Silexion Therapeutics Announces First Patient Successfully Dosed in Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer
The study moves into patient treatment, with an initial safety cohort preceding randomized evaluation against chemotherapy alone.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Silexion Therapeutics (NASDAQ: SLXN) has dosed the first patient in its Phase 2/3 trial of SIL204 for locally advanced pancreatic cancer. Treatment began at Tel Aviv Sourasky Medical Center in Israel.
The multinational, randomized, open-label study, in which treatment assignments are known, compares SIL204 plus standard chemotherapy with chemotherapy alone. An initial safety cohort of approximately 18 patients precedes a randomized cohort of approximately 166 patients. Treatment combines ultrasound-guided injections directly into the pancreatic tumor with injections under the abdominal skin.
The Israeli center received institutional ethics approval and Ministry of Health authorization. Additional Israeli and German sites are progressing through activation; Silexion expects them to join in the coming months and is working toward preliminary clinical readouts in the near term.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFirst patient dosed advances SIL204 into active Phase 2/3 treatment at Tel Aviv Sourasky Medical Center.
- Minor point. Forward-looking: it has not happened yet and may not happen.Planned enrollment includes approximately 18 safety-cohort patients, followed by approximately 166 randomized-cohort patients.
- Minor pointIsraeli ethics approval and Ministry of Health authorization received for the anchor clinical center.
- Minor pointGerman institutions approved under the EU clinical trials framework by BfArM, Germany's medicines regulator.
- Minor point. Forward-looking: it has not happened yet and may not happen.Additional Israeli and German sites are expected to join the program in the coming months.
- Minor point. Forward-looking: it has not happened yet and may not happen.Preliminary clinical readouts are a company-stated near-term goal.
Negative
- Minor pointAdditional site activation remains in progress for Israeli and German centers before they join the trial.
Details
Market move: SLXN -16.39% vs previous close. Phase 2/3 trial dosing
On Sep 30, the day this news came out, the latest delayed price for SLXN is 16.39% below the previous close. Our momentum scanner has recorded 6 alerts for this stock so far that day. The latest delayed price is $0.27. Relative volume is exceptionally heavy at 5.4x the average.
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Key Figures
- Safety run-in cohort
- approximately 18 patients
- Initial safety run-in
- Randomized cohort
- approximately 166 patients
- Global expansion cohort
Previous Clinical trial Reports
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Activated first trial site at Tel Aviv; screening cleared, with first dosing expected.
-
German BfArM approval, alongside prior Israeli authorization, cleared the Phase 2/3 trial to start.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
rna interference technical
endoscopic ultrasound medical
subcutaneous medical
small interfering rna technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Global Phase 2/3 trial evaluates SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer
Integrated regimen combines direct EUS-guided intratumoral delivery to penetrate tumor stroma with subcutaneous dosing; first patient treated at Tel Aviv Sourasky Medical Center (Ichilov)
Grand Cayman, Cayman Islands and Ramat Gan, Israel, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that the first patient worldwide has been successfully dosed in its Phase 2/3 clinical trial evaluating the Company's lead candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC). The treatment was administered at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov") in Israel, marking a defining transition into active clinical execution for the Company's global therapeutics program.
The trial is a prospective, randomized, controlled, multinational, Phase 2/3, open-label study evaluating the efficacy and safety of SIL204 administered as an integrated therapeutic regimen in combination with standard-of-care chemotherapy, versus chemotherapy alone, in patients with LAPC. The study is structured with an initial safety run-in cohort of approximately 18 patients, followed by global expansion to enroll a randomized cohort of approximately 166 patients. The trial enrolls newly diagnosed, treatment-naïve adult patients with unresectable Stage 3 LAPC without distant metastases whose tumors harbor a confirmed KRAS mutation. SIL204 is administered as a first-line regimen alongside standard chemotherapy, with the choice of chemotherapy at the treating physician's discretion.
In this trial, SIL204 is administered via an innovative dual-route delivery strategy designed to address the anatomical and biological barriers of pancreatic tumors. Treatment combines direct intratumoral administration via an endoscopic ultrasound (EUS)-guided procedure, targeting the primary pancreatic lesion to bypass dense tumor stroma, with subcutaneous abdominal injections designed to provide systemic exposure and address potential micro-metastases.
"Successfully dosing the first patient in our Phase 2/3 clinical trial of SIL204 is a defining operational and clinical milestone for Silexion, transitioning our lead RNAi program into active patient treatment," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Locally advanced pancreatic cancer is one of the most aggressive and lethal solid tumors, with patients facing a persistent lack of new therapeutic options. By combining direct local tumor penetration with systemic coverage, our integrated regimen is engineered to overcome the critical delivery barriers that have historically limited pancreatic cancer treatments. We are thrilled to initiate dosing at Tel Aviv Sourasky Medical Center and look forward to advancing additional clinical trial sites across Israel and Germany, as we work toward preliminary clinical readouts in the near term to evaluate SIL204's potential to improve response rates and survival outcomes for patients with locally advanced pancreatic cancer."
Tel Aviv Sourasky Medical Center serves as the anchor clinical center for the trial in Israel following receipt of institutional ethics approval and authorization from the Israeli Ministry of Health. Additional Israeli oncology centers, alongside leading academic medical institutions in Germany approved under the European Union Clinical Trials Regulation (EU CTR) framework by the Federal Institute for Drugs and Medical Devices (BfArM), are progressing through site activation and are expected to join the Phase 2/3 program in the coming months.
About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers that have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product candidate, which showed a positive trend in comparison to the control of chemotherapy alone, and is now advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), through Phase 2/3 clinical evaluation. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology and further developing its lead product candidate for locally advanced pancreatic cancer. 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 the clinical development, timing, enrollment, protocol execution, and anticipated outcomes of the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer; the timing, availability, and potential clinical significance of anticipated preliminary clinical readouts in the near term; the potential of SIL204 to improve response rates, survival outcomes, or other clinical metrics; the therapeutic potential, biological mechanism, and clinical utility of SIL204 and the Company’s integrated treatment regimen; the anticipated activation and onboarding of additional clinical trial sites in Israel and Germany; Silexion's transition into active clinical execution; and the Company's future strategy, operations, and milestones, are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "possible", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "prospective", or "potential", 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 in those statements. Important factors that could cause such differences include, but are not limited to: (i) the ability of Silexion and its participating clinical trial centers to successfully enroll, treat, and evaluate patients in accordance with the study protocol, including the initial safety run-in cohort of approximately 18 patients and the randomized expansion cohort of approximately 166 patients; (ii) the risk that preliminary clinical safety, tolerability, response rate, or survival data may not be achieved, confirmed, or replicated as the trial advances, that early observations may not be predictive of final trial results, or that SIL204 may not demonstrate statistically significant improvements in clinical efficacy compared to chemotherapy alone; (iii) the ability of Silexion to complete standard site activation procedures at additional medical centers in Israel and Germany on anticipated timelines; (iv) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (v) the impact of the regulatory environment and compliance complexities, including site-level approvals, conditions, and clearances required prior to study commencement in each jurisdiction; (vi) expectations regarding future clinical, academic, or commercial partnerships; (vii) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional financing to fund clinical trials; (viii) Silexion's ability to maintain its Nasdaq listing; and (ix) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026, and the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 14, 2026. 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
info@silexion.com
Investor Relations Contact
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What milestone did Silexion reach in the SIL204 Phase 2/3 pancreatic cancer trial?
The first patient worldwide was dosed at Tel Aviv Sourasky Medical Center in Israel. The trial evaluates the efficacy and safety of SIL204 combined with standard chemotherapy versus chemotherapy alone in locally advanced pancreatic cancer.
Who is eligible for Silexion's SIL204 Phase 2/3 trial?
The trial enrolls newly diagnosed, treatment-naïve adults with unresectable Stage 3 locally advanced pancreatic cancer, no distant metastases and a confirmed KRAS mutation in their tumors. Treatment-naïve means patients have not previously received treatment.
Why does Silexion's SIL204 trial use two delivery routes?
Silexion designed the dual-route regimen to address pancreatic tumors' anatomical and biological barriers. Ultrasound-guided delivery directly into the tumor is intended to bypass dense tissue surrounding tumor cells, while injections under the abdominal skin are designed to provide systemic exposure and address potential microscopic metastases.
How is chemotherapy selected in Silexion's SIL204 trial?
The treating physician chooses the chemotherapy used alongside SIL204. The investigational combination is administered as a first-line regimen, and the study compares it with chemotherapy alone.