COM701 / Compugen - LARVOL DELTA

COM701 in ovarian cancer: A pooled analysis of 3 phase I clinical trials (ESMO 2025) - P1/2 | "A post hoc pooled analysis was conducted to characterize the safety and efficacy of COM701 in 3 Phase 1 trials, as monotherapy, doublet with PD-1 blocker (Nivolumab) and triplet with PD-1 (Nivolumab/ Pembrolizumab) and TIGIT blockers (BMS986207/COM902) in heavily pretreated platinum-resistant ovarian cancer (PROC). The observed clinical benefit suggests a rational for a maintenance strategy, thus NCT06888921 is evaluating COM701 monotherapy as maintenance therapy in relapsed platinum sensitive ovarian cancer, for which there is an unmet need. Legal entity responsible for the study Compugen Ltd."

P1 data • Retrospective data • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL6 • TIGIT

Compugen to Present Pooled Analysis of COM701 in Three Phase 1 Trials in Patients with Platinum Resistant Ovarian Cancer at ESMO 2025 (PRNewswire) - "'The pooled analysis demonstrates that COM701 was well tolerated and showed consistent, durable responses in patients with heavily pretreated platinum-resistant ovarian cancer - particularly in those without liver metastases, representing patients with lower disease burden and potentially less immunosuppressive tumor microenvironment'."

Platinum resistant • Retrospective data • Ovarian Cancer

Compugen to Present a Pooled Analysis of COM701 Phase 1 trials in Platinum Resistant Ovarian Cancer at ESMO 2025 (Compugen Press Release) - "Compugen...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....Poster details: Title: COM701 in Ovarian Cancer: A Pooled Analysis of 3 Phase 1 Clinical Trials...; Poster presentation number: 1196P; Date of poster presentation: Saturday, October 18; 12:00-12:45 CEST."

Platinum resistant • Retrospective data • Ovarian Cancer

Compugen Announces First Patient Dosed in COM701 Global Platform Trial in Platinum Sensitive Ovarian Cancer (PRNewswire) - "Compugen...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....An interim analysis of sub-trial 1 of MAIA-ovarian is planned to take place in the second half of 2026."

P1/2 data • Platinum sensitive • Trial status • Ovarian Cancer

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Compugen Ltd | Initiation date: Apr 2025 ➔ Jul 2025

Monotherapy • Platinum sensitive • Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor

CPG-02-101: COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=110 | Active, not recruiting | Sponsor: Compugen Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment closed • Platinum resistant • Trial completion date • Trial primary completion date • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Plasmacytoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Compugen Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Compugen Ltd

Monotherapy • New P1/2 trial • Oncology • Ovarian Cancer • Solid Tumor

Compugen Reports Fourth Quarter and Full Year 2024 Results (PRNewswire) - "Next Planned Milestones: Q2 2025 – initiation of a randomized adaptive platform trial comparing COM701 maintenance therapy to placebo in total of 60 patients with relapsed platinum sensitive ovarian cancer; 2025 – Compugen's partner, AstraZeneca, plans to share early data for rilvegostomig in combination with their ADCs; H2 2026 – data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer."

Clinical data • New trial • Ovarian Cancer

Triple blockade of DNAM-1axis with COM701(anti-PVRIG)+COM902(anti-TIGIT)+Pembrolizumab shows prelim antitumor activity in pts with platinum resistant ovarian cancer, interim results of phase I trial (SITC 2024) - P1 | "A 20% objective response rate (ORR) following combination COM701 + BMS-986207 (anti-TIGIT) + nivolumab in PROC was previously reported.3 We present an additional cohort of PROC pts treated with COM701, COM902 and pembrolizumab demonstrating encouraging antitumor activity, and safety, consistent with the prior report.4 Methods CPG-02-101 is ongoing...One PR pt had prior treatment with mirvetuximab soravtansine-gynx...Ethics Approval The CPG-02-101 trial is being conducted in accordance with the ethical principles stipulated in the Declaration of Helsinki. View this table:View inline View popup Download powerpoint Abstract 985 Table 1 Subject dispositionView this table:View inline View popup Download powerpoint Abstract 985 Table 2 Summary of overall response rate (ORR) and disease control rate (DCR)View this table:View inline View popup Download powerpoint Abstract 985 Table 3 Overall Summary of TEAEs ovarian cancer, triplet dose expansionView this table:View inline..."

Clinical • P1 data • Oncology • Ovarian Cancer • Solid Tumor • IFNG • TIGIT

Compugen Reports Third Quarter 2024 Results (PRNewswire) - "Next Planned Milestones: (i) Q4 2024- on track to initiate Phase 1 study of COM503 in solid tumors; (ii) Q2 2025- plan to initiate an adaptive platform trial starting with sub-study 1, randomizing patients with relapsed platinum sensitive ovarian cancer ineligible for PARPi or bevacizumab to single agent COM701 maintenance treatment or placebo; (iii) H2 2026- data from projected COM701 interim analysis from sub-study 1."

Clinical data • New trial • Ovarian Cancer

Compugen to Present Anti-Tumor Activity and Safety Data of COM701, COM902 and Pembrolizumab Combination in Patients with Platinum Resistant Ovarian Cancer at SITC 2024 (PRNewswire) - P1 | N=110 | NCT04354246 | Sponsor: Compugen Ltd | "Compugen Ltd...announced that data supporting the anti-tumor activity and safety profile of the triple combination COM701, COM902 and pembrolizumab in advanced heavily pre-treated patients with platinum resistant ovarian cancer (PROC) has been published as an abstract released by the Society for Immunotherapy of Cancer (SITC)....'The data from this study along with data Compugen previously presented, demonstrate that COM701 is active, has a favorable safety profile, and is a differentiated immune checkpoint inhibitor. COM701 in combination with COM902 (Fc reduced anti-TIGIT) and pembrolizumab (anti-PD-1) resulted in durable objective responses in late-stage ovarian cancer patients typically not responsive to other immunotherapeutic agents'."

P1 data • Ovarian Cancer

Compugen to Present New Clinical Data at SITC 2024 (PRNewswire) - "Compugen Ltd...today announced, that new clinical data supporting the anti-tumor activity and safety of the triple combination COM701, COM902 and 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."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer

Compugen Reports Second Quarter 2024 Results (PRNewswire) - "Upcoming Expected Milestones - COM701 +COM902 + pembrolizumab proof-of-concept study: Platinum resistant ovarian cancer - data presentation in the fourth quarter of 2024. COM503 (licensed to Gilead; Compugen leads through Phase 1 development): Initiation of COM503 Phase 1 trial in the fourth quarter of 2024. Rilvegostomig (AstraZeneca's PD-1/TIGIT bispecific, TIGIT component derived from COM902): AstraZeneca anticipates data from Phase 1/2 ARTEMIDE-01 trial in the second half of 2024; poster presentation from Phase 2 GEMINI-Gastric trial accepted at ESMO 2024."

New P1 trial • P1 data • P1/2 data • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=48 | Completed | Sponsor: Compugen Ltd | Active, not recruiting ➔ Completed | N=100 ➔ 48

Combination therapy • Enrollment change • Metastases • Trial completion • Endometrial Cancer • Head and Neck Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • TNFRSF9

COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=121 | Completed | Sponsor: Compugen Ltd | Active, not recruiting ➔ Completed | Trial completion date: May 2024 ➔ Jan 2024

Combination therapy • Metastases • Monotherapy • Trial completion • Trial completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • BRAF • BRCA • ER • HER-2 • KRAS • PGR • TNFRSF9

Preliminary antitumor activity of COM701 in combination with COM902 and pembrolizumab in patients with MSS-CRC and liver metastases. (ASCO 2024) - P1 | "Key inclusion criteria: Age ≥ 18 yrs, measurable disease, MSS by IHC or genomic testing, ≤3 prior lines including fluroropyrimidines, irinotecan, and oxaliplatin. The data further supports the antitumor activity of the combination of COM701 + COM902 + pembrolizumab in pts with MSS-CRC and specifically in patients with liver metastases. Of note the data further reinforces the data previously disclosed in a similar pt population of 22 pts that received COM701 + nivolumab 1 . No new safety signals are reported."

Clinical • Combination therapy • Colorectal Cancer • Fatigue • Immune Modulation • Immunology • Musculoskeletal Pain • Oncology • Pain • PD-1 • TIGIT

Compugen Reports First Quarter 2024 Results (PRNewswire) - "Upcoming Expected Milestones - COM701 +COM902 + pembrolizumab proof-of-concept studies: Microsatellite stable colorectal cancer – ASCO poster presentation, June 1, 2024; Platinum resistant ovarian cancer - planned data presentation in the fourth quarter of 2024....Rilvegostomig (AstraZeneca's PD-1/TIGIT bispecific, TIGIT component derived from COM902): Data in the second half of 2024 from Phase 1/2 ARTEMIDE-01 trial in advanced/metastatic NSCLC."

P1 data • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Compugen to Present New Clinical Data Showing COM701 Triple Combination Preliminary Anti-Tumor Activity in Microsatellite Stable Colorectal Cancer with Liver Metastases at ASCO 2024 (PRNewswire) - "Compugen...today 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."

Clinical data • Colorectal Cancer

PVRIG is uniquely expressed in tumor dendritic cells-rich niches on stem-like memory T cells and its blockade may induce immune infiltration and activation in non-inflamed tumors (AACR 2024) - "Treatment with COM701, anti-PVRIG antibody, as monotherapy or in combination with nivolumab resulted in an increased tumor T cell infiltration, accompanied by TCR clonality expansion, which were associated with clinical benefit. In summary, our study identifies PVRIG as uniquely expressed on TSCM in the TME, with its ligand PVRL2 expressed on activated DCs. Blockade of PVRIG/PVRL2 interaction by COM701 antibody emerges as a promising strategy to induce potent T cell responses, providing a novel approach overcoming resistance to immunotherapy in immune excluded tumors."

IO biomarker • Oncology • Ovarian Cancer • Solid Tumor • CD28 • CD63 • CD8 • CTLA4 • HAVCR2 • LAMP3 • PD-1

Compugen Reports Fourth Quarter and Full Year 2023 Results (PRNewswire) - "COM701 +COM902 + pembrolizumab proof-of-concept studies: Microsatellite stable colorectal cancer - data in the first half of 2024; Platinum resistant ovarian cancer - on track to complete enrolment of at least 20 patients in the first quarter of 2024, and data in the fourth quarter of 2024."

Enrollment status • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=140 | Active, not recruiting | Sponsor: Compugen Ltd | Phase classification: P1a/1b ➔ P1 | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ Feb 2024

Combination therapy • Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • BRAF • BRCA • ER • HER-2 • KRAS • PGR • TNFRSF9

COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=100 | Active, not recruiting | Sponsor: Compugen Ltd | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Dec 2023 ➔ May 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Endometrial Cancer • Head and Neck Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • TNFRSF9

COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Compugen Ltd | Trial completion date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Plasmacytoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Compugen's COM701 (anti-PVRIG) Mediates Anti-Tumor Activity in Patients Typically Not Responding to Immunotherapy (PRNewswire) - P1/2 | N=100 | NCT04570839 | Sponsor: Compugen Ltd | "At SITC, we presented for the first time initial data suggesting an association between baseline levels of the ligand for PVRIG, PVRL2, and clinical benefit, suggesting PVRL2 may be a predictive biomarker to help enrich for patients who may derive clinical benefit from our COM701 combinations...Durable partial responses lasting more than 16 months is clinically meaningful in patients with high grade epithelial platinum resistant ovarian cancer. While the numbers are small, typical median duration of response is 3-4 months with standard chemotherapy and 6.9 months reported in patients treated with the recently approved antibody drug conjugate; Following treatment with COM701 in combination with nivolumab, it is encouraging to see a complete response of greater than 21 months and a partial response of 10 months in patients with metastatic breast cancer..."

P1/2 data • Breast Cancer • HER2 Negative Breast Cancer • Ovarian Cancer • Triple Negative Breast Cancer