HOLON, Israel, July 2, 2018 /PRNewswire/ --
Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer
immunotherapy company and a leader in predictive target discovery,
today announced that the U.S. Food and Drug Administration (FDA)
has removed the clinical hold on its investigational new drug (IND)
application for COM701, a first-in-class immuno-oncology
therapeutic antibody targeting PVRIG in patients with advanced
solid tumors, and informed the Company it may initiate the clinical
study.
"Today is a significant milestone for Compugen, having received
clearance from the FDA to advance our lead immuno-oncology program
into the clinic. COM701 is a first-in-class drug opportunity that
was developed by Compugen from discovery of the drug target by
computer prediction through preclinical development, to IND
clearance," stated Anat Cohen-Dayag,
PhD, President and CEO of Compugen. "We believe the COM701
preclinical data suggest that targeting PVRIG may effectively
stimulate an anti-tumor immune response in certain cancers such as
breast, endometrial, ovarian and lung, and specifically in patient
populations that are unresponsive to current checkpoint
inhibitors."
"The PVRIG pathway, a new pathway on which we have shed light,
is part of a larger complex immuno-oncology biological axis
involving the TIGIT and PD-1 pathways. By targeting this pathway,
our COM701 program clearly presents a differentiated profile from
other drug targets and combination options in the clinic. We are
confident we are the only company with an anti-PVRIG candidate
available for clinical testing, either as a single agent and in
combination with a PD-1 and TIGIT inhibitors, and we are excited to
initiate patient dosing with COM701 in a multicenter Phase 1 trial,
early in the fall," Dr. Cohen-Dayag added.
"We worked closely with the FDA in connection with this IND
application and are eager to evaluate COM701 in a clinical
setting," said Henry Adewoye, MD,
Chief Medical Officer of Compugen. "We received positive feedback
from leading clinical investigators in the field of immuno-oncology
who share our excitement for the potential role of the PVRIG
pathway in immuno-oncology and our overall clinical program and
strategy. We look forward to collaborating with them on this
trial."
Under this IND, the Company intends to initiate a first-in-human
Phase 1 study in patients with advanced solid tumors and for whom
standard of care therapies are currently ineffective. The clinical
trial is designed to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics, and preliminary efficacy of
COM701 as monotherapy and in combination with a PD-1 inhibitor. The
Phase 1 trial is planned to be conducted at multiple centers in
the United States and site
initiation activities are currently underway.
About COM701
COM701 is a humanized hybridoma antibody that binds with high
affinity to PVRIG, a novel B7/CD28-like immune checkpoint target
candidate discovered by Compugen, blocking its interaction with its
ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated potent,
reproducible enhancement of T cell activation, consistent with the
desired mechanism of action of activating T cells in the tumor
microenvironment to generate anti-tumor immune responses. In
addition, COM701 combined with antagonist anti-PD-1 antibodies has
demonstrated synergistic effects on human T cell stimulation,
indicating the potential of these combinations to further enhance
immune response against tumors.
Preclinical data for COM701 suggest that PVRIG may be a dominant
checkpoint in diverse patient populations with tumors that express
elevated PVRL2 as compared to expression of the TIGIT ligand PVR.
This include patients with breast, endometrial, and ovarian
cancers. In addition, expression studies show that PVRIG and TIGIT,
and their respective ligands, are expressed in a broad variety of
tumor types, such as those noted above, as well as lung, kidney,
and head & neck cancers. In these tumors the blockade of both
TIGIT and PVRIG may be required to sufficiently stimulate an
anti-tumor immune response, with or without additional PD-1 pathway
blockade.
About Compugen
Compugen is a therapeutic discovery and development company
utilizing its broadly applicable predictive discovery
infrastructure to identify novel drug targets and develop
first-in-class therapeutics in the field of cancer immunotherapy.
The Company's therapeutic pipeline consists of immuno-oncology
programs against novel drug targets it has discovered, including T
cell immune checkpoints and myeloid target programs. Compugen's
business model is to selectively enter into collaborations for its
novel targets and related drug product candidates at various stages
of research and development. The Company is headquartered in
Israel with R&D facilities in
both Israel and South San Francisco, CA. Compugen's ordinary
shares are listed on Nasdaq and the Tel Aviv Stock Exchange under
the ticker symbol CGEN. For additional information, please visit
Compugen's corporate website at http://www.cgen.com.
Forward-Looking Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by the use of
terminology such as "will," "may," "expects," "anticipates,"
"believes," "potential," "plan," "goal," "estimate," "likely,"
"should," "confident," and "intends," and describe opinions about
possible future events. These forward-looking statements involve
known and unknown risks and uncertainties that may cause the actual
results, performance or achievements of Compugen to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Among
these risks: Compugen's business model is substantially dependent
on entering into collaboration agreements with third parties and
Compugen may not be successful in generating adequate revenues or
commercializing aspects of its business model. Moreover, the
development and commercialization of therapeutic candidates involve
many inherent risks, including failure to progress to clinical
trials or, if they progress to or enter clinical trials, failure to
receive regulatory approval. These and other factors, including the
ability to finance the Company, are more fully discussed in the
"Risk Factors" section of Compugen's most recent Annual Report on
Form 20-F as filed with the Securities and Exchange Commission
(SEC) as well as other documents that may be subsequently filed by
Compugen from time to time with the SEC. In addition, any
forward-looking statements represent Compugen's views only as of
the date of this release and should not be relied upon as
representing its views as of any subsequent date. Compugen does not
assume any obligation to update any forward-looking statements
unless required by law.
Company contact:
Elana Holzman
Director, Investor Relations and Corporate Communications
Compugen Ltd.
Email: elanah@cgen.com
Tel: +972(3)765-8124
Investor Relations contact:
Burns McClellan, Inc.
Jill Steier
Email: jsteier@burnsmc.com
Tel: 212-213-0006
SOURCE Compugen Ltd.