Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced
data from the lead-in portion of the Phase 2 clinical trial
evaluating casdozokitug (casdozo), a selective and potent
IL-27-targeting antibody, in combination with atezolizumab (atezo)
and bevacizumab (bev) in treatment naïve patients with unresectable
locally advanced or metastatic hepatocellular carcinoma (uHCC).
These data are being presented at the 2024 ASCO Gastrointestinal
Cancers Symposium taking place January 18-20, 2024 at
Moscone West in San Francisco, California. Interleukin (IL)-27 is
an immunoregulatory cytokine involved in suppressing anti-tumor
immune responses and an important new target for cancer treatment.
Casdozo is a first-in-class antibody, and the only clinical stage
immunomodulatory cytokine antagonist targeting IL-27.
“Doublet immunotherapy combinations for the treatment of liver
cancer have improved outcomes for patients for whom surgery is not
an option or whose cancer has spread. However, not all patients
respond to current therapy and novel treatment options that can
further improve survival without added toxicity are needed,” said
Daneng Li, M.D., Associate Professor in the Department of Medical
Oncology & Therapeutics Research and Co-Director, Liver Cancer
Collaborative Program, City of Hope Comprehensive Cancer Center.
“The addition of casdozo to standard of care is encouraging and
supports further evaluation of cazdozo, and its novel anti-IL-27
mechanism, as part of triplet therapy in HCC. Additionally, each
person with advanced HCC is unique with respect to their tumor,
co-morbidities and other factors – the biomarker data showing an
association of IL-27 biology and response to casdozo is
particularly interesting and the potential to identify biomarkers
of response would be an important benefit to patients with liver
cancer.”
“These impressive early clinical and immune activitation data
for casdozo in HCC demonstrating an ORR of 38%, including 3
complete reponses, and a favorable safety profile add to the
growing body of data supporting IL-27 as a promising novel target
in combination therapy for advanced solid tumors,” said Rosh Dias,
M.D., Coherus’ Chief Medical Officer. “We now have data across
several tumor types for casdozo demonstrating clinical activity.
Our comprehensive clinical development program of ongoing and
planned clinical trials including casdozokitug in combination with
our anti-PD-1 antibody backbone of toripalimab-tpzi, will further
advance our internal next-generation immuno-oncology combinations
focused on overcoming immune suppression in the tumor
microenvironment with the goal of extending survival and improving
outcomes for patients.”
Lead-in portion of Phase 2 clinical trial
designThe open-label lead-in portion of the Phase 2
clinical trial evaluated casdozo in combination with atezo and bev
in 30 patients with treatment-naïve uHCC. Patients received casdozo
10 mg/kg IV q3w, in combination with atezo (1200 mg) and bev (15
mg/kg). The primary endpoint of the lead-in portion of the study
was safety and tolerability. Key secondary endpoints included
progression-free survival (PFS) and overall response rate (ORR)
based on investigator review per RECIST v1.1 (primary) and mRECIST
(secondary), as well as disease control rate (DCR). Further [Phase
2] clinical development of cazdozo in HCC is planned to evaluate
casdozo/toripalimab (anti-PD-1 antibody)/bev.
Lead-in portion of Phase 2 clinical trial
dataAs of the data cutoff date (November 9, 2023): Triplet
blockade of the IL-27, PD-(L)1 and VEGF pathways with
casdozo/atezo/bev has an acceptable safety profile to date with
promising antitumor activity in IO naïve HCC.
- Triplet combination treatment was well tolerated with side
effect profile consistent with known adverse event (AE) profiles of
atezo/bev.
- Encouraging early activity with casdozo/atezo/bev:
- RECIST v1.1: ORR of 38% (n=29) with 11 durable objective
responses including 3 complete responses and 8 partial responses (1
unconfirmed); median progression-free survival of 8.1 months and
disease control rate of 58.6%.
- mRECIST: ORR of 43% (n=28) with 12 durable objective responses
including 3 complete responses and 9 partial responses (1
unconfirmed); median progression-free survival not reached and
disease control rate of 60.7%.
- Further analyses of samples from patients who responded to
treatment (small n) indicate preliminary association between
response and biomarkers of IL-27.
These results support continued evaluation of casdozo with VEGF
and PD-(L)1 blockade in HCC. Coherus plans to evaluate the
combination of casdozo/toripalimab-tpzi(Coherus’ anti-PD-1
antibody)/bev in future clinical trials.
Poster presentation details:Title: Results from
a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VegF
pathways with casdozokitug (casdozo, CHS-388) in combination with
atezolizumab (atezo) and bevacizumab (bev) in patients with
unresectable, locally advanced or metastatic hepatocellular
carcinoma (uHCC)Poster Board number: B15Abstract number: 470Date
and Time: Friday, January 19, 2024, 12:30 – 2:00 pm PTPresenter:
Daneng Li, MDLocation: Level 1, West Hall, Moscone West
About CasdozokitugCasdozokitug 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. 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). An ongoing trial is studying combinations with
PD-(L)1 pathway blockade in NSCLC and a planned clnical trial will
study the triplet combination of IL-27, PD-(L)1 and VEGF pathway
blockade in hepatocellular carcinoma (HCC). Casdozokitug has been
granted Orphan Drug designation and Fast Track designation for the
treatment of refractory hepatocellular carcinoma from the FDA. It
is the first IL-27 antibody to enter the clinic.
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’ 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. Casdozokitug is a
novel anti-IL-27 antibody currently being evaluated in two on-going
clinical studies: a Phase 1/2 study in advanced solid tumors and a
Phase 2 study in hepatocellular carcinoma. CHS-114 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. CHS-1000 is a preclinical
candidate targeting immune-suppressive mechanisms via the novel
pathway ILT4 with an IND filing planned in the first half of
2024.
Coherus markets LOQTORZI™ (toripalimab-tpzi), a novel next
generation PD-1 inhibitor, 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 find
synergies between its I-O pipeline and its commercial operations;
expectations for the timing of an IND filing for CHS-1000;
statements that the Coherus immuno-oncology pipeline will extend
survival and enhance outcomes for cancer 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 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 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 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, Head of Investor Relationsir@coherus.com
Media:Mike Beyer, Red House
Communicationsmike@redhousecomms.com
Jodi Sievers, VP Corporate Communicationsmedia@coherus.com
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