Silexion Therapeutics (NASDAQ: SLXN), a clinical-stage biotech company developing cutting-edge RNA interference (RNAi) therapies, has announced compelling new findings from its Phase 2 trial of LODER™ in patients with non-resectable locally advanced pancreatic cancer (LAPC). The updated data shows a 56% objective response rate (ORR) and a 67% improvement in tumor resectability, a significant step forward in treating a cancer type that has long been resistant to effective intervention. But the implications of these findings may extend beyond pancreatic cancer, potentially impacting a much broader range of KRAS-driven cancers.

A Potential Turning Point in Pancreatic Cancer Treatment—And Beyond

Pancreatic cancer is among the most lethal forms of cancer, typically diagnosed at a late stage when treatment options are limited and often ineffective. For many patients, surgery is not an option due to the tumor's location or the extent of its spread. The recent results from Silexion’s Phase 2 trial suggest that LODER™ could change this landscape by making previously inoperable tumors surgically treatable.

The trial targeted patients with KRAS G12D or G12V mutations, which are present in approximately 70% of pancreatic cancer cases. These mutations are notoriously difficult to treat, as conventional therapies struggle to effectively target these genetic drivers. Silexion’s LODER™ technology, however, uses a localized drug delivery system to deliver siRNA directly into the tumor, silencing the KRAS gene and preventing the production of cancer-promoting proteins. This approach not only tackles the underlying genetic issue but also offers a more targeted treatment option, minimizing damage to healthy tissues.

Beyond Pancreatic Cancer: The Broader Impact of KRAS Mutations

While pancreatic cancer is a critical focus, KRAS mutations play a role in many other aggressive cancers, including lung, colorectal, and ovarian cancers. In fact, KRAS is one of the most common oncogenes found in human cancers, especially in solid tumors. The challenge of effectively targeting KRAS mutations has been a major obstacle in oncology, as these mutations are often associated with resistance to standard therapies and poor patient outcomes.

This is where Silexion’s broader ambitions come into play. The company's next-generation product, SIL-204, is designed to target a wider range of KRAS mutations, including those beyond the G12D/V mutations found in pancreatic cancer. By addressing multiple KRAS-driven cancers, SIL-204 could potentially transform treatment for a large number of patients who currently have limited therapeutic options.

Understanding the Clinical Trial Results

The Phase 2 trial, conducted in the U.S. and Israel, enrolled 48 patients with locally advanced pancreatic cancer that could not be surgically removed or tumors that were only marginally operable. The goal was to assess how effectively Silexion’s LODER™ technology could improve treatment outcomes for these patients.

To put it simply, the trial was divided into two groups. In the first group, 29 patients received either LODER™ combined with standard chemotherapy or chemotherapy alone. This helped researchers compare the overall survival rates between the two approaches. The second group consisted of 19 patients with tumors deemed inoperable, where the focus was on measuring how well the treatment worked and its safety.

The results were promising: 56% of patients with the targeted KRAS mutations responded positively to the treatment. Even more striking, 67% of tumors that were initially considered too complex for surgery shrank enough to become operable. This is a significant development because surgery remains the best chance for long-term survival in pancreatic cancer patients. By potentially turning previously inoperable tumors into candidates for surgery, LODER™ offers a new lifeline for those battling this deadly disease.

“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,” 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.”

The Broader Promise of SIL-204

Building on the success of LODER™, Silexion is also developing SIL-204, a next-generation siRNA therapy designed to target a broader range of KRAS mutations, including those that are currently beyond the reach of existing treatments. SIL-204 has shown promising preclinical results, demonstrating improved stability and enhanced delivery capabilities, which could make it more effective in silencing the KRAS gene.

The company plans to move SIL-204 into Phase 2/3 clinical trials in 2025-2026, aiming to establish its efficacy in not just pancreatic cancer, but a variety of KRAS-driven cancers. Given the high prevalence of KRAS mutations in many aggressive cancers, the potential impact of SIL-204 is enormous. This advancement could represent a major leap forward in the field of precision oncology, where effective treatment options for KRAS-driven cancers have long been limited.

Looking Ahead: A Unique Approach to a Complex Problem

Silexion’s RNAi technology stands out because it tackles the genetic drivers of cancer directly, rather than simply targeting the symptoms of the disease. By delivering treatment directly to the tumor site and silencing the KRAS gene at its source, Silexion’s approach has the potential to overcome some of the barriers that have historically limited progress in treating not just pancreatic cancer, but a wide array of KRAS-driven cancers.

As Silexion advances its clinical trials and explores the full potential of its RNAi technology, it may be poised to play a crucial role in the future of precision oncology. The recent new data from Phase 2 trials seem like a potentially promising sign that the company’s innovative approach could offer new hope to patients facing some of the most challenging cancers.

This update is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [https://justpaste.it/ab9dn/pdf]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news and developments related to innovative companies as detailed in the full documentation and it is thus subject to conflicts of interest.

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