COM503 / Compugen, Gilead - LARVOL DELTA

A Clinical Trial to Assess COM503 in Participants with Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Compugen Ltd

New P1 trial • Oncology • Solid Tumor

Compugen Announces First Patient Dosed in Phase 1 Clinical Trial to Evaluate COM503 as Monotherapy and in Combination with Zimberelimab in Advanced Solid Tumors (PRNewswire) - "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. This Phase 1 multi-center dose escalation and dose expansion trial will evaluate the safety, tolerability, and pharmacokinetics of COM503 as monotherapy and in combination with Gilead's anti-PD1, zimberelimab in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor

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 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

Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors (PRNewswire) - "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). The IND clearance triggered a $30 million milestone payment from Gilead and Compugen is on track to initiate the Phase 1 trial in solid tumors, in the fourth quarter of 2024."

Financing • IND • New P1 trial • Oncology • Solid Tumor

Unleashing natural IL-18 activity using an anti-IL-18BP blocker antibody induces potent immune stimulation and anti-tumor effects (AACR 2024) - "Anti-IL-18BP Ab approach has a leading edge in inhibiting tumor growth while avoiding peripheral toxicity associated with administration of a cytokine. COM503 is currently undergoing IND-enabling studies."

Oncology • CD8 • GZMB • IFNG • IL12A • IL18 • TNFA

Compugen Publishes Paper in Cancer Immunology Research Demonstrating Therapeutic Potential of COM503 (PRNewswire) - "Our paper published online yesterday in Cancer Immunology Research describes how COM503, a potential first-in-class high affinity monoclonal antibody, blocks the interaction between IL-18 and IL-18BP, unleashing the activity of endogenous IL-18 in the tumor. By relying on endogenous production of IL-18, we found that COM503's activity is localized to the tumor microenvironment with the additional advantage of a wider therapeutic window than systemic IL-18 delivery."

Preclinical • Oncology • Solid Tumor

Unleashing Natural IL18 Activity Using an Anti-IL18BP Blocker Induces Potent Immune Stimulation and Antitumor Effects. (PubMed, Cancer Immunol Res) - "To restore the activity of endogenous IL18, we generated COM503, a high-affinity anti-IL18BP that blocks the IL18BP:IL18 interaction and displaces precomplexed IL18, thereby enhancing T- and NK-cell activation. In contrast, no increase in inflammatory cytokines and lymphocyte numbers or activation state was observed in serum and spleen. Taken together, blocking IL18BP using an Ab is a promising approach to harness cytokine biology for the treatment of cancer."

Journal • Immune Modulation • Immunology • Oncology • IFNG • IL18BP

Compugen to Present Data Reflecting its Diversified Immuno-Oncology Pipeline at AACR 2024 (PRNewswire) - "Compugen Ltd...announced that it will present data from its differentiated immuno-oncology preclinical and clinical pipeline, in two poster presentations at the American Association for Cancer Research (AACR) annual meeting on April 5-11, 2024, in San Diego, California....'At ACCR we will present data supporting the unique biology of PVRIG suggesting its role in sensitizing tumors to other immune checkpoints TIGIT and PD-(L)1. In addition, in a second presentation we will present data supporting the therapeutic potential of our high affinity, potential first-in-class, anti-IL-18 binding protein antibody, COM503, showing its activity is localized to the tumor microenvironment with the potential advantage of a wider therapeutic window than systemically delivered cytokines.'"

Clinical data • Preclinical • Oncology • Solid Tumor

Compugen Reports Fourth Quarter and Full Year 2023 Results (PRNewswire) - "COM503: IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance."

IND • New P1 trial • Oncology • Solid Tumor

Compugen to Host Conference Call to Discuss Exclusive License Agreement with Gilead for COM503, Novel Immuno-Oncology Pre-Clinical Program Harnessing IL-18 Biology (PRNewswire) - "Compugen Ltd...announced that it will host a conference call at 8:30 AM ET today, to discuss the exclusive license agreement with Gilead announced today, for the development and commercialization of its anti-IL-18 binding protein program including COM503, a pre-clinical potential first-in-class high affinity antibody targeting IL-18 binding protein with potential to treat multiple tumor types."

Preclinical • Oncology • Solid Tumor

Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program (Businesswire) - "Gilead Sciences...announced an agreement with Compugen...to exclusively license its potential first-in-class, pre-clinical antibody program against IL-18 binding protein, including the COM503 drug candidate....Under the terms of the agreement, Compugen will be responsible for the ongoing pre-clinical development and the future Phase 1 study of COM503. Thereafter, Gilead will have the sole right to develop and commercialize COM503. Gilead will make Compugen an upfront payment of $60 million and $30 million in a near term milestone payment subject to IND clearance of COM503 expected in 2024. Compugen will also be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of $848 million."

IND • Licensing / partnership • Oncology

Harnessing natural IL-18 activity through IL-18BP blockade reshapes the tumor microenvironment for potent anti-tumor immune response (SITC 2023) - "4 Taken together, blocking IL-18BP is a promising novel approach to harness cytokine potency for the treatment of cancer. COM503 is currently undergoing IND-enabling studies."

Biomarker • Tumor microenvironment • Oncology • CD8 • IFNG • IL18

Compugen to Present New Data at SITC 2023 Suggesting Leading Edge of Anti-IL18 Binding Protein Antibody, COM503, in Treating Cancer (PRNewswire) - "We show that following antibody blockade of IL-18BP, endogenous IL-18 levels in human tumors are sufficient to provoke an anti-tumor immune response. In addition, we show that administering an anti-IL18BP antibody is expected to have a better therapeutic window than administering an engineered IL-18 cytokine. Our data suggest that our anti-IL18BP antibody approach has a leading edge in inhibiting tumor growth while avoiding peripheral toxicity associated with administration of a cytokine. We look forward to discussing the data at SITC over the coming days and the IND filing in 2024.'"

IND • Preclinical • Oncology • Solid Tumor

Compugen Reports Second Quarter 2023 Results (PRNewswire) - "Next Planned Milestones in H2 2023...Presentation of new data from the metastatic breast cancer cohort expansion study of patients treated with COM701 and nivolumab. Presentation of data from COM503 lead pre-clinical program. Rilvegostomig (PD-1/TIGIT bispecific derived from COM902): AstraZeneca continues to advance the development of rilvegostomig in multiple trials, including a Phase 2 trial in checkpoint inhibitor naïve NSCLC and a Phase 2 trial in hepatobiliary cancer. AstraZeneca disclosed plans to initiate a Phase 3 trial with rilvegostomig this year."

New P3 trial • P1 data • Preclinical • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Compugen to Present Data on its Lead Pre-Clinical Asset COM503 in an Oral Presentation at the 20th CIMT Annual Meeting (PRNewswire) - "Compugen Ltd...announced that it will present pre-clinical data on its lead pre-clinical asset COM503 in an oral presentation at the 20th CIMT annual meeting, Europe's Cancer Immunotherapy Meeting, on May 3-5, 2023, in Mainz, Germany....'During our oral presentation at CIMT we will present pre-clinical data showing that COM503 binds with high affinity to IL-18 binding protein, freeing IL-18 and restoring NK and T cell activity. We will also show that blocking IL-18 binding protein prevents tumor growth and releases IL-18 to activate immunity in the TME without affecting peripheral immunity in murine tumor models. This is a differentiated approach to harness cytokine biology for cancer therapeutics'."

Preclinical • Oncology • Solid Tumor

Compugen Reports Fourth Quarter and Full Year 2022 Results (PRNewswire) - "Upcoming Expected Milestones...Additional data from cohort expansion studies (COM701 + nivolumab +/-BMS-986207): Continue to monitor patients in studies with Bristol Myers Squibb; Report findings including PROC longer term follow-up and data collected from biopsies in 2023. COM503: Present pre-clinical data in 2023; File an IND in 2024."

IND • P1 data • Preclinical • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer