Corvus Pharmaceuticals Presents Preclinical and Initial Clinical Data from the Phase 1/1b Trial of CPI-818 at the American So...
December 07 2019 - 9:00AM
Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of precisely targeted oncology therapies with
biomarker patient enrichment selection, announced initial results
from its Phase 1/1b trial of CPI-818, the Company’s ITK-inhibitor.
The early clinical data from the study demonstrated specific target
engagement by CPI-818. The results were presented in a poster at
the American Society of Hematology (ASH) 61st Annual Meeting 2019
in Orlando, Florida, taking place December 7-10, 2019.
“We are excited to report the first clinical experience with
CPI-818, our selective covalent ITK inhibitor designed to address
T-cell lymphomas, a category of hematologic cancers with great need
for novel therapeutic options,” said Richard A. Miller, M.D.,
co-founder, president and chief executive officer of Corvus. “The
results show that CPI-818 achieved specific and sustained target
occupancy and we look forward to continuing the dose escalation
portion of the study to identify an optimum dose. In addition to
T-cell lymphomas, we believe CPI-818 may have applications in other
immune mediated diseases. Overall, our team is now advancing
three candidates in clinical trials for a wide range of cancers,
and each of our programs remains on track with enrollment and
progress towards next data milestones.”
The CPI-818 Phase 1/1b study is currently enrolling patients
with several types of advanced, refractory T-cell lymphomas,
including peripheral T-cell lymphoma (PTCL), angioimmunoblastic
T-cell lymphoma (AITL), cutaneous T-cell lymphoma (CTCL) and other
T-cell lymphomas. The study employs an adaptive, expansion cohort
design to select the dose and evaluate the safety, pharmacokinetics
(PK), target occupancy, immune-related biomarkers and efficacy of
CPI-818. The initial phase of the trial is evaluating
escalating doses in successive cohorts of patients in order to
determine the optimum dose. A second phase will evaluate safety and
tumor response to this optimum dose of CPI-818 in disease-specific
patient cohorts that may be expanded based on early signs of
efficacy. The study is enrolling patients at major medical
centers in the United States, Australia and South Korea.
CPI-818 Phase 1/1b Results
at ASH 2019 The preclinical and early clinical
data from the Phase 1/1b trial of CPI-818 was presented by Patrick
Ng, PhD, Corvus Senior Scientist, in a poster session at the ASH
Annual Meeting. The key highlights from the poster, which is titled
“Preliminary Clinical Data from a Phase 1 Trial with CPI-818, A
Selective ITK Inhibitor that Preferentially Blocks the Growth of T
Lymphoma Cells,” include:
- Seven patients have been enrolled in the first two dose cohorts
in the initial phase of the trial, receiving a 100 mg or 200 mg
oral dose of CPI-818 two times per day, with no dose limiting
toxicities and no grade 3 or 4 adverse events observed.
- The results from the pharmacokinetic and occupancy studies for
the first seven patients have been in-line with expectations. The
Company anticipates that a dose that achieves maximum target
occupancy will be achieved in the next one or two dose
cohorts.
- CPI-818 has been shown to bind covalently to ITK at low
nanomolar concentrations without reacting with other kinases.
- In vitro studies demonstrated selective cytotoxicity to Sezary
cells (malignant cells from patients with CTCL), while sparing
normal T-cells, in three subjects not enrolled in the study.
- Preclinical murine models of lymphoproliferative and autoimmune
disease showed CPI-818 inhibited the development of lymph node and
spleen enlargement by preventing proliferation of abnormal
T-cells. Treatment with CPI-818 led to regression of
lymphadenopathy and splenomegaly in animals with established
disease.
About Corvus Pharmaceuticals Corvus
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the development and commercialization of precisely
targeted oncology therapies. 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 blockade
of adenosine production. These product candidates are being studied
in ongoing Phase 1 and 2 clinical trials in patients with a wide
range of advanced solid tumors. Ciforadenant is being evaluated in
a successive expansion cohort 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 in
combination with 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.
About CPI-818CPI-818 is a small molecule drug
given orally that has been shown to selectively inhibit ITK
(interleukin-2-inducible T-cell kinase). It was developed to
possess dual properties: to block malignant T-cell growth and
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 normal
immune function. Interference with ITK signaling can modulate
immune responses to various antigens. The inhibition of specific
molecular targets in T-cells may be of therapeutic benefit for
patients with T-cell lymphomas – similar to the role of Bruton’s
tyrosine kinase (BTK) in B-cells. BTK is now an established target
for treating various B-cell lymphomas, and two BTK inhibitors,
ibrutinib and aclarabrutinib, have been approved by the U.S. Food
and Drug Administration for lymphoma indications.
Forward-Looking Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of 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 1/1b clinical trial of CPI-818, and
the ability of the Company to select the appropriate dosing regimen
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
September 30, 2019, filed with the Securities and Exchange
Commission on October 29, 2019, 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
accuracy of the Company’s estimates relating to its ability to
initiate and/or complete clinical trials; the Company’s ability to
demonstrate sufficient evidence of efficacy and safety in its
clinical trial of CPI-818; the results of preclinical studies may
not be predictive of future results; the unpredictability of the
regulatory process; and regulatory developments in the United
States and foreign countries. 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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