SIL-204 subcutaneous / Silexion Therapeutics - LARVOL DELTA

Silexion Therapeutics Reports New Positive Preclinical Findings Demonstrating Multi-Mechanism Immune Sensitization by SIL204 in KRAS-Driven Cancers (GlobeNewswire) - "New preclinical data demonstrate that SIL204 treatment produced statistically significant upregulation of FAS (CD95), the immune 'death receptor,' and statistically significant downregulation of HLA-G, an established immune checkpoint, in human KRAS-mutant pancreatic and non-small cell lung cancer cell lines representing three distinct KRAS mutations (G12D, G12V, and G12C)....Findings emerge as Silexion advances SIL204 into Phase 2/3 clinical evaluation, following successful initiation of the Company’s first clinical trial site at Tel Aviv Sourasky Medical Center at the end of July 2026."

Preclinical • Trial status • Non Small Cell Lung Cancer • Pancreatic Cancer

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 Therapeutics Reports Positive Preliminary Immunotherapy Findings for SIL204 in KRAS-Driven Pancreatic Cancer (GlobeNewswire) - "Preliminary results from a preclinical study demonstrated statistically significant increase in MHC-I expression following SIL204 treatment in human pancreatic and non-small cell lung cancer cells harboring a KRAS mutation."

Preclinical • Non Small Cell Lung Cancer • 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 Successful Submission of Phase 2/3 Clinical Trial Application to Germany’s BfArM for SIL204 in KRAS-Driven Locally Advanced Pancreatic Cancer (GlobeNewswire) - "The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State - the country that will lead the scientific assessment of the trial across the European Union....Overall Phase 2/3 trial initiation remains planned for the second quarter of 2026....The planned Phase 2/3 trial will 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."

New P2/3 trial • Pancreatic Cancer

Silexion Therapeutics Receives Approval from Israeli Ministry of Health to Initiate Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer (GlobeNewswire) - "This approval represents a major regulatory milestone and a critical advancement for the Company, enabling the transition of SIL204 into human clinical evaluation and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers....The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of this current quarter, with additional regulatory filings across the European Union planned in early 2027."

New P2/3 trial • Pancreatic Cancer

Silexion Therapeutics Announces Submission of Phase 2/3 Clinical Trial Application to Israel for SIL204 in Locally Advanced Pancreatic Cancer (GlobeNewswire) - "Regulatory submission marks a significant milestone as the Company advances toward Phase 2/3 trial initiation in Q2 2026 at full speed....Regulatory filings in Germany and the EU are planned for Q1 2026, with U.S. expansion anticipated following the safety run-in." "

New P2/3 trial • Pancreatic Cancer

Silexion Therapeutics Corp…announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the proposed design of the Company’s planned Phase 2/3 clinical trial for SIL204, the Company’s lead product candidate for locally advanced pancreatic cancer. (GlobeNewswire) - "The written feedback covers several core components of the program, including clinical design, dosing plans, patient population strategy, nonclinical support, and CMC/manufacturing considerations, and will be incorporated into Silexion’s upcoming regulatory submissions in Israel, which are expected by the end of 2025, and in Germany, which are expected during the first quarter of 2026....Silexion remains on track to initiate its Phase 2/3 clinical trial of SIL204 in the first half of 2026, pending regulatory clearance."

New P2/3 trial • Pancreatic Cancer

Silexion Therapeutics Successfully Completes Toxicology Studies for SIL204, Next-Generation RNA Silencing Therapy, Ahead of Phase 2/3 Clinical Trial in Pancreatic Cancer (GlobeNewswire) - "Successful completion of two-species toxicology studies confirms no systemic organ toxicity, advancing the Company towards its planned regulatory submissions to Israel and Germany. Company remains on track to initiate Phase 2/3 clinical trial in locally advanced pancreatic cancer in Q2 2026."

New P2/3 trial • Preclinical • Pancreatic Cancer

Clinical Trial Preparation On Track (GlobeNewswire) - "Silexion continues to advance operational readiness for its planned Phase 2/3 clinical trials of SIL204, with toxicology studies progressing as planned. Regulatory submissions are expected to be filed with the Israel Ministry of Health in Q4 2025 and in Germany and in the European Union in Q1 2026, with clinical trial initiation anticipated in the first half of 2026."

New P2/3 trial • Solid Tumor

Silexion Therapeutics Announces Positive New Human Cell Line Data Confirming Pan-KRAS Activity of SIL204, Demonstrating Up to 99.7% Inhibition and First Evidence in Gastric Cancer (GlobeNewswire) - "Highest activity to date: NCIH2009 lung cancer cells (G12A mutation) showed 99.7% inhibition, marking the strongest activity reported for SIL204; Expanded colorectal cancer validation: HCT 116 cell line (G13D mutation) demonstrated an IC50 of 105 nM, adding validation in a second colorectal cancer cell line with a different mutation; First gastric cancer data: SNU-601 cell line (G12D mutation) demonstrated 89.2% inhibition, expanding SIL204's potential to a fifth cancer type; Pancreatic cancer G12R confirmation: KP2 cell line showed 91.5% inhibition with an IC50 of 31.5 nM, providing first human cell line data for a mutation affecting 17% of pancreatic cancer patients."

Preclinical • Colorectal Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Silexion Therapeutics Reports Positive Preclinical Data Demonstrating SIL204’s Reach and Activity in Major Pancreatic Cancer Metastatic Sites Following Systemic Administration (GlobeNewswire) - "SIL204 successfully distributed to all major metastatic sites following a single subcutaneous injection at 5mg/mouse (mid-range human equivalent dose for planned clinical trials); Reductions in bioluminescent signal, indicating decreased tumor burden, were observed at day 7 across all evaluated organs; Statistically significant reductions (p<0.01) were achieved in the peritoneum (mesentery), lung, and intestine."

Preclinical • Pancreatic Cancer

Silexion Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "The Company remains on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, focusing initially on locally advanced pancreatic cancer....Silexion plans for regulatory submission to initiate the Phase 2/3 trial to the Israel Ministry of Health in the fourth quarter of 2025 and the European Union in the first quarter of 2026."

New P2/3 trial • Pancreatic Cancer

Silexion Therapeutics Announces New Preclinical Data Showing Up to 97% Inhibition of Cancer Cell Growth, Including New Evidence Against New Previously Untested KRAS Mutation (GlobeNewswire) - "Silexion Therapeutics...announced groundbreaking new preclinical data revealing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and almost 90% in colorectal cancer cells....Key findings from the preclinical studies include: (i) SIL204 demonstrated dose-dependent inhibition of up to 94% in pancreatic cancer cells harboring KRAS G12D mutations at nanomolar concentrations; (ii) SIL204 showed comparable efficacy of approximately 97% inhibition in pancreatic cancer cells with KRAS Q61H mutations, a variant not previously reported in the Company's studies; (iii) SIL204 produced an inhibition rate of nearly 90% in colorectal cancer cells with KRAS G12D mutations, extending previous evidence of its effectiveness beyond pancreatic cancer."

Preclinical • Colorectal Cancer • Pancreatic Cancer

Silexion Therapeutics Announces Positive Results in Preclinical Study Demonstrating Significant SIL204 Efficacy in Human Lung Cancer Cell Lines (GlobeNewswire) - "Silexion Therapeutics...announced new positive preclinical data demonstrating SIL204's significant efficacy in human lung cancer cell lines. The Company is also pleased to announce that it is in the process of conducting a new study examining the efficacy of SIL204 on a new previously untested KRAS mutation, the results of which it plans to release shortly. If positive, such results could further help establish SIL204 as a potential pan-KRAS treatment. In parallel, Silexion's dual-route administration strategy, leveraging both intratumoral and systemic delivery approaches, remains on track. The Company continues to prepare for the initiation of a Phase 2/3 clinical trial in Q2 2026 to investigate SIL204 for the treatment of KRAS-driven solid tumor cancers....The study revealed significant dose-dependent inhibition in lung cancer cells harboring KRAS G12D mutations, with notable efficacy, highlighting SIL204's potential as a versatile therapeutic for lung cancer."

New P2/3 trial • Preclinical • Non Small Cell Lung Cancer

Silexion Therapeutics Announces Groundbreaking Preclinical Results: SIL204 Shows Strong Efficacy in Pancreatic, Colorectal, and Lung Cancers (Streetinsider.com) - "Silexion Therapeutics Corp...today announced compelling preclinical data demonstrating the efficacy of its next-generation RNAi therapeutic candidate, SIL204, against human pancreatic, colorectal and lung (NSCLC) cancer cell lines. These results significantly expand SIL204's therapeutic potential beyond pancreatic cancer, allowing it to potentially address major KRAS-driven cancers with substantial unmet medical needs....The data reveals SIL204 successfully inhibited the proliferation and metabolic activity of human cancer cell lines harboring a specific KRAS mutation (G12D): GP2D (colorectal), A427 (lung) and Panc-1 (pancreatic), in a statistically significant manner. The significant inhibition was observed in a dose-dependent manner down to nanomolar concentrations."

Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Silexion Therapeutics Completes Key Preclinical Studies Exploring SIL204’s Potential Impact on Colorectal and Lung Cancer (GlobeNewswire) - "Silexion Therapeutics Corp...today announced the completion of a comprehensive preclinical study assessing SIL204's therapeutic potential across multiple cancer types beyond pancreatic cancer. The Company is currently finalizing its analysis of the data and expects to announce comprehensive results within the next few days....The now-completed studies evaluated SIL204, the Company's next-generation RNAi therapeutic candidate, in multiple cancer cell lines harboring KRAS mutations: GP2D (colorectal cancer), A427 (lung cancer), and Panc-1 (pancreatic cancer)."

Preclinical • Colorectal Cancer • Lung Cancer • Pancreatic Cancer

Silexion Therapeutics Announces Collaboration with Global Therapeutics Leader Catalent on Advanced siRNA Formulation Development & Clinical Manufacturing Activities (GlobeNewswire) - "This collaboration builds upon Silexion's recently reported breakthrough preclinical data demonstrating SIL204's significant efficacy in reducing both primary tumor growth and metastatic spread in clinically relevant orthotopic pancreatic cancer models....Catalent's expertise in complex formulation development will be instrumental as we work toward our goal of initiating human clinical trials in the first half of 2026....This collaboration is part of Silexion's comprehensive strategy to advance SIL204 through preclinical development and into clinical trials, with plans to conduct additional toxicology and pharmacodynamic studies throughout 2025, followed by potential regulatory submissions to the Israel Ministry of Health in the second half of 2025 and to the European Union in the first half of 2026."

Licensing / partnership • New trial • Preclinical • Pancreatic Cancer

Silexion Therapeutics Unveils Innovative Expanded Development Plan for SIL204 Based on Recent Groundbreaking Preclinical Data (GlobeNewswire) - "Silexion Therapeutics Corp...announced an expanded development plan for its next-generation siRNA candidate, SIL204....The decision to expand the development plan follows recently reported promising preclinical findings demonstrating that systemic administration of SIL204 significantly inhibits tumor growth in clinically relevant orthotopic models of pancreatic cancer....Company plans to conduct additional toxicology and pharmacodynamic studies throughout the remainder of 2025, followed by potential regulatory submissions to the Israel Ministry of Health in H2 2025 and to the European Union in H1 2026. These submissions would initiate the next stage of clinical development for SIL204 in patients with advanced localized KRAS-driven pancreatic cancer."

New trial • Preclinical • Pancreatic Cancer

Silexion Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Advancing Toward SIL204 Clinical Trials:...Silexion is preparing SIL204 for toxicology studies, with plans to initiate Phase 2/3 clinical trials by the first half of 2026, targeting LAPC....In parallel, the Company plans to initiate preclinical studies for SIL204 in colorectal cancer models, expanding its potential applications across additional KRAS-driven cancers."

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

PESG Report: Silexion Therapeutics’ Breakthrough Data Shows SIL204's impact on both Primary Tumors & Metastasis – Signaling a Potential Paradigm Shift in Cancer Treatment (Businesswire) - "Silexion's orthotopic model studies have unveiled remarkable capabilities of SIL204 that could revolutionize cancer treatment approaches. The research demonstrated unprecedented efficacy across multiple pancreatic cancer models, with results that challenge existing therapeutic limitations: In the AsPC-1 model (KRAS G12D mutation), the therapy showed approximately 70% reduction in tumor cell bioluminescence. The Panc-1 model revealed dose-dependent tumor cell reductions, while the BxPC-3 model exhibited up to 80% overall tumor cell reduction. Most critically, the study marks the first systematic validation of a therapy's ability to suppress metastatic spread through systemic administration."

Preclinical • Pancreatic Cancer

Silexion Therapeutics Reports Groundbreaking Positive Initial Data from Systemic Administration of SIL204 in Orthotopic Pancreatic Cancer Models (GlobeNewswire) - "Silexion Therapeutics...announced positive data from orthotopic pancreatic cancer models demonstrating that subcutaneously administered SIL204 effectively reduces both primary tumor growth and metastatic spread....SIL204 administered subcutaneously (systemically) showed significant efficacy in orthotopic xenograft models where tumors grow in their native pancreatic environment, representing a more clinically relevant setting than our previous subcutaneous xenograft models....In AsPC-1 (harboring KRAS G12D mutation): ~70% reduction in overall bioluminescence (an indication of tumor cell number) as compared to the control group, by day 28."

Preclinical • Pancreatic Cancer