Israeli-based Compugen Achieves FDA IND Clearance & Commences Site Selection in America for Immune-oncology Therapeutic Antibody

Israeli-based Compugen Achieves FDA IND Clearance & Commences Site Selection in America for Immune-oncology Therapeutic Antibody TrialsiteN

Israel-based Compugen, Ltd. (CGEN), a clinical-stage cancer immunotherapy company positioned as a leader in predictive target therapy reported that the U.S. Food and Drug Administration has cleared its investigational new drug application (IND) application for COM902, its immune-oncology therapeutic antibody targeting TIGITin pateints with advanced malignancies.

Next Steps: Phase I Clinical Trial

Now with approval for in-man studies, the clinical sponsor seeks to initiate a clinical trial, by 2020, in patients with advanced malignancies where the standard of care therapies are presently ineffective. The study sponsors and investigators will seek to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of COM902.

Multiple Sites

The study sponsor plans on conducting the site at several multicenter centers in America—site selection is presently underway.

Value Proposition

The team believes that TIGIT inhibitors could possibly play a strategic role in the immunotherapy space—and that their biology-driven methods—combining anti-TIGIT and anti-PVRIG inhibitors (with or without PD-1 blockers) represent the ability to improve clinical responses in those patients that are unresponsive and refractory to presently approved immunotherapies. Compugen management posits that they are the “only company with clinical candidates targeting both PVRIG and TGIT” and hence “hold a differentiated position in the crowded immune-oncology space.”

What is COM902?

COM902, a high affinity, fully human antibody targeting TIGIT, 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).

Who is Compugen?

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. The Company’s therapeutic pipeline consists of immuno-oncology programs against novel drug targets it has discovered computationally, including T cell immune checkpoints and additional early-stage immune-oncology programs focused largely on myeloid targets. Compugen’s business model is to selectively enter into collaborations for its novel targets and related drug product candidates at various stages of research and development. The Company is headquartered in Israel, with facilities in South San Francisco, CA. Compugen’s shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen’s corporate website here.