Gilead Sciences, Inc. (Nasdaq: GILD) and Gritstone Oncology,
Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company
developing next generation cancer and infectious disease
immunotherapies, today announced that the companies have entered
into a collaboration, option and license agreement to research and
develop a vaccine-based immunotherapy as part of Gilead’s efforts
to find a curative treatment for human immunodeficiency virus (HIV)
infection.
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Gilead and Gritstone will develop an HIV-specific therapeutic
vaccine using Gritstone’s proprietary prime-boost vaccine platform,
comprised of self-amplifying mRNA (SAM) and adenoviral vectors,
with antigens developed by Gilead.
“While HIV treatment has advanced dramatically over the past
three decades, people living with HIV still face a lifetime of
therapy,” said Diana Brainard, MD, Senior Vice President, Virology
Therapeutic Area, Gilead Sciences. “Curing HIV remains the ultimate
aspiration for Gilead’s HIV research and development efforts.
Gritstone’s vaccine technology has the potential to educate the
immune system to specifically recognize and destroy HIV-infected
cells by leveraging SAM and adenoviral vectors. This, along with
our other partnerships and internal programs, reflects Gilead’s
commitment to continuing innovation to discover a cure for HIV and
bring about an end to the HIV epidemic.”
“We are excited to be partnering with Gilead, a company that has
decades long experience improving care for people living with HIV,
to advance a novel immunotherapy using our proprietary platform for
the treatment of HIV infection,” said Andrew Allen, MD, PhD,
Co-Founder, President and Chief Executive Officer of Gritstone. “It
is well-established that CD8+ T cells are critical for the
elimination of virally infected cells, and we have built a highly
differentiated vaccine platform that has been shown to generate
large numbers of antigen-specific T cells, including CD8+ T cells,
even in advanced and immunocompromised cancer patients. On the
heels of our recent COVID-19 program initiation in partnership with
the NIH, this program adds to our growing infectious disease
pipeline supported by collaborations with leading biopharma and
renowned institutions.”
“Delivery of viral antigens in potent vaccine vectors to elicit
a strong immune response is a cornerstone of successful infectious
disease vaccines,” said Karin Jooss, PhD, Executive Vice President
of Research and Chief Scientific Officer of Gritstone. “Our
preclinical work at Gritstone developing our powerful prime-boost
vaccine technology utilized simian immunodeficiency virus (SIV)
derived antigens as model antigens, which are very similar to
HIV-1. The resulting strong, durable and broad anti-SIV CD8+ T cell
responses and T cell memory data captured the attention of Gilead’s
virology team. We jointly performed further experiments that
generated additional compelling data, which was also complemented
by our exciting clinical data with neoantigens in cancer patients.
We are delighted to now advance our partnership and product
candidates for the treatment of patients with HIV infection.”
Terms of the Agreement
Under the terms of the agreement, Gilead will make a $60 million
payment at closing, consisting of a $30 million upfront cash
payment and a $30 million equity investment at a premium. Gilead
will be responsible for conducting a Phase 1 study for the
HIV-specific therapeutic vaccine and holds an exclusive option
under the collaboration to obtain an exclusive license to develop
and commercialize the HIV-specific therapeutic vaccine beyond Phase
1. Gritstone is also eligible to receive up to an additional $725
million if the option is exercised and if certain clinical,
regulatory and commercial milestones are achieved, as well as mid
single-digit to low double-digit tiered royalties on net sales upon
commercialization.
Locust Walk served as transaction advisor to Gritstone.
About Gritstone Oncology
Gritstone Oncology (Nasdaq: GRTS), a clinical-stage
biotechnology company, is developing the next generation of
immunotherapies against multiple cancer types and infectious
diseases. Gritstone develops its products by leveraging two key
pillars—first, a proprietary machine learning-based platform,
Gritstone EDGE™, which is designed to predict antigens that are
presented on the surface of cells, such as tumor or
virally-infected cells, that can be seen by the immune system; and
second, the ability to develop and manufacture potent
immunotherapies utilizing these antigens to potentially drive the
patient’s immune system to specifically attack and destroy
disease-causing cells. The company’s lead oncology programs include
an individualized neoantigen-based immunotherapy, GRANITE, and an
“off the shelf” shared neoantigen-based immunotherapy, SLATE, which
are being evaluated in clinical studies. The company also has a
bispecific antibody (BiSAb) program for solid tumors in lead
optimization. Within its infectious disease pipeline, Gritstone is
advancing CORAL, a COVID-19 program to develop a second-generation
vaccine with support from departments within the National
Institutes of Health (NIH) and the Bill & Melinda Gates
Foundation and a license agreement with La Jolla Institute for
Immunology. Additionally, the company has a global collaboration
for the development of a therapeutic HIV vaccine with Gilead
Sciences. For more information, please visit
gritstoneoncology.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Gritstone Forward-Looking
Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the potential
of Gritstone’s therapeutic programs; the advancements in the
Company’s ongoing clinical trials; the timing of data announcements
related to ongoing clinical trials and the initiation of future
clinical trials.
Such forward-looking statements involve substantial risks and
uncertainties that could cause Gritstone’s research and clinical
development programs, future results, performance or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the drug development
process, including Gritstone’s programs’ early stage of
development, the process of designing and conducting preclinical
and clinical trials, the regulatory approval processes, the timing
of regulatory filings, the challenges associated with manufacturing
drug products, Gritstone’s ability to successfully establish,
protect and defend its intellectual property and other matters that
could affect the sufficiency of existing cash to fund operations.
Gritstone undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of the company in general, see
Gritstone’s most recent Quarterly Report on Form 10-Q filed on
November 5, 2020 and any current and periodic reports filed with
the Securities and Exchange Commission.
Gilead Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the ability of the parties to meet potential milestones
in the estimated timelines or at all and the risk that the parties
may not realize the expected benefits of this collaboration. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2020, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
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Gilead Contacts: Jacquie Ross, Investors (650)
425-8408
Mark Snyder, Media (650) 446-6957
Gritstone Contacts: Alexandra Santos, Investors (510)
871-6161
Dan Budwick, Media (973) 271-6085
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