engineering.
Intellia Therapeutics is a clinical stage, leading genome
editing company focused on developing curative therapeutics using
CRISPR/Cas9 technology. Cellex Cell Professionals GmbH holds the
clinical-stage biopharmaceutical company GEMoaB, which is focused
on the development of next-generation immunotherapies and cell
therapies for hard-to-treat cancers.
The new company will be headquartered in Cambridge,
Massachusetts and will acquire Cellex’s subsidiary GEMoaB GmbH with
established offices and labs in Dresden, Germany. GEMoaB is
developing a switchable universal platform to improve the
therapeutic window of CAR T-cell therapies. This approach enables
increased efficacy and safety across a range of cancers, including
solid tumors, that are currently a challenge for existing cell
therapies. In addition, the new company and Intellia will gain
access to Cellex’s established cell therapy manufacturing
capabilities to accelerate their respective ex vivo programs.
Andrew Schiermeier, Ph.D., current Executive Vice President and
Chief Operating Officer of Intellia, will lead the launch as
President and Chief Executive Officer.
“This launch represents the first of many steps to addressing
the various limitations that currently exist in the cell therapy
space, and I am both humbled and excited to be leading the creation
of this company with a team of extremely talented individuals,”
said Schiermeier. “Bringing together GEMoaB’s universal CAR-T
platform with Intellia’s differentiated allogeneic T cell platform
and CRISPR-based cell engineering provides a unique opportunity to
move cell therapy technology to new heights. Our focus is on
providing significantly safer and more efficacious treatments to
patients who are suffering from hard-to-treat cancers and
autoimmune diseases.”
“We can now build on our established and ongoing collaboration
with Intellia,” said Dr. Armin Ehninger, GEMoaB’s Chief Scientific
Officer. “With Blackstone’s contribution of funds and expertise, we
will be able to combine our switchable CAR-T platform which has
broad potential applicability and has already shown early signs of
efficacy and a favorable side effect profile in an ongoing Phase Ia
trial, with Intellia’s leading genome editing technology,” added
Gerhard Ehninger, M.D., founder of Cellex and GEMoaB. “This will
allow us to potentially replace the living drug, currently
manufactured from the patient’s own immune cells, by cells from
healthy donors. Our goal is for these cells to be immediately
available to patients. This is a good day for patients.”
“Collaborations like this one are a key instrument for Intellia
to strengthen investment in areas of strategic importance to us,
enabling us to more quickly realize the full scope and potential of
our genome-editing technology for patients in need of more
effective therapies. With today’s announcement, we can drive the
expansion of our pipeline into new areas, accelerating clinical
validation of what we believe to be a platform for universal,
allogeneic CAR-T cell therapies. Further, we can fortify our
allogeneic cell engineering capabilities for wholly owned programs
through a preferred relationship with Cellex,” said Intellia
President and Chief Executive Officer, John Leonard, M.D.
“We believe that this exciting effort has the potential to
leapfrog current CAR-T technologies and improve the standard of
care for a broad range of patients,” said Dr. Nicholas Galakatos,
Global Head of Blackstone Life Sciences. “As the sole founding
investor, Blackstone will be actively involved in building this
platform, leveraging our deep expertise in oncology and our scale
capital. Our partnership with Intellia and Cellex is customized to
address the new company’s needs and set it up for success from day
one, and while it is an earlier-stage, growth investment for us, it
demonstrates the versatility of our investment platform and
commitment to advance potentially transformational technologies to
benefit patients.”
Business transformation and responsibilities
Key components of the new company upon formation include the
following highlights:
- The new company will have an exclusive license to combine
Intellia’s CRISPR/Cas9 allogeneic platform with GEMoaB’s
switchable, universal CAR T-cell platforms (UniCAR and
RevCAR).
- GEMoaB will become a subsidiary of the newly established
company and will continue to advance its clinical stage CAR T-cell
programs.
- The new company and Intellia will also simultaneously enter
into a co-development and co-funding (Co-Co) agreement to develop
an allogeneic universal CAR T-cell product for an immuno-oncology
indication. Intellia will have one additional option to enter into
a second Co-Co agreement from selected allogeneic universal CAR
T-cell therapy products that the parties will develop under the
collaboration.
- Blackstone Life Sciences, Intellia and Cellex (and certain
related entities) will each have equal ownership of the new
company.
Experienced management to drive growth and scientific
advancement
Dr. Schiermeier has spent more than two decades as an executive
in the biotech and pharmaceutical industries, with experience
ranging from managing the growth and operations for startups to
directing the strategic and operational expansion of global brands
for large pharma companies. At Intellia, he was responsible for
working with the board of directors and executive committee in
establishing and overseeing the implementation of Intellia’s
strategic direction in both in vivo and ex vivo (engineered cell
therapy) areas. He also oversaw the company’s portfolio management,
drug development, manufacturing, and business development efforts.
Prior to Intellia, he served as SVP and Global Head of Merck KGaA’s
Oncology Business, a global operation with revenues in excess of $1
billion across 66 countries.
The new company includes a seasoned management team, including
Chief Medical Officer Professor Gerhard Ehninger, a founding
shareholder of GEMoaB who served as its Chief Medical Officer.
Prof. Ehninger is also a founding shareholder and Chief Executive
Officer of GEMoaB’s parent company Cellex. Prof. Ehninger was the
Head of Hematology and Oncology at University Hospital Carl Gustav
Carus of the Technical University Dresden, Germany, as well as the
former President of the German Society of Hematology and Oncology
(DGHO). As one of the world’s leading researchers in the areas of
acute leukemias and solid tumors, Prof. Ehninger has published more
than 700 scientific articles in peer-reviewed journals and was
principal investigator for multiple pivotal studies in hematology
and oncology. The new company has also appointed Dr. Armin Ehninger
as its Chief Scientific Officer. Dr. Ehninger has served as Chief
Scientific Officer of GEMoaB since 2014. He has more than 15 years
of research and drug discovery experience in oncology and
hematology, stem cell biology as well as cancer immunotherapy. Dr.
Ehninger’s expertise and leadership were decisive in establishing
GEMoaB’s Research & Development and pre-clinical capabilities.
At GEMoaB, he was responsible for pre-clinical Research and
Development, the translational programs for clinical studies as
well as for Quality Systems and Quality Management.
The new company’s Board of Directors will be chaired by Dr.
Olivier Brandicourt, a Senior Advisor to Blackstone Life Sciences
and the former CEO of Sanofi S.A.
The transaction is expected to close in the third quarter of
2021 and is subject to customary closing conditions, including
regulatory clearances.
Goldman Sachs & Co. LLC served as exclusive financial
advisor to Intellia and Goodwin Procter and Hogan Lovells (Germany)
acted as Intellia’s legal advisors. Ropes & Gray and
Freshfields (Germany) acted as legal advisors to Blackstone Life
Sciences. Noerr and Morgan Lewis acted as legal advisors to Cellex
and GEMoaB.
Intellia Therapeutics Webcast Information
Intellia management will host a live webcast today, June 22,
2021 at 8:00 a.m. E.T. to discuss the corporate development. To
join the webcast, please visit this link, or the Events and
Presentations page of the Investors & Media section of the
company’s website at www.intelliatx.com. A replay of the webcast
will be available on Intellia’s website for at least 30 days
following the call.
About Blackstone Life Sciences
Blackstone Life Sciences is an industry-leading private
investment platform with capabilities to invest across the life
cycle of companies and products within the key life science
sectors. By combining scale investments and hands-on operational
leadership, Blackstone Life Sciences helps bring to market
promising new medicines that improve patients’ lives. More
information is provided at
https://www.blackstone.com/our-businesses/life-sciences/.
About Intellia Therapeutics
Intellia Therapeutics is a leading clinical-stage genome editing
company, focused on the development of proprietary, potentially
curative therapeutics using the CRISPR/Cas9 system. Intellia
believes the CRISPR/Cas9 technology has the potential to transform
medicine by both producing therapeutics that permanently edit
and/or correct disease-associated genes in the human body with a
single administration, and creating enhanced engineered cells that
can treat oncological and immunological diseases. Intellia’s
combination of deep scientific, technical and clinical development
experience, along with its leading intellectual property portfolio,
puts it in a unique position to unlock broad therapeutic
applications of the CRISPR/Cas9 technology and create new classes
of therapeutic products. Learn more about Intellia and CRISPR/Cas9
at intelliatx.com. Follow us on Twitter @intelliatweets.
About GEMoaB
GEMoaB is a privately owned, clinical-stage biopharmaceutical
company.
GEMoaB is developing switchable universal CAR-T platforms
(UniCAR and RevCAR) to improve the therapeutic window and increase
efficacy and safety of CAR-T cell therapies in challenging cancers,
including acute leukemias and solid tumors. Conventional CAR-T
cells depend on the presence and direct binding of cancer antigens
for activation and proliferation. An inherent key feature of the
GEMoaB platforms is a switchable on/off mechanism enabled by
pharmacokinetic half-life and internalization of soluble adaptors
termed targeting modules (TMs). These TMs provide the
antigen-specificity to activate UniCAR or RevCAR gene-modified
T-cells (UniCAR-T or RevCAR-T) and consist of a highly flexible
antigen-binding moiety, linked to a motif recognized by UniCAR-T or
RevCAR-T respectively.
GEMoaB has a broad pipeline of product candidates in
pre-clinical and clinical development for the treatment of
hematological malignancies as well as solid tumors. Its clinical
stage assets GEM333, a T-cell engaging bispecific antibody (TCE)
with binding specificity to CD33 in relapsed/refractory AML, and
GEM3PSCA, a TCE with binding specificity to PSCA for the treatment
of castrate-resistant metastatic prostate cancer and other PSCA
expressing late-stage solid tumors, are currently investigated in
Phase I studies and globally partnered with Bristol-Myers Squibb.
Phase I studies of the lead UniCAR assets UniCAR-T-CD123 in
hematological malignancies and UniCAR-T-PSMA in solid tumors are
currently recruiting patients. Clinical proof-of-concept data were
recently published in Blood and at key scientific meetings
including the 3rd EHA-EBMT European CAR T-Cell Meeting and the 2021
AACR Annual Meeting. More information can be found at
www.gemoab.com.
About Cellex Cell Professionals
Cellex Cell Professionals is a world leader in manufacturing
hematopoietic blood stem cell products and a leading European
manufacturer for CAR-T cell products, co-operating in that area
with several large pharma and biotech companies. Their large,
experienced collection centers and fully automated, audited and
inspected GMP facility for UniCAR production support the worldwide
distribution of cell products, including same-day delivery in the
U.S. and Europe.
More information is provided at www.cellex.me.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, express or implied
statements regarding Intellia’s beliefs and expectations regarding:
its strategy, business plans and focus; its ability to quickly and
efficiently realize the scope and potential of its genome-editing
technology; its ability to maintain, expand and maximize its
intellectual property portfolio and pipeline as well as accelerate
clinical validation for its platform; the therapeutic value and
development potential of CRISPR/Cas9 gene editing technologies and
therapies; its ability to combine its allogeneic T cell platform
and CRISPR-based cell engineering with GEMoaB’s universal CAR-T
platform; the expected strategic benefits of the formation of the
new company and resulting collaborations; its expectations on the
new company’s ability to develop CAR-T Cell therapies for
immuno-oncology and autoimmune diseases and the timing and
potential success of such therapies; its ability to optimize the
impact of its collaborations on its development programs, including
but not limited to its collaboration with Blackstone Life Sciences,
Cellex, or the new company; its and the new company’s ability to
enter into a license and collaboration agreement and co-development
and co-promotion agreement; the new company’s use of capital,
expenses, future accumulated deficit, future results, and ability
to fund operations at least through the next 24 months.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs of future events,
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks related to Intellia’s ability to protect and
maintain its intellectual property position; risks related to
Intellia’s relationship with third parties, including its licensors
and licensees; risks related to the ability of Intellia’s licensors
to protect and maintain their intellectual property position;
uncertainties related to the authorization, initiation and conduct
of studies and other development requirements for the new company’s
product candidates; the risk that any one or more of the new
company’s product candidates will not be successfully developed and
commercialized; the risk that the results of preclinical studies or
clinical studies will not be predictive of future results in
connection with future studies; and the risk that Intellia’s
collaborations with Blackstone Life Sciences, Cellex, or the new
company or its other collaborations will not continue or will not
be successful. These and other risks and uncertainties are
described in greater detail in the section entitled “Risk Factors”
in Intellia’s most recent annual report on Form 10-K and quarterly
report on Form 10-Q filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in
Intellia’s other filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release represent Intellia’s views only as of the date hereof and
should not be relied upon as representing its views as of any
subsequent date. Intellia explicitly disclaims any obligation to
update any forward-looking statements, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210622005618/en/
BLACKSTONE LIFE SCIENCES Paula Chirhart +1-347-463-5453
paula.chirhart@blackstone.com
GEMOAB and Cellex Marika Geissler +49-351-4466-45011
m.geissler@gemoab.com
INTELLIA:
Investor Relations: Lina Li Director Investor Relations
+1-857-706-1612 lina.li@intelliatx.com
Media: Julie Ferguson (Interim) Head of External Affairs
& Communications +1-312-385-0098 julie.ferguson@intelliatx.com
media@intelliatx.com
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