- Phase 3 trial evaluating rilvegostomig as monotherapy and in
combination with AstraZeneca and Daiichi Sankyo's datopotamab
deruxtecan in first-line nonsquamous non-small cell lung
cancer
- Broadening the assessment of rilvegostomig reinforces
Compugen's partnering strategy to expand opportunities for its
pipeline
- Compugen to receive $5 million
milestone payment from AstraZeneca
HOLON, Israel, May 30, 2024
/PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE:
CGEN), a clinical-stage cancer immunotherapy company and a pioneer
in computational target discovery, today announced it is
entitled to receive a milestone payment from AstraZeneca
(LSE/STO/Nasdaq: AZN) triggered by the dosing of the first patient
in a Phase 3 trial evaluating rilvegostomig, AstraZeneca's
PD-1/TIGIT bispecific antibody. The TIGIT component of
rilvegostomig is derived from Compugen's clinical-stage anti-TIGIT
antibody, COM902. Both rilvegostomig and COM902 are designed to
have reduced Fc effector function.
The trial, called TROPION-Lung10, is evaluating the efficacy and
safety of rilvegostomig as monotherapy and in combination with
datopotamab deruxtecan (Dato-DXd), AstraZeneca and Daiichi Sankyo's
(TSE: 4568) TROP2-directed antibody drug conjugate versus
pembrolizumab as first-line treatment for patients with locally
advanced or metastatic non-squamous non-small cell lung cancer with
high PD-L1 expression (TC ≥ 50%) and without actionable genomic
alterations. The trial is sponsored by AstraZeneca in collaboration
with Daiichi Sankyo and is expected to enrol approximately 675
patients in more than 14 countries. Further details about
TROPION-Lung10 are available on ClinicalTrials.gov, identifier:
NCT06357533.
"We are very excited to see the advancement of rilvegostomig
into its second Phase 3 trial by AstraZeneca in collaboration with
Daiichi Sankyo, two global leaders in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief
Executive Officer of Compugen. "TROPION-Lung10 follows the start of
the ARTEMIDE-Biliary01 Phase 3 trial evaluating rilvegostomig in
biliary tract cancer, for which we received a $10 million milestone payment. Now, after dosing
the first patient in this lung cancer trial, we are eligible to
receive a $5 million milestone
payment from AstraZeneca. Broadening the assessment of
rilvegostomig reinforces our partnering strategy to expand
opportunities for our pipeline and brings us closer to
realizing potential future milestone payments and royalties."
The ARTEMIDE-Biliary01 Phase 3 trial is evaluating the efficacy
and tolerability of rilvegostomig compared to placebo in
combination with investigator's choice of chemotherapy in patients
with biliary tract cancer after surgical resection with curative
intent. Further details about the ARTEMIDE-Biliary01 trial are
available on ClinicalTrials.gov, identifier: NCT06109779.
About the Compugen-AstraZeneca license agreement
In
2018, Compugen and AstraZeneca entered into an agreement by which
Compugen provided an exclusive license to AstraZeneca to use
Compugen's monospecific antibodies that bind to TIGIT, including
COM902, for the development of bispecific and multispecific
antibody products, excluding such bispecific and multispecific
antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca
is responsible for all research, development, and commercial
activities. AstraZeneca has the right to create multiple products
under this license. Compugen has received $35.5 million in upfront and milestone payments
to date and is eligible to receive an additional $5 million milestone payment as described in this
press release. Compugen is eligible to receive up to an aggregate
milestone amount of $200 million in
development and regulatory milestones for the first and second
indications for the first product and commercial milestones for the
first product, as well as tiered royalties on future product sales.
If additional bi- or multi-specific products are developed based on
Compugen's monospecific antibodies that bind to TIGIT, additional
milestones and royalties would be due to Compugen.
Rilvegostomig (previously AZD2936) is a PD-1/TIGIT bispecific
antibody where the TIGIT component is derived from Compugen's
clinical stage anti-TIGIT antibody, COM902. Rilvegostomig is in
Phase 3 development by AstraZeneca through this license agreement.
Both rilvegostomig and COM902 are designed to have reduced Fc
effector function to avoid depletion of CD8+ T cells.
About Compugen
Compugen is a
clinical-stage therapeutic discovery and development company
utilizing its broadly applicable predictive computational discovery
capabilities to identify new drug targets and biological pathways
for developing cancer immunotherapies. Compugen has developed
two proprietary product candidates: COM701, a potential
first-in-class anti-PVRIG antibody and COM902, a potential
best-in-class antibody targeting TIGIT for the treatment of solid
tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the
TIGIT component is derived from Compugen's clinical stage
anti-TIGIT antibody, COM902, is in Phase 3 development by
AstraZeneca through a license agreement for the development of
bispecific and multispecific antibodies. In addition, the
Company's therapeutic pipeline of early-stage immuno-oncology
programs consists of programs aiming to address various mechanisms
of immune resistance, of which the most advanced program, COM503,
in IND enabling studies is licensed to Gilead. COM503 is a
potential first-in-class, high affinity antibody which blocks the
interaction between IL-18 binding protein and IL-18, thereby
freeing natural IL-18 in the tumor microenvironment to inhibit
cancer growth. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are
listed on Nasdaq and the Tel Aviv Stock Exchange under the
ticker symbol CGEN.
Forward-Looking Statement
This press release contains
"forward-looking statements" within the meaning of the Securities
Act of 1933 and the Securities Exchange Act of 1934, as amended,
and the safe-harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are based on
the current beliefs, expectations, and assumptions of Compugen.
Forward-looking statements can be identified using terminology such
as "will," "may," "expects," "anticipates," "believes,"
"potential," "plan," "goal," "estimate," "likely," "should,"
"confident," and "intends," and similar expressions that are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements include, but are not limited to,
statements relating to our expectation to receive the milestone
payment from AstraZeneca and statements regarding the progress of
the rilvegostomig clinical program. 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; Compugen's approach to the discovery of therapeutic
products is based on its proprietary computational target discovery
infrastructure, which is unproven clinically; Compugen does not
know whether it will be able to discover and develop additional
potential product candidates or products of commercial value; and
the general market, political and economic conditions in the
countries in which Compugen operates, including Israel; and the effect of the evolving nature
of the recent war in Gaza between
Israel and Hamas. These risks and
other risks 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:
Yvonne
Naughton, Ph.D.
Head of Investor Relations and Corporate Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
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SOURCE Compugen Ltd.