SIL-204 intratumoral / Silexion Therapeutics - LARVOL DELTA

Silexion Therapeutics Receives Approval from Germany's BfArM to Initiate Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer (GlobeNewswire) - "The trial has been approved without conditions, with both Part I and Part II of the assessment determined to be justifiable, following the positive opinion of the Ethics Committee of the North Rhine Medical Association regarding the conduct of the trial in Germany....The decision also builds on the March 24, 2026 approval from the Israeli Ministry of Health, which authorized initiation of the same Phase 2/3 trial in Israel....The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion's innovative dual-route administration strategy - combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients."

New P2/3 trial • Pancreatic Cancer

Silexion announced the initiation of Good Manufacturing Practice (GMP) clinical batch manufacturing of SIL204, the Company’s next-generation siRNA therapy targeting mutated KRAS, in support of the planned upcoming Phase 2/3 clinical trial in locally advanced pancreatic cancer (LAPC). (The Manila Times) - "The company announced that it has received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for the planned Phase 2/3 trial of SIL204 at its site...With the Israeli Ministry of Health's recent approval of the Phase 2/3 trial and the Company's Clinical Trial Application (CTA) submitted to Germany, Silexion is continuing to advance the operational steps to bring SIL204 into human trials."

New P2/3 trial • Pancreatic Cancer

Silexion Therapeutics Announces Completion of Innovative Expanded Development Plan for SIL204 which will be unveiled at the 2025 NeauxCancer Conference (GlobeNewswire) - "Silexion Therapeutics Corp...announced it has completed an expanded development plan for its next-generation siRNA candidate, SIL204, which the company’s management will be presenting at the upcoming Cancer Advocacy Group of Louisiana (CAGLA) NeauxCancer 2025 Conference being held March 27th-29th, 2025 at The Roosevelt New Orleans Hotel in New Orleans, LA. The newly completed strategic plan builds upon Silexion's recent promising preclinical data and is designed to maximize SIL-204's potential across multiple delivery approaches to address the challenges of KRAS-driven cancers. The Company plans to report further details on the expanded plan alongside its presentation at the conference."

Preclinical • Oncology

Silexion Therapeutics Announces Completion of Initial Study in Orthotopic Pancreatic Cancer Models Evaluating Systemic Administration of SIL-204 (GlobeNewswire) - "This milestone represents the first systematic evaluation of SIL-204 administered subcutaneously in clinically relevant pancreatic cancer models. The study specifically evaluated two critical aspects of SIL-204's potential therapeutic profile: SIL-204's ability to reduce primary tumor growth when administered systemically in orthotopic pancreatic cancer models, where human tumor cells are implanted directly into the pancreas; SIL-204's capacity to reduce metastatic spread from these orthotopic tumors to secondary organs....The Company anticipates sharing initial results from the study in March 2025."

Preclinical • Pancreatic Cancer

Silexion Therapeutics Reports Strong Tumor Growth Reduction from Systemic Administration of SIL-204 in Preclinical Pancreatic Cancer Models (GlobeNewswire) - "SIL-204 administered in an extended release formulation reduced tumor growth by ~50% after 30 days, with ~50% of tumors showing complete necrosis, in human pancreatic tumors harboring a G12D mutation xenografted into mice. SIL-204 administered subcutaneously inhibited tumor growth in mouse metastatic pancreatic orthotopic models. A single systemic administration of SIL-204 maintained effective drug levels in rat plasma and tissues for over 56 days....Intratumoral administration of SIL-204 microparticles reduced tumor cell numbers by ~3-fold, tumor area by ~1.5-fold, and increased tumor necrosis by ~5-fold after 15 days in human pancreatic cancer xenograft harboring a KRAS G12V mutation in mice."

Preclinical • Pancreatic Cancer

Silexion Therapeutics Announces Additional Promising Preclinical Data for SIL-204, Demonstrating Impressive Synergy with First-Line Pancreatic Cancer Chemotherapies (GlobeNewswire) - "The additional preclinical data show that SIL-204 exhibits significant synergistic activity with 5-fluorouracil and irinotecan-two main components commonly used in pancreatic cancer treatments-when tested in human pancreatic tumor cell lines harboring KRAS G12D mutations, the most common mutation in pancreatic cancer. Moreover, synergistic activity was also observed with the chemotherapeutic agent gemcitabine....Silexion is...planning to initiate toxicology studies with SIL-204 within the upcoming months and to advance SIL-204 into Phase 2/3 clinical trials in the first half of 2026, focusing initially on locally advanced pancreatic cancer (LAPC) which has a notoriously high mortality rate. In parallel, the company plans to initiate preclinical studies for SIL-204, in colorectal cancer models."

New P2/3 trial • Preclinical • Colorectal Cancer • Pancreatic Cancer

Silexion Therapeutics to Present SIL-204 Data in KRAS-Driven Pancreatic Cancer at the 2025 ASCO Gastrointestinal Cancers Symposium (GlobeNewswire) - "Silexion to present SIL-204 data at leading Cancer Symposium designed to feature the latest science in the field of GI cancers....Silexion’s abstract will be published on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025."

Preclinical • Pancreatic Cancer

Silexion Therapeutics collaborates with Evonik on advanced siRNA Formulation Development (GlobeNewswire) - "Silexion Therapeutics Corp...revealed its ongoing collaboration with Evonik, a global leader in specialty chemicals, for the development of an advanced siRNA formulation aimed at enhancing cancer treatment efficacy. Through this existing collaboration, Evonik’s proprietary biodegradable long-acting PLGA (RESOMER) microparticle formulation was used for SIL-204, Silexion’s next-generation siRNA candidate. This innovative formulation has demonstrated high efficacy in preclinical models using mice with human pancreatic tumor cell lines carrying various KRAS mutations. By leveraging Evonik’s formulation expertise, Silexion aims to deliver sustained-release RNAi therapy, allowing for more effective targeting of KRAS mutations—one of the most challenging genetic drivers in oncology."

Licensing / partnership • Pancreatic Cancer

Silexion Therapeutics Reports Breakthroughs From SIL-204 Preclinical Studies (Businesswire) - "Silexion Therapeutics Corp...announced new preclinical findings for SIL-204, its second-generation siRNA candidate, following the optimization of its extended-release formulation....Significant Anti-tumor Activity: In recent mouse xenograft studies, SIL-204 demonstrated substantial tumor reduction in the human pancreatic tumor cell lines with the KRAS G12D (Panc -1) mutations using the innovative approach of oncogene silencing with siRNA....Silexion plans to initiate toxicology studies with SIL-204 within the upcoming months and has plans to advance SIL-204 into Phase 2/3 clinical trials in the first half of 2026, focusing initially on locally advanced pancreatic cancer (LAPC) which has a notoriously high mortality rate. In parallel, the company plans to initiate preclinical studies for SIL-204, in colorectal cancer models."

New P2/3 trial • Preclinical • Colorectal Cancer • Pancreatic Cancer

PESG Releases Report on Silexion Therapeutics: Pioneering RNAi Technology in the Fight Against KRAS-Driven Cancers (GlobeNewswire) - P2 | N=80 | PROTACT (NCT01676259) | Sponsor: Silenseed Ltd | "Silexion's second-generation improved product, SIL-204, is an optimized siRNA formulation expected to enter Phase 2/3 clinical trials in 2025-2026....Key findings include a 9.3-month improvement in overall survival when LODER was combined with standard chemotherapy, compared to chemotherapy alone in patients with non-resectable pancreatic cancer harboring KRAS G12D/V mutations. The study also revealed an increased objective response rate (ORR) of 55% with LODER™ plus chemotherapy, compared to 20% for standard chemotherapy alone. Notably, the ORR increased to 64% when considering tumors that were initially non-resectable becoming resectable."

New P2/3 trial • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor