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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
Oncodesign Precision Medicine (OPM) Announces Protocol Submission for its Phase 1b/2a Study, REVERT for OPM-101 in Combination with Pembrolizumab in Patients
About this update from Oncodesign Precision Medicine S.a.
[{"type":"text","content":"\nRegulatory News:\n\nOncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Ticker: ALOPM), a clinical-stage company developing innovative therapies to overcome immune evasion and drug resistance, today 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, its RIPK2 inhibitor in advanced melanoma patients with resistance to anti-PD-1. This submission of the study protocol follows the announcement of positive results from the Phase 1 study in October 2024.\n\nOPM-101 is a first-in-class RIPK2 inhibitor administered orally, with the potential to treat several cancers. This milestone underscores OPM's commitment to addressing significant unmet medical needs in oncology.\n\nGlobally, melanoma accounts for approximately 325,000 new cases and more than 57,000 deaths annually, with the highest incidences observed in regions such as Europe, North America, and Oceania. In Europe, the incidence of melanoma is rising, and there is an increasing focus on improving treatments for patients who develop resistance to immune checkpoint inhibitors (ICIs) like anti-CTLA4 and anti-PD1/PD-L1 therapies. Although ICIs have become a cornerstone of advanced melanoma treatment for several years, approximately 40-60% of patients experience resistance or progression, creating a pressing need for innovative therapeutic options.\n\nIn experimental cancer models, the addition of OPM-101 to anti-PD-1 antibody therapy has been shown to significantly enhance anti-tumor efficacy and promote greater sensitivity to PD-1 blockade, delaying or reducing loss of response to ICI therapy and demonstrating durable responses in preclinical models studied to date. The OPM team has shown that the underlying mechanisms of OPM-101 involve enhanced tumor antigen presentation and recognition, associated with remodelling of CD8+ T cell infiltration into the tumor stroma. Moreover, OPM-101 alone has also demonstrated significant antitumor activity based on its immunomodulatory properties.\n\nREVERT Study Objectives and Design\nThis Phase 1b/2a clinical trial is an international, multicenter, open-label study designed to assess the safety and preliminary efficacy of OPM-101 in combination with pembrolizumab in metastatic melanoma patients treated with anti-...