Silexion Therapeutics Announces Collaboration with Global Therapeutics Leader Catalent on Advanced siRNA Formulation Development & Clinical Manufacturing Activities
Silexion Therapeutics (NASDAQ: SLXN) has announced a strategic collaboration with Catalent for the formulation development and clinical manufacturing of SIL204, their next-generation siRNA candidate. The partnership will utilize Catalent's Limoges facility in France to optimize both systemic and intratumoral delivery formulations of SIL204.
The collaboration follows Silexion's recent preclinical breakthrough showing SIL204's efficacy in reducing primary tumor growth and metastatic spread in pancreatic cancer models. SIL204 targets multiple KRAS mutations (G12D, G12V, G12R, Q61H, and G13D) important in pancreatic, colorectal, and lung cancers.
The company aims to initiate human clinical trials in H1 2026, with plans for regulatory submissions to the Israel Ministry of Health in H2 2025 and to the European Union in H1 2026. Throughout 2025, Silexion will conduct additional toxicology and pharmacodynamic studies as part of their comprehensive development strategy.
Silexion Therapeutics (NASDAQ: SLXN) ha annunciato una collaborazione strategica con Catalent per lo sviluppo della formulazione e la produzione clinica di SIL204, il loro candidato siRNA di nuova generazione. La partnership sfrutterà lo stabilimento di Catalent a Limoges, in Francia, per ottimizzare le formulazioni di somministrazione sia sistemica che intratumorale di SIL204.
La collaborazione segue la recente scoperta preclinica di Silexion che ha dimostrato l’efficacia di SIL204 nel ridurre la crescita del tumore primario e la diffusione metastatica nei modelli di cancro al pancreas. SIL204 mira a diverse mutazioni di KRAS (G12D, G12V, G12R, Q61H e G13D) rilevanti nei tumori pancreatici, del colon-retto e del polmone.
L’azienda punta ad avviare studi clinici sull’uomo nella prima metà del 2026, con l’intenzione di presentare le domande regolatorie al Ministero della Salute israeliano nella seconda metà del 2025 e all’Unione Europea nella prima metà del 2026. Nel corso del 2025, Silexion condurrà ulteriori studi tossicologici e farmacodinamici come parte della loro strategia di sviluppo completa.
Silexion Therapeutics (NASDAQ: SLXN) ha anunciado una colaboración estratégica con Catalent para el desarrollo de formulaciones y la fabricación clínica de SIL204, su candidato siRNA de nueva generación. La alianza utilizará la planta de Catalent en Limoges, Francia, para optimizar las formulaciones de administración sistémica e intratumoral de SIL204.
La colaboración sigue al reciente avance preclínico de Silexion que demostró la eficacia de SIL204 para reducir el crecimiento del tumor primario y la diseminación metastásica en modelos de cáncer de páncreas. SIL204 apunta a múltiples mutaciones de KRAS (G12D, G12V, G12R, Q61H y G13D) relevantes en cánceres de páncreas, colorrectal y de pulmón.
La compañía tiene como objetivo iniciar ensayos clínicos en humanos en la primera mitad de 2026, con planes para presentar solicitudes regulatorias al Ministerio de Salud de Israel en la segunda mitad de 2025 y a la Unión Europea en la primera mitad de 2026. Durante 2025, Silexion realizará estudios adicionales de toxicología y farmacodinámica como parte de su estrategia integral de desarrollo.
Silexion Therapeutics (NASDAQ: SLXN)는 차세대 siRNA 후보물질인 SIL204의 제형 개발 및 임상 제조를 위해 Catalent와 전략적 협력을 발표했습니다. 이번 협력은 프랑스 리모주에 위치한 Catalent 시설을 활용하여 SIL204의 전신 및 종양 내 투여 제형을 최적화할 예정입니다.
이번 협력은 췌장암 모델에서 SIL204가 원발 종양 성장 및 전이 확산을 감소시키는 효능을 입증한 Silexion의 최근 전임상 성과에 따른 것입니다. SIL204는 췌장암, 대장암, 폐암에서 중요한 여러 KRAS 돌연변이(G12D, G12V, G12R, Q61H, G13D)를 표적으로 합니다.
회사는 2026년 상반기에 인간 대상 임상시험을 시작할 계획이며, 2025년 하반기에 이스라엘 보건부에, 2026년 상반기에 유럽연합에 규제 승인 신청을 할 예정입니다. 2025년 동안 Silexion은 종합 개발 전략의 일환으로 추가 독성학 및 약력학 연구를 진행할 것입니다.
Silexion Therapeutics (NASDAQ : SLXN) a annoncé une collaboration stratégique avec Catalent pour le développement de la formulation et la fabrication clinique de SIL204, leur candidat siRNA de nouvelle génération. Ce partenariat utilisera l’usine de Catalent à Limoges, en France, pour optimiser les formulations de délivrance systémique et intratumorale de SIL204.
Cette collaboration fait suite à une avancée préclinique récente de Silexion démontrant l’efficacité de SIL204 dans la réduction de la croissance tumorale primaire et de la propagation métastatique dans des modèles de cancer du pancréas. SIL204 cible plusieurs mutations KRAS (G12D, G12V, G12R, Q61H et G13D) importantes dans les cancers du pancréas, colorectal et du poumon.
L’entreprise prévoit de lancer des essais cliniques chez l’humain au premier semestre 2026, avec des plans de soumission réglementaire au ministère de la Santé d’Israël au second semestre 2025 et à l’Union européenne au premier semestre 2026. Tout au long de 2025, Silexion mènera des études supplémentaires de toxicologie et de pharmacodynamie dans le cadre de sa stratégie de développement globale.
Silexion Therapeutics (NASDAQ: SLXN) hat eine strategische Zusammenarbeit mit Catalent zur Entwicklung der Formulierung und klinischen Herstellung von SIL204, ihrem siRNA-Kandidaten der nächsten Generation, angekündigt. Die Partnerschaft wird die Limoges-Anlage von Catalent in Frankreich nutzen, um sowohl systemische als auch intratumorale Verabreichungsformeln von SIL204 zu optimieren.
Die Zusammenarbeit folgt auf den jüngsten präklinischen Durchbruch von Silexion, der die Wirksamkeit von SIL204 bei der Verringerung des Primärtumorwachstums und der Metastasenausbreitung in Pankreaskarzinom-Modellen zeigte. SIL204 zielt auf mehrere KRAS-Mutationen (G12D, G12V, G12R, Q61H und G13D) ab, die bei Pankreas-, Darm- und Lungenkrebs eine Rolle spielen.
Das Unternehmen plant, Anfang 2026 mit klinischen Studien am Menschen zu beginnen und beabsichtigt, im zweiten Halbjahr 2025 Anträge bei der israelischen Gesundheitsbehörde und im ersten Halbjahr 2026 bei der Europäischen Union einzureichen. Im Laufe des Jahres 2025 wird Silexion weitere Toxikologie- und Pharmakodynamikstudien im Rahmen seiner umfassenden Entwicklungsstrategie durchführen.
- Strategic partnership with global leader Catalent enhances manufacturing capabilities
- Successful preclinical results showing efficacy in reducing tumor growth and metastasis
- Clear regulatory pathway with submissions planned for Israel and EU
- Broad-spectrum targeting of multiple KRAS mutations expands market potential
- Clinical trials not expected to begin until H1 2026
- Additional studies required throughout 2025 before regulatory submissions
- No immediate revenue generation from the development program
Insights
Silexion's partnership with Catalent advances SIL204 formulation development for both systemic and intratumoral delivery of their KRAS-targeting RNAi therapy.
This strategic collaboration with Catalent represents a critical advancement in Silexion's SIL204 development program. The partnership specifically addresses one of the most significant challenges in RNAi therapeutics - effective drug delivery. Catalent's expertise at their Limoges facility will be leveraged to optimize both systemic and intratumoral delivery formulations, supporting Silexion's dual-route strategy.
SIL204's mechanism targeting multiple KRAS mutations (G12D, G12V, G12R, Q61H, and G13D) is particularly noteworthy as these mutations drive numerous hard-to-treat cancers including pancreatic, colorectal, and lung malignancies. The development of both delivery routes could potentially address both primary tumors and metastatic spread - a comprehensive approach that aligns with clinical needs.
The timeline presented is informative for tracking development progress: additional toxicology and pharmacodynamic studies throughout 2025, regulatory submissions to Israel's Ministry of Health in H2 2025 and to the EU in H1 2026, with potential clinical trials initiating in first half of 2026. This partnership builds on Silexion's previously reported preclinical data showing efficacy in orthotopic pancreatic cancer models.
Catalent's specialized capabilities in complex injectable formulations and sustained-release technologies directly address the formulation challenges that have historically RNAi therapeutic potential. This collaboration represents a standard but necessary progression in Silexion's preclinical development program.
Standard pipeline advancement for Silexion with established manufacturing partner, but clinical trials remain distant (2026) with no financial terms disclosed.
This manufacturing collaboration with Catalent represents a necessary infrastructure-building step for Silexion's SIL204 program as it advances toward clinical development. For a micro-cap biotech (
The partnership focuses on formulation development for Silexion's RNAi therapeutic targeting KRAS mutations - a biologically relevant target that has historically presented significant drug development challenges. The dual-route development strategy (systemic and intratumoral delivery) aims to address both primary tumors and metastases, potentially expanding therapeutic utility if successful.
Importantly, this collaboration establishes a timeline with specific development milestones for investors to monitor: toxicology studies throughout 2025, regulatory submissions to Israel in H2 2025 and EU in H1 2026, with clinical trials potentially initiating in first half of 2026. This relatively extended timeline to human data means that near-term catalysts will remain preclinical in nature.
Catalent brings established expertise in complex formulation development, which could potentially enhance SIL204's stability and bioavailability - critical parameters for RNAi therapeutic success. This partnership represents standard progression for a preclinical-stage program rather than a transformative event that significantly alters Silexion's fundamental prospects or timeline to potential commercialization.
Collaboration Reinforces Silexion's Commitment to Bringing Transformative RNAi Cancer Therapies to Market as it Advances toward Clinical Trials
Grand Cayman, Cayman Islands, April 23, 2025 (GLOBE NEWSWIRE) -- 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.
About Silexion Therapeutics
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. For more information please visit: https://silexion.com
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding Silexion's business strategy, collaboration with Catalent, and plans to initiate further studies and make regulatory submissions are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion's ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; and (vi) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the company, including the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 18, 2025. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.
Company Contact
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Capital Markets & IR Contact
Arx Capital Markets
North American Equities Desk
silexion@arxadvisory.com
FAQ
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