Compugen to Receive Milestone Payment as Second Phase 3 Rilvegostomig Trial Begins

Compugen Ltd., a clinical-stage cancer immunotherapy company known for its computational target discovery capabilities, is on track to receive a $5 million milestone payment from AstraZeneca. The payment is triggered as the first patient has been dosed in a Phase 3 trial evaluating rilvegostomig, a PD-1/TIGIT bispecific antibody developed by AstraZeneca from Compugen’s anti-TIGIT antibody, COM902.

This new trial, TROPION-Lung10, is designed to assess the efficacy and safety of rilvegostomig both as a standalone treatment and in combination with datopotamab deruxtecan (Dato-DXd), an antibody drug conjugate from AstraZeneca and Daiichi Sankyo. The comparison is drawn against pembrolizumab as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer, particularly those exhibiting high PD-L1 expression and lacking actionable genetic alterations. The study is being conducted across multiple countries with a projected enrollment of approximately 675 patients.

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, expressed enthusiasm about the trial’s progression, emphasizing the collaboration with AstraZeneca and Daiichi Sankyo. This marks the second Phase 3 trial for rilvegostomig, following the ARTEMIDE-Biliary01 trial, which assesses the drug in biliary tract cancer. The advancement in the lung cancer trial activates a $5 million milestone payment to Compugen, supplementing a previous $10 million payment received for the biliary tract cancer trial.

The ARTEMIDE-Biliary01 trial focuses on the efficacy and tolerability of rilvegostomig compared to a placebo when combined with chemotherapy in patients who have undergone surgical resection with curative intent for biliary tract cancer. Further details on both trials can be found on ClinicalTrials.gov.

Compugen and AstraZeneca’s partnership, initiated in 2018, granted AstraZeneca exclusive rights to develop bispecific and multispecific antibody products from Compugen’s anti-TIGIT antibodies, excluding those that also target PVRIG, PVRL2, and/or TIGIT. AstraZeneca manages all research, development, and commercial activities under this agreement. To date, Compugen has received $35.5 million in upfront and milestone payments and is eligible for up to $200 million in development and regulatory milestones, along with tiered royalties on future sales. Developments may include multiple products under this license.

Rilvegostomig, earlier known as AZD2936, is characterized by reduced Fc effector function to prevent depletion of CD8+ T cells, a feature derived from Compugen’s COM902. The drug is now in Phase 3 development under the Compugen-AstraZeneca agreement.

Compugen’s broader pipeline includes various early-stage immuno-oncology programs. Among these, COM503, licensed to Gilead, is a promising candidate awaiting an investigational new drug (IND) application. It is designed to inhibit the interaction between IL-18 binding protein and IL-18, potentially freeing IL-18 in the tumor microenvironment to counteract cancer growth.

Headquartered in Israel with offices in San Francisco, Compugen’s shares trade on Nasdaq and the Tel Aviv Stock Exchange under the ticker CGEN. The company's strategy focuses on leveraging computational discovery to identify novel drug targets and pathways, thereby expanding its therapeutic pipeline in the immuno-oncology space.

Compugen’s business model is reliant on successful collaborations, such as the one with AstraZeneca, to achieve its financial and clinical objectives. Though the company faces risks, including market conditions and geopolitical factors, it continues to pursue innovative cancer therapies, underscoring its commitment to scientific advancement and potential therapeutic breakthroughs.