A Comment from Compugen
Commenting on the FDA’s IND approval, Anat Cohen- Dayag, Ph.D., President and CEO of Compugen, said, “IND clearance for COM902 is an important milestone that marks the third program based on new drug targets we discovered to be evaluated in the clinic. We believe that TIGIT inhibitors may have an important role in the immunotherapy landscape and that our biology driven approach of combining anti-TIGIT and anti-PVRIG inhibitors, with or without PD-1 blockers, has the potential to improve clinical responses in patients who are unresponsive and refractory to currently approved immunotherapies. As the only company with clinical candidates targeting both PVRIG and TIGIT, we hold a differentiated position in the crowded immuno-oncology space.”
Dr. Cohen-Dayag continued, “We are proud of our tremendous progress in recent years, transforming into a clinical-stage company with three anticipated Phase 1 programs in the clinic expected in 2020, two of which we are being developed internally. Importantly, these three programs address targets which originated from our unique computational discovery platform, highlighting the power and value of our computational capabilities to discover new, potentially significant biological pathways and targets for innovative therapeutics.”
COM902 is a high affinity, fully human antibody targeting TIGIT. COM902 was developed for combination treatment with COM701. Preclinical data demonstrate that TIGIT inhibition, either alone or in combination with other checkpoint inhibitors, can enhance T cell activation and increase anti-tumor immune responses. Parallel inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM-1 axis, results in synergistic effects on effector T cell function and tumor growth inhibition in various model systems that can be further increased with the addition of PD-1 blockade.
Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition.
Compugen discovered TIGIT in 2009 leveraging its immune checkpoint computational discovery platform through which PVRIG was also discovered. The TIGT discovery was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).
Perseverance is the key to accomplishing important and historical tasks. The time consumed over far-reaching tasks aimed at solving mysteries of diseases will not go down the drain but the patient scientists will be well rewarded when finding the solutions always appreciated by humans. Compugen has the technology and the scientists that can use it at best. During the firm’s bad times, these scientists never abandoned the tasks they believe in knowing well what they can achieve.
Approving the clinical trials for COM902 will now enable testing a combination treatment of this product with COM701, Compugen’s anti-PVRIG inhibitor.
The firms’ scientists and many others believe that this combination will help conquer advanced cancers.
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The FDA Approves Compugen’s IND for Its Oncology Product COM902
Compugen FDA Approval for COM902
Compugen (CGEN) is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy.
In the NEWS
The U.S. Food and Drug Administration (FDA) has cleared Compugen’s investigational new drug (IND) application for COM902 its immuno-oncology therapeutic antibody targeting TIGIT in patients with advanced cancers.
With the FDA approval of the IND Compugen decided to initiate a Phase 1 clinical trial in patients with advanced malignancies for whom the standard of care therapies are currently ineffective. The clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of COM902. The study is planned to be conducted at multiple centers in the United States and site selection activities are currently underway.
The trial is expected to start early next year.