The FDA Clears Compugen’s and Bayer’s IND Application for Their Checkpoint Inhibitor Immunotherapy Product

Finally, we are hearing what we were constantly expecting to hear coming out of Compugen’s (CGEN) technological capability. Yesterday, the U.S. Food and Drug Administration (FDA) has cleared Bayer AG’s investigational new drug (IND) application for BAY 1905254, a first-in-class immuno- oncology therapeutic antibody targeting ILDR2. The target ILDR2 is a novel immune checkpoint protein discovered by Compugen through its predictive computational capabilities, which enable the discovery of new drug targets and biological pathways.

Under a collaboration and license agreement, Compugen and Bayer pursued preclinical research advancing BAY 1905254 while Bayer is now responsible for conducting clinical development of this candidate.

Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen said, “Clearance of a second IND for a therapeutic antibody against a novel Compugen- discovered target provides substantial validation of our powerful computational platform. Bayer has been an excellent partner for us, and we are delighted to see their commitment to advance this promising program. Together with COM701, our anti-PVRIG therapeutic antibody, there are now two new first-in-class programs, discovered by our unique computational platform, in the clinic.”

In accordance with the agreement signed between Compugen and Bayer, Compugen is entitled to receive a milestone payment upon the first patient dosing with BAY 1905254 in Phase 1 clinical trial expected this year.

The Target

ILDR2 is a novel B7/CD28-like immune checkpoint target candidate protein discovered computationally by Compugen. Studies testing the immune function of ILDR2, demonstrated inhibitory effects on T cells consistent with it being an immune checkpoint ligand. Additional expression and functional studies suggest that ILDR2 acts as an inhibitor of the priming step of T cell activation, thereby muting T cell response to cancer.

The Drug

BAY 1905254 is a novel immune checkpoint inhibitor for cancer immunotherapy targeting ILDR2. It is a human/mouse cross-reactive antibody blocking the immunosuppressive activity of ILDR2. BAY 1905254 exhibited anti-tumor activity as a monotherapy in various mouse models and was also shown to have additive anti-tumor effects in combination with other cancer therapy approaches in those models, indicating the possibility for multiple combinations uses in cancer immunotherapy.


Compugen is a clinical-stage, therapeutic discovery, and development company utilizing its broadly applicable predictive discovery infrastructure to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy.

The Firm’s Pipeline consists of immuno-oncology programs against novel drug targets it has discovered, including T cell immune checkpoints and myeloid target programs.

The firm’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.

Compugen is headquartered in Israel with R&D facilities in both Israel and South San Francisco.


The Symbol:                            CGEN

The Stock Exchange:           NASDAQ

Stock Price:                            $3.28

52-week range:                      $2.25-$5.00

Market Cap:                            $187.07 M

Prohost Observations

We believe in science. We picked Compugen years ago, based on its strong scientific fundamentals. Although we recognize the fact that strong scientific fundamentals bringing in important discoveries do not alone guarantee the success of a small biotech firm, in the case of Compugen, in spite of its inability to translate its discoveries into therapeutics for long years, we decided not to abandon it. Instead, we kept it, but in the Prohost aggressive portfolio. This portfolio comprises small firms with scientific fundamentals whose stocks have plummeted for drugs’ failures in trials or other disagreeable reasons that can be reversed.

We always believed that Compugen’s extraordinary technological capability would save it.

Having said that, we do not expect CGEN to stage a quick rally following the announced good news. Investors’ skepticism does not fade quickly following an FDA’s granted IND. However, skepticism could fade when positive news comes out of the clinical trials, or from a succession of good news that the firm could bring from other accomplishments. The superior news might also come out from sudden collaboration agreement with a large drug developer, who might be persuaded by the superiority of Compugen’s technological capability and valued discoveries.

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