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
COM503, COM701, and COM902. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
COM503 - FDA Regulatory Timeline and 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
- 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- Drug:
- COM503
- Announced Date:
- July 29, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 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
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:
- 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- Drug:
- COM701
- Announced Date:
- April 25, 2024
- Indication:
- Solid tumors
Announcement
Compugen Ltd announced that it will present new clinical data on COM701 (anti-PVRIG) in triple combination with COM902 (anti-TIGIT) and pembrolizumab in microsatellite stable colorectal cancer at the American Society of Clinical Oncology (ASCO) annual meeting on May31-June 4 2023, in Chicago, Illinois.
AI Summary
Compugen Ltd., a clinical-stage cancer immunotherapy company, announced it will present new clinical data at the upcoming ASCO annual meeting in Chicago, Illinois, from May 31 to June 4, 2023. The study focuses on a triple combination treatment that uses COM701 (an anti-PVRIG antibody), COM902 (an anti-TIGIT antibody), and pembrolizumab to treat patients with microsatellite stable colorectal cancer. This innovative approach aims to explore new options in cancer immunotherapy by targeting multiple pathways simultaneously. Researchers believe the combination could offer promising antitumor activity, especially in challenging cases of colorectal cancer. The data presentation is part of Compugen’s ongoing efforts to advance its pipeline of immunotherapy treatments, using advanced computational methods to discover new drug targets and improve cancer treatment outcomes.
Read Announcement
COM902 - FDA Regulatory Timeline and 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
