Silexion (SLXN) reports immune-related SIL204 signal in KRAS pancreatic cancer
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Silexion Therapeutics reported early laboratory findings suggesting its lead RNAi candidate SIL204 may have an immune-modulating effect in KRAS-driven cancers. In a preclinical study using human pancreatic cancer cells with a KRAS G12R mutation, SIL204 treatment led to a statistically significant increase in MHC-I (HLA-ABC) expression, a key signal that helps cytotoxic T cells recognize tumor cells. The company notes this could support future evaluation of SIL204 in combination with anti-PD-1 immunotherapies such as pembrolizumab, although these results remain preliminary and preclinical. Silexion is advancing SIL204 towards clinical trials in Israel and the European Union for locally advanced pancreatic cancer.
Positive
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8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
SIL204 concentration: 60 nM
Statistical significance: P<0.05
Lead indication: Locally advanced pancreatic cancer
+2 more
5 metrics
SIL204 concentration
60 nM
Preclinical KP2-G12R pancreatic cancer cell experiment
Statistical significance
P<0.05
Increase in surface MHC-I vs. control
Lead indication
Locally advanced pancreatic cancer
Target for SIL204 clinical development
Planned trial phase
Phase 2/3
Planned SIL204 trial in locally advanced pancreatic cancer
Company listing
Nasdaq: SLXN
Exchange listing for Silexion Therapeutics
Key Terms
RNA interference (RNAi), major histocompatibility complex class I (MHC-I), KRAS G12R mutation, anti-PD-1 therapies, +2 more
6 terms
RNA interference (RNAi) medical
"a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers"
A natural cellular process in which small RNA molecules shut down the production of a specific protein by blocking the instructions that make it, like flipping a precise light switch to silence one appliance without affecting others. For investors, RNA interference is important because it underpins a class of highly targeted therapies and research tools that can create new drugs, shorten development paths, and change the potential market and regulatory risks for companies working on gene-based treatments.
major histocompatibility complex class I (MHC-I) medical
"a statistically significant increase in surface expression of major histocompatibility complex class I (MHC-I)"
KRAS G12R mutation medical
"human pancreatic cancer cells harboring the KRAS G12R mutation, as measured by flow cytometry"
anti-PD-1 therapies medical
"supporting potential future evaluation alongside anti-PD-1 therapies including pembrolizumab (Keytruda®)"
immune checkpoint inhibitor therapies medical
"limited responsiveness to immune checkpoint inhibitor therapies such as anti-PD-1 agents"
clinical trials regulatory
"is currently advancing its lead, second-generation, product candidate, SIL204, towards clinical trials in Israel and the European Union"
Clinical trials are carefully controlled studies that test whether a new drug, device or treatment is safe and effective in people, moving through successive stages that increase the number of participants and the rigor of testing. Investors care because trial outcomes determine whether a product can be approved and sold, shaping a company’s future revenue, valuation and risk profile—think of it as proof-of-concept testing that decides if a prototype becomes a market-ready product.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Securities Exchange Act of 1934
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-3-756-4999
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Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if
the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On May 14, 2026, Silexion Therapeutics
Corp issued a press release entitled “Silexion Therapeutics Reports Positive Preliminary Immunotherapy Findings for SIL204 in KRAS-Driven
Pancreatic Cancer”. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”) and is incorporated herein by reference.
The information in this Item 7.01 of Form 8-K, including the information in the press release furnished pursuant to
this Item 7.01, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. Furthermore, the information in this Item 7.01, including the
information in the press release, shall not be deemed to be incorporated by reference in the filings of the registrant under the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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99.1
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Press Release dated May
14, 2026
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104
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Cover Page Interactive Data File (formatted in Inline XBRL)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
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SILEXION THERAPEUTICS CORP
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Date: May 14, 2026
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/s/ Ilan Hadar
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Name:
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Ilan Hadar
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Title:
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Chief Executive Officer
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Exhibit 99.1
Silexion Therapeutics Reports Positive Preliminary Immunotherapy Findings for SIL204 in
KRAS-Driven Pancreatic Cancer
Preliminary results from a preclinical study demonstrated statistically significant increase in
MHC-I expression following SIL204 treatment in human pancreatic and non-small cell lung
cancer cells harboring a KRAS mutation, supporting potential future evaluation alongside
anti-PD-1 therapies including pembrolizumab (Keytruda®)
Image Caption: SIL204 increases surface MHC-I (HLA-ABC) expression in human KRAS G12R-mutated
pancreatic cancer cells (KP2-G12R) at 60 nM, as measured by flow cytometry. *P<0.05 vs.
control.
1 See Bear AS et al., Cancer Cell (2020); Canon J et al., Nature (2019)
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, which showed a positive trend in comparison to the control of chemotherapy alone, and is currently advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), towards clinical trials in Israel and the European Union. 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
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 therapeutic potential, immune-modulating activity, mechanism of action, translational significance, future development, and planned studies relating to SIL204, including its potential role in modulating antigen presentation, restoring immune recognition, enhancing responsiveness to checkpoint inhibitor therapies, and future immuno-oncology or combination applications, are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", 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) Silexion's ability to successfully complete preclinical studies and initiate and conduct clinical trials, including the Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities, including the outcome of the CTA’s review of the Company’s application to commence clinical trials in Germany and other jurisdictions, as well as site-level approvals, conditions and clearances (including outstanding regulatory forms and any initial participant caps) required prior to study commencement at each clinical site; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion's ability to maintain its Nasdaq listing; and (vii) 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. 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.
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Arx Investor Relation
North American Equities Desk
silexion@arxhq.com
FAQ
What did Silexion Therapeutics (SLXN) report about SIL204 in this 8-K?
Silexion reported positive preclinical data for SIL204 in KRAS-mutated pancreatic cancer cells, showing increased MHC-I expression after treatment. This may support future exploration of SIL204 in immunotherapy combinations for difficult-to-treat pancreatic tumors.
How does SIL204 appear to affect KRAS-driven pancreatic cancer cells?
In preclinical tests, SIL204 increased surface MHC-I (HLA-ABC) expression on KRAS G12R-mutated pancreatic cancer cells. Higher MHC-I levels can help cytotoxic T cells better recognize tumor cells, potentially improving immune-mediated anti-tumor responses.
Why is MHC-I upregulation by SIL204 important for Silexion (SLXN)?
MHC-I enables immune cells to identify and attack cancer cells. Because KRAS signaling often suppresses antigen presentation, the observed MHC-I increase with SIL204 suggests a possible way to counter immune evasion in KRAS-driven tumors, including pancreatic cancer.
Could SIL204 be combined with checkpoint inhibitors like pembrolizumab?
Silexion states the preclinical findings support potential future evaluation of SIL204 alongside anti-PD-1 therapies such as pembrolizumab. The idea is that restoring MHC-I expression might enhance responsiveness to PD-1/PD-L1 blockade in KRAS-driven tumors.
What development stage is SIL204 currently in at Silexion Therapeutics?
SIL204 is described as a lead, second-generation siRNA product candidate being advanced toward clinical trials in Israel and the European Union. The company previously ran a Phase 2a trial with a first-generation product showing a positive trend versus chemotherapy alone.
What forward-looking risks does Silexion (SLXN) highlight for SIL204?
Silexion cites risks around completing preclinical work, initiating and conducting clinical trials, regulatory reviews of trial applications, capital needs, maintaining its Nasdaq listing, and other uncertainties detailed in its Form 10-K for the year ended December 31, 2025.