Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq:
CRVS), a clinical-stage biopharmaceutical company, is hosting an
R&D Symposium today in New York City. During the event, which
will also be available via webcast, the Company plans to provide
updates on its three clinical programs: mupadolimab (anti-CD73),
ciforadenant (adenosine 2A receptor antagonist) and CPI-818 (ITK
inhibitor).
“Current therapies for T cell lymphoma have limited efficacy,
highlighting the need for new approaches that rely on novel
mechanisms of action,” said Neel K. Gupta, M.D., Clinical Assistant
Professor of Medicine at Stanford University School of Medicine –
Division of Oncology. “The monotherapy activity and responses in
advanced refractory T cell lymphoma seen with the ITK inhibitor
CPI-818 so far is impressive. Its novel mechanism of action and
safety provide many opportunities for single agent and combination
with other therapies both in front line and relapsed disease
settings, giving CPI-818 the potential to be an important new
therapeutic option for T cell lymphoma patients.”
New CPI-818 Phase 1/1b DataThe R&D
Symposium will include a review of patient case studies from the
ongoing Phase 1/1b clinical trial of CPI-818 in patients with
relapsed T cell lymphomas, including peripheral T cell lymphoma
(PTCL), cutaneous T cell lymphoma (CTCL), angioimmunoblastic T cell
lymphoma (AITL) and others. In this trial, which was designed to
select the optimal dose of CPI-818, doses of 100, 200, 400 and 600
mg taken twice a day were given to successive cohorts of patients.
The 200 mg dose was identified as the optimal dose, and at this
dose, four of five patients are responding to therapy as follows
(with an April 30, 2022 cut-off date):
- PTCL patient achieved a complete response lasting 12 months on
CPI-818 treatment with complete remission duration extending an
additional 7 months with no further therapy (total complete
remission duration of 19 months)
- PTCL patient achieved a partial response with treatment
ongoing
- AITL patient that is responding on treatment
- CTCL patient achieved nodal complete response with treatment
lasting 21 months
- In addition, a PTCL patient receiving the 600 mg dose achieved
a partial response that lasted for several months; the patient went
on to receive a bone marrow transplant
- Lab studies on the blood and tumors of responding patients
showed:
- Evidence for Th1 skewing
- Evidence for increase in T effector cells in blood and
tumor
- Evidence for increase activation of T cells in tumor and
blood
- Evidence that CPI-818 does not directly kill the cancer cells;
rather the effects appear to be mediated by the patient’s immune
response against the tumor
- Identification of a dose level that drives Th1 cell
differentiation without compromising T effector cell function
CPI-818 is a novel compound that Corvus founders invented and
developed based on their prior experience and success with the
first BTK inhibitor, ibrutinib.
“We have learned a tremendous amount about ITK, T cell biology
and potential indications for this therapy from the development of
CPI-818,” said Richard A. Miller, M.D., Chief Executive Officer
& President of Corvus Pharmaceuticals. “The new interim data
from our Phase 1/1b study are consistent with our pre-clinical
results, and the research of others, which reveal the role of ITK
in T cell function, and the exquisite regulation of T cell
differentiation by ITK. Based on this, we believe CPI-818 could be
used to enhance anti-tumor immunity in T cell lymphoma and solid
tumors by stimulating anti-tumor T cells to attack the cancer
cells. The mechanism, and preclinical data, also support its role
in immune mediated diseases such as allergy and autoimmunity.”
“We are expanding our CPI-818 Phase 1/1b study with a focus on
the 200 mg BID dose in PTCL. Angel Pharmaceuticals, our Chinese
partner, is also enrolling patients, which we anticipate will help
accelerate overall development timelines. Our goal is to share
additional data from both studies later this year, and if current
trends continue, we anticipate initiating a global Phase 2 clinical
trial. We will also be evaluating CPI-818’s potential in front line
combination therapy with chemotherapy and preparing for clinical
studies in autoimmune diseases,” added Dr. Miller.
Corvus R&D Pipeline Approach The
R&D Symposium program will cover the scientific rationale,
preclinical and clinical data for the Company’s three programs,
along with the overarching scientific and clinical strategies
driving the Company’s development activities. Key elements of the
overarching strategy include:
- Corvus’ precision immunotherapy approach focuses on controlling
multiple steps in the “tumor-immunity axis,” which is comprised of
the tumor, lymph nodes (LN) and blood stream. The Company’s product
candidates are designed to modulate tumor immunity, target precise
molecular structures and have broad clinical applications.
Specifically, mupadolimab, ciforadenant, and CPI-818 all interact
with distinct and connected components of the tumor-immunity axis
to enhance immunity to cancers:
- Mupadolimab is designed to induce the activation of B cells
involved in antibody production, and antigen presentation in the
tumor, blood and in LN
- Ciforadenant is designed to block adenosine-induced
immunosuppression in tumors and in LN
- CPI-818 is designed to induce the activation and expansion of T
cell subsets involved in killing cancer cells in tumor, in LN and
in blood through the skewing of T cell differentiation to a Th1
helper T cell phenotype. The formation of Th1 cells leads to
production of T cells that are capable of killing cancer cells and
viral infected cells
- Corvus’ clinical development strategy aims to increase clinical
development success by first establishing monotherapy activity,
followed by potential combinations with other immuno-oncology and
standard of care therapies
R&D Symposium DetailsThe R&D symposium
will be webcast live from Corvus’s website at www.corvuspharma.com
and a replay will be available for 90 days following the event. A
copy of the presentation slides will also be available on Corvus’
website after the conclusion of the event. It will be hosted by
Corvus President and CEO Richard A. Miller, M.D., and include
speakers from Corvus as well as leading researchers:
- Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine
at Stanford University School of Medicine – Division of
Oncology
- Suresh Mahabhashyam, M.D., Vice President of Clinical
Development at Corvus Pharmaceuticals
- Erik Verner, Ph.D., Senior Vice President of Research at Angel
Pharmaceuticals
About Corvus PharmaceuticalsCorvus
Pharmaceuticals is a clinical-stage biopharmaceutical company.
Corvus’ lead product candidate is mupadolimab (CPI-006), a
humanized monoclonal antibody directed against CD73 that has
exhibited immunomodulatory activity and activation of immune cells
in preclinical and clinical studies. The Company’s second clinical
program, CPI-818, is 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. Its third clinical program, ciforadenant
(CPI-444), is an oral, small molecule inhibitor of the A2A
receptor. For more information, visit www.corvuspharma.com.
About MupadolimabMupadolimab (CPI-006) is an
investigational, potent humanized monoclonal antibody that is
designed to react with a specific site on CD73. In preclinical
studies, it has demonstrated immunomodulatory activity resulting in
activation of lymphocytes, induction of antibody production from B
cells and effects on lymphocyte trafficking. While there are other
anti-CD73 antibodies and small molecules in development for
treatment of cancer, such agents react with a different region of
CD73. Mupadolimab is designed to react with a region of the
molecule that acts to stimulate B cells and block production of
immunosuppressive adenosine. Mupadolimab is being studied in
combination with pembrolizumab in a Phase 1b/2 clinical trial in
patients with advanced head and neck cancers and in patients with
NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is
postulated that the activation of B cells will enhance immunity
within the tumors of these patients, leading to improved clinical
outcomes.
About CPI-818CPI-818 is an investigational
small molecule drug given orally that has selectively inhibited ITK
(interleukin-2-inducible T-cell kinase) in preclinical studies. It
was designed to block malignant T-cell growth and to modulate
immune responses. ITK, an enzyme, is expressed predominantly in
T-cells and plays a role in T-cell and natural killer (NK) cell
lymphomas and leukemias, as well as in T cell differentiation, T
cell receptor signaling and other normal immune functions.
Interference with ITK signaling can modulate immune responses to
various antigens. The Company believes the inhibition of specific
molecular targets in T-cells may be of therapeutic benefit for
patients with T-cell lymphomas and leukemias and in patients with
autoimmune diseases. The Company is conducting a Phase 1/1b trial
in patients with refractory T-cell lymphomas that was designed to
select the optimal dose of CPI-818 and evaluate its safety, PK,
target occupancy, biomarkers and efficacy. Interim data from the
Phase 1/1b clinical trial of CPI-818 for T cell lymphoma
demonstrated tumor responses in very advanced, refractory,
difficult to treat T cell malignancies.
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
tri-phosphate), 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 Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of mupadolimab, CPI-818 and
ciforadenant; the Company’s ability and Angel Pharmaceutical’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 and Angel’s
potential global Phase 2 clinical trial in advanced PTCL; and the
timing of the availability and announcement of clinical data and
certain other product development milestones, including the timing
of results in the Phase 1b/2 clinical trial for CPI-818. 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 March 31, 2022, filed
with the Securities and Exchange Commission on May 5, 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
mupadolimab, CPI-818 and ciforadenant; 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; 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:Sheryl SeapyReal
Chemistry+1-949-903-4750sseapy@realchemistry.com
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