This section highlights FDA-related milestones and regulatory updates for drugs developed by Silexion Therapeutics (SLXN).
Over the past two years, Silexion Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LODER, SIL204, and SIL-204. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LODER - FDA Regulatory Timeline and Events
LODER is a drug developed by Silexion Therapeutics for the following indication: In patients with non-resectable locally advanced pancreatic cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LODER
- Announced Date:
- September 24, 2024
- Indication:
- In patients with non-resectable locally advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp. announced significant new findings from its Phase 2 trial of LODER™ in patients with non-resectable locally advanced pancreatic cancer (LAPC) which bear the KRAS G12D or G12V mutation (approximately 70% of pancreatic cancer patients).
AI Summary
Silexion Therapeutics announced important Phase 2 trial results for its LODER™ treatment in patients with non-resectable locally advanced pancreatic cancer carrying the KRAS G12D or G12V mutation—mutations found in about 70% of pancreatic cancer cases. The trial revealed a 56% objective response rate (ORR) among treated patients. More notably, 67% of patients experienced enough tumor shrinkage to allow surgical removal, converting previously non-resectable tumors into resectable ones. This improvement in resectability offers significant hope by increasing the number of patients who could potentially benefit from surgery, a key factor in better long-term outcomes. These findings highlight LODER’s potential as an impactful treatment option for hard-to-treat pancreatic cancer and strengthen the company’s approach to targeting KRAS-driven tumors.
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SIL204 - FDA Regulatory Timeline and Events
SIL204 is a drug developed by Silexion Therapeutics for the following indication: Across Multiple Cancer Types Beyond Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SIL204
- Announced Date:
- July 9, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp. announced new positive preclinical data demonstrating SIL204's significant efficacy in human lung cancer cell lines.
AI Summary
Silexion Therapeutics Corp. has released new preclinical data showing that its product, SIL204, is significantly effective in human lung cancer cell lines. The study demonstrated that SIL204 produces a strong, dose-dependent inhibition in lung cancer cells with KRAS G12D mutations, suggesting it could become a valuable treatment for lung cancer patients. The findings highlight the importance of SIL204’s lipid-conjugated delivery system, which helps the drug enter tumor cells more efficiently. This innovative approach aims to overcome major barriers typically seen with siRNA therapies in solid tumors. Additionally, the company is planning to test SIL204 against a new KRAS mutation and is preparing to begin a Phase 2/3 clinical trial in 2026. These promising results pave the way for further clinical evaluation of SIL204 as a potential pan-KRAS treatment for challenging lung cancers.
Read Announcement- Drug:
- SIL204
- Announced Date:
- May 29, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp. announced compelling preclinical data demonstrating the efficacy of its next-generation RNAi therapeutic candidate, SIL204, against human pancreatic, colorectal and lung (NSCLC) cancer cell lines.
AI Summary
Silexion Therapeutics, a clinical-stage biotech company, announced compelling preclinical results for its next-generation RNAi therapeutic candidate, SIL204. The data showed that SIL204 effectively inhibited the growth and metabolic activity of human cancer cell lines, including those from pancreatic, colorectal, and non-small cell lung cancers (NSCLC). The therapy worked in a dose-dependent way, even at very low, nanomolar levels, which suggests it is potent in targeting the KRAS G12D mutation known to drive these cancers.
These findings broaden SIL204’s potential use beyond pancreatic cancer. By silencing the KRAS mutation at the RNA level, the treatment could offer a new approach to combat several aggressive and hard-to-treat tumors. This promising preclinical evidence supports the idea that SIL204 may become a valuable option for patients with various KRAS-driven cancers, addressing a significant unmet medical need.
Read Announcement- Drug:
- SIL204
- Announced Date:
- May 21, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced the completion of a comprehensive preclinical study assessing SIL204's therapeutic potential across multiple cancer types beyond pancreatic cancer.
AI Summary
Silexion Therapeutics Corp recently announced that it has completed a comprehensive preclinical study for its next-generation RNA interference therapeutic candidate, SIL204. This study expanded the focus beyond pancreatic cancer to include multiple KRAS-driven cancers. Researchers evaluated SIL204 in various cancer cell lines, including those from colorectal cancer, lung cancer, and pancreatic cancer. The selection of these cancer types was based on the high prevalence of KRAS mutations and significant unmet treatment needs. The promising results from these studies could allow the company to broaden its development strategy and offer a new treatment option for patients suffering from difficult-to-treat cancers. Silexion is now finalizing its data analysis and expects to announce full results in the coming days, signaling a potential new path in the fight against multiple types of cancer.
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SIL-204 - FDA Regulatory Timeline and Events
SIL-204 is a drug developed by Silexion Therapeutics for the following indication: In advanced pancreatic cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SIL-204
- Announced Date:
- March 5, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp. announced positive data from orthotopic pancreatic cancer models demonstrating that subcutaneously administered SIL204 effectively reduces both primary tumor growth and metastatic spread.
AI Summary
Silexion Therapeutics Corp. recently announced promising preclinical data showing that its RNA interference therapy, SIL204, significantly reduces both primary tumor growth and metastatic spread in orthotopic pancreatic cancer models. In these studies, the therapy was given subcutaneously and demonstrated its ability to reach pancreatic tumors grown in the organ itself—offering a more realistic simulation of human disease compared to earlier models.
The new findings are important because they show that SIL204 not only shrinks the main tumor but also lowers the risk of cancer spreading to other organs. This suggests that a minimally-invasive, systemic delivery method could effectively treat both primary and metastatic pancreatic cancer, potentially offering a better treatment option for patients battling this devastating disease.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- January 28, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp announced promising new preclinical data for SIL-204, its next-generation siRNA therapeutic candidate.
AI Summary
Silexion Therapeutics has released promising preclinical data for SIL-204, its next-generation siRNA therapeutic candidate. The new findings show that systemic administration of SIL-204 can effectively target aggressive KRAS mutations found in pancreatic cancer. Studies on animal models demonstrated that an extended release formulation of SIL-204 reduced tumor growth by about 50% in just 30 days, with nearly half of the tumors showing complete necrosis. Other experiments revealed that a single systemic dose maintained drug levels in plasma and tissues for over 56 days and that subcutaneous dosing inhibited growth in metastatic cancer models. The data supports SIL-204’s potential to address some of the most challenging cancers by targeting key mutations with prolonged therapeutic activity. Silexion plans to conduct further studies to evaluate its effect on metastases and refine its treatment strategy for KRAS-driven cancers.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- January 15, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp announced new preclinical results demonstrating the synergistic efficacy of its proprietary second-generation siRNA candidate, SIL-204, in combination with components of first-line chemotherapy for pancreatic cancer.
AI Summary
Silexion Therapeutics Corp. recently announced promising preclinical results for its second-generation siRNA candidate, SIL-204, designed to target pancreatic cancer. The studies revealed that SIL-204 works well with standard chemotherapy drugs, showing strong synergistic effects when combined with first-line treatments such as 5-fluorouracil, irinotecan, and gemcitabine. Researchers tested the combination on human pancreatic tumor cell lines carrying the KRAS G12D mutation, the most common mutation found in pancreatic cancer, and observed a significant reduction in cancer cell growth compared to using chemotherapy alone.
These results suggest that SIL-204 could potentially enhance the effectiveness of existing chemotherapy regimens. The success seen in these studies supports Silexion's plans to further develop SIL-204 in upcoming clinical trials, offering hope for improved treatment options for patients with pancreatic cancer. The focus remains on targeting tough-to-treat KRAS-mutated cancers with innovative RNA interference technologies.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- January 13, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp announced that it will be presenting a poster at the 2025 ASCO Gastrointestinal (GI) Cancers Symposium taking place January 23-25, 2025, in San Francisco, California.
AI Summary
Silexion Therapeutics Corp. recently announced that it will be presenting a poster at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco from January 23-25, 2025. The symposium aims to highlight the latest science related to gastrointestinal cancers. Silexion’s poster will focus on their work with SIL-204 siRNA, which is designed to treat localized and systemic cancers with KRAS mutations, including G12x, Q61H, or G13D.
Dr. Mitchell Shirvan will present the research during a session dedicated to cancers of the pancreas, small bowel, and hepatobiliary tract on January 24, 2025, from 11:30 AM to 1:00 PM PST. The abstract for the study will be published on the ASCO Symposium website on January 21, 2025, at 5:00 PM ET, and the poster will later be available on Silexion’s website under the "Our Science" section.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- October 1, 2024
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp. announced new preclinical findings for SIL-204, its second-generation siRNA candidate, following the optimization of its extended-release formulation.
AI Summary
Silexion Therapeutics Corp. has announced encouraging preclinical results for its second-generation siRNA candidate, SIL-204. The new data reveal that SIL-204, which has been optimized with an extended-release microparticle formulation, can significantly reduce tumors in pancreatic cancer models. In studies using mouse models, a single dose of SIL-204 showed strong anti-tumor activity, effectively targeting KRAS mutations—specifically the KRAS G12D mutation common in pancreatic cancer. This breakthrough is promising because it could lead to a treatment option that not only reduces tumor size but also causes tumor necrosis without daily injections. These preclinical results mark a significant step forward as Silexion plans to progress to toxicology studies and eventually initiate Phase 2/3 clinical trials by 2026, potentially changing the approach for treating aggressive KRAS-driven cancers.
Read Announcement
