KRAS G12V

April 23, 2025 -- Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced a strategic collaboration with Catalent, a global leader in advanced delivery technologies, clinical development, and manufacturing solutions for therapeutics. Under the agreement, Catalent will conduct formulation development and clinical manufacturing activities for Silexion's next-generation siRNA candidate, SIL204, at its state-of-the-art facility in Limoges, France. The collaboration will focus on optimizing both the systemic and intratumoral delivery formulations of SIL204, supporting Silexion's recently announced dual-route development strategy designed to target both primary tumors and metastases in KRAS-driven cancers. 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. SIL204 targets a broad spectrum of KRAS mutations (including G12D, G12V, G12R, Q61H, and G13D), which are critical drivers in pancreatic, colorectal, and lung cancers. "Our collaboration with Catalent represents a significant advancement in our SIL204 development program," said Ilan Hadar, Chairman and CEO of Silexion Therapeutics. "Following our recent promising preclinical results and the unveiling of our expanded development plan, we look forward to this partnership advancing the optimization of SIL204's formulation for both systemic and intratumoral delivery routes. 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." Catalent's Limoges facility is its European center of excellence for clinical biologics formulation development and drug product manufacturing, specializing in complex injectable formulations. The collaboration will leverage Catalent's extensive experience in developing sustained-release technologies to enhance SIL204's therapeutic potential through improved stability, bioavailability, and delivery precision. 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. Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company developing innovative RNA interference (RNAi) therapies to treat solid tumors driven by KRAS mutations, the most common oncogenic driver in human cancers. The Company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer. Silexion is also advancing its next-generation siRNA candidate, SIL204, designed to target a broader range of KRAS mutations and showing significant potential in preclinical studies. The Company remains committed to pushing the boundaries of therapeutic innovation in oncology, with a focus on improving outcomes for patients with difficult-to-treat cancers. The content above comes from the network. if any infringement, please contact us to modify.

Study results of two investigational drugs that target KRAS-driven cancers co-developed by RAS Initiative investigators at the Frederick National Laboratory for Cancer Research (FNL) and now being tested in patients will be presented at the American Association for Cancer Research Annual Meeting April 25-30 at McCormick Place in Chicago.  Both compounds, BBO-8520 and BBO-11818, were developed in partnership via Cooperative Research and Development Agreement (CRADA) with BridgeBio Oncology Therapeutics (BBOT) and Lawrence Livermore National Laboratory.  Representatives of BBOT, sponsor of the clinical trials for both agents, will present the data during the AACR meeting.  James P. Stice, an associate director at BBOT, will discuss results of pre-clinical studies on BBO-8520 in a mini symposium on novel antitumor agents, Monday, April 28 in room S103. BBO-8520 targets KRAS G12C, the most common KRAS variant in lung cancer.   On Tuesday, April 29, BBOT Associate Director Carlos Stahlhut will present a poster on preclinical studies of BBO-11818, which shows activity against multiple KRAS mutants, and falls into the category of a pan-KRAS inhibitor.  The poster is in section 21 from 9 a.m. to noon.  Laboratory tests show BBO-8520 blocks the active “ON” and inactive “OFF” states of KRAS G12C, resulting in rapid KRAS inhibition. While existing treatments for KRAS G12C-driven cancer have shown promising clinical efficacy, they block the KRAS G12C “OFF” state only, and patients develop resistance to the drug. The collaborators published results of pre-clinical assays in Cancer Discovery.   There are no approved targeted therapies against other KRAS variants, which drive several major cancer types including pancreatic, colorectal and non-small cell lung cancer. BBO-11818 has shown activity against multiple KRAS mutants including KRAS G12D and KRAS G12V in their active and inactive states. The National Cancer Institute established the RAS Initiative in 2013 to explore and target RAS, the most frequently mutated oncogene in cancer, which at the time had no viable treatments. FNL is at the center of the hub-and-spoke model of a worldwide collaboration to investigate the complexity of RAS biology and therapy through the RAS Initiative.   Mary Ellen Hackett Manager, Communications Office 301-401-8670

SÖDERTÄLJE, Sweden I March 17, 2025 I Anocca AB, a leading T-cell immunotherapy company, announces the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state. VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility. The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy. Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025. Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years.” Zahid Bashir, Chief Medical Officer at Anocca, elaborated, “We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer.” About the VIDAR-1 clinical programme VIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product. More information about the clinical trial can be found at the EU’s clinical trials website . About KRAS and PDAC Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2). References 1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol . 10(1):10–27. doi: 10.14740/wjon1166 2 . Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-w About Anocca Anocca is a fully integrated clinical-stage biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalised treatments for the broadest patient populations. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and an in-house cGMP manufacturing and process development facility. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden. SOURCE: Anocca