Compugen will be Eligible to Receive $10 Million Milestone Payment upon Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer

Rhea-AI Summary

Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) to receive $10 million milestone payment from AstraZeneca for dosing the first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody

Biotechnology Analyst

The initiation of a Phase 3 trial for rilvegostomig, especially one that triggers a substantial milestone payment, is a critical juncture in the drug's development pathway. This event is particularly significant for Compugen, given the financial implications and the validation of their computational target discovery platform. In the biotechnology sector, such milestones are closely watched as they often indicate the confidence a larger partner, in this case, AstraZeneca, has in the compound's potential.

Investors should note the strategic importance of PD-1/TIGIT inhibitors in the oncology market, a field that is rapidly evolving with immuno-oncology therapies. The dual mechanism of action could offer a competitive edge over existing therapies if the clinical outcomes are positive. However, the inherent risk of clinical trials, especially at the Phase 3 level, is substantial. The success of this trial will likely have a notable impact on Compugen’s stock performance and could influence AstraZeneca’s portfolio in immuno-oncology.

Financial Analyst

From a financial perspective, the $10 million milestone payment is a liquidity event that can bolster Compugen's cash reserves, which is vital for a clinical-stage company. The market often reacts favorably to such news as it reduces immediate dilution risk for shareholders. However, the overall financial impact must be weighed against the company's burn rate and the total cost of bringing a drug to market, which can exceed $1 billion.

Long-term investors should consider the potential market size for rilvegostomig and the competitive landscape. If the drug reaches commercialization, it could provide significant returns, but the timeline is long and uncertain. Additionally, AstraZeneca's involvement may offer strategic advantages in terms of market penetration and future partnership opportunities.

Oncology Clinical Researcher

As an oncology researcher, the advancement of rilvegostomig to Phase 3 trials is a promising development in the fight against cancer. The bispecific nature of the antibody, targeting both PD-1 and TIGIT, is designed to enhance the immune system's response to cancer cells. While the efficacy of such treatments has been established, this particular combination therapy could potentially improve patient outcomes over monotherapies.

Clinical trial data will be pivotal in understanding the safety profile and efficacy of rilvegostomig. The oncology community will be looking for improvements in survival rates and quality of life metrics. It's also important to consider the potential side effects and the drug's performance in comparison to the current standard of care. The implications for patients could be far-reaching if this therapy proves to be superior.

• Dosing of first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody, will trigger $10 million milestone payment from AstraZeneca

HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it will be eligible to receive a milestone payment of $10 million from AstraZeneca (LSE/STO/Nasdaq: AZN), when the first patient is dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig. Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.

"I am delighted to see the advancement of rilvegostomig into Phase 3 by AstraZeneca, a global leader in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "I believe that the progress of the rilvegostomig clinical program in this Phase 3 trial along with the Phase 1 and 2 trials in additional indications, demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902."

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. In addition to the $10 million milestone payment described here which Compugen will be eligible to receive on dosing of the first patient in the Phase 3 ARTEMIDE-Bil01 trial, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory 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.

Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.

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. Compugen also has a clinical stage partnered program, rilvegostomig (previously AZD2936), a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, 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, is in IND enabling studies. 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 statement regarding the progress of the rilvegostomig clinical program and our belief that it demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902. 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.

What is the ticker symbol for Compugen Ltd.?

The ticker symbol for Compugen Ltd. is CGEN on Nasdaq and CGEN on TASE.

What is the milestone payment Compugen Ltd. will receive from AstraZeneca?

Compugen Ltd. will receive a $10 million milestone payment from AstraZeneca for dosing the first patient in the Phase 3 trial of rilvegostomig.

What is rilvegostomig?

Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902.

What is the ARTEMIDE-Bil01 trial?

The ARTEMIDE-Bil01 trial is AstraZeneca's trial with rilvegostomig, the PD-1/TIGIT bispecific antibody, expected to recruit the first patient soon.

What is Compugen Ltd.'s role in the development of rilvegostomig?

Compugen Ltd. is a pioneer in computational target discovery and has contributed to the development of rilvegostomig, a PD-1/TIGIT bispecific antibody.