Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced
data from the ongoing Phase 1b/2 clinical trial of casdozokitug
(casdozo), a first-in-class IL-27-targeting antibody, being
presented at the 2023 ESMO Immuno-Oncology Congress taking
place December 6 – 8, 2023 at Palexpo Exhibition Centre
in Geneva, Switzerland. The presentation includes updated data for
casdozo monotherapy dose escalation and expansion cohorts and a
cohort evaluating treatment with casdozo in combination with the
anti-PD-1 antibody pembrolizumab (pembro) in patients with
non-small cell lung cancer (NSCLC) who have progressed after 2-4
prior lines of therapy, including chemotherapy and anti-PD-1
agents. 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.
“‘Cold’ and ‘excluded’ tumor immune microenvironments are the
least likely to respond to checkpoint blockade and present a unique
challenge to the field of cancer immunotherapy, and IL-27
production by tumor infiltrating macrophages may be one key
mechanism by which tumors exclude key anti-tumor lymphocytes,” said
Thomas Marron, M.D., Ph.D., Director, Early Phase Trials Unit, The
Tisch Cancer Center. “The responses in pre-treated patients who
have progressed on PD-1 blockade are extremely encouraging and
warrant further investigation both in the relapsed/refractory
setting and potentially up-front. The responses we saw in patients
with squamous cell carcinoma are particularly intriguing, and
further analysis of the tissue and blood of these patients will
hopefully reveal biomarkers to further enrich for patients likely
to respond to casdozo.”
“We are pleased to see that casdozo has demonstrated immune
activation and monotherapy anti-tumor activity with an acceptable
safety profile in NSCLC. These data continue to support the
blocking of IL-27 as a novel strategy to overcome immune
suppression in difficult to treat patients with solid tumors,” said
Rosh Dias Coherus’ Chief Medical Officer. “The casdozo and anti
PD-1 antibody combination has been well tolerated in this study,
and as we continue to advance our own internal next-generation
immuno-oncology combinations, we look forward to the results of the
novel combination of casdozo and our anti-PD-1 antibody
toripalimab-tpzi which will enroll as the final cohort in this
study.”
Phase 1b/2 clinical trial designThe ongoing
first-in-human open-label Phase 1b/2 dose escalation and expansion
study of casdozo in advanced solid tumors comprises multiple parts:
Part A monotherapy dose escalation (N=29; NSCLC N=5), Part B
monotherapy dose expansion in NSCLC (N=40), HCC (N=17), and ccRCC
(N=27), Part C combination with pembro in anti PD-(L)1 R/R NSCLC
(N=6), HCC (N=7), and RCC (N=3) and Part D combination with
toripalimab in anti PD-(L)1 R/R NSCLC (Target N=40). As
monotherapy, casdozo demonstrated favorable safety and preliminary
anti-tumor activity. Expansion cohorts in NSCLC have evaluated
casdozo 10 mg/kg IV q4w as monotherapy and q3w in combination with
pembrolizumab in treatment-refractory NSCLC. Part C was halted
early due to changes in company objectives, and the Part D cohort
evaluating casdozo in combination with toripalimab-tpzi is now
enrolling. The primary endpoint is objective response rate (ORR)
based on investigator review per RECIST v1.1. Key secondary
endpoints include safety and tolerability and additional measures
of efficacy (duration of response (DoR) and disease control rate
(DCR) based on investigator review per RECIST v1.1).
Phase 1b/2 clinical trial dataAs of the cutoff
date (September 21, 2023), in response-evaluable patients (n=43)
there were two confirmed partial responders (PRs) in PD-L1 negative
or low, squamous NSCLC and one durable disease stabilization in
adenocarcinoma. All three patients received casdozo monotherapy and
had been previously treated with anti-PD-L1 antibodies.
Immunohistochemistry (HC) analysis of tissue from one squamous
NSCLC patient who experienced a partial response shows features of
an immune excluded tumor microenvironment which can indicate
anti-tumor response to treatment, as well as prominent IL-27
staining indicative of high target engagement. The overall response
rate (ORR) in the subset of patients with squamous NSCLC (n=2/9)
was 22% in this data cut. Casdozo continues to demonstrate an
acceptable safety profile as monotherapy or in combination with a
PD-1 inhibitor (pembro).
Poster presentation details:Title: Casdozokitug
(casdozo, CHS-388), a first-in-class IL-27 targeting antibody as
monotherapy or in combination with pembrolizumab (pembro) in
treatment-refractory non-small cell lung cancer (NSCLC)Presentation
number: #122PDate and Time: Thursday, December 7, 2023, 12:00 –
13:00 CETPresenter: Thomas Marron, M.D., Ph.D.Location: Foyer
mezzanine – Palexpo Exhibition Centre, Geneva
Poster presentation data are summarized as follows:
- Casdozokitug has demonstrated immune activation and single
agent responses in PD-(L)1 experienced, PD-L1 low NSCLC patients,
with an acceptable safety profile alone and in combination with a
PD-1 inhibitor (pembro); in squamous NSCLC, two of nine patients
had confirmed PRs
- The combination of casdozo + pembrolizumab was well tolerated
with a best response of stable disease in the first five
response-evaluable NSCLC patients treated
- Results support continued evaluation of casdozo to relieve
tumor immune suppression in combination with PD-1 inhibitors and
other novel agents in NSCLC
- Phase 2 study of the PD-1 antibody, toripalimab, and casdozo is
currently enrolling
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. 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). Coherus anticipates data from the
HCC clinical trial in Q1 2024. 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.
Coherus’ earlier-stage immuno-oncology pipeline targets
immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted
antibody, being evaluated in a Phase 1/2 clinical trial in
combination with LOQTORZI in patients with advanced solid tumors,
and CHS-1000, a preclinical program targeting the novel pathway
ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of
Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®,
YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and plans to
launch LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1
inhibitor, in the U.S. in January 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 find
synergies between its I-O pipeline and its commercial operations;
and expectations for the launch date of LOQTORZI.
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:Jodi Sievers, VP Corporate
Communicationsmedia@coherus.com
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