Silexion Therapeutics Announces Completion of Initial Study in Orthotopic Pancreatic Cancer Models Evaluating Systemic Administration of SIL-204
Silexion Therapeutics (NASDAQ: SLXN) has completed its initial study evaluating SIL-204 in orthotopic pancreatic cancer models, marking the first systematic evaluation of this RNA interference therapy administered subcutaneously in clinically relevant models.
The study assessed two critical aspects of SIL-204's potential:
- Ability to reduce primary tumor growth when administered systemically
- Capacity to reduce metastatic spread from orthotopic tumors to secondary organs
Unlike standard subcutaneous xenograft models, the orthotopic models used in this study better represent the complex microenvironment of pancreatic tumors and their metastatic behavior by allowing tumors to develop in their native environment.
Data analysis is currently underway, with initial results expected to be reported in March 2025. These findings will inform Silexion's development strategy for SIL-204 in addressing both localized and metastatic pancreatic cancer.
Silexion Therapeutics (NASDAQ: SLXN) ha completato il suo studio iniziale che valuta SIL-204 in modelli di cancro pancreatico ortotopico, segnando la prima valutazione sistematica di questa terapia di interferenza RNA somministrata sottocute in modelli clinicamente rilevanti.
Lo studio ha valutato due aspetti critici del potenziale di SIL-204:
- Capacità di ridurre la crescita del tumore primario quando somministrato sistemicamente
- Capacità di ridurre la diffusione metastatica dai tumori ortotopici agli organi secondari
Rispetto ai modelli standard di xenotrapianto sottocutaneo, i modelli ortotopici utilizzati in questo studio rappresentano meglio il complesso microambiente dei tumori pancreatici e il loro comportamento metastatico, consentendo ai tumori di svilupparsi nel loro ambiente nativo.
L'analisi dei dati è attualmente in corso, con i risultati iniziali previsti per essere riportati a marzo 2025. Questi risultati informeranno la strategia di sviluppo di Silexion per SIL-204 nell'affrontare sia il cancro pancreatico localizzato che quello metastatico.
Silexion Therapeutics (NASDAQ: SLXN) ha completado su estudio inicial que evalúa SIL-204 en modelos de cáncer pancreático ortotópico, marcando la primera evaluación sistemática de esta terapia de interferencia de ARN administrada por vía subcutánea en modelos clínicamente relevantes.
El estudio evaluó dos aspectos críticos del potencial de SIL-204:
- Capacidad para reducir el crecimiento del tumor primario cuando se administra de forma sistémica
- Capacidad para reducir la diseminación metastásica de tumores ortotópicos a órganos secundarios
A diferencia de los modelos estándar de xenoinjerto subcutáneo, los modelos ortotópicos utilizados en este estudio representan mejor el complejo microambiente de los tumores pancreáticos y su comportamiento metastásico, permitiendo que los tumores se desarrollen en su entorno nativo.
El análisis de datos está actualmente en curso, con resultados iniciales que se espera sean reportados en marzo de 2025. Estos hallazgos informarán la estrategia de desarrollo de Silexion para SIL-204 en el tratamiento del cáncer pancreático tanto localizado como metastásico.
실렉시온 테라퓨틱스 (NASDAQ: SLXN)는 SIL-204를 정위치 췌장암 모델에서 평가하는 초기 연구를 완료하였으며, 이는 임상적으로 관련된 모델에서 피하로 투여된 RNA 간섭 치료법에 대한 첫 번째 체계적 평가를 의미합니다.
이 연구는 SIL-204의 잠재력에 대한 두 가지 중요한 측면을 평가했습니다:
- 전신적으로 투여했을 때 주요 종양 성장 감소 능력
- 정위치 종양에서 2차 장기로의 전이 확산 감소 능력
표준 피하 이식 모델과 달리, 이 연구에서 사용된 정위치 모델은 췌장 종양의 복잡한 미세 환경과 그 전이 행동을 더 잘 나타내며, 종양이 그들의 고유한 환경에서 발전할 수 있도록 합니다.
데이터 분석이 현재 진행 중이며, 초기 결과는 2025년 3월에 보고될 것으로 예상됩니다. 이러한 발견은 SIL-204의 국소 및 전이성 췌장암 치료를 위한 실렉시온의 개발 전략에 정보를 제공할 것입니다.
Silexion Therapeutics (NASDAQ: SLXN) a terminé son étude initiale évaluant SIL-204 dans des modèles de cancer du pancréas orthotopiques, marquant la première évaluation systématique de cette thérapie par interférence ARN administrée par voie sous-cutanée dans des modèles cliniquement pertinents.
L'étude a évalué deux aspects critiques du potentiel de SIL-204 :
- Capacité à réduire la croissance de la tumeur primaire lorsqu'elle est administrée de manière systémique
- Capacité à réduire la propagation métastatique des tumeurs orthotopiques vers des organes secondaires
Contrairement aux modèles standards de xénogreffe sous-cutanée, les modèles orthotopiques utilisés dans cette étude représentent mieux le microenvironnement complexe des tumeurs du pancréas et leur comportement métastatique en permettant aux tumeurs de se développer dans leur environnement natif.
L'analyse des données est actuellement en cours, avec des résultats initiaux attendus pour être rapportés en mars 2025. Ces résultats informeront la stratégie de développement de Silexion pour SIL-204 dans le traitement du cancer du pancréas à la fois localisé et métastatique.
Silexion Therapeutics (NASDAQ: SLXN) hat seine erste Studie zur Bewertung von SIL-204 in orthotopischen Modellen von Bauchspeicheldrüsenkrebs abgeschlossen, was die erste systematische Bewertung dieser subkutan verabreichten RNA-Interferenztherapie in klinisch relevanten Modellen darstellt.
Die Studie bewertete zwei kritische Aspekte des Potenzials von SIL-204:
- Fähigkeit zur Reduzierung des Wachstums des primären Tumors bei systemischer Verabreichung
- Kapazität zur Reduzierung der metastatischen Ausbreitung von orthotopischen Tumoren zu sekundären Organen
Im Gegensatz zu standardmäßigen subkutanen Xenotransplantationsmodellen repräsentieren die in dieser Studie verwendeten orthotopischen Modelle besser die komplexe Mikroumgebung von Bauchspeicheldrüsentumoren und ihr metastatisches Verhalten, indem sie es den Tumoren ermöglichen, sich in ihrer natürlichen Umgebung zu entwickeln.
Die Datenanalyse ist derzeit im Gange, wobei erste Ergebnisse für März 2025 erwartet werden. Diese Ergebnisse werden die Entwicklungsstrategie von Silexion für SIL-204 zur Behandlung von lokalisiertem und metastasierendem Bauchspeicheldrüsenkrebs informieren.
- First systematic evaluation of SIL-204 in clinically relevant pancreatic cancer models
- Orthotopic models provide more translational value than standard subcutaneous xenograft models
- Study evaluates SIL-204's potential against both primary tumors and metastases
- Results expected in March 2025 will inform development strategy
- Results of the study are not yet available
- CEO expressed only 'cautious optimism' about potential findings
- No efficacy data reported yet for SIL-204 in pancreatic cancer models
Insights
Silexion Therapeutics has completed its initial study evaluating SIL-204 in orthotopic pancreatic cancer models, marking a significant pre-clinical milestone in the company's RNA interference (RNAi) program targeting KRAS-driven cancers. This development warrants investor attention for several key reasons.
The study design represents a important advancement in pre-clinical evaluation methodology. Unlike standard subcutaneous xenograft models where tumors grow beneath the skin, orthotopic models involve implanting human tumor cells directly into the pancreas, creating an environment that more accurately mimics human disease progression, including metastatic spread patterns. This approach provides substantially higher translational value and predictive power for clinical outcomes.
What makes this particularly significant is the focus on KRAS mutations, which drive approximately 90% of pancreatic cancers and have historically been considered "undruggable" targets. While companies like Amgen have made progress with small molecule KRAS inhibitors (Lumakras/sotorasib), RNAi approaches like Silexion's offer potential advantages in specificity and reduced resistance mechanisms.
For investors tracking Silexion's $6.4M micro-cap valuation, several critical data points from the upcoming March results will determine potential value inflection:
- Primary tumor reduction efficacy compared to control groups
- Evidence of metastasis prevention or reduction
- Pharmacokinetic data showing successful delivery to pancreatic tissue
- Safety signals from systemic administration
The pancreatic cancer therapeutics market, projected to reach $4.2 billion by 2027, represents a substantial opportunity given the dismal 5-year survival rate of approximately 10% and treatment options. If SIL-204 demonstrates promising activity in these translational models, Silexion could attract partnership interest from larger oncology players seeking to expand their KRAS-targeting portfolios.
However, investors should recognize that Silexion remains in pre-clinical development despite being described as "clinical-stage," suggesting a lengthy timeline before potential commercialization. The March data readout will provide important insights into whether SIL-204 merits advancement toward IND-enabling studies and eventual clinical trials, representing the next significant value-creating milestone for this emerging therapy.
Silexion Completes Data Collection Phase in First-Ever Evaluation of SIL-204 in Clinically Relevant Orthotopic Models; Analysis Underway with Initial Results Expected in Coming Weeks
Grand Cayman, Cayman Islands, Feb. 25, 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 the completion of its initial study evaluating SIL-204 in orthotopic pancreatic cancer models. 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
"Completing this initial study in orthotopic models represents a significant milestone in our SIL-204 development program," said Mitchell Shirvan, Ph.D., CSO of Silexion. "These clinically relevant models provide substantially more translational value than standard subcutaneous xenograft models, as they better represent both the complex microenvironment of pancreatic tumors and their characteristic metastatic behavior."
The orthotopic models used in this study are designed to more accurately reflect human pancreatic cancer biology by allowing tumors to develop in their native environment. This stands in contrast to subcutaneous xenograft models, where tumors grow beneath the skin rather than in the organ of origin. Importantly, orthotopic pancreatic models demonstrate metastatic spread patterns similar to human disease, enabling evaluation of potential therapies against both primary and metastatic disease.
"We are particularly excited about this initial study because it represents the first evaluation of SIL-204 against both primary tumors and their metastases following systemic administration," said Ilan Hadar, Chairman and CEO of Silexion. "Our team is currently analyzing the data, and we expect to begin reporting results in the coming weeks. We are cautiosly optimistic that the findings could provide important insights into SIL-204's potential to address both localized and metastatic pancreatic cancer, which could significantly broaden its therapeutic applications."
The Company anticipates sharing initial results from the study in March 2025. These results will inform Silexion's development strategy for SIL-204.
About Silexion Therapeutics
Silexion Therapeutics (NASDAQ: SLXN) 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, SIL-204, designed to target a broader range of KRAS mutations. 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 and ongoing studies 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. 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 Advisors
North American Equities Desk
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FAQ
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