Silexion Therapeutics Unveils Major Breakthrough in Cancer Treatment

Silexion Therapeutics Makes Significant Progress in Cancer Research

In an exciting development, Silexion Therapeutics Corp. (NASDAQ: SLXN), a clinical-stage biotechnology company focused on RNA interference (RNAi) therapies, announced that their product SIL204 displayed remarkable activity against multiple human cancer cell lines characterized by various KRAS mutations. This breakthrough marks a significant step in tackling challenging cancers, particularly pancreatic and colorectal types.

Exceptional Findings in Human Cell Lines

The recently concluded studies revealed that SIL204 has achieved inhibition rates ranging from a striking 83.5% to an impressive 99.7% across eleven human cell lines derived from five distinct organ cancer sites. Most notably, it showcases its first indications of effective treatment in gastric cancer, along with verified efficacy in colorectal cancer.

Understanding the Mutations

In its preclinical assays, SIL204 was found to target clinically significant KRAS mutations including G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D. These mutations are known to be critical players in the proliferation of various cancers, making this result highly relevant to patients whose tumors are driven by KRAS mutations.

What the CEO Says

According to Ilan Hadar, Chairman and CEO of Silexion Therapeutics, "These results validate SIL204 as a true pan-KRAS therapeutic candidate, demonstrating exceptional efficacy against a diverse array of KRAS mutations and across multiple cancer types." This reinforces Silexion's commitment to addressing a broader patient demographic than currently possible with existing therapies.

Key Highlights from SIL204's Preclinical Data

• Outstanding efficacy: The product achieved a maximum inhibition range of 83.5% to 99.7% at nanomolar concentrations with IC50 values between 23.4 nM and 85.3 nM.
• Best performance recorded: Notably, the NCIH2009 lung cancer cells exhibited a phenomenal 99.7% inhibition, reflecting the superior potential of SIL204.
• Colorectal cancer validation: The HCT 116 cell line (G13D mutation) demonstrated an IC50 of 105 nM, underlining its role in targeting difficult mutations in colorectal cancer.
• Expanding cancer horizons: Initial results in gastric cancer were promising, with the SNU-601 cell line achieving an 89.2% inhibition rate.
• Solid proof in pancreatic cancer: Data from the KP2 cell line showed a 91.5% inhibition with an IC50 of 31.5 nM, confirming SIL204's potential effectiveness against prevalent mutations in pancreatic cancer.

The Impact of SIL204 on Cancer Treatment

The findings greatly enhance our understanding of how SIL204 operates against KRAS mutation variants, covering nearly all KRAS-driven cancers, including pancreatic, colorectal, and non-small cell lung cancers. As KRAS mutations are notably present in a significant percentage of these cancers, SIL204 presents a compelling single-agent therapeutic option.

Looking Ahead: Development Plans for SIL204

Silexion Therapeutics is poised to advance SIL204 into Phase 2/3 clinical trials, expected to commence in the first half of 2026. With regulatory submissions planned for the Israel Ministry of Health in late 2025 and the European Union soon after, the company is gearing up for expansive clinical development.

About Silexion Therapeutics

Silexion Therapeutics is an innovative biotechnology company dedicated to delivering groundbreaking treatments for solid tumor cancers driven by mutated KRAS oncogenes. As the seemingly pervasive role of KRAS in cancer continues to challenge the oncology community, Silexion is determined to explore avenues beyond traditional methods, evidenced by a promising Phase 2a clinical trial of its initial product line. The commitment to advancing therapeutic options for those suffering from difficult-to-treat cancers underscores Silexion's pioneering vision for the industry.

Frequently Asked Questions

What is SIL204?

SIL204 is a therapeutic candidate developed by Silexion Therapeutics, targeting KRAS mutations commonly found in various cancer types.

What key findings were reported related to gastric cancer?

Recent studies indicated that SIL204 achieved an 89.2% inhibition in a gastric cancer cell line, marking its first demonstration of activity in this type of cancer.

What is the significance of KRAS mutations?

KRAS mutations are prevalent in several cancers, such as pancreatic and colorectal, with SIL204 targeting a wide range of these mutations.

When are clinical trials for SIL204 expected to begin?

Silexion Therapeutics plans to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026.

How does SIL204 compare to existing therapies?

SIL204 demonstrates a broader range of activity against various KRAS mutations compared to existing targeted therapies, potentially benefiting a larger patient population.

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