Silexion Therapeutics Announces Significant New Data from Phase 2 Trial of LODER™ in Non-Resectable Pancreatic Cancer
Silexion Therapeutics (NASDAQ: SLXN) has announced significant new data from its Phase 2 trial of LODER™ in non-resectable locally advanced pancreatic cancer (LAPC) patients with KRAS G12D or G12V mutations. The updated analysis shows:
- A 56% objective response rate (ORR) in patients treated with LODER
- ORR increasing to 67% in patients whose tumors became resectable
- A 9.3-month improvement in overall survival compared to chemotherapy alone
The company is also developing SIL-204, a next-generation product targeting a broader range of KRAS mutations, with improved stability and enhanced ability to silence the KRAS oncogene. These findings validate Silexion's oncogene silencing approach in KRAS-driven cancers.
Silexion Therapeutics (NASDAQ: SLXN) ha annunciato dati significativi dal suo trial di Fase 2 per LODER™ in pazienti con carcinoma pancreatico avanzato localmente non resecabile (LAPC) portatori di mutazioni KRAS G12D o G12V. L'analisi aggiornata mostra:
- Un tasso di risposta obiettiva (ORR) del 56% nei pazienti trattati con LODER
- Un ORR che aumenta al 67% nei pazienti i cui tumori sono diventati resecabili
- Un miglioramento della sopravvivenza complessiva di 9,3 mesi rispetto alla chemioterapia da sola
La compagnia sta anche sviluppando SIL-204, un prodotto di nuova generazione che mira a una gamma più ampia di mutazioni KRAS, con maggiore stabilità e una capacità migliorata di silenziare l'oncogene KRAS. Questi risultati convalidano l'approccio di silenziamento degli oncogeni di Silexion nei tumori guidati da KRAS.
Silexion Therapeutics (NASDAQ: SLXN) ha anunciado datos significativos de su ensayo de Fase 2 sobre LODER™ en pacientes con cáncer de páncreas avanzado localmente no resecable (LAPC) con mutaciones KRAS G12D o G12V. El análisis actualizado muestra:
- Una tasa de respuesta objetiva (ORR) del 56% en pacientes tratados con LODER
- Una ORR que aumenta al 67% en pacientes cuyos tumores se volvieron resecables
- Una mejora de 9,3 meses en la supervivencia general en comparación con la quimioterapia sola
La empresa también está desarrollando SIL-204, un producto de próxima generación que apunta a un rango más amplio de mutaciones KRAS, con mayor estabilidad y una mejor capacidad para silenciar el oncogén KRAS. Estos hallazgos validan el enfoque de silenciación de oncogenes de Silexion en los cánceres impulsados por KRAS.
시렉시온 테라퓨틱스 (NASDAQ: SLXN)는 KRAS G12D 또는 G12V 변이가 있는 절제 불가능한 국소 진행 췌장암(LAPC) 환자에 대한 LODER™의 2상 임상시험에서 중요한 새로운 데이터를 발표했습니다. 업데이트된 분석 결과는 다음과 같습니다:
- LODER로 치료받은 환자에서 56%의 객관적 반응률 (ORR)
- 종양이 절제 가능해진 환자에서 ORR이 67%로 증가
- 화학요법 단독에 비해 전체 생존율이 9.3개월 개선됨
또한 이 회사는 더 넓은 범위의 KRAS 변이를 대상으로 하며, 더욱 향상된 안정성과 KRAS 종양 유전자를 억제하는 능력을 향상시킨 차세대 제품 SIL-204를 개발하고 있습니다. 이러한 발견은 KRAS 기반 암에서 시렉시온의 종양 유전자 억제 접근 방식을 검증합니다.
Silexion Therapeutics (NASDAQ: SLXN) a annoncé des données significatives de son essai de Phase 2 sur LODER™ chez des patients atteints de cancer du pancréas avancé localement non résécable (LAPC) porteurs de mutations KRAS G12D ou G12V. L'analyse mise à jour montre :
- Un taux de réponse objective (ORR) de 56% chez les patients traités avec LODER
- Un ORR augmentant à 67% chez les patients dont les tumeurs sont devenues résécables
- Une amélioration de la survie globale de 9,3 mois par rapport à la chimiothérapie seule
La société développe également SIL-204, un produit de nouvelle génération ciblant une gamme plus large de mutations KRAS, avec une stabilité améliorée et une capacité accrue à réduire l'oncogène KRAS. Ces résultats valident l'approche de silenciation des oncogènes de Silexion dans les cancers à médiation KRAS.
Silexion Therapeutics (NASDAQ: SLXN) hat bedeutende neue Daten aus seiner Phase-2-Studie zu LODER™ bei nicht resezierbaren lokal fortgeschrittenen Pankreaskrebs (LAPC) Patienten mit KRAS G12D oder G12V Mutationen veröffentlicht. Die aktualisierte Analyse zeigt:
- Eine objektive Ansprechrate (ORR) von 56% bei mit LODER behandelten Patienten
- ORR steigt auf 67% bei Patienten, deren Tumoren resezierbar wurden
- Eine Verbesserung der Gesamtüberlebenszeit um 9,3 Monate im Vergleich zur Chemotherapie allein
Das Unternehmen entwickelt auch SIL-204, ein Produkt der nächsten Generation, das eine breitere Palette von KRAS-Mutationen anvisiert und verbesserte Stabilität sowie eine verbesserte Fähigkeit zum Silencing des KRAS-Onkogens bietet. Diese Ergebnisse validieren Silexions Ansatz zum Silencing von Onkogenen bei KRAS-gestützten Krebsarten.
- 56% objective response rate (ORR) in patients treated with LODER
- 67% ORR in patients whose tumors became resectable
- 9.3-month improvement in overall survival compared to chemotherapy alone
- Increased tumor resectability in non-resectable pancreatic cancer patients
- Development of SIL-204 with broader KRAS mutation targeting and improved properties
- None.
Insights
The new Phase 2 data for LODER™ in non-resectable pancreatic cancer is highly promising. A
The 9.3-month overall survival benefit previously reported is substantial in pancreatic cancer, where median survival is often less than a year. If these results hold up in larger trials, LODER could represent a major advancement in pancreatic cancer treatment.
The development of SIL-204, targeting a broader range of KRAS mutations, is also noteworthy. KRAS mutations drive many aggressive cancers and effective RNAi therapies could have wide-reaching implications beyond pancreatic cancer.
This data significantly derisks Silexion's lead program and validates their RNAi platform. With a market cap of only
Investors should note that while promising, this is still Phase 2 data. Larger trials are needed to confirm efficacy and safety. However, the magnitude of benefit seen here is rarely observed in pancreatic cancer trials. If replicated in Phase 3, LODER could become a blockbuster therapy.
The broader implications for Silexion's RNAi platform in targeting KRAS mutations could make the company an attractive acquisition target for larger oncology players. Overall, this news significantly enhances Silexion's value proposition and growth potential.
New analysis from Silexion's Phase 2 trial of LODER shows a
Silexion had previously reported that patients treated with LODER in combination with standard-of-care (SoC) chemotherapy experienced a 9.3-month improvement in overall survival (OS) compared to chemotherapy alone. The new data now underscores LODERs additional potential to increase the resectability of tumors, opening up more surgical options for patients with otherwise inoperable pancreatic cancer.
Silexion is also progressing with the development of its next generation product, SIL-204, which builds upon the efficacy of the LODER. SIL-204 is designed to target a broader range of KRAS mutations, covering pan- G12x and G13D, as well as the previously reported findings of properties which should make it more effective clinically such as improved stability and enhanced ability to get to the site of action for silencing the KRAS oncogene. These improved properties demonstrated in preclinical models position SIL-204 as a promising option for the treatment of difficult-to-treat cancers such as locally advanced pancreatic cancer. Silexion continues to proceed with the development of this optimized candidate.
"We are very encouraged by these new findings, which demonstrate LODER's ability to significantly improve tumor resectability in patients with non-resectable pancreatic cancer, and the improved profile of SIL-204" said Ilan Hadar, Chairman and CEO of Silexion. "As we advance our broader pipeline to address KRAS-driven cancers, this data further validates our oncogene silencing approach."
About the Phase 2 Trial of LODER
The open-label Phase 2 trial enrolled 48 patients in the mITT population with non-resectable locally advanced pancreatic cancer (LAPC) and borderline resectable pancreatic cancer (BRPC) across the
- Cohort 1 (n=29): Patients were randomized 1:1 to receive either LODER with SoC chemotherapy or SoC chemotherapy alone. The primary endpoint was overall survival (OS), with 16 patients confirmed to harbor the KRAS G12D/V mutation.
- Cohort 2 (n=19): This cohort enrolled patients with non-resectable tumors, LAPC or BRPC, with the key endpoints focused on ORR and safety. Seven patients in this cohort were confirmed to have KRAS G12D/V mutations.
- Objective Response Rate for 23 patients confirmed with KRAS G12D/V (Cohorts 1+2)
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 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
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 plans and objectives of management for future operations, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “pro forma”, “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 market opportunity; (ii) Silexion’s strategy, future operations, financial position, projected costs, prospects and plans; (iii) the impact of the regulatory environment and complexities with compliance related to such environment; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion’s future capital requirements and sources and uses of cash, including Silexion’s ability to obtain additional capital in the future; and (vi) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the company, including the proxy statement/prospectus filed with the SEC on July 17, 2024. 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.
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Company Contact
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Investor Contact
ARX | Capital Markets Advisors
North American Equities Desk
silexion@arxadvisory.com
Source: Silexion Therapeutics
FAQ
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