renvistobart (BMS-986207) / BMS, Ono Pharma - 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

Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT (clinicaltrials.gov) - P1/2 | N=14 | Terminated | Sponsor: Multiple Myeloma Research Consortium | Trial completion date: Dec 2024 ➔ Aug 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Aug 2024; Pharmaceutical support has been discontinued.

Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

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

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

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=101 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | N=241 ➔ 101 | Trial completion date: Feb 2025 ➔ Jan 2024

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Oncology • Solid Tumor • PD-L1

A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=1 | Completed | Sponsor: Bristol-Myers Squibb | Terminated ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

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

Durable responses with triple blockade of the DNAM-1 axis with COM701 + BMS-986207 + nivolumab in patients with platinum resistant ovarian cancer (SITC 2023) - P1/2 | "Data extract 06/09/2023. Acknowledgements We thank the patients for participating in this clinical trial and their families, the investigators and their staff at the clinical trial sites."

Clinical • Oncology • Ovarian Cancer • Solid Tumor • TIGIT

The combination of COM701 + nivolumab demonstrates preliminary antitumor activity in patients with metastatic breast cancer (SITC 2023) - P1a/1b | "We have reported preliminary antitumor activity with objective responses [partial responses and a complete response] in patients with solid tumors (MSS-CRC, platinum resistant OVCA, anal squamous CA, MSS-endometrial cancer] who received COM701 +/- nivolumab + BMS-986207 (anti-TIGIT antibody). Additional clinical and translational data will be presented at the conference. Data extract 06/09/2023."

Clinical • Metastases • Breast Cancer • Endometrial Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • IFNG • PD-L1 • PGR • TIGIT • TMB

Immune modulation and baseline biomarker correlation with clinical benefit following treatment with COM701+nivolumab+/-BMS-986207 in patients with platinum resistant ovarian cancer (SITC 2023) - P1/2, P1a/1b | "Conclusions These results demonstrate the efficacy of COM701 treatment combinations in terms of clinical responses and immune modulation, regardless of the tumor baseline inflammatory status. In addition, the preliminary correlation between the expression of the PVRIG ligand, PVRL2, and clinical benefit may suggest the potential of baseline PVRL2 as a biomarker to enrich for responding patients."

Biomarker • Clinical • IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD8 • TIGIT • TRB

Compugen to Present New Clinical and Pre-Clinical Data in Multiple Presentations at SITC 2023 (PRNewswire) - "Compugen...announced, it will present new clinical and pre-clinical data supporting its vision to extend the reach of cancer immunotherapies to new patient populations, in an oral presentation and four poster presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)..."

Clinical data • Preclinical • Breast Cancer • Ovarian Cancer

Biophysical characterization of PVR family interactions and therapeutic antibody recognition to TIGIT. (PubMed, MAbs) - "Furthermore, the anti-TIGIT monoclonal antibody BMS-986207 crystal structure in complex with TIGIT was determined and shows that the antibody binds an epitope that is commonly targeted by the CD155 ligand as well as other clinical anti-TIGIT antibodies...Thus, TIGIT and other PVR inhibitory receptors likely elicit immune suppression via increased surface expression rather than inherent differences in affinity. This work provides an improved foundational understanding of the PVR family network and mechanistic insight into therapeutic antibody intervention."

IO biomarker • Journal • Oncology • CD96 • PVR • TIGIT

Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT (clinicaltrials.gov) - P1/2 | N=14 | Active, not recruiting | Sponsor: Multiple Myeloma Research Consortium | Recruiting ➔ Active, not recruiting | N=104 ➔ 14 | Trial primary completion date: Dec 2024 ➔ Dec 2023

Enrollment change • Enrollment closed • Immuno-oncology • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Preliminary antitumor activity of the combination of COM701 + BMS-986207 + nivolumab in patients with recurrent, metastatic MSS endometrial cancer. (ASCO 2023) - P1/2 | "The combination of COM701 + BMS-986207 + nivolumab demonstrates encouraging preliminary signal of antitumor activity in pts with EC including in a pt refractory to prior exposure to lenvatinib + pembrolizumab. The triplet combination has a favorable safety/tolerability profile. Additional data analyses and pt follow up are ongoing and will be presented at the conference."

Clinical • Metastases • Back Pain • Dermatology • Endometrial Cancer • Immune Modulation • Musculoskeletal Pain • Oncology • Ovarian Cancer • Pain • Pruritus • Solid Tumor • TIGIT

Compugen’s COM701 (anti-PVRIG) Demonstrates Preliminary Durable Anti-Tumor Activity in Triple Immunotherapy Combination in Patients with Recurrent Metastatic MSS Endometrial Cancer (PRNewswire) - P1/2 | N=100 | NCT04570839 | Sponsor: Compugen Ltd | "Compugen Ltd...announced data to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, showing that Compugen's COM701 (anti-PVRIG) in triple combination with nivolumab and BMS-986207 (anti-TIGIT) demonstrated preliminary signal of durable anti-tumor activity in patients with recurrent, metastatic MSS endometrial cancer with a favorable safety profile. Preliminary translational data showed an association between greater peripheral immune activation and clinical benefit. The poster presentation takes place today, June 5, 2023....'A patient with prior treatment refractory disease to standard of care lenvatinib and pembrolizumab, experienced a partial response and remained on treatment with triple combination for almost 7 months pointing to the potential contribution of blocking PVRIG and TIGIT to the benefit seen'."

P1/2 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=241 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2024 ➔ Feb 2025 | Trial primary completion date: Aug 2024 ➔ Mar 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

Compugen to Present New Clinical Data Showing Preliminary Anti-Tumor Activity of COM701 Triple Combination in Recurrent MSS-Metastatic Endometrial Cancer at ASCO 2023 (PRNewswire) - "Compugen Ltd...announced that it will present new clinical data on COM701 in triple combination with BMS-986207 (anti-TIGIT) and nivolumab in metastatic endometrial cancer at the American Society of Clinical Oncology (ASCO) annual meeting on June 2-6, 2023, in Chicago, Illinois."

P1/2 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Uterine Cancer

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=241 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Feb 2025 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

Durable responses following anti-TIGIT (BMS-986207) and anti-LAG3 (BMS-980616) in combination with pomalidomide in relapsed myeloma: MMRF MyCheckpoint trial (AACR 2023) - P1/2 | "Anti-LAG-3 and anti-TIGIT mAb alone and in combination with Pom are safe, feasible and clinically active in relapsed MM after Pom and anti-CD38 mAb. These data provide the first evidence of clinical activity of TIGIT and LAG-3 blockade in MM. Translational results utilizing serial analyses with mass cytometry suggest evidence of immune activation following combination therapy."

Combination therapy • Hematological Malignancies • Multiple Myeloma • Oncology • TIGIT

Triple blockade of the DNAM-axis with COM701 + BMS-986207 + nivolumab demonstrates preliminary antitumor activity in patients with platinum resistant OVCA. (ESMO-IO 2022) - P1/2 | "Vaena D et al, COM701±nivolumab: Results of an ongoing P1 study of safety, tolerability & preliminary antitumor activity in pts with advanced solid malig. J Clin Onco 39, 2021 (suppl 15; abst 2504)."

Clinical • Oncology • Ovarian Cancer • Solid Tumor • TIGIT

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 | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2023 ➔ Dec 2023

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

A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Bristol-Myers Squibb | N=180 ➔ 1 | Trial completion date: Aug 2026 ➔ Dec 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Dec 2022; The Study has been terminated due to safety reasons, adverse change in the risk/benefit.

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=241 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Oncology • Solid Tumor • PD-L1