HOLON, Israel, May 31, 2017 /PRNewswire/ --
Compugen Ltd. (NASDAQ: CGEN), a therapeutic discovery
company, announced today that it anticipates a delay of several
months in the submission of an investigational new drug application
(IND) for COM701, Compugen's clinical candidate antibody targeting
CGEN-15029/PVRIG. Previously the Company had disclosed an
expectation of IND filing in Q4 of this year.
The Company was recently informed by its manufacturing service
provider for COM701 - a global contract development and
manufacturing organization (CDMO) - that the batch of material they
manufactured for Compugen's planned GLP (good laboratory practice)
toxicity studies was contaminated during the manufacturing process.
The contamination was discovered during quality control procedures
prior to release of the affected batch and, as such, was not used
in any preclinical studies. This contamination has necessitated the
production of a new batch of material for the execution of these
studies. As a result, Compugen anticipates a delay of several
months in the submission of an investigational new drug application
(IND) for COM701 and will provide further updates as
appropriate.
Anat Cohen-Dayag, PhD, CEO and
President of Compugen, commented, "As previously disclosed, the
COM701 program is one of the four program areas that are currently
the focus of the Company's therapeutics and business development
efforts. While we are disappointed in the delay of our anticipated
IND filing date, we would like to stress that this contamination
and resulting delay are related to a technical issue in the CDMO's
manufacturing process, and does not detract from the quality of the
data generated by the Company supporting the clinical rationale for
COM701. Therefore, based on the information currently available to
us, we expect this delay may have a limited effect with respect to
our on-going business development discussions for this
program."
As previously announced, new data on COM701 will be presented at
the American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, Illinois next week.
Compugen's poster presentation at ASCO will take place on
Monday, June 5 at 8:00-11:30am CT (Abstract 3074, location: Hall
A). The following day, Tuesday, June
6 at 2:00 pm ET, Dr.
Cohen-Dayag will present at the Jefferies Global Healthcare
Conference. A live webcast and slide presentation of the Jefferies
talk will be available on the Company's website.
About Compugen
Compugen is a leading therapeutic discovery company whose
mission is to utilize its broadly applicable predictive discovery
infrastructure to discover novel drug targets and develop
first-in-class therapeutics. Our current pipeline consists of early
and preclinical stage immuno-oncology programs based on novel drug
targets discovered internally, primarily immune checkpoint and
myeloid protein target candidates. These programs focus on the
development of first-in-class cancer immunotherapy drugs with the
potential to harness the immune system to provide treatment
solutions in areas of unmet medical need in various cancer types
and patient populations, both as monotherapy and in combination
with other drugs. In addition, our pipeline currently includes a
preclinical fusion protein autoimmune product candidate. Compugen's
business model is based on selectively entering into collaborations
for its novel target candidates and related drug product candidates
at various stages of research and development under
revenue-sharing agreements. The Company is headquartered in
Israel, with R&D facilities in
Israel and South San Francisco. At
the US facilities, therapeutic monoclonal antibodies are discovered
and developed against the Company's novel drug target candidates.
For additional information, please visit Compugen's corporate
website at http://www.cgen.com.
Forward-looking Statements
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,"
and "intends," and describe opinions about possible future events,
including the status of development of our product candidates, the
manufacturing process for those product candidates and the
potential timing of planned regulatory filings. 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 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:
Susanna Chau
Director, Investor Relations and Corporate Communications
Compugen
Email: susannac@cgen.com
Tel: +1-(650)-263-7001
SOURCE Compugen Ltd.