Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced
data from three immuno-oncology pipeline programs at the 38th
Annual Meeting of SITC taking place November 1 - 5,
2023 at the San Diego Convention Center in San
Diego, CA. Preclinical data presented support differentiated
mechanisms of its next-generation immunotherapies potentially
enabling the antitumor immune activation in more cancer patients
and enhanced treatment outcomes.
“These data presented at SITC highlight the complementary
mechanisms that we have in our innovative immunotherapy portfolio,
including anti-PD-1, anti-IL27 and anti-CCR8, and the promise of
novel immuno-oncology treatment combinations that may overcome the
challenging tumor microenvironment,” said Theresa LaVallee, Ph.D.,
Coherus’ chief development officer. “LOQTORZI™ is the first
approved treatment option for patients with nasopharyngeal
carcinoma (NPC), and we will continue to generate and use data to
optimize our clinical development plans through the selection of
additional tumor types and immuno-oncology combinations that can
have the greatest impact on extending survival for cancer
patients.”
Casdozokitug (CHS-388, formerly SRF388), a
first-in-class anti-IL-27 antibodyInterleukin (IL)-27 is
an immunoregulatory cytokine involved in resolving inflammation and
inhibiting anti-tumor immune responses. Blocking IL-27 with
casdozokitug in clinical trials has led to monotherapy tumor growth
inhibition and partial responses in patients with non-small cell
lung cancer (NSCLC) and renal cell carcinoma (RCC) (NCT04374877)
and ongoing trials are studying combinations with PD-1/PD-L1
pathway blockade in NSCLC and hepatocellular carcinoma (HCC). Data
presented at SITC 2023 demonstrate IL-27-mediated gene expression,
highlighting its critical role in immune suppressive mechanisms in
the tumor microenvironment and importance as a new target for
cancer treatment, as well as an opportunity to identify biomarkers
that could determine patients most likely to respond to anti-IL-27
treatment.
Abstract #1351: Identifying IL-27
dependent biomarkers in lymphocytes, NK cells, and myeloid cells in
peripheral blood and the tumor microenvironmentDate and
Time: Friday, November 3, 9 a.m.–7 p.m. Pacific Daylight Time
(PDT)Location: Exhibit Halls A and B1 – San Diego Convention
Center
Poster presentation data are summarized as follows:
- In human immune cells from peripheral blood, IL-27 induces the
expression of interferon (IFN)-stimulated genes, which are
associated with drug resistance in cancer
- Although many known IFN-responsive genes were induced by both
IFNs and IL-27 treatment, distinct gene expression was observed in
different immune cell types
- IL-27 and IFNs induce unique gene expression in different cell
types, for example, GBP5 (guanylate-binding protein 5) and IRF1
(interferon regulatory factor 1), two interferon stimulated genes,
are preferentially elevated by IL-27 in NK cells and CD8+ T
cells
- Immunohistochemistry (IHC) analysis of treatment-naïve NSCLC
tumor samples showed that IL-27+ macrophages are co-localized with
GBP5+ T-cell-rich areas in the TME
- These studies lend insights into the immune interplay between
IFNs and IL-27 signaling across different immune cells and within
the TME and ascertain the immunosuppressive role of IL-27 and may
inform casdozo clinical development.
CHS-114 (formerly SRF114), an anti-CCR8
antibodyCCR8 is a chemokine receptor predominantly
expressed by tumor infiltrating Tregs that suppress the body’s
natural anti-cancer immune response. Targeting CCR8 is a promising
potential therapeutic strategy designed to deplete Tregs, reshape
the tumor microenvironment and enhance anti-tumor immune response.
CHS-114 is designed to selectively target human CCR8 and
preferentially depletes CCR8+ Treg cells and not T effector (Teff)
cells in tumors or normal tissue. Data presented demonstrate the
role of CCR8+ Tregs as dominant immunosuppressive cells in the TME
and highlight head and neck squamous cell carcinoma (HNSCC) as a
promising tumor type in which CHS-114 could have anti-tumor
activity as monotherapy or in combination with an anti-PD1
antibody. CHS-114 is currently being evaluated in a Phase 1
clinical trial (NCT05635643).
Abstract #1354: Anti-CCR8 antibody
SRF114 depletes tumor-infiltrating regulatory T cells in
dissociated tumors from patients with head and neck squamous cell
carcinomaDate and Time: Saturday, November 4, 9 a.m.–8:30
p.m. PDTLocation: Exhibit Halls A and B1 – San Diego Convention
Center
Poster presentation data are summarized as follows:
- Chemokine receptor 8 (CCR8) expression is highly enriched on
intratumoral Tregs within the TME cells, particularly in HNSCC
- In multiple model systems, CHS-114, a cytolytic antibody
selective for CCR8, activates natural killer (NK) cells and
specifically induces NK-mediated cytotoxicity against
tumor-infiltrating CCR8+ Tregs and results in the expansion of
effector CD8 T cells
- Enhanced antitumor immunity is observed with combination of
Anti-CCR8 and anti-PD-1 combination treatment
- CHS-114, a CCR8-specific cytotoxicity-inducing antibody that
preferentially depletes CCR8+ Treg cells and not T effector (Teff)
cells, is currently being evaluated in a Phase 1 clinical trial
(NCT05635643).
LOQTORZI™ (toripalimab-tpzi), a next generation
anti-PD-1 antibodyPD-L1 is a protein found on the surface
of some cancer cells that can help evade the body’s immune system
by suppressing T cell activation and inhibiting the T cell’s
ability to kill cancer cells. LOQTORZI™ is an anti-PD-1 monoclonal
antibody that blocks PD-L1 binding to the PD-1 receptor at a
unique site with high affinity to activate antitumor immunity. Data
presented compare mechanistic data for LOQTORZI™ to commercially
available anti-PD-1 monoclonal antibodies and demonstrate higher
expression of key immune system biomarkers with LOQTORZI™.
Additionally, LOQTORZI™ in combination with chemotherapy shows
enhanced clinical efficacy irrespective of PD-L1 status across
multiple tumor types in post hoc analyses of 3 randomized
controlled clinical trials in NPC, NSCLC and
esophageal squamous-cell carcinoma (ESCC). LOQTORZI™
(toripalimab-tpzi) was recently approved by the U.S. Food and Drug
Administration (FDA) for metastatic or recurrent NPC as first-line
treatment in combination with chemotherapy or as second- or
greater-line monotherapy treatment.
Abstract #468: Characteristics of
toripalimab: a next generation anti-PD-1 antibody with potent T
cell activation and enhanced clinical efficacy irrespective of
PD-L-1 statusDate and Time: Saturday, November 4, 9
a.m.–8:30 p.m. PDTLocation: Exhibit Halls A and B1 – San Diego
Convention Center
Poster presentation data are summarized as follows:
- Toripalimab in combination with chemotherapy demonstrates
clinical efficacy irrespective of PD-L1 status
- Toripalimab exhibits a 12-fold higher binding affinity to PD-1
compared to pembrolizumab
- Toripalimab promotes a stronger Th1-mediated response than
pembrolizumab in vitro in human peripheral blood mononuclear
cells (PBMCs)
- Toripalimab induced an elevated IFN- gene signature in NSCLC
dissociated tumor cells with different kinetics and higher
intensity compared to pembrolizumab
- In comparison to other commercially available anti-PD-1
antibodies, toripalimab exhibits the lowest potential for partial
agonism by recruiting low levels of SHP1 and SHP2, negative
regulators of T cell activation
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 antitumor immunity demonstrating improvement in the
overall survival of cancer patients in several tumor types.For more
information, please see LOQTORZI.com for FDA-approved indications
and full prescribing information.
About CasdozokitugCasdozokitug (formerly
SRF388) is a first-in-class human anti-IL-27 antibody designed to
inhibit the activity of this immunosuppressive cytokine. Particular
tumor types have been identified where IL-27 appears to play an
important role in the immunosuppressive tumor microenvironment and
may contribute to resistance to treatment with checkpoint
inhibitors. Furthermore, a potential biomarker associated with
IL-27 has been identified that may be useful in helping identify
patients most likely to respond to casdozokitug. It is the first
IL-27 antibody to enter the clinic.
About CHS-114CHS-114 (formerly SRF114) is a
human, cytolytic anti-CCR8 antibody designed to preferentially
deplete CCR8+ Treg cells within the tumor microenvironment and not
T effector (Teff) calls in normal tissue. In preclinical studies,
CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC)
and/or antibody-dependent cellular phagocytosis (ADCP) pathways to
deplete intertumoral Treg cells. In addition, CHS-114 reduced tumor
growth in murine models. CHS-114 is currently being evaluated in a
Phase 1 clinical trial (NCT05635643) as a therapeutic candidate
that holds the potential to drive anti-tumor immunity in
patients.
About Coherus’ Immuno-oncology
PipelineCoherus is developing an innovative
immuno-oncology pipeline that will be synergistic with its proven
commercial capabilities in oncology. The foundational therapy in
our immuno-oncology pipeline is LOQTORZI™ (toripalimab-tpzi), a
next-generation, FDA-approved PD-1 inhibitor.
Through its 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 ADCC-enhanced anti-CCR8 antibody currently in a Phase
1/2 study as a monotherapy in patients with advanced solid
tumors.
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 is developing an innovative immuno-oncology
pipeline that will be synergistic with its proven commercial
capabilities in oncology.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of
Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®,
YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and expects to
launch LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1
inhibitor, in the U.S. in Q1 2024.
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
realize synergies between its commercial capabilities in oncology
and its immuno-oncology pipeline; Coherus’ expectations of the
launch timing for LOQTORZI™; expectations about the timing and
ability of Coherus to advance the development of its product
candidates; and Coherus’ expectation that its product candidates
may advance treatment outcomes for patients.
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®, YUSIMRY™ and LOQTORZI™, 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:
Investors:Jami Taylor, VP, Investor Relationsir@coherus.com
Media:Jodi Sievers, VP Corporate
Communicationsmedia@coherus.com
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