Compugen to Receive Milestone Payment Triggered by Dosing of First Patient in the Second Phase 3 Trial Evaluating Rilvegostomig
Compugen has announced that it will receive a $5 million milestone payment from AstraZeneca following the dosing of the first patient in the Phase 3 TROPION-Lung10 trial. This trial evaluates the efficacy and safety of rilvegostomig, a PD-1/TIGIT bispecific antibody, as monotherapy and in combination with datopotamab deruxtecan for first-line treatment of non-squamous non-small cell lung cancer patients with high PD-L1 expression. The trial is expected to enroll approximately 675 patients across 14 countries. This milestone is part of Compugen's strategy to expand its pipeline through partnerships, following a previous $10 million payment related to the ARTEMIDE-Biliary01 Phase 3 trial.
- Compugen will receive a $5 million milestone payment from AstraZeneca.
- TROPION-Lung10 Phase 3 trial to enroll approximately 675 patients across 14 countries.
- Rilvegostomig is being evaluated both as a monotherapy and in combination with a promising drug, datopotamab deruxtecan.
- Previous $10 million milestone payment from ARTEMIDE-Biliary01 Phase 3 trial.
- Collaboration with global oncology leaders AstraZeneca and Daiichi Sankyo.
- Potential for delays or complications in enrolling the expected 675 patients.
- Rilvegostomig's efficacy and safety are still under investigation and not guaranteed.
- Dependence on milestone payments indicates reliance on the success of clinical trials for revenue.
Insights
Compugen Ltd. earning a
In terms of stock performance, short-term impacts might include increased trading volume and a potential uptick in share price due to positive investor sentiment. Long-term, the successful progression through Phase 3 trials could lead to larger milestone payments and future royalties. However, investors should be cautious about the high risks associated with clinical trials, as failures could negatively impact stock prices significantly.
The advancement of rilvegostomig into its second Phase 3 trial is pivotal. It targets non-small cell lung cancer (NSCLC), specifically in patients with high PD-L1 expression. This demographic is significant because therapies targeting PD-L1 are generally associated with higher response rates. Furthermore, the collaboration with AstraZeneca and Daiichi Sankyo implies a rigorous assessment process, enhancing the credibility of the trial results.
The differentiation of rilvegostomig as a bispecific antibody (targeting PD-1/TIGIT) could provide a competitive edge over existing monotherapies. However, the complexity of bispecific antibodies also means there are unique risks, such as unexpected safety issues or manufacturing challenges. Investors need to be aware of these dynamics when evaluating the potential success of this drug. Additionally, the mention of reduced Fc effector function implies a focus on minimizing adverse immune responses, which can be a significant advantage in terms of patient safety and treatment efficacy.
The involvement of 675 patients across 14 countries in the TROPION-Lung10 trial indicates a substantial scale and global focus, reflecting the importance of this study. This breadth increases the likelihood of statistically significant results and could expedite regulatory approvals across different regions. If successful, rilvegostomig could capture a segment of the large NSCLC market, which continues to grow as new treatments emerge and patient survival rates improve.
However, competition in the oncology market is fierce, with numerous companies developing PD-1 and TIGIT inhibitors. Thus, Compugen’s strategy to position rilvegostomig both as a monotherapy and in combination therapies is a smart move to differentiate its product. Still, investors should monitor competitor advancements closely, as any breakthrough from rivals could impact rilvegostomig's market potential.
- 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
HOLON,
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 ≥
"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
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
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
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
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.
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