Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today
announced a presentation of toripalimab data at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics
being held October 11-15, 2023
at the Hynes Convention Center in Boston.
PD-L1, a protein found on the surface of some cancer cells,
suppresses T cell activation and inhibits the ability of the body’s
immune system to kill cancer cells. Toripalimab is an anti-PD-1
monoclonal antibody that binds with high affinity to a unique site
on PD-1, thereby blocking the interaction of PD-1 and PD-L1.
Preclinical mechanistic data demonstrate statistically
significantly higher activation of T cells and higher expression of
key immune system activators with toripalimab compared to
pembrolizumab, clinically a widely used anti-PD-1 monoclonal
antibody for the treatment of cancer patients. These data may
provide a mechanistic explanation for the improvements in overall
survival irrespective of PD-L1 expression levels observed in
clinical trials in multiple tumor types evaluating toripalimab in
combination with chemotherapy. A biologics license application
(BLA) for toripalimab in combination with chemotherapy as treatment
for recurrent or metastatic nasopharyngeal carcinoma (NPC) is
currently under review by the U.S. Food and Drug Administration
(FDA).
“PD-1 inhibition has been a significant advancement in cancer
treatment across tumor types but better treatments are needed to
increase response rates and drive improved outcomes for patients.
These data support toripalimab as a next-generation PD-1 inhibitor
that, in combination with chemotherapy, may have greater antitumor
activity in less inflamed tumors than more commonly used PD-1
inhibitors in certain cancers due to its unique binding
properties,” said Theresa LaVallee, Ph.D., Coherus’ chief
development officer. “We look forward to delivering this important
new treatment option to patients, first in NPC, if approved, and
continuing to evaluate its efficacy in combination with
chemotherapy in multiple cancer types and in combination with novel
I-O agents.”
Poster presentation data are summarized as follows:
- Toripalimab in combination with chemotherapy significantly
improved overall survival irrespective of PD-L1 status in post hoc
analyses of 3 randomized controlled clinical trials, including in
NPC, non-small cell lung cancer (NSCLC) and
esophageal squamous-cell carcinoma (ESCC)
- Toripalimab exhibits a 12-fold higher binding affinity for PD-1
compared to pembrolizumab that is driven by a slow-off rate
- Toripalimab is more potent than pembrolizumab in enhancing
levels of Th1 cytokines and cytotoxicity in human peripheral blood
mononuclear cells (PBMCs)
- In comparison to pembrolizumab, binding of toripalimab to PD-1
induced low levels of SHP1 and SHP2 recruitment, thereby minimizing
a key process of T cell suppression
- Toripalimab induced and elevated IFN-y gene signature in NSCLC
dissociated tumor cells with different kinetics and intensity
compared to pembrolizumab
Poster presentation details:
- Poster Number C069: Toripalimab, an anti-PD-1 antibody that
demonstrates potent T cell activation and enhanced clinical
efficacy irrespective of PD-L1 statusSession: Poster Session CDate
and time: Saturday, October 14, 12:30 pm-4:00 pm EDTLocation: Level
2, Exhibit Hall D
About toripalimabToripalimab 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 antitumor immunity demonstrating improvement in the
overall survival of cancer patients in several tumor types. The BLA
for toripalimab in combination with chemotherapy as the first-line
treatment for recurrent or metastatic NPC and toripalimab
monotherapy for the second-line or later treatment of recurrent or
metastatic NPC after platinum-containing chemotherapy is under
review by the FDA. In Europe, the marketing authorization
applications (MAA) for toripalimab for the first-line treatment of
NPC and esophageal squamous cell carcinoma (ESCC) are under review
by the European Medicines Agency (EMA) and the United Kingdom’s
Medicines and Healthcare products Regulatory Agency (MHRA).
The FDA granted Breakthrough Therapy designation for toripalimab
in combination with chemotherapy for the first-line treatment of
recurrent or metastatic NPC in 2021 as well as for toripalimab
monotherapy in the second or third-line treatment of recurrent or
metastatic NPC in 2020. Additionally, the FDA has granted Fast
Track designation for toripalimab for the treatment of mucosal
melanoma and Orphan Drug designations for the treatment of ESCC,
NPC, mucosal melanoma, soft tissue sarcoma, and small-cell lung
cancer (SCLC).
More than 40 company-sponsored toripalimab clinical studies
covering over fifteen indications have been conducted globally by
Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences),
including in China, the United States, Southeast
Asia, and European countries. Ongoing or completed pivotal clinical
trials evaluating the safety and efficacy of toripalimab cover a
broad range of tumor types including cancers of the lung,
nasopharynx, esophagus, stomach, bladder, breast, liver, kidney,
and skin.
About Coherus’ Immuno-oncology
PipelineCoherus is developing an innovative
immuno-oncology pipeline that will be synergistic with its proven
commercial capabilities in oncology. Through an in-licensing
agreement with Junshi Biosciences, Coherus is developing
toripalimab, an anti-PD-1 antibody, in the United
States and Canada. A biologics license application for
toripalimab for the treatment of NPC is under review by the FDA.
Toripalimab is approved in China for the treatment of
melanoma, urothelial cancer, esophageal squamous cell carcinoma,
nasopharyngeal carcinoma and non-small cell lung cancer.
Through its recent acquisition of Surface Oncology, Coherus’
immuno-oncology pipeline now 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. Casdozokitug
(formerly SRF388) is a novel anti-IL-27 antibody currently being
evaluated in Phase 1/2 clinical trials in lung and liver cancer.
CHS-114 (formerly SRF114) is a highly selective, competitively
positioned anti-CCR8 antibody currently in a Phase 1/2 study as a
monotherapy in patients with advanced solid tumors. There are also
two out-licensed partnership programs to advance its
next-generation cancer therapies.
Coherus’ earlier-stage immuno-oncology pipeline targets
immune-suppressive mechanisms in the tumor microenvironment,
including CHS-006, a TIGIT-targeted antibody, being evaluated in a
Phase 1/2 clinical trial in combination with toripalimab in
patients with advanced solid tumors, and CHS-1000, a preclinical
program targeting the novel pathway ILT4.
About Coherus BioSciencesCoherus is a
commercial-stage biopharmaceutical company focused on the research,
development and commercialization of innovative immunotherapies to
treat cancer. Coherus’ strategy is to build a leading
immuno-oncology franchise funded with cash generated through net
sales of its diversified portfolio of FDA-approved
therapeutics.
In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody,
in the United States and Canada. The Biologics
License Application for toripalimab in combination with
chemotherapy as treatment for recurrent or metastatic
nasopharyngeal carcinoma is currently under review by the FDA.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar
of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of
Lucentis®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of
Humira®.
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 build
its immuno-oncology franchise to achieve a leading market position;
Coherus’ ability to generate cash and net sales; Coherus’
investment plans; Coherus’ ability to find synergies between its
I-O pipeline and its commercial operations; expectations about the
efficacy and safety profile of any product candidate; and Coherus’
ability to launch or achieve FDA approvals for any product
candidate in the future.
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, the risks and uncertainties inherent in the clinical
drug development process; risks related to integration of Surface’s
programs and operations; risks related to realizing the anticipated
benefits of the acquisition of Surface; risks related to Coherus’
existing and potential collaboration partners; risks of Coherus’
competitive position; the risks and uncertainties of the regulatory
approval process, including the speed of regulatory review,
international aspects of Coherus’ business and the timing of
Coherus’ regulatory filings; the risk of FDA review issues; the
risk that Coherus is unable to complete commercial transactions and
other matters that could affect the availability or commercial
potential of Coherus’ products and product candidates; 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 fiscal quarter ended June 30, 2023 filed with
the Securities and Exchange Commission on August 2,
2023, including the section therein captioned “Risk Factors” and in
other documents Coherus files with the Securities and Exchange
Commission.
UDENYCA®, CIMERLI® and YUSIMRY™, whether or not appearing
in large print or with the trademark symbol, are trademarks of
Coherus, its affiliates, related companies or its licensors or
joint venture partners unless otherwise noted. Trademarks and trade
names of other companies appearing in this press release are, to
the knowledge of Coherus, the property of their respective
owners.
Coherus Contact Information:For Investors &
MediaJodi Sievers, VP, Corporate Communicationsir@coherus.com
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