OPM-101 / Oncodesign - LARVOL DELTA

Oncodesign Precision Medicine (OPM) Announces Protocol Submission for its Phase 1b/2a Study, REVERT for OPM-101 in Combination with Pembrolizumab in Patients with Advanced Melanoma Resistant to Anti-PD1 (Businesswire) - "Oncodesign...announced the submission to Swiss authorities of the study protocol for its Phase 1b/2a clinical trial REVERT (RIPK2 for rEsistant and adVanced mElanoma tReatmenT) with OPM-101...Phase 1b: to assess the safety of OPM-101 in combination with pembrolizumab in patients who have developed resistance to this treatment by anti-PD1, and to select the recommended dose to be used...Phase 2a: to assess the Disease Control Rate (DCR), safety and key biomarkers associated with immune response with the selected dose of OPM-101 in combination with pembrolizumab...study is scheduled to start by July 2025...Submission of the application for clinical trial authorization in these selected European Union countries will take place in the 4th quarter of 2025, in order to obtain authorization to conduct the extension phase of the study, which could start in the first quarter of 2026....Completion of this Phase 1b/2a clinical is trial expected by the end of 2027."

Clinical protocol • New P1/2 trial • Trial completion date • Trial initiation date • Melanoma

OPM Reports Final Results of Its Phase 1 Study With RIPK2 Inhibitor OPM-101, With Strong Safety Data and No Cardiac Toxicity, Paving the Way for the Launch of Phase 1b/2a (Businesswire) - P1 | N=104 | "Oncodesign Precision Medicine...today confirms and details the final results of its Phase 1 clinical trial with OPM-101, its RIPK2 inhibitor and drug candidate administered orally to healthy volunteers...OPM-101 was very well tolerated after administration in SAD and MAD....OPM-101 significantly inhibits the RIPK2 pathway. Target engagement kinetics and pharmacodynamic results showed a fast and marked onset of inhibitory effect, already observed 2-6h after first administration, with maximal inhibition of 90-100%, and minimal inhibition of 65%-85% maintained over 14 days of dose-dependent administration....The pharmacokinetic parameters of OPM-101 showed consistent results between the SAD and MAD parts, and characteristics suitable for use in patients....Based on the results presented today, OPM plans to submit a protocol for a phase 1b/2a clinical study in the fourth quarter of 2024."

New P1/2 trial • P1 data • Immunology • Inflammatory Bowel Disease

OPM Announces Poster Presentation on OPM-101, a RIPK2 Kinase Inhibitor, in Healthy Volunteers at UEG Week 2024 Conference (Businesswire) - "Oncodesign Precision Medicine...announced that a scientific abstract on its leading drug candidate, OPM-101, has been presented at the United European Gastroenterology (UEG) Week congress, October 12-15, 2024, in Vienna, Austria....'I am thrilled to have had the opportunity to present for the first time the results of the Phase 1 clinical trial with OPM-101 in healthy volunteers at UEG Week'...'This presentation provides strong evidence that OPM has the potential to advance the treatment of Chronic Inflammatory Bowel Disease as a daily oral therapy for people living with ulcerative colitis.'"

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

UNVEILING THE STRONG SAFETY PROFILE AND HIGH TARGET ENGAGEMENT OF OPM-101, A FIRST-IN-CLASS ORALLY AVAILABLE RIPK2 INHIBITOR, IN A PHASE 1 CLINICAL TRIAL IN HEALTHY VOLUNTEERS (UEGW 2024) - "Following a single administration in both male and female healthy volunteers, OPM-101 exhibited a highly favorable safety profile. Its pharmacokinetic properties are well-suited for oral administration, demonstrating rapid target engagement after a single oral dose leading to an immunomodulation. This phase 1 study unveils OPM-101 as a potent RIPK2 inhibitor paving the way for groundbreaking therapeutic advancements in inflammatory colitis."

Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Oncology • RIPK2 • TNFA

OPM Announces Its First-half 2024 Results and Provides an Update on Its Clinical Developments, and Its Financial Situation (Businesswire) - "OPM-101 successfully completed its Phase 1 trial with healthy volunteers, enabling the company to anticipate the start of a Phase 1b/2a clinical trial in 2024/early 2025...OPM-201, licensed to Servier for the treatment of Parkinson's disease, completed its Phase I trial in healthy volunteers this year, with Phase II scheduled to start in 2025."

New P1/2 trial • New P2 trial • CNS Disorders • Immunology • Inflammatory Bowel Disease • Parkinson's Disease

OPM Announces Positive Results of Its Phase 1 in Healthy Volunteers with OPM-101: Strong Target Engagement With Excellent Safety Profile (Businesswire) - P1 | N=104 | "Oncodesign Precision Medicine...announced positive results of phase 1 trial testing the drug candidate OPM-101, administered orally in single ascending doses (SAD) and multiple ascending doses (MAD), in healthy volunteers (HV)....The results of the SAD and MAD administrations in the clinical trial demonstrated that OPM-101 is well tolerated and significantly inhibits the RIPK2 pathway at doses as low as 60 mg single administration and 75 mg b.i.d. (bis in die - Twice daily)....The pharmacokinetic results in the MAD part are consistent with those observed in the SAD part of the study....OPM plans to present additional results from the phase 1 cohorts at a future medical meeting in Q4 2024, subject to acceptance of the abstract by the United European Gastroenterology Week (UEGW) organizing committee. Based on the results presented today, OPM plans to initiate enrolment in a phase 1b/2a clinical trial in the fourth quarter of 2024."

New P1/2 trial • P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Oncodesign Precision Medicine (OPM) obtains €5.6 million in public funding for its DEMOCRITE program dedicated to the clinical development of OPM-101 (Businesswire) - "Oncodesign Precision Medicine...announced today that it has received notice of the grant of funding associated with the 'i-Démo n°2' call for projects as part of the France 2030 plan. The aim of this call for projects is to develop industrial and service companies in growth markets that create value and competitiveness for our economy and contribute to the energy, ecological and digital transitions...The government has allocated €5.6 M of funding to the DEMOCRITE program for a total project cost of €12.5 M. The funding will be provided as a grant (€1.7 M) and repayable advances (€3.9 M) for a project period of 43 months....The main purpose of the DEMOCRITE project for OPM is to demonstrate proof of concept of the efficiency of OPM-101 in patients suffering from IIUC in order to reach a commercial agreement with a pharmaceutical partner, while continuing the development of OPM-101 for the treatment of UC."

Financing • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

OPM Publishes Its Annual Results for 2023 and Provides an Update on Its Clinical Developments (Businesswire) - "R&D investment up 27% to €8.8 M, mainly linked to the clinical development of OPM-101 and the start of a preclinical program in oncology OPM-102...OPM-101 in inflammatory bowel disease: pursuit of Phase I in healthy volunteers with multiple-dose escalation administration and a very comfortable therapeutic margin in preparation for Phase IIa in 2024."

Commercial • New P2a trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Oncodesign Precision Medicine Announces a 6 Million Euros Bank Financing from Caisse d'Épargne Bourgogne Franche Comté, Crédit Agricole de Champagne Bourgogne and Société Générale (Yahoo Finance) - "Oncodesign Precision Medicine...announces the successful signing of a financing agreement of €6 M granted by three regional banks: Caisse d'Épargne Bourgogne Franche Comté, Crédit Agricole Champagne Bourgogne and Société Générale. This financing is guaranteed by Bpifrance and P.C.G....This financing increases OPM's cash position to €13.35 M on 03/10/2023. It enables OPM to progress as planned in the clinical development of OPM-101, specifically by continuing the MAD part of the ongoing Phase I trial in healthy volunteers and preparing Phase IIa, while continuing to develop the companies’ technologies and product portfolio."

Financing • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

OPM Announces Positive Interim Results of Its Phase 1 Study Evaluating OPM-101 in Healthy Volunteers (Businesswire) - P1 | N=NA | "Oncodesign Precision Medicine (OPM)...announces positive interim results at the end of the first part of the Phase 1 single-ascending-dose oral administration (SAD) study of its drug candidate OPM-101 in healthy volunteers....This study demonstrated that OPM-101 had a significant safety range, as doses tested varied from 5 to 1000 mg, and the maximum tolerated dose was not reached. Moreover OPM-101 demonstrated significant target engagement over a 24-hour period, starting with low doses. At the end of the SAD, OPM-101 demonstrated excellent tolerability in all cohorts....No serious or severe adverse events or dose-limiting toxicities leading to study discontinuation were observed during the SAD part of the study....OPM capitalized on the analysis of OPM-101 data obtained during the SAD to optimize preparation of the second part of the study, scheduled to start in Q4 2023..."

P1 data • Trial status • Immunology • Inflammatory Bowel Disease

Oncodesign Precision Medicine Announces the Initiation of Phase I of its RIPK2 Inhibitor ODS-101, a New Therapeutic Agent for IBD (Businesswire) - "ncodesign Precision Medicine...announces the clinical entry of its drug candidate ODS-101 with the first subject dosing in Phase 1 clinical trial in healthy volunteers....'This molecule is based on our Nanocyclix® technology and our strategy is to finance the development ourselves until proof of concept in Phase 2a in 2024. Before that, we will determine the most appropriate clinical indication for the continuation of this phase I and finally, we will seek a pharmaceutical licensing partner.'"

New P2a trial • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis