Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage
biopharmaceutical company, today announced that it has initiated a
Phase 1 study to investigate a novel immunotherapy approach for
patients with COVID-19. The first cohort of five patients enrolled
in the study was treated at Temple University Hospital in
Philadelphia, PA. The study is expected to enroll up to 30 patients
at several sites in the United States. This follows the U.S. Food
and Drug Administration’s (FDA) review and acceptance of the
Company’s investigational new drug (IND) application for the
COVID-19 study.
Corvus is studying an agonistic (immunostimulatory) humanized
monoclonal antibody, designated as CPI-006, which has demonstrated
a potential new approach to immunotherapy of infectious diseases
and cancer. In both in vitro and in vivo studies in cancer
patients, CPI-006 has demonstrated binding to various immune cells
and the inducement of a humoral adaptive immune response – B cell
activation and lymphocyte trafficking leading to the production of
antigen-specific immunoglobulin (IgM and IgG) antibodies.
Administration of CPI-006 has also led to increased levels of
memory B cells, which are the cells responsible for long-term
immunity. The similar production of antibodies and memory cells to
pathogens such as severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), the virus that causes COVID-19, may provide immediate
and long-term clinical benefits for patients including shortened
recovery time and improved long-term protective immunity.
To date, over 90 cancer patients have been treated with CPI-006
in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg
every three weeks. CPI-006 has been well tolerated in these
patients and evidence of B-cell activation and lymphocyte
trafficking was observed in patients that received single doses as
low as 1 mg/kg. Corvus’ study showed that CPI-006 is associated
with increases in memory B cells, the emergence of new B cell
clones and, in some patients, the production of novel anti-tumor
antibodies. These results have been previously reported in
presentations at the Society of Immunotherapy of Cancer annual
meeting in 2018 and 2019 and in a presentation at the American
Society of Clinical Oncology annual meeting in 2019. CPI-006 was
designed to bind to an epitope on an antigen known as CD73. This
antigen is known to be involved in lymphocyte migration and
activation. CPI-006 binds to a distinct region of CD73 and behaves
as an agonist that serves as a signal to activate certain immune
cells. As previously reported, binding of CPI-006 affects B cells,
T cells and antigen presenting cells. The collection of observed
changes are consistent with enhanced antigen recognition and
induction of an adaptive immune response.
A recently enrolled patient with advanced metastatic non-small
cell lung cancer (NSCLC) was diagnosed with concomitant COVID-19 by
nasal swab PCR testing (polymerase chain reaction) at the time of
initiating CPI-006 therapy for cancer. The patient was in a very
high-risk group for potential progression of her COVID-19 including
elderly, prior immunosuppressive therapies for cancer and chronic
obstructive pulmonary disease as comorbidities. The patient
remained asymptomatic from COVID-19 following treatment with
CPI-006. Serum antibody testing demonstrated no anti-SARS-CoV-2
antibody at baseline and the development of high titers of
anti-SARS-CoV-2 IgG and IgM of >1:100,000 and 1:3,200,
respectively, within six weeks of treatment with CPI-006. The
patient’s PCR viral test converted to negative along with the
rising titers of antibody. The anti-SARS-CoV-2 antibody titers seen
in this patient would be considered to be high as recovered
patients with serum titers of 1:320 or higher are candidates to
donate blood for COVID-19 convalescent plasma therapy. Memory B
cells in the blood of this patient also increased to 30% of total B
cells, from 16% previously.
“Our B cell activating monoclonal antibody may be a potential
immunotherapy for COVID-19 based on its ability to stimulate the
production of anti-SARS-CoV-2 antibodies,” said Richard A. Miller,
M.D., president and chief executive officer of Corvus. “Our
preclinical and clinical research has elucidated important
biological mechanisms underlying this approach and we are eager to
apply it to addressing the devastating COVID-19 pandemic. We
believe that COVID-19 patients treated with CPI-006 may benefit
from an improved time to recovery and building longer term
immunity. This program will also help inform the potential to apply
this approach in treatment of other infectious diseases, including
variants of coronaviruses and as adjuvants in subjects who may
respond poorly to preventative vaccination. We believe this opens
an entirely new area of investigation and opportunities to both
treat and prevent serious infectious diseases.”
Dr. Miller added, “This COVID-19 study broadens our pipeline as
we continue to advance our core cancer programs with ciforadenant
and CPI-006 addressing the adenosine cancer pathway and CPI-818 for
T cell lymphomas. Our recent data for ciforadenant at ASCO further
confirmed the benefit of blocking the adenosine 2A receptor and has
provided the opportunity to initiate a biomarker driven pivotal
trial in renal cell cancer. In addition, we remain on track to
provide data updates on CPI-006 for cancer and CPI-818 at medical
meetings later this year.”
About the Phase 1 StudyThe open-label, Phase 1
study is expected to enroll up to 30 COVID-19 patients with mild to
moderate symptoms. Patients will receive a single dose of CPI-006,
with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four
cohorts as the study progresses. Patients will receive medications,
therapies, and interventions per standard treatment protocols for
COVID-19 for the duration of the study. The primary efficacy
endpoint is the change in serum immunoglobulin (IgM and IgG)
anti-SARS-CoV-2 levels compared to baseline at day 28. The study
also will examine safety and other clinical endpoints, including
time to resolution of symptoms and duration of hospitalization.
Data from this study should be available later this year.
The objective of the study is to show that CPI-006 has the
potential to induce the patient to produce an enhanced antibody
response to SARS-CoV-2. The expected benefit for patients is the
potential eradication of the virus, leading to a better clinical
outcome – less severe disease, prevention of complications, and
faster recovery – and the potential for long term immunity. If the
study meets its objectives, Corvus intends to work with the FDA to
initiate a broader, randomized study at a fixed dose of CPI-006
that could potentially be adapted into a pivotal study to support a
regulatory submission for FDA approval.
Conference Call, Webcast and Slide Presentation
DetailsCorvus will host a conference call and webcast
today, July 7, 2020, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the
CPI-006 clinical trial for COVID-19. The conference call can be
accessed by dialing 1-877-423-9813 (toll-free domestic) or
1-201-689-8573 (international) and using the conference ID
13706663. The live webcast, which will include presentation slides,
may be accessed via the investor relations section of the Corvus
website. A replay of the webcast will be available on Corvus'
website for 90 days.
About CPI-006CPI-006 is a potent humanized
monoclonal antibody that reacts with a specific site on CD73. It
has demonstrated immunomodulatory activity resulting in activation
of lymphocytes, induction of antibody production from B cells and
effects on lymphocyte trafficking. Other anti-CD73 antibodies are
in development for treatment of cancer. Those antibodies react with
a different region of CD73 and are designed to block production of
adenosine, which is not involved in the immunomodulatory processes
seen with CPI-006.
About Corvus PharmaceuticalsCorvus
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the development and commercialization of precisely
targeted oncology therapies and the utilization of novel biomarkers
to enhance patient selection. Corvus’ lead product candidates are
ciforadenant (CPI-444), a small molecule inhibitor of the A2A
receptor, and CPI-006, a humanized monoclonal antibody directed
against CD73 that exhibits immunomodulatory activity and activation
of immune cells. These product candidates are being studied in
ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with
a wide range of advanced solid tumors. Ciforadenant is being
evaluated in a successive expansion cohort Phase 1b/2 trial
examining its activity both as a single agent and in combination
with an anti-PD-L1 antibody. CPI-006 is being evaluated in a
multicenter Phase 1/1b clinical trial as a single agent, in
combination with ciforadenant and pembrolizumab. The Company’s
third clinical program, CPI-818, an oral, small molecule drug that
has been shown to selectively inhibit ITK, is in a multicenter
Phase 1/1b clinical trial in patients with several types of T-cell
lymphomas. For more information, visit www.corvuspharma.com.
Forward-Looking Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of ciforadenant, CPI-006, and
CPI-818, the Company’s ability to develop and advance product
candidates into and successfully complete preclinical studies and
clinical trials, including the Company’s Phase 1 clinical trial of
CPI-006 for COVID-19, and the impact of COVID-19 and related
“shelter in place” orders and other public health guidance measures
on the Company’s clinical programs and business operations. 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, 2020, filed
with the Securities and Exchange Commission on April 30, 2020, 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-006;
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 foreign countries; the costs
of clinical trials may exceed expectations; the Company’s ability
to raise additional capital; and the effects of COVID-19 on the
Company’s clinical programs and business operations. 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 SeapyW2O pure+1
213-262-9390sseapy@purecommunications.com
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