Silexion Therapeutics Shares Positive Initial Data from SIL204's Orthotopic Pancreatic Cancer Models

2025-03-05 09:36:56 ET

DENVER, Colo., Mar 05, 2025 ( 247marketnews.com )- Silexion Therapeutics (NASDAQ: SLXN ) announced positive preclinical data for SIL204, its next-generation RNA interference (RNAi) therapy. SIL204 administered subcutaneously, demonstrated efficacy in reducing primary tumor growth and metastatic spread, in orthotopic pancreatic cancer model tests. These findings mark a pivotal advancement for Silexion, elevating SIL204’s potential.

Mitchell Shirvan, Ph.D., Silexion’s CSO, stated, “These orthotopic model results represent a pivotal advancement in our development program. While our previous data showed SIL204’s ability to reduce tumor growth in standard models, these new findings provide initial validation of its potential effectiveness in a much more clinically relevant setting. Particularly exciting is the demonstration that SIL204 can significantly reduce metastatic spread when administered subcutaneously, suggesting potential for treating both primary and metastatic disease with a minimally-invasive delivery method.”

What sets this announcement apart is the use of orthotopic models, where human pancreatic tumor cells are implanted directly into the pancreas. Unlike the simpler subcutaneous models used in earlier studies, this approach mirrors the complexities of human disease progression—including, for the first time, metastatic patterns. SIL204 not only shrank primary tumors but also curbed the cancer’s spread to secondary organs in Panc-1 and BxPC-3 models. This dual-action efficacy is a rare breakthrough for pancreatic cancer, which is notorious for its aggressive metastasis and low survival rates.

In AsPC-1 models (harboring the KRAS G12D mutation), SIL204 slashed tumor cell bioluminescence—a proxy for tumor burden—by 70% compared to controls by day 28. In Panc-1 models (also KRAS G12D), the highest-dose group saw a 12% reduction in tumor cells by day 14, while the control group ballooned by over 100% (P-value < 0.05). Even in BxPC-3 models (KRAS wild-type), SIL204 delivered an 80% reduction in bioluminescence by day 28. These cell line-specific profiles underscore SIL204’s versatility across diverse KRAS mutation statuses—a key advantage given KRAS mutations drive up to 90% of pancreatic cancers.

Ilan Hadar, Silexion’s Chairman and CEO, added, “These results mark the first time we’ve demonstrated SIL204’s ability to address metastatic disease through subcutaneous administration. The ability to deliver our therapy systemically and still effectively target both primary pancreatic tumors and their metastases represents a significant potential advantage for treating this devastating disease.”

Buoyed by these results, Silexion is finalizing an expanded development plan for SIL204, leaning heavily on the systemic administration approach. Expect more details in the coming weeks, as promised in recent updates. The roadmap likely includes additional preclinical studies to refine dosing and explore synergies—past data already showed SIL204 enhancing chemotherapy drugs like 5-fluorouracil, irinotecan, and gemcitabine—followed by a push into Phase 2/3 clinical trials slated for 2026.

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