Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage
biotechnology company pioneering a new class of immuno-oncology
agents that combine the targeting precision of antibodies with the
power of both the innate and adaptive immune systems, and Innovent
Biologics, Inc. (HKEX: 01801), a world-class biopharmaceutical
company that develops, manufactures and commercializes high quality
medicines for the treatment of oncology, metabolic, autoimmune,
ophthalmology and other major diseases, today announced a drug
research and development collaboration to develop three new
anti-cancer therapeutic immune-stimulating antibody conjugate
(ISAC) candidates.
The parties will leverage Innovent’s proprietary
therapeutic antibody portfolio and discovery capability against
undisclosed oncology targets in combination with Bolt’s advanced
ISAC technology and myeloid biology expertise to create three new
cancer treatments with the potential to provide significant benefit
to patients. The Boltbody ISAC platform combines a tumor-targeting
antibody, a stable, non-cleavable linker, and a proprietary immune
stimulant. Boltbody ISACs unite the precision of antibody targeting
with the power of innate and adaptive immune system response.
"Innovent is a leader in the development of
innovative antibody therapeutics for the treatment of cancer, with
advanced research and development teams and an expanding commercial
infrastructure in China. We look forward to collaborating with
Innovent on the development of novel ISAC anti-cancer therapeutic
candidates,” said Randall Schatzman, Ph.D., CEO of Bolt Bio. “Our
preclinical and early clinical studies have demonstrated the safety
and efficacy of the ISAC approach and the benefits of stimulating
both the innate and adaptive arms of the immune system in the fight
against cancer.”
“We are very excited about the potential for the
Boltbody ISAC platform to generate best-in-class approaches
treating multiple tumor types,” said Dr. Yong Jun Liu, President of
Innovent Biologics. “Bolt has spent several years building and
optimizing this platform, which we can leverage to expedite the
development of important new products. We look forward to working
together with Bolt to bring innovative therapies to patients as
soon as possible.”
Under the agreement, Innovent has the rights to all
three programs in Greater China, and retains an option to license
global rights for one program, as well as rights for all
territories except North America for another program. Bolt retains
the option to license global rights outside of Greater China for
one program, and North American rights for another program.
Innovent is responsible for all research and development costs
through clinical proof-of-concept. Upon review of the initial
clinical proof-of-concept data, the companies can exercise
licensing options for continued development and exclusive
commercialization rights in specific territories on a
program-by-program basis. Bolt will receive an upfront payment of
$5 million in cash from Innovent at signing and a possible future
equity investment of up to $10 million. Furthermore, both Bolt and
Innovent are eligible to receive additional milestone payments and
royalties associated with the development and commercialization of
products in each other’s territories.
About the Boltbody™ Immune-Stimulating
Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that
combines the precision of antibody targeting with the strength of
the innate and adaptive immune systems. Boltbody ISACs are
comprised of three primary components: a tumor-targeting antibody,
a non-cleavable linker, and a proprietary immune stimulant to
activate the patient’s innate immune system. By initially targeting
a single marker on the surface of a patient’s tumor cells, an ISAC
can create a new immune response by activating and recruiting
myeloid cells. The activated myeloid cells start a feed-forward
loop by releasing cytokines and chemokines, chemical signals that
attract other immune cells and lower the activation threshold for
an immune response. This reprograms the tumor microenvironment and
invokes an adaptive immune response that targets the tumor, with
the goal of durable responses for patients with cancer.
About Bolt Biotherapeutics,
Inc.
Bolt Biotherapeutics, Inc. is a clinical-stage
biotechnology company pioneering a new class of immuno-oncology
agents that combine the targeting precision of antibodies with the
power of both the innate and adaptive immune systems. Bolt’s
proprietary Boltbody™ Immune-stimulating Antibody Conjugates
(ISACs) are designed to target tumor cells for elimination by
myeloid cells, which then activates the myeloid cells to recruit
the adaptive immune system in the anti-tumor response. This leads
to the conversion of immunologically “cold” tumors to “hot” tumors.
Bolt’s lead candidate, BDC-1001, is a Boltbody ISAC comprised of a
HER2-targeting biosimilar of trastuzumab conjugated with a
non-cleavable linker to one of Bolt’s proprietary TLR7/8 agonists
for the treatment of patients with HER2-expressing solid tumors.
Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and
a pipeline of other immuno-oncology products.
About Innovent Biologics, Inc.
Inspired by the spirit of "Start with Integrity,
Succeed through Action,” Innovent’s mission is to develop,
manufacture and commercialize high-quality biopharmaceutical
products that are affordable to ordinary people. Established in
2011, Innovent is committed to developing, manufacturing and
commercializing high-quality innovative medicines for the treatment
of cancer, autoimmune, metabolic and other major diseases. On
October 31, 2018, Innovent was listed on the Main Board of the
Stock Exchange of Hong Kong Limited with the stock code:
01801.HK.
Since its inception, Innovent has developed a fully
integrated multi-functional platform which includes R&D, CMC
(Chemistry, Manufacturing, and Controls), clinical development and
commercialization capabilities. Leveraging the platform, the
company has built a robust pipeline of 25 valuable assets in the
fields of cancer, metabolic, autoimmune disease and other major
therapeutic areas, with 5 products – TYVYT® (sintilimab injection),
BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab
biosimilar injection), HALPRYZA® (rituximab biosimilar injection)
and Pemazyre® (pemigatinib oral inhibitor) – officially approved
for marketing, 1 asset’s NDA under NMPA review, sintilimab’s
Biologics License Application (BLA) acceptance in the U.S., 5
assets in Phase 3 or pivotal clinical trials, and an additional 14
molecules in clinical studies.
Innovent has built an international team with
advanced talent in high-end biological drug development and
commercialization, including many global experts. The company has
also entered into strategic collaborations with Eli Lilly and
Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other
international partners. Innovent strives to work with many
collaborators to help advance China’s biopharmaceutical industry,
improve drug availability and enhance the quality of the patients’
lives. For more information, please visit: www.innoventbio.com and
www.linkedin.com/company/innovent-biologics/.
Forward-Looking Statements
This press release contains forward-looking
statements about us and our industry that involve substantial risks
and uncertainties and are based on our beliefs and assumptions and
on information currently available to us. All statements other than
statements of historical facts contained in this press release,
including statements regarding our ability to collaborate with
Innovent to discover and develop therapeutics for the treatment of
multiple types of cancer, our ability to leverage Innovent’s
antibody portfolio in connection with our technology and expertise,
our ability to develop multiple ISAC therapeutics with Innovent,
the achievement of milestone payments or royalties, and our future
results of operations, financial condition, business strategy and
plans and objectives of management for future operations, are
forward-looking statements. In some cases, you can identify
forward-looking statements because they contain words such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
or “would,” or the negative of these words or other similar terms
or expressions. Forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements.
Forward-looking statements represent our current beliefs, estimates
and assumptions only as of the date of this press release and
information contained in this press release should not be relied
upon as representing our estimates as of any subsequent date. These
statements, and related risks, uncertainties, factors and
assumptions, include, but are not limited to: the potential product
candidates that we develop may not progress through clinical
development or receive required regulatory approvals within
expected timelines or at all; clinical trials may not confirm any
safety, potency or other product characteristics described or
assumed in this press release; such product candidates may not be
beneficial to patients or become commercialized. These risks are
not exhaustive. Except as required by law, we assume no obligation
to update these forward-looking statements, or to update the
reasons actual results could differ materially from those
anticipated in the forward-looking statements, even if new
information becomes available in the future. Further information on
factors that could cause actual results to differ materially from
the results anticipated by our forward-looking statements is
included in the reports we have filed or will file with the SEC,
including our Quarterly Report on Form 10-Q for the three months
ended June 30, 2021. These filings, when available, are available
on the investor relations section of our website at
investors.boltbio.com and on the SEC’s website at www.sec.gov.
Investor Relations and Media
Contacts: Karen L. BergmanVice
President, Communications and Investor RelationsBolt
Biotherapeutics, Inc.650-665-9295 kbergman@boltbio.com
Sarah McCabeStern Investor Relations,
Inc.212-362-1200sarah.mccabe@sternir.com
Maggie Beller or David Schull Russo Partners, LLC
646-942-5631 maggie.beller@russopartnersllc.com
david.schull@russopartnersllc.com
Bolt Biotherapeutics (NASDAQ:BOLT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Bolt Biotherapeutics (NASDAQ:BOLT)
Historical Stock Chart
From Sep 2023 to Sep 2024