- Bristol Myers Squibb secures global exclusive
license to Immatics’ TCR bispecific program IMA401; companies will
collaborate on development with Immatics retaining a co-promotion
option in the US
- Immatics to receive upfront payment of $150
million and additional milestone payments of up to $770 million
plus tiered double-digit royalties on net product sales
Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage
biopharmaceutical company active in the discovery and development
of T cell-redirecting cancer immunotherapies, and Bristol Myers
Squibb (NYSE: BMY), today announced that they have entered into a
license, development and commercialization agreement (the
“agreement”) for Immatics’ TCR Bispecific candidate, IMA401.
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Under the terms of the agreement, Immatics will receive an
upfront payment of $150 million as well as up to $770 million in
development, regulatory and commercial milestone payments, in
addition to tiered double-digit royalty payments on net sales of
IMA401. Immatics retains the options to co-fund U.S. development in
exchange for enhanced U.S. royalty payments and/or to co-promote
IMA401 in the US.
IMA401 is the most advanced product candidate in Immatics’ TCR
Bispecifics pipeline, called TCER® (T Cell Engaging Receptors), in
which one binding region targets MAGEA4/8, a highly prevalent
antigen in multiple solid tumors, and the other region engages and
activates T cells. In preclinical proof-of-concept studies, IMA401
has shown anti-tumor activity with complete remissions in various
in vivo tumor models including patient-derived xenograft models.
The agreement outlines a development plan under which both
companies will collaborate to advance the program through clinical
development.
In November 2021, Immatics filed a Clinical Trial Application
(CTA)1 with Paul-Ehrlich-Institute (PEI), the German federal
regulatory authority, for the development of IMA401. The clinical
trial, which is planned to commence in the first half of 2022, will
enroll patients across various solid tumor types.
1
Clinical Trial Application – the European
equivalent of an Investigational New Drug (IND) application
“At Immatics, we are committed to our goal of delivering
meaningful clinical benefits to cancer patients, and based on the
promising preclinical data, we see remarkable potential for our
TCER® platform” said Carsten Reinhardt, M.D., Ph.D., Chief
Development Officer at Immatics. “We are delighted to extend our
existing collaboration with Bristol Myers Squibb to the IMA401
program and view this as an important validation of the therapeutic
potential of our TCER® approach. Bristol Myers Squibb’s global
clinical development and commercialization capabilities in oncology
make them the ideal partner for the further development of
IMA401.”
“We are pleased to expand our collaboration with Immatics to now
include IMA401,” said Teri Foy, Senior Vice President, Research and
Early Development, Immuno-Oncology and Cell Therapy at Bristol
Myers Squibb. “TCER®s are an important, emerging modality for solid
tumors with the potential for cell therapy-like efficacy in an
off-the-shelf platform offering potentially broader patient access.
We look forward to advancing IMA401 into the clinic to further
assess its potential as an innovative medicine to help patients
prevail over serious diseases.”
Immatics entered a strategic collaboration in 2019 with Celgene
Corporation, a wholly owned subsidiary of Bristol-Myers Squibb
Company, to develop novel adoptive cell therapies. This new
collaboration to develop Immatics’ Bispecific candidate TCER®
IMA401 complements ongoing cell therapy activities - both
therapeutic modalities built on Immatics’ capabilities to identify
novel targets and develop high-affinity, target-specific TCRs. The
terms of the current agreement regarding Immatics’ TCER® IMA401
program exclude any MAGEA4/8 targets for cell therapy. The
agreement is subject to customary clearance by antitrust
regulators.
About IMA401
IMA401 is Immatics’ half-life extended TCER® molecule that
targets an HLA-A*02-presented (human leukocyte antigen) peptide
derived from two different cancer-associated proteins,
melanoma-associated antigen 4 and/or 8 (“MAGEA4/8”). MAGEA4/8 is
highly prevalent in several solid tumor types including squamous
non-small-cell lung carcinoma, head and neck squamous cell
carcinoma, bladder, uterine, esophageal and ovarian carcinomas, as
well as melanoma, sarcoma subtypes and other solid cancer
types.
About TCER®
Immatics’ TCER® molecules are antibody-like “off-the-shelf”
biologics that leverage the body’s immune system by redirecting and
activating T cells towards cancer cells expressing a specific tumor
target. To do so, the proprietary biologics are engineered to have
two binding regions. The first region contains an affinity- and
stability-improved TCR that binds specifically to the cancer target
on the cell surface presented by an HLA molecule. The second region
is derived from an antibody domain that recruits endogenous T cells
to the tumor to become activated. The design of the TCER® molecules
enables the activation of any T cell in the body to attack the
tumor, regardless of the T cells’ intrinsic specificity. In
addition, the TCER® molecule has a Fc-part conferring stability,
half-life extension and enhanced manufacturability.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook, and
Instagram.
About Immatics
Immatics combines the discovery of true targets for cancer
immunotherapies with the development of the right T cell receptors
with the goal of enabling a robust and specific T cell response
against these targets. This deep know-how is the foundation for our
pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as
our partnerships with global leaders in the pharmaceutical
industry. We are committed to delivering the power of T cells and
to unlocking new avenues for patients in their fight against
cancer.
For regular updates about Immatics, visit www.immatics.com. You
can also follow us on Twitter and LinkedIn.
Bristol Myers Squibb Cautionary Statement Regarding
Forward-Looking Statements:
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products and the agreement. All
statements that are not statements of historical facts are, or may
be deemed to be, forward-looking statements. Such forward-looking
statements are based on historical performance and current
expectations and projections about our future financial results,
goals, plans and objectives and involve inherent risks, assumptions
and uncertainties, including internal or external factors that
could delay, divert or change any of them in the next several
years, that are difficult to predict, may be beyond our control and
could cause our future financial results, goals, plans and
objectives to differ materially from those expressed in, or implied
by, the statements. These risks, assumptions, uncertainties and
other factors include, among others, that the expected benefits of,
and opportunities related to, the agreement may not be realized by
Bristol Myers Squibb or may take longer to realize than
anticipated, that Bristol Myers Squibb may fail to discover and
develop any commercially successful product candidates for IMA401
through the agreement, that IMA401 may not receive regulatory
approval for the indications described in this release in the
currently anticipated timeline or at all, and if approved, whether
such treatment for such indications described in this release will
be commercially successful, and that the agreement will receive
clearance under the Hart-Scott-Rodino Antitrust Improvements Act of
1976. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be
evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2020, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
Immatics Forward-Looking Statements:
Certain statements in this press release may be considered
forward-looking statements. Forward-looking statements generally
relate to future events or Immatics’ future financial or operating
performance. For example, statements concerning the timing of
product candidates and Immatics’ focus on partnerships to advance
its strategy are forward-looking statements. In some cases, you can
identify forward-looking statements by terminology such as “may”,
“should”, “expect”, “intend”, “will”, “estimate”, “anticipate”,
“believe”, “predict”, “potential” or “continue”, or the negatives
of these terms or variations of them or similar terminology. Such
forward-looking statements are subject to risks, uncertainties, and
other factors which could cause actual results to differ materially
from those expressed or implied by such forward looking statements.
These forward-looking statements are based upon estimates and
assumptions that, while considered reasonable by Immatics and its
management, are inherently uncertain. New risks and uncertainties
may emerge from time to time, and it is not possible to predict all
risks and uncertainties. Factors that may cause actual results to
differ materially from current expectations include, but are not
limited to, various factors beyond management's control including
general economic conditions and other risks, uncertainties and
factors set forth in filings with the SEC. Nothing in this press
release should be regarded as a representation by any person that
the forward-looking statements set forth herein will be achieved or
that any of the contemplated results of such forward-looking
statements will be achieved. You should not place undue reliance on
forward-looking statements, which speak only as of the date they
are made. Immatics undertakes no duty to update these
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20211214005182/en/
Immatics Media: Anja Heuer, +49 89 540415-606,
media@immatics.com
Investors Jordan Silverstein, +1 281-810-7545,
InvestorRelations@immatics.com
Bristol Myers Squibb Media: +1 609-252-3345,
media@bms.com
Investors: Tim Power, +1 609-252-7509, timothy.power@bms.com
Nina Goworek, +1-908-673-9711, nina.goworek@bms.com
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