Black Diamond Therapeutics' Silevertinib Progress in NSCLC: Enough to Compete with JNJ's Rybrevant and AZN's Tagrisso?

Black Diamond Therapeutics' (BDTX) lead pipeline candidate, silevertinib, is a brain penetrant EGFR MasterKey inhibitor targeting EGFRm NSCLC and GBM. BDTX completed enrollment in a mid-stage study of silevertinib in frontline NSCLC patients with non-classical EGFR mutations. The company plans to disclose objective response rate and preliminary duration of response data in Q4 2025. BDTX is seeking strategic partners to advance further development of silevertinib in a competitive NSCLC space.

Silexion Therapeutics Corp. (NASDAQ: SLXN), a biotechnology company specializing in RNA interference (RNAi) therapies for KRAS-driven cancers, has announced the selection of AMS Advanced Medical Services GmbH (AMS) as its contract research organization (CRO) to support upcoming Phase 2/3 clinical trials for SIL204 [1]. The partnership aims to facilitate regulatory submissions and clinical trial commencement, with Phase 2/3 trials expected to start in the first half of 2026 following Q4 2025 and Q1 2026 submissions [1].

AMS, with over 28 years of experience in drug development and a proven track record in managing complex international clinical trials, brings extensive expertise in oncology clinical development and regulatory affairs. The collaboration will support Silexion's planned regulatory submissions to the Israel Ministry of Health in Q4 2025 and to the European Union in Q1 2026 [1].

Ilan Hadar, Chairman and CEO of Silexion Therapeutics, commented on the partnership, "Selecting AMS as our CRO partner represents a critical milestone as we advance SIL204 toward clinical development. This partnership brings the deep oncology expertise and regulatory knowledge essential for executing our dual-route administration strategy effectively" [1].

Silexion expects to finalize the partnership agreement with AMS shortly. The collaboration will encompass regulatory strategy, clinical trial design, site selection and management, and data analysis for the planned Phase 2/3 study evaluating SIL204's dual-route administration approach in patients with locally advanced pancreatic cancer (LAPC) [1].

The upcoming Phase 2/3 trial aims to evaluate SIL204's innovative dual-route administration strategy, integrating both intratumoral delivery to target primary tumors and systemic administration to address metastatic disease. This approach is supported by preclinical data demonstrating SIL204's ability to significantly reduce both primary tumor growth and metastatic spread in clinically relevant orthotopic pancreatic cancer models [1].

References:
[1] Silexion Therapeutics Corp. (2025). Silexion Therapeutics Announces Selection of Contract Research Organization to Support Upcoming Phase 2/3 Clinical Trials for SIL204. Retrieved from https://www.morningstar.com/news/globe-newswire/1001126369/silexion-therapeutics-announces-selection-of-contract-research-organization-to-support-upcoming-phase-23-clinical-trials-for-sil204