RNA interference (RNAi) therapies

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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· 2025-07-31 13:55
Core Insights - Silexion Therapeutics Corp. announced new preclinical data showing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and nearly 90% in colorectal cancer cells, highlighting SIL204's potential as a pan-KRAS therapeutic [1][6][7] - The findings include the first evidence of SIL204's efficacy against the KRAS Q61H mutation, which was previously untested, indicating a significant advancement in the company's research [1][2][8] - Silexion is preparing to initiate a Phase 2/3 clinical trial in Q2 2026 to further investigate SIL204 for treating KRAS-driven solid tumors [1][8] Preclinical Study Findings - The comprehensive CTG analysis demonstrated significantly higher inhibition rates, with SIL204 achieving up to 94% inhibition in pancreatic cancer cells with KRAS G12D mutations and comparable 97% inhibition in cells with KRAS Q61H mutations [2][6] - SIL204 also showed an inhibition rate of nearly 90% in colorectal cancer cells with KRAS G12D mutations, extending its effectiveness beyond pancreatic cancer [6][7] - The results provide compelling evidence of SIL204's potent activity against multiple KRAS mutations across different cancer types, including pancreatic, colorectal, and lung cancers [6][8] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers, which are among the most common oncogenic drivers in human cancers [9] - The company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer, while SIL204 is designed to target a broader range of KRAS mutations [9]
Silexion Therapeutics Announces 1-for-15 Reverse Share Split
Globenewswire· 2025-07-16 12:44
Core Viewpoint - Silexion Therapeutics Corp. announced a 1-for-15 reverse share split to comply with NASDAQ requirements, enhance market position, and support strategic growth initiatives [1][4]. Group 1: Reverse Share Split Details - The reverse share split will take effect after market close on July 28, 2025, with trading on a split-adjusted basis starting July 29, 2025 [1]. - Every fifteen ordinary shares will be combined into one share, increasing the par value from $0.0009 to $0.0135 per share, with no fractional shares issued [2]. - Shareholders in book-entry form will see automatic adjustments, and those holding shares through brokers will also have their shares adjusted automatically [3]. Group 2: Strategic Rationale - The reverse share split aims to help Silexion regain compliance with NASDAQ's minimum bid price requirement, thereby enhancing its market position and supporting growth initiatives [4]. - The company is focused on advancing RNA interference (RNAi) therapies for KRAS-driven cancers, with recent preclinical breakthroughs and an expanded development strategy [3][5]. Group 3: Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company developing RNAi therapies targeting solid tumors driven by KRAS mutations, with promising results from its first-generation product, LODER™ [5]. - The next-generation siRNA candidate, SIL204, is designed to target a broader range of KRAS mutations and has shown significant potential in preclinical studies [5].
Silexion Therapeutics Completes Key Preclinical Studies Exploring SIL204’s Potential Impact on Colorectal and Lung Cancer
Globenewswire· 2025-05-21 12:45
Core Insights - Silexion Therapeutics is advancing its next-generation RNA interference (RNAi) therapeutic candidate, SIL204, targeting KRAS-driven cancers beyond pancreatic cancer, with treatment markets estimated at over $30 billion annually [1][3]. Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNAi therapies for solid tumors driven by KRAS mutations, which are prevalent in various cancers [4]. - The company's first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer [4]. Study Details - The completed preclinical studies evaluated SIL204 in cancer cell lines with KRAS mutations, including colorectal cancer (GP2D), lung cancer (A427), and pancreatic cancer (Panc-1), chosen for their high prevalence of KRAS mutations and significant unmet medical needs [2][3]. - KRAS mutations are found in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-squamous non-small-cell lung cancers, highlighting the potential market for SIL204 [3]. Future Prospects - The completion of the expanded preclinical evaluation is seen as a significant milestone for the SIL204 development program, with expectations for positive results that could broaden the company's development strategy [3].
Silexion Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-13 20:45
Core Insights - Silexion Therapeutics Corp. has made significant advancements in its preclinical pipeline for SIL204, demonstrating efficacy against both primary tumors and metastases in orthotopic models, which could represent a paradigm shift in treating KRAS-driven cancers [1][2] - The company has strengthened its financial position by raising over $9 million in gross funds during Q1 2025, enhancing its ability to advance its clinical development pipeline [1][2] Recent Milestones & Business Highlights - Positive data from orthotopic pancreatic cancer models showed that SIL204 reduced primary tumor growth by approximately 70% in the AsPC-1 model and 80% in the BxPC-3 model by day 28, along with significant reductions in metastases [5] - A single systemic dose of SIL204 maintained effective drug levels for over 56 days, indicating potential for long-term therapeutic exposure [5] - An expanded dual-route development strategy for SIL204 was unveiled, integrating systemic and intratumoral administration to target both primary tumors and metastatic progression [5] - A strategic collaboration with Catalent was announced to conduct formulation development and clinical manufacturing activities for SIL204 [5] Financial Results Highlights - Cash and cash equivalents increased to $6.2 million as of March 31, 2025, from $1.2 million as of December 31, 2024, primarily due to successful financing activities [10] - Total operating expenses for Q1 2025 were $1.7 million, compared to $1.3 million in Q1 2024, with research and development expenses decreasing to $0.6 million [6][10] - The net loss for Q1 2025 was $1.7 million, compared to $1.4 million for the same period in 2024, attributed to higher general and administrative expenses [10][14]
Silexion Therapeutics Announces Collaboration with Global Therapeutics Leader Catalent on Advanced siRNA Formulation Development & Clinical Manufacturing Activities
Globenewswire· 2025-04-23 13:20
Core Insights - Silexion Therapeutics has announced a strategic collaboration with Catalent to advance its RNA interference (RNAi) cancer therapies, specifically targeting KRAS-driven cancers [1][4] - The collaboration will focus on the formulation development and clinical manufacturing of Silexion's siRNA candidate, SIL204, at Catalent's facility in Limoges, France [2][4] - Silexion aims to initiate human clinical trials for SIL204 in the first half of 2026, following promising preclinical results [4][5] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNAi therapies for solid tumors driven by KRAS mutations, which are prevalent in various cancers [6] - The company's first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer [6] - SIL204 is designed to target a broader range of KRAS mutations and has demonstrated significant efficacy in preclinical studies [3][6] Collaboration Details - Catalent will optimize both systemic and intratumoral delivery formulations of SIL204, supporting Silexion's dual-route development strategy [2][4] - The collaboration leverages Catalent's expertise in complex formulation development to enhance SIL204's stability, bioavailability, and delivery precision [4] - Silexion plans to conduct additional toxicology and pharmacodynamic studies throughout 2025, with regulatory submissions anticipated in late 2025 and early 2026 [5]
Silexion Therapeutics Announces Completion of Innovative Expanded Development Plan for SIL204 which will be unveiled at the 2025 NeauxCancer Conference
Globenewswire· 2025-03-21 12:30
Core Viewpoint - Silexion Therapeutics is set to present an expanded development plan for its siRNA candidate SIL204 at the upcoming NeauxCancer Conference, following promising preclinical data related to KRAS-driven cancers [1][2][4]. Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies for solid tumors driven by KRAS mutations, which are prevalent in human cancers [5]. - The company's first-generation product, LODER™, has shown promising results in a Phase 2 clinical trial for non-resectable pancreatic cancer [5]. - Silexion is advancing its next-generation siRNA candidate, SIL204, which targets a broader range of KRAS mutations and has demonstrated significant potential in preclinical studies [5]. Development Plan - The newly completed strategic plan aims to maximize SIL204's potential through various delivery approaches to tackle the challenges posed by KRAS-driven cancers [2]. - Further details regarding the expanded development plan will be disclosed during the presentation at the conference [2][3]. Conference Presentation - A presentation by Silexion will occur during the conference's Innovation track on March 28th at 1:00 PM, where the company will share its strategic vision and recent preclinical findings related to SIL204 [3]. - The management team will be available for one-on-one meetings with interested investors during the conference [4].
Silexion Therapeutics Reports Groundbreaking Positive Initial Data from Systemic Administration of SIL204 in Orthotopic Pancreatic Cancer Models
Globenewswire· 2025-03-05 13:30
Core Insights - Silexion Therapeutics announced positive data indicating that SIL204, when administered subcutaneously, effectively reduces both primary tumor growth and metastatic spread in orthotopic pancreatic cancer models [1][4] Group 1: Efficacy of SIL204 - SIL204 demonstrated significant efficacy in orthotopic xenograft models, which better mimic human disease progression compared to previous models [2][3] - In AsPC-1 models with KRAS G12D mutation, SIL204 achieved approximately 70% reduction in overall bioluminescence by day 28 compared to control [3] - In Panc-1 models, tumor cell numbers decreased significantly in a dose-dependent manner, with a 12% decrease in bioluminescence compared to baseline by day 14, while control increased by over 100% [3] - In BxPC-3 models, SIL204 resulted in around 80% reduction in overall bioluminescence by day 28 compared to control [3] Group 2: Metastasis Reduction - For the first time, SIL204 treatment showed a significant reduction in metastatic spread to secondary organs, lowering metastatic burden in the liver, intestine, spleen, and stomach [3][4] Group 3: Systemic Delivery Validation - Subcutaneous administration of SIL204 confirmed its effectiveness in treating pancreatic tumors and their metastases, validating systemic delivery as a viable route [4] - The company is exploring an expanded development plan for SIL204 based on these findings, with an updated strategy expected soon [4][5] Group 4: Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for KRAS-driven cancers, with SIL204 being a next-generation candidate targeting a broader range of KRAS mutations [5]