This section highlights FDA-related milestones and regulatory updates for drugs developed by Compugen (CGEN).
Over the past two years, Compugen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
COM701, COM503, and COM902. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
COM701 FDA Regulatory Timeline and Events
COM701 is a drug developed by Compugen for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COM701
- Announced Date:
- October 13, 2025
- Indication:
- Solid tumors
Announcement
Compugen Ltd. announced that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC), has been published as an abstract released by the European Society of Medical Oncology (ESMO).
AI Summary
Compugen Ltd. announced that a pooled analysis of previously presented data on COM701 in heavily pre-treated, platinum-resistant ovarian cancer patients has been published as an abstract by the European Society for Medical Oncology (ESMO). The analysis pooled results from 60 evaluable patients in Phase 1 trials, highlighting progression-free survival outcomes and characterizing those who derived clinical benefit. An extra year of follow-up data will be added to the poster, which will be presented in Berlin on October 18, 2025.
Lead investigator Dr. Oladapo Yeku reported that COM701 was well tolerated and showed consistent, durable anti-tumor responses, especially in patients without liver metastases. These findings support testing COM701 as maintenance therapy earlier in treatment. Compugen is now enrolling patients in the MAIA-ovarian trial of COM701 monotherapy for relapsed platinum-sensitive ovarian cancer, with sites active in the U.S., Israel, and France and an interim analysis expected by year-end 2026.
Read Announcement- Drug:
- COM701
- Announced Date:
- July 28, 2025
- Indication:
- Solid tumors
Announcement
Compugen Ltd. announced that it will present a pooled analysis of data from three Phase 1 trials evaluating COM701 as monotherapy and combination therapy in heavily pretreated platinum resistant ovarian cancer patients at ESMO 2025, being held on October 17-21, 2025, in Berlin, Germany.
AI Summary
Compugen Ltd. announced it will present a pooled analysis of data from three Phase 1 trials of COM701 at the European Society for Medical Oncology (ESMO) Congress 2025. The analysis covers both monotherapy and combination therapy with COM701 in heavily pretreated, platinum-resistant ovarian cancer patients. ESMO 2025 is scheduled for October 17-21, 2025, in Berlin, Germany.
The poster, titled “COM701 in Ovarian Cancer: A Pooled Analysis of 3 Phase 1 Clinical Trials,” will be presented by Dr. Oladapo Yeku from Massachusetts General Hospital. Poster presentation number 1196P is set for Saturday, October 18, from 12:00 to 12:45 CEST.
After the congress, the poster will be available for download in the Publications section of Compugen’s website at www.cgen.com.
Read Announcement- Drug:
- COM701
- Announced Date:
- July 21, 2025
- Indication:
- Solid tumors
Announcement
Compugen Ltd. announced that the first patient was dosed in the global randomized sub-trial 1 of adaptive platform trial, MAIA-ovarian (which stands for MAintenance Immunotherapy with an Anti-PVRIG antibody), evaluating maintenance therapy with single agent COM701, a potential first-in-class anti-PVRIG antibody in patients with relapsed platinum sensitive ovarian cancer.
AI Summary
Compugen Ltd announced the first patient was dosed in randomized sub-trial 1 of the MAIA-ovarian trial. MAIA-ovarian (MAintenance Immunotherapy with an Anti-PVRIG antibody) tests COM701, a potential first-in-class anti-PVRIG antibody, as maintenance therapy in relapsed, platinum-sensitive ovarian cancer.
The trial is backed by a strong biological rationale, as PVRIG pathway expression is high in ovarian tumors. Early data showed that COM701 paired with PD-1 and TIGIT inhibitors achieved durable responses and was well tolerated in resistant ovarian cancer. One patient also responded for over 18 months on COM701 alone.
Sub-trial 1 is a double-blind, placebo-controlled study with 60 patients randomized 2:1 to COM701 or placebo. Compugen expects around six months median progression-free survival and sees a three-month improvement as meaningful. An interim analysis is slated for the second half of 2026 to assess safety and efficacy and could support registration.
Read Announcement- Drug:
- COM701
- Announced Date:
- March 4, 2025
- Indication:
- Solid tumors
Announcement
Compugen Ltd provided a corporate update.
AI Summary
Compugen Ltd provided a corporate update highlighting key progress in its cancer immunotherapy program. The company shared that clinical data presented at SITC 2024 supports advancing its potential first-in-class anti-PVRIG antibody COM701. This data has strengthened Compugen’s plan to evaluate COM701 as a maintenance therapy option for patients with platinum sensitive ovarian cancer. They are on track to start a randomized adaptive platform trial in Q2 2025 that will initially test COM701 as a single agent compared to a placebo. The update noted that this development is rooted in strong clinical and biological reasoning, which could lead to further studies combining COM701 with other drugs. Compugen also emphasized its strong financial footing, with cash available to fund operations into 2027, and its ongoing efforts using its AI/ML-driven UnigenTM platform to drive future innovations.
Read Announcement- Drug:
- COM701
- Announced Date:
- October 7, 2024
- Indication:
- Solid tumors
Announcement
Compugen Ltd announced, that new clinical data supporting the anti-tumor activity and safety of the triple combination COM701 pembrolizumb in heavily pre-treated patients with platinum resistant ovarian cancer will be presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place between November 8-10, 2024, in Houston, Texas.
AI Summary
Compugen Ltd recently announced that it will present new clinical data at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Houston, Texas, from November 8–10, 2024. The presentation will detail the safety and anti-tumor activity of a triple-combination therapy that includes COM701, COM902, and pembrolizumab. This Phase I trial data comes from heavily pre-treated patients with platinum resistant ovarian cancer and highlights preliminary evidence supporting the effectiveness of targeting the DNAM-1 axis using a combined approach.
Dr. Oladapo Yeku from Massachusetts General Hospital will lead the poster presentation, emphasizing the potential benefits of combining anti-PVRIG (COM701) and anti-TIGIT (COM902) antibodies with pembrolizumab. These promising early results demonstrate Compugen’s commitment to advancing innovative cancer immunotherapy strategies.
Read Announcement
COM503 FDA Regulatory Events
COM503 is a drug developed by Compugen for the following indication: For the Treatment of Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COM503
- Announced Date:
- January 8, 2025
- Indication:
- For the Treatment of Solid Tumors
Announcement
Compugen Ltd. announced that the first patient was dosed in a Phase 1 clinical trial with COM503, a potential first-in-class antibody against IL-18 binding protein licensed by Compugen to Gilead. Compugen is responsible for running the Phase 1 trial.
AI Summary
Compugen Ltd. announced that the first patient has been dosed in a Phase 1 clinical trial for COM503, a potential first-in-class antibody that targets the IL-18 binding protein. The trial will test the drug’s safety, tolerability, and pharmacokinetics in patients with advanced solid tumors. COM503 is being evaluated both as a standalone treatment and in combination with Gilead’s anti-PD1 antibody, zimberelimab.
Compugen, which licensed COM503 to Gilead, is managing the Phase 1 trial. By blocking the IL-18 binding protein, COM503 aims to release natural IL-18 within the tumor environment, potentially boosting the body’s immune response against cancer. This milestone trial, which started in late 2024, marks an important step in cancer immunotherapy research and shows promise for improving patient outcomes.
Read Announcement- Drug:
- COM503
- Announced Date:
- July 29, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- For the Treatment of Solid Tumors
Announcement
Compugen announced that its on track to initiate the Phase 1 trial in solid tumors, in the fourth quarter of 2024.
AI Summary
Compugen announced that the FDA has cleared the IND for its experimental drug, COM503, which has led to a $30 million milestone payment from Gilead. The company is on track to begin a Phase 1 trial in advanced solid tumors in the fourth quarter of 2024. The trial will be the first in human and will assess the safety and tolerability of COM503, a unique antibody that targets the IL-18 binding protein, both on its own and in combination with Gilead’s anti-PD-1 agent, zimberelimab. This development highlights Compugen’s promise in cancer immunotherapy and its advanced computational approach in drug discovery. The initiation of this trial marks a significant step forward in proving the potential benefits of COM503 for cancer treatment and is an important milestone in the company’s ongoing clinical development program.
Read Announcement- Drug:
- COM503
- Announced Date:
- July 29, 2024
- Indication:
- For the Treatment of Solid Tumors
Announcement
Compugen Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a Phase 1 trial for COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody licensed to Gilead Sciences, Inc. (Gilead).
AI Summary
Compugen Ltd. announced that the FDA has cleared the IND application for COM503, a potential first-in-class, high affinity anti‑IL‑18 binding protein antibody. This milestone clearance will trigger a $30 million payment from Gilead Sciences, Inc., which holds the license for COM503. The clearance is a key step that enables the start of a Phase 1 trial, planned for Q4 2024, in patients with advanced or metastatic solid tumors.
The Phase 1 trial is designed to evaluate the safety and tolerability of COM503, both as a standalone treatment and in combination with Gilead’s anti-PD-1 therapy, zimberelimab. Compugen’s innovative approach, using advanced computational discovery, has helped them uncover this promising drug candidate. This achievement not only demonstrates their strong capabilities in drug discovery but also boosts their financial outlook, as the clearance cements the collaboration with Gilead.
Read Announcement
COM902 FDA Regulatory Events
COM902 is a drug developed by Compugen for the following indication: Advanced malignancies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COM902
- Announced Date:
- November 27, 2024
- Indication:
- Advanced malignancies
Announcement
Compugen Ltd announced that the United States Patent and Trademark Office (USPTO) has granted the Company a new patent covering method of use for COM902, the Company's potential best-in-class reduced Fc, clinical stage antibody targeting TIGIT, and additional TIGIT backup antibodies in triple combination with any anti-PD-1 antibody and any anti-PVRIG antibody for the treatment of cancer.
AI Summary
Compugen Ltd. announced that the United States Patent and Trademark Office (USPTO) has granted a new patent for a method of using its clinical-stage antibody COM902, a potential best-in-class reduced Fc anti-TIGIT antibody. The patent covers a triple combination therapy that uses COM902 together with any anti-PD-1 antibody and any anti-PVRIG antibody for treating cancer. This new protection expands Compugen’s intellectual property portfolio and builds on its earlier patents by safeguarding the use of COM902 and its backup antibodies when used in this triplet regimen. The company believes that this strategy may help overcome resistance in certain tumors that do not respond well to PD-1 inhibition alone, suggesting that blocking both PD-1 and PVRIG, along with TIGIT, could offer improved anti-tumor activity. This patent is expected to remain valid until at least August 2037 in the United States.
Read Announcement- Drug:
- COM902
- Announced Date:
- October 7, 2024
- Indication:
- Advanced malignancies
Announcement
Compugen Ltd. announced, that new clinical data supporting the anti-tumor activity and safety of the triple combination pembrolizumb in heavily pre-treated patients with platinum resistant ovarian cancer will be presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place between November 8-10, 2024, in Houston, Texas.
AI Summary
Compugen Ltd. announced that it will present new clinical data at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) from November 8-10, 2024, in Houston, Texas. The data focus on a Phase I trial that evaluates a triple combination therapy for heavily pre-treated patients with platinum-resistant ovarian cancer. This innovative treatment combines pembrolizumab with two novel antibodies, COM701 (anti-PVRIG) and COM902 (anti-TIGIT), designed to block the DNAM-1 axis. Early results show promising anti-tumor activity and safety for patients who have limited treatment options. Dr. Oladapo Yeku from Massachusetts General Hospital will present the study's interim findings, highlighting the potential of this combination therapy as a new approach in cancer immunotherapy. This research aims to offer a hopeful alternative for patients battling resistant forms of ovarian cancer.
Read Announcement
