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Silexion Therapeutics Completes Key Preclinical Studies Exploring SIL204’s Potential Impact on Colorectal and Lung Cancer

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Silexion Therapeutics (NASDAQ: SLXN) has completed a crucial preclinical study evaluating its RNAi therapeutic candidate SIL204 across multiple cancer types. The study assessed SIL204's potential in treating colorectal cancer (GP2D), lung cancer (A427), and pancreatic cancer (Panc-1) cell lines with KRAS mutations.

The company plans to announce comprehensive results in the coming days. This expansion beyond pancreatic cancer targets a significant market opportunity, as KRAS mutations occur in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-small-cell lung cancers. The combined treatment market for these indications exceeds $30 billion annually.

Silexion Therapeutics (NASDAQ: SLXN) ha completato uno studio preclinico fondamentale per valutare il suo candidato terapeutico RNAi SIL204 su diversi tipi di cancro. Lo studio ha esaminato il potenziale di SIL204 nel trattamento delle linee cellulari di cancro colorettale (GP2D), cancro polmonare (A427) e cancro pancreatico (Panc-1) con mutazioni KRAS.

L'azienda prevede di annunciare i risultati completi nei prossimi giorni. Questa espansione oltre il cancro pancreatico rappresenta un'importante opportunità di mercato, poiché le mutazioni KRAS si riscontrano in circa il 90% dei tumori pancreatici, il 45% dei tumori colorettali e il 35% dei carcinomi polmonari non a piccole cellule. Il mercato combinato per questi trattamenti supera i 30 miliardi di dollari all'anno.

Silexion Therapeutics (NASDAQ: SLXN) ha completado un estudio preclínico crucial para evaluar su candidato terapéutico de ARN interferente SIL204 en varios tipos de cáncer. El estudio analizó el potencial de SIL204 para tratar líneas celulares de cáncer colorrectal (GP2D), cáncer de pulmón (A427) y cáncer de páncreas (Panc-1) con mutaciones en KRAS.

La compañía planea anunciar los resultados completos en los próximos días. Esta expansión más allá del cáncer de páncreas representa una importante oportunidad de mercado, ya que las mutaciones KRAS se presentan en aproximadamente el 90% de los cánceres de páncreas, 45% de los cánceres colorrectales y 35% de los cánceres de pulmón no microcítico. El mercado combinado para estos tratamientos supera los 30 mil millones de dólares anuales.

Silexion Therapeutics (NASDAQ: SLXN)는 여러 암 유형에 걸친 RNAi 치료 후보물질 SIL204의 중요한 비임상 연구를 완료했습니다. 본 연구는 KRAS 돌연변이를 가진 대장암(GP2D), 폐암(A427), 췌장암(Panc-1) 세포주에서 SIL204의 치료 가능성을 평가했습니다.

회사는 향후 며칠 내에 종합적인 결과를 발표할 계획입니다. 췌장암을 넘어선 이번 확장은 상당한 시장 기회를 의미하며, KRAS 돌연변이는 약 췌장암의 90%, 대장암의 45%, 비소세포폐암의 35%에서 발생합니다. 이 적응증들의 치료 시장 규모는 연간 300억 달러 이상에 달합니다.

Silexion Therapeutics (NASDAQ : SLXN) a achevé une étude préclinique cruciale évaluant son candidat thérapeutique ARN interférent SIL204 sur plusieurs types de cancers. L'étude a examiné le potentiel de SIL204 dans le traitement des lignées cellulaires de cancer colorectal (GP2D), cancer du poumon (A427) et cancer du pancréas (Panc-1) présentant des mutations KRAS.

L'entreprise prévoit d'annoncer les résultats complets dans les prochains jours. Cette extension au-delà du cancer du pancréas cible une opportunité de marché importante, car les mutations KRAS se retrouvent dans environ 90 % des cancers du pancréas, 45 % des cancers colorectaux et 35 % des cancers du poumon non à petites cellules. Le marché combiné de ces traitements dépasse 30 milliards de dollars par an.

Silexion Therapeutics (NASDAQ: SLXN) hat eine entscheidende präklinische Studie zur Bewertung seines RNAi-Therapeutikums SIL204 bei verschiedenen Krebsarten abgeschlossen. Die Studie untersuchte die Wirksamkeit von SIL204 bei der Behandlung von Kolorektalkrebs (GP2D), Lungenkrebs (A427) und Bauchspeicheldrüsenkrebs (Panc-1) Zelllinien mit KRAS-Mutationen.

Das Unternehmen plant, in den kommenden Tagen umfassende Ergebnisse bekanntzugeben. Diese Ausweitung über Bauchspeicheldrüsenkrebs hinaus eröffnet eine bedeutende Marktchance, da KRAS-Mutationen bei etwa 90 % der Bauchspeicheldrüsenkrebsfälle, 45 % der kolorektalen Krebsfälle und 35 % der nicht-kleinzelligen Lungenkarzinome auftreten. Der kombinierte Behandlungsmarkt für diese Indikationen übersteigt jährlich 30 Milliarden US-Dollar.

Positive
  • Potential expansion into multiple cancer types with large market opportunities worth over $30B annually
  • Strategic targeting of high-prevalence KRAS mutations across three major cancer types
  • Completion of comprehensive preclinical studies, with results expected within days
Negative
  • Results of the preclinical studies are not yet disclosed
  • Early-stage research (preclinical) with significant development path ahead
  • Faces competition in a crowded oncology market

Insights

Silexion's preclinical study completion suggests potential expansion of their RNAi therapy to larger addressable cancer markets beyond pancreatic cancer.

Silexion Therapeutics has completed a key preclinical evaluation of their RNA interference (RNAi) therapeutic candidate SIL204 across multiple KRAS-driven cancer types. While previously focused on pancreatic cancer, this expansion to colorectal and lung cancer cell lines (GP2D and A427, respectively) represents a strategic market opportunity. The selection of these cancer types is scientifically sound, as KRAS mutations occur in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-small-cell lung cancers.

The therapeutic approach targeting KRAS mutations is particularly significant as these mutations have historically been considered "undruggable" using conventional approaches like small molecules or antibodies. RNAi represents an alternative mechanism that could potentially overcome these limitations by silencing the expression of mutant KRAS at the RNA level.

It's important to note that while the study completion is promising, the results remain unreported and are expected "within the next few days." The actual efficacy data will be critical in determining whether SIL204 shows meaningful activity across these different cancer types. If positive, Silexion could potentially expand their development pipeline to address a combined market estimated at over $30 billion annually.

The preclinical stage represents an early phase in drug development, with significant hurdles still ahead including IND-enabling studies, clinical trials, and regulatory approvals. However, establishing preclinical proof-of-concept across multiple indications could substantially enhance Silexion's strategic position and partnership opportunities in the competitive oncology space. The expansion beyond pancreatic cancer to these larger patient populations could dramatically increase the drug's commercial potential if development succeeds.

Silexion’s new groundbreaking study explores the potential impact of its next generation RNAI therapeutic candidate beyond pancreatic cancer aiming to address critical unmet needs in additional KRAS-driven tumor types with treatment markets estimated at over $30 Billion Dollars a year

GRAND CAYMAN, Cayman Islands, May 21, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotech company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the completion of a comprehensive preclinical study assessing SIL204's therapeutic potential across multiple cancer types beyond pancreatic cancer. The Company is currently finalizing its analysis of the data and expects to announce comprehensive results within the next few days.

The now-completed studies evaluated SIL204, the Company's next-generation RNAi therapeutic candidate, in multiple cancer cell lines harboring KRAS mutations: GP2D (colorectal cancer), A427 (lung cancer), and Panc-1 (pancreatic cancer). These cancer types were strategically selected based on their high prevalence of KRAS mutations and significant unmet medical needs.

"Completing this expanded preclinical evaluation represents an important milestone in our SIL204 development program," said Ilan Hadar, Chairman and CEO of Silexion Therapeutics. "While our initial focus has been on pancreatic cancer, we recognized the potential of our RNAi approach to address other KRAS-driven malignancies. We look forward to sharing the detailed results from these studies in the coming days after completing the final analysis of the studies data. If positive, we believe these results have the potential to significantly expand our development strategy going forward."

KRAS mutations are among the most common oncogenic drivers in human cancers, occurring in roughly 90% of pancreatic cancers, about 45% of colorectal cancers, and around 35% of non-squamous non-small-cell lung cancers. Together, these three indications underpin global treatment markets already worth well over US $30 billion a year1, yet most KRAS variants remain difficult to drug with small-molecule or antibody approaches—underscoring the potential significance of Silexion’s RNAi-based strategy.

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, ongoing preclinical studies evaluating SIL204 in colorectal and lung cancer applications, potential expansion of development strategy, plans to announce comprehensive results in the coming days, and the therapeutic potential of SIL204 across multiple cancer types, 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 by 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; (vi) Silexion’s ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the Company, including the Company's 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


1 (i) Pancratic Cancer Treatment Mark; (ii) Colorectal Cancer Therapeutics Market; (iii) NSCLC Lunc Cancer Therapeutics Market


FAQ

What is the market potential for SLXN's SIL204 cancer treatment?

The combined treatment market for the three cancer types targeted by SIL204 (pancreatic, colorectal, and lung cancer) exceeds $30 billion annually.

What types of cancer is Silexion Therapeutics (SLXN) targeting with SIL204?

SIL204 targets cancers with KRAS mutations, specifically pancreatic cancer (Panc-1), colorectal cancer (GP2D), and lung cancer (A427) cell lines.

What is the prevalence of KRAS mutations in the cancers targeted by SLXN?

KRAS mutations occur in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-squamous non-small-cell lung cancers.

When will Silexion Therapeutics (SLXN) announce the results of their preclinical studies?

The company expects to announce comprehensive results within the next few days following the completion of final data analysis.

What technology does Silexion Therapeutics use in SIL204?

SIL204 uses RNA interference (RNAi) technology, a novel therapeutic approach targeting KRAS-driven cancers.
Silexion Therapeutics Corp

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