Silexion Therapeutics Announces Completion of Initial Study in Orthotopic Pancreatic Cancer Models Evaluating Systemic Administration of SIL-204

Rhea-AI Summary

Silexion Therapeutics (NASDAQ: SLXN) has completed its initial study evaluating SIL-204 in orthotopic pancreatic cancer models, marking the first systematic evaluation of this RNA interference therapy administered subcutaneously in clinically relevant models.

The study assessed two critical aspects of SIL-204's potential:

• Ability to reduce primary tumor growth when administered systemically
• Capacity to reduce metastatic spread from orthotopic tumors to secondary organs

Unlike standard subcutaneous xenograft models, the orthotopic models used in this study better represent the complex microenvironment of pancreatic tumors and their metastatic behavior by allowing tumors to develop in their native environment.

Data analysis is currently underway, with initial results expected to be reported in March 2025. These findings will inform Silexion's development strategy for SIL-204 in addressing both localized and metastatic pancreatic cancer.

Positive

• First systematic evaluation of SIL-204 in clinically relevant pancreatic cancer models
• Orthotopic models provide more translational value than standard subcutaneous xenograft models
• Study evaluates SIL-204's potential against both primary tumors and metastases
• Results expected in March 2025 will inform development strategy

Negative

• Results of the study are not yet available
• CEO expressed only 'cautious optimism' about potential findings
• No efficacy data reported yet for SIL-204 in pancreatic cancer models

Silexion Completes Data Collection Phase in First-Ever Evaluation of SIL-204 in Clinically Relevant Orthotopic Models; Analysis Underway with Initial Results Expected in Coming Weeks

Grand Cayman, Cayman Islands, Feb. 25, 2025 (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 the completion of its initial study evaluating SIL-204 in orthotopic pancreatic cancer models. This milestone represents the first systematic evaluation of SIL-204 administered subcutaneously in clinically relevant pancreatic cancer models.

The study specifically evaluated two critical aspects of SIL-204's potential therapeutic profile:

1. SIL-204's ability to reduce primary tumor growth when administered systemically in orthotopic pancreatic cancer models, where human tumor cells are implanted directly into the pancreas
2. SIL-204's capacity to reduce metastatic spread from these orthotopic tumors to secondary organs

"Completing this initial study in orthotopic models represents a significant milestone in our SIL-204 development program," said Mitchell Shirvan, Ph.D., CSO of Silexion. "These clinically relevant models provide substantially more translational value than standard subcutaneous xenograft models, as they better represent both the complex microenvironment of pancreatic tumors and their characteristic metastatic behavior."

The orthotopic models used in this study are designed to more accurately reflect human pancreatic cancer biology by allowing tumors to develop in their native environment. This stands in contrast to subcutaneous xenograft models, where tumors grow beneath the skin rather than in the organ of origin. Importantly, orthotopic pancreatic models demonstrate metastatic spread patterns similar to human disease, enabling evaluation of potential therapies against both primary and metastatic disease.

"We are particularly excited about this initial study because it represents the first evaluation of SIL-204 against both primary tumors and their metastases following systemic administration," said Ilan Hadar, Chairman and CEO of Silexion. "Our team is currently analyzing the data, and we expect to begin reporting results in the coming weeks. We are cautiosly optimistic that the findings could provide important insights into SIL-204's potential to address both localized and metastatic pancreatic cancer, which could significantly broaden its therapeutic applications."

The Company anticipates sharing initial results from the study in March 2025. These results will inform Silexion's development strategy for SIL-204.

About Silexion Therapeutics
Silexion Therapeutics (NASDAQ: SLXN) is a pioneering clinical-stage, oncology-focused biotechnology company developing innovative RNA interference (RNAi) therapies to treat solid tumors driven by KRAS mutations, the most common oncogenic driver in human cancers. The company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer. Silexion is also advancing its next-generation siRNA candidate, SIL-204, designed to target a broader range of KRAS mutations. The company remains committed to pushing the boundaries of therapeutic innovation in oncology, with a focus on improving outcomes for patients with difficult-to-treat cancers. 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 Silexion's business strategy and ongoing studies are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", 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 clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (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; and (vi) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the company. 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
mirit@silexion.com

Capital Markets & IR Contact
ARX | Capital Markets Advisors
North American Equities Desk
silexion@arxadvisory.com

FAQ

What is the significance of Silexion's (SLXN) orthotopic pancreatic cancer study for SIL-204?

The study represents the first evaluation of SIL-204 against both primary tumors and metastases following systemic administration, providing more translational value than standard models by better representing the complex microenvironment of pancreatic cancer.

When will Silexion (SLXN) release results from its SIL-204 pancreatic cancer study?

Silexion expects to begin reporting initial results from the study in March 2025.

How does Silexion's (SLXN) orthotopic model differ from standard cancer models?

Orthotopic models allow tumors to develop in their native environment (pancreas) rather than beneath the skin, demonstrating metastatic spread patterns similar to human disease, which enables evaluation against both primary and metastatic disease.

What therapeutic targets does Silexion's (SLXN) SIL-204 focus on?

SIL-204 is an RNA interference (RNAi) therapy specifically targeting KRAS-driven cancers, including pancreatic cancer.

How was SIL-204 administered in Silexion's (SLXN) pancreatic cancer study?

SIL-204 was administered subcutaneously (under the skin) as a systemic treatment in the orthotopic pancreatic cancer models.