- Combination therapy to be evaluated in
a Phase 3 trial in patients with
locoregionally
advanced, high-risk, HPV16/18-positive
head and neck cancer
PLYMOUTH
MEETING, Pa. and REDWOOD CITY,
Calif., Jan. 4, 2024 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on developing
and commercializing DNA medicines to help treat and protect
people from HPV-associated diseases, cancer and infectious
diseases, today announced a clinical collaboration and supply
agreement with Coherus BioSciences, Inc. (Coherus, NASDAQ:
CHRS) to evaluate the combination of INO-3112
and LOQTORZI™ (toripalimab-tpzi) as a
potential treatment for patients with locoregionally
advanced, high-risk, HPV16/18 positive oropharyngeal
squamous cell carcinoma (OPSCC), a type of head and neck
cancer commonly known as throat cancer.
Under the terms of the supply agreement, Coherus will provide
LOQTORZI™ (toripalimab-tpzi), for a Phase 3 clinical trial to
be conducted by INOVIO, pending alignment with the U.S. Food and
Drug Administration (FDA) on study design. LOQTORZI™ is a
PD-1 inhibitor recently approved by the FDA for the treatment of
recurrent locally advanced/metastatic nasopharyngeal carcinoma
(R/P NPC).
"Existing trial data highlights the strong rationale for and
potential benefit of combining INO-3112 with a PD-1 inhibitor to
generate tumor-specific T cells in HPV-related head and neck
cancer," said Dr. Glenn Hanna,
Director of the Center for Cancer Therapeutic Innovation (early
drug development program) at Dana Farber Cancer Institute,
Assistant Professor of Medicine at Harvard
Medical School and principal investigator for the planned
trial. "I look forward to advancing this research for patients by
harnessing their immune system to fight against this life-altering,
virally mediated cancer."
"We are very pleased to be collaborating with Coherus on this
novel combination therapy and are excited about the opportunity to
build on encouraging data from our previous trials involving
INO-3112 in HPV-related head and neck cancer," said INOVIO's
President and Chief Executive Officer, Dr. Jacqueline Shea. "There is unique potential in
combining our DNA medicines platform, which a growing body of
research indicates is adept at fighting HPV-related diseases, with
a proven PD-1 inhibitor to improve clinical outcomes for
patients."
"We are delighted to be partnering with INOVIO on the
development of the toripalimab/INO-3112 combination in HPV-related
OPSCC, a tumor type that is synergistic to the current toripalimab
indication in R/P NPC," said Rosh
Dias, M.D., Chief Medical Officer at Coherus. "With its
differentiated mechanism of action, toripalimab in combination with
the INO-3112 vaccine may hold promise for these patients in
earlier-stage disease, where treatment options are more limited.
This partnership fits in well with our strategic vision to
investigate toripalimab across additional tumor types as the PD-1
backbone in combination with novel agents of multiple modalities
with the goal of improving patient benefit."
About Oropharyngeal Squamous Cell
Carcinoma
Oropharyngeal squamous cell carcinoma, commonly
known as throat cancer, is a type of head and neck cancer that
occurs in the base of the tongue, tonsils and/or soft palate. OPSCC
is typically causally related to high-risk subtypes of human
papillomavirus (HPV), but some cases are carcinogen-driven due to
tobacco and/or alcohol use. HPV-positive OPSCC is rapidly
increasing in incidence among patients in high-income countries and
has surpassed cervical cancer as the most common HPV-related cancer
diagnosed in the United States,
with nearly 20,000 new cases each year. HPV is thought to cause
70%-80% of all oropharyngeal cancers diagnosed in the United States.
About INO-3112
INO-3112 is a DNA medicine candidate
targeting HPV 16/18 combined with a DNA plasmid for IL-12 as an
immune activator. INOVIO is investigating the potential benefit of
the antigen-specific T cell generation and tumor infiltration
abilities of INO-3112 in HPV-related cancers, especially when used
in novel combinations. Results from a Phase 1/2a trial of INO-3112
alone in 22 HPV-positive head and neck squamous cell carcinoma
(HNSCC) patients, published in Clinical Cancer Research in
2019, included the observation of T cell responses
and infiltration of CD8+ T cells into the head and
neck tumors. In early 2023, updated results were published in
Clinical Cancer Research from a Phase 1b/2a trial of INO-3112 in combination with
AstraZeneca's PD-L1 checkpoint inhibitor, durvalumab, showing an
ORR of 27.6% (4 CR, 4 PR) in 29 evaluable patients and increased
peripheral HPV-specific T cells and tumoral CD8+ T cells.
About LOQTORZI™ (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that
blocks PD-L1 binding to the PD-1 receptor at a unique site with
high affinity and activates anti-tumor immunity demonstrating
improvement in the overall survival of cancer patients in several
tumor types. LOQTORZI was recently approved by the FDA for the
treatment of recurrent locally advanced/metastatic NPC. For more
information about LOQTORZI, including important safety information,
please visit www.loqtorzi.com.
About INOVIO
INOVIO is a biotechnology company focused
on developing and commercializing DNA medicines to help treat and
protect people from HPV-related diseases, cancer, and infectious
diseases. INOVIO's technology optimizes the design and delivery of
innovative DNA medicines that teach the body to manufacture its own
disease-fighting tools. For more information, visit
www.inovio.com.
About Coherus
Coherus is a commercial-stage
biopharmaceutical company focused on the research, development and
commercialization of innovative immunotherapies to treat cancer.
Coherus is developing an innovative immuno-oncology pipeline that
will be synergistic with its proven commercial capabilities in
oncology.
Coherus' immuno-oncology pipeline includes multiple antibody
immunotherapy candidates focused on enhancing the innate and
adaptive immune responses to enable a robust immunologic response
and enhance outcomes for patients with cancer.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar
of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of
Lucentis®, YUSIMRY™ (adalimumab-aqvh), a biosimilar of
Humira® and LOQTORZI (toripalimab-tpzi), a novel next
generation PD-1 inhibitor. For more information, visit
www.coherus.com.
INOVIO Forward-Looking Statements
This press release
contains certain forward-looking statements relating to INOVIO's
business, including its plans to develop and commercialize DNA
medicines and its expectations regarding its research and
development programs, including plans to advance development of
INO-3112 in a Phase 3 clinical trial in combination with LOQTORZI
(toripalimab-tpzi). Actual events or results may differ from the
expectations set forth herein as a result of a number of factors,
including uncertainties inherent in pre-clinical studies, clinical
trials, product development programs and commercialization
activities and outcomes, the availability of funding to support
continuing research and studies in an effort to prove safety and
efficacy of electroporation technology as a delivery mechanism or
develop viable DNA medicines, INOVIO's ability to support its
pipeline of DNA medicine products, the ability of INOVIO's
collaborators to attain development and commercial milestones for
products INOVIO licenses and product sales that will enable INOVIO
to receive future payments and royalties, the adequacy of INOVIO's
capital resources, the availability or potential availability of
alternative therapies or treatments for the conditions targeted by
INOVIO or its collaborators, including alternatives that may be
more efficacious or cost effective than any therapy or treatment
that INOVIO and its collaborators hope to develop, issues involving
product liability, issues involving patents and whether they or
licenses to them will provide INOVIO with meaningful protection
from others using the covered technologies, whether such
proprietary rights are enforceable or defensible or infringe or
allegedly infringe on rights of others or can
withstand claims of invalidity and whether INOVIO can finance or
devote other significant resources that may be necessary to
prosecute, protect or defend them, the level of corporate
expenditures, assessments of INOVIO's technology by potential
corporate or other partners or collaborators, capital market
conditions, the impact of government healthcare proposals and other
factors set forth in INOVIO's Annual Report on Form 10-K for the
year ended December 31,
2022, its Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023, and other filings
INOVIO makes from time to time with the Securities and Exchange
Commission. There can be no assurance that INO-3112 or any other
product candidate in INOVIO's pipeline will be successfully
developed, manufactured, or commercialized, that the results of
clinical trials will be supportive of regulatory approvals required
to market products, or that any of the forward-looking information
provided herein will be proven accurate. Forward-looking statements
speak only as of the date of this release, and INOVIO undertakes no
obligation to update or revise these statements, except as may be
required by law.
Coherus Forward-Looking Statements
Except for the historical information contained herein, the matters
set forth in this press release are forward-looking statements
within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 including, but not limited
to, statements regarding Coherus' ability to achieve synergies
between its I-O pipeline and its commercial capabilities; Coherus'
projections about synergies for LOQTORZI between NPC and
HPV-associated HNSC; and Coherus' expectations that it will be able
to benefit patients by investigating LOQTORZI in combination with
multiple novel agents. Such forward-looking statements involve
substantial risks and uncertainties that could cause Coherus'
actual results, performance or achievements to differ significantly
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, risks and uncertainties
inherent in the clinical drug development process; risks related to
our existing and potential collaboration partners; risks of the
drug development position of Coherus' competitors; the risks and
uncertainties of the collaboration between Coherus and INOVIO; the
risks and uncertainties of the regulatory approval process,
including the speed of regulatory review, international aspects of
Coherus' business; the risk of FDA review issues; the risk that
Coherus is unable to complete commercial transactions; and the
risks and uncertainties of possible litigation. All forward-looking
statements contained in this press release speak only as of the
date of this press release. Coherus undertakes no obligation to
update or revise any forward-looking statements. For a further
description of the significant risks and uncertainties that could
cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Coherus'
business in general, see Coherus' Quarterly Report on Form 10-Q for
the quarter ended September 30, 2023, filed with
the Securities and Exchange Commission on November
6, 2023, including the section therein captioned "Risk Factors" and
in other documents that Coherus files with the Securities and
Exchange Commission.
INOVIO Contacts
Media: Jennie
Willson, (267) 429-8567, jennie.willson@inovio.com
Investors: Thomas Hong, (267) 440-4298,
thomas.hong@inovio.com
Coherus Contact
Investors & Media:
Jami Taylor, Head of Investor
Relations for Coherus
IR@coherus.com
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SOURCE INOVIO Pharmaceuticals, Inc.; Coherus BioSciences,
Inc.