Corvus Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Ciforadenant as Potential First Line Treatment for Patients with Renal Cell Cancer
October 25 2022 - 4:05PM
Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq:
CRVS), a clinical-stage biopharmaceutical company, today announced
the initiation of a Phase 1b/2 clinical trial evaluating
ciforadenant as a potential first line therapy for metastatic renal
cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and
nivolumab (anti-PD-1). The Phase 1b/2 study is being conducted by
the Kidney Cancer Research Consortium (KCRC) and is led by The
University of Texas MD Anderson Cancer Center, one of seven partner
institutions that make up the KCRC. The study is expected to enroll
up to 60 patients at KCRC partner institutions.
“Ciforadenant is one of the most studied adenosine receptor
antagonists and we have presented encouraging clinical data in very
advanced refractory patients with renal cell cancer, demonstrating
its anti-tumor activity as a monotherapy and in combination with
anti-PD-L1 therapy,” said Richard A. Miller, M.D., co-founder,
president and chief executive officer of Corvus. “In addition, we
published preclinical data in Cancer Immunology Research in 2018
that showed that ciforadenant combined with anti-CTLA-4 and
anti-PD-1 therapy is highly active, which resulted in complete
elimination of tumors, even in the setting of treatment of
established tumors. Further laboratory studies have uncovered a
novel mechanism of action that we believe may synergize with
anti-CTLA-4 therapy. Together we believe this provides strong
rationale for this Phase 1b/2 clinical trial in first line renal
cell cancer and we are excited to partner with the Kidney Cancer
Research Consortium, who is leading the clinical trial. And given
this is an open-label study, we hope to have preliminary results
relatively early in the trial.”
About the Ciforadenant Phase 1b/2 TrialThe
open-label Phase 1b/2 clinical trial is expected to enroll up to 60
patients with newly diagnosed or recurrent stage IV clear cell RCC
that have not received any prior systemic therapy. Patients will
receive ciforadenant 100 mg oral, twice-daily in combination with
ipilimumab (anti-CTLA-4) 1mg/kg given once every three weeks for
twelve weeks (4 doses) and nivolumab (anti-PD-1) 3mg/kg given once
every three weeks. In the Phase 1b portion of the clinical trial
(N=8), the primary endpoints are safety, tolerability and
anti-tumor activity. In the Phase 2 portion of the clinical trial,
the primary endpoint is the percent of patients that achieve a deep
response, defined as complete response or depth of partial response
of >50% tumor reduction. Historical data has shown that deep
responses correlate with prolonged progression free survival and is
seen in approximately 35% of patients receiving ipilimumab and
nivolumab. The trial design is based on Corvus’ preclinical
research published in 2018 in Cancer Immunology Research, which
demonstrated antitumor control and complete elimination of
tumors in several animal models using ciforadenant in
combination with anti-CTLA4 and anti-PD1.
About the Kidney Cancer Research ConsortiumThe
KCRC is comprised of seven partner institutions at top academic
research institutions across the country. The pooled expertise of
KCRC members ensures the highest quality of clinical study design,
accelerated execution of clinical trials, cost-effective access to
multiple research centers, and accurate interpretation and
reporting of results. The KCRC was founded in 2018 through the
Department of Defense (DoD) Consortium Development Award and was
subsequently awarded the DoD Clinical Consortium Award in 2020. For
more information, visit www.kidneycancerconsortium.org.
About Corvus PharmaceuticalsCorvus
Pharmaceuticals is a clinical-stage biopharmaceutical company.
Corvus’ lead product candidate is CPI-818, an investigational,
oral, small molecule drug that selectively inhibited ITK in
preclinical studies and is in a multicenter Phase 1/1b clinical
trial in patients with several types of T-cell lymphomas. The
Company’s second clinical program, ciforadenant (CPI-444), is an
oral, small molecule inhibitor of the A2A receptor. Its third
clinical program, mupadolimab (CPI-006), is a humanized monoclonal
antibody directed against CD73 that has exhibited immunomodulatory
activity and activation of immune cells in preclinical and clinical
studies. For more information, visit www.corvuspharma.com.
About CiforadenantCiforadenant
(CPI-444) is an investigational small molecule, oral, checkpoint
inhibitor designed to disable a tumor’s ability to subvert attack
by the immune system by blocking the binding of adenosine in the
tumor microenvironment to the A2A receptor. Adenosine, a metabolite
of ATP (adenosine triphosphate), is produced within the tumor
microenvironment where it may bind to the adenosine A2A receptor
present on immune cells and block their activity.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of CPI-818, mupadolimab and
ciforadenant; the Company’s ability, as well as the timing thereof,
to develop and advance product candidates into and successfully
complete preclinical studies and clinical trials, including the
Company’s Phase 1b/2 clinical trial with ciforadenant in
collaboration with the KCRC; the timing of the availability and
announcement of clinical data and certain other product development
milestones, including the timing of initial results in the Phase
1b/2 clinical trial for ciforadenant; and the expected trial design
and number of patients enrolled in the Company’s upcoming planned
clinical trials such as the Phase 1b/2 clinical trial for
ciforadenant. All statements other than statements of historical
fact contained in this press release are forward-looking
statements. These statements often include words such as “believe,”
“expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,”
“will,” “may” or similar expressions. Forward-looking statements
are subject to a number of risks and uncertainties, many of which
involve factors or circumstances that are beyond the Company’s
control. The Company’s actual results could differ materially from
those stated or implied in forward-looking statements due to a
number of factors, including but not limited to, risks detailed in
the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022, filed with the Securities and Exchange Commission on
August 8, 2022, as well as other documents that may be filed by the
Company from time to time with the Securities and Exchange
Commission. In particular, the following factors, among others,
could cause results to differ materially from those expressed or
implied by such forward-looking statements: the Company’s ability
to demonstrate sufficient evidence of efficacy and safety in its
clinical trials of CPI-818, ciforadenant and mupadolimab; the
accuracy of the Company’s estimates relating to its ability to
initiate and/or complete preclinical studies and clinical trials;
the results of preclinical studies may not be predictive of future
results; the unpredictability of the regulatory process; regulatory
developments in the United States, and other foreign countries;
regulatory developments in the United States, and other foreign
countries; the costs of clinical trials may exceed expectations;
the ability of third-parties to successfully conduct the Company’s
clinical trials in a timely manner; and the Company’s ability to
raise additional capital. Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, it cannot guarantee that the events and circumstances
reflected in the forward-looking statements will be achieved or
occur, and the timing of events and circumstances and actual
results could differ materially from those projected in the
forward-looking statements. Accordingly, you should not place undue
reliance on these forward-looking statements. All such statements
speak only as of the date made, and the Company undertakes no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise.
INVESTOR CONTACT:Leiv LeaChief Financial
OfficerCorvus Pharmaceuticals,
Inc.+1-650-900-4522llea@corvuspharma.com
MEDIA CONTACT:Aulani CapuchinReal
Chemistry+1-559-355-2673acapuchin@realchemistry.com
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