Silexion Therapeutics Advances Toward a Late-Stage Phase 2/3 Trial in Pancreatic Cancer With Strong Regulatory Momentum (NASDAQ: SLXN)

WSW, NY, December 2nd, 2025, FinanceWire

Today, Silexion Therapeutics announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the design of its planned Phase 2/3 clinical trial for SIL204, the company’s lead RNAi therapy for locally advanced pancreatic cancer. For a clinical-stage company working in one of the most complex and unforgiving areas of oncology, the feedback represents a meaningful step forward as Silexion prepares major regulatory submissions in Israel and Germany.

Pancreatic cancer remains one of the deadliest malignancies, defined by its rapid progression, resistance to existing treatments, and the near-universal presence of KRAS mutations—a genetic driver long viewed as one of the hardest targets in cancer biology. Patients with locally advanced disease face some of the bleakest outcomes in oncology, and effective progress has been painfully slow. This is the backdrop against which SIL204 is being developed, and it is what makes every step toward clinical advancement so consequential.

SIL204 is built on RNA interference (RNAi), a precision genetic approach designed to silence disease-driving genes at their source. RNAi has already demonstrated therapeutic impact in other areas of medicine, but applying it to KRAS-mutated solid tumors represents one of the more ambitious extensions of the technology. Silexion’s strategy is not to offer small, incremental improvements, but to intervene directly on the biology underlying the cancer itself—by shutting down mutant KRAS signaling upstream rather than trying to chase it downstream after the protein is formed. The company’s preclinical data, including pan-KRAS activity, dual-route delivery, and synergy with standard chemotherapy, have been striking.

The written Scientific Advice received today covers critical components of Silexion’s program, including clinical design, patient-population strategy, dosing plans, nonclinical support, and the CMC/manufacturing requirements necessary for this next-generation therapy. While Scientific Advice is not approval or authorization, it does provide clarity—and in drug development, clarity is often one of the most important de-risking forces. It aligns expectations, removes guesswork, and allows a company to finalize its submission packages with greater confidence and discipline.

That matters especially now, because Silexion may be approaching an inflection point. The company expects to complete its regulatory submission in Israel by the end of 2025 and in Germany during the first quarter of 2026. Pending regulatory clearance, the Phase 2/3 trial is planned to begin in the first half of 2026. Alongside this regulatory track, Silexion continues progressing essential operational work, including manufacturing readiness, toxicology data integration, and preparations for clinical site activation.

For those watching, today’s development is more than a procedural update. It strengthens the company’s positioning within a high-value therapeutic area and brings more visibility to the path ahead. Pancreatic cancer is a multibillion-dollar unmet-need market, and therapies that can meaningfully influence outcomes—particularly in KRAS-mutated disease—have the potential to reshape standards of care. Silexion is working in one of the few spaces where even incremental improvements can produce significant clinical and economic impact.

The company’s earlier clinical work adds important context to why investors are watching. Its first-generation therapy, LODER, has reported improved outcomes when added to standard chemotherapy in non-resectable locally advanced pancreatic cancer. In a Phase 2 proof-of-concept trial in patients whose tumors carried KRAS G12D or G12V mutations, Silexion reported a 56% objective response rate, 67% of tumors becoming resectable, and a trend toward a 9.3-month improvement in median overall survival versus chemotherapy alone. Building on that foundation, SIL204 is a next-generation RNAi candidate designed to target a broader range of KRAS mutations using an optimized siRNA construct, updated extended-release delivery formulation, and an integrated dual-route regimen (intratumoral plus subcutaneous).

In a disease where overall survival remains among the lowest of all major cancers, the potential of a therapy that directly targets the KRAS “engine” of the tumor is drawing increasing attention from both the scientific and investment communities.

With written guidance from a key European regulatory body, Silexion has strengthened the foundation for its upcoming filings and moved one step closer to bringing SIL204 into a Phase 2/3 trial. As the company moves toward 2026, the story is increasingly compelling: a targeted therapy addressing a devastating cancer, a modality rooted in modern genetic science, and tangible regulatory momentum guiding the next major step in development. For investors seeking early-stage oncology companies with clearly defined paths and meaningful upcoming catalysts, Silexion continues to emerge as a name worth watching.

Recent News Highlights from Silexion

Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer

Silexion Therapeutics Successfully Completes Toxicology Studies for SIL204, Next-Generation RNA Silencing Therapy, Ahead of Phase 2/3 Clinical Trial in Pancreatic Cancer

Silexion Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update

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