Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program
- Exclusive rights to a potential first-in-class, pre-clinical antibody program with significant potential in cancer immunotherapy
- Potential for new combination therapies with programs in Gilead's growing oncology portfolio
- Expected reduction in Gilead's GAAP and non-GAAP 2023 EPS by approximately $0.03 - $0.05
Insights
The licensing agreement between Gilead Sciences and Compugen involves a significant financial commitment, with an upfront payment of $60 million and additional near-term and long-term milestone payments that could total up to $848 million. This collaboration reflects a strategic investment in the oncology sector, with the potential to diversify and strengthen Gilead's pipeline. It is crucial to evaluate the deal's scale relative to Gilead's overall financial health and the potential revenue from COM503, should it gain regulatory approval and achieve commercial success. The impact on Gilead's earnings per share (EPS) is projected to be a slight negative in the short term, which investors should weigh against the long-term potential of the drug candidate.
The strategic partnership for the development of COM503, an anti-IL18 binding protein antibody, represents a significant move within the biotechnology sector. The molecule's mechanism, aiming to enhance the immune response against tumors, is a novel approach that could address unmet needs in cancer treatment. The potential for COM503 to be a first-in-class therapy offers a competitive advantage. However, it's important to consider the inherent risks of drug development, particularly in the pre-clinical phase where many candidates fail to progress to later stages. The deal's structure, with milestone payments contingent upon development progress, suggests a risk-sharing model between Gilead and Compugen.
The therapeutic potential of COM503 in oncology is based on its unique mechanism of action, which involves modulating the tumor microenvironment to enhance anti-tumor immune responses. By blocking the interaction between IL-18 binding protein and IL-18, natural IL-18 is released, potentially leading to improved cancer treatment outcomes. This innovative approach could be transformative if clinical efficacy is demonstrated. However, the translation from pre-clinical success to clinical efficacy is a significant hurdle and thus, the true impact on patient care remains speculative until further clinical data are available.
– Gilead Will Have Exclusive Rights to Later Stage Development and Commercialization of Anti-IL18 Binding Protein Antibodies with Potential to Treat Various Tumor Types –
– Gilead to Make
Compugen utilizes its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing novel cancer immunotherapies. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth.
“We are very pleased to add COM503 to our pipeline of investigational immuno-oncology therapies that have the potential to transform care for patients with cancer,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. “We believe that this collaboration complements our strategy of developing modalities which promote immune-mediated tumor killing and may enable new combination therapies with programs in our growing oncology portfolio.”
“We are delighted to enter into this collaboration with Gilead and believe that Gilead’s confidence in our differentiated approach to harness cytokine biology for cancer therapeutics speaks to the quality of our computational discovery capabilities as well as our ability to translate our novel discoveries into investigational drugs in the clinic and we look forward to working together to bring new treatment options to patients,” said Anat Cohen-Dayag, Ph.D., President, and CEO at Compugen. “IL-18 is one of the rare cytokines which is naturally inhibited by an endogenous binding protein, presenting a unique opportunity to use a blocking antibody to increase the local concentrations of IL-18 within the tumor where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines.”
Terms of the Partnership
Under the terms of the agreement, Compugen will be responsible for the ongoing pre-clinical development and the future Phase 1 study of COM503. Thereafter, Gilead will have the sole right to develop and commercialize COM503.
Gilead will make Compugen an upfront payment of
Beginning in the first quarter of 2022, consistent with recent industry communications from the
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
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in
Compugen Forward-Looking Statements
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, statement regarding our expectation from the collaboration, statement regarding our belief that using a blocking antibody to increase the local concentrations of IL-18 within the tumor where, can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines and statement regarding the expected time for IND clearance of COM503. 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: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; 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; general market, political and economic conditions in the countries in which Compugen operates, including
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the collaboration with Compugen; difficulties or unanticipated expenses in connection with the collaboration, and the potential effects on Gilead’s earnings; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from trials, including those involving COM503, and additional programs that may become subject of the collaboration; the possibility that the parties may make a strategic decision to terminate the collaboration or discontinue development of any of the investigational agents under the collaboration, and therefore these investigational agents may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, as filed with the
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The Compugen name and logo are trademarks of Compugen Ltd.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231218814564/en/
Compugen Ltd.
Yvonne Naughton, Ph.D., Investors and Media
ir@cgen.com
Gilead
Investors:
Jacquie Ross
investor_relations@gilead.com
Media:
Meaghan Smith
public_affairs@gilead.com
Source: Gilead Sciences, Inc.
FAQ
What is the latest agreement announced by Gilead Sciences, Inc. (Nasdaq: GILD)?
What is the total deal value of the agreement?
What are the positive aspects of the agreement for Gilead Sciences, Inc. (Nasdaq: GILD)?
What are the negative impacts of the agreement on Gilead Sciences, Inc. (Nasdaq: GILD)?
