Tel Aviv Sourasky Medical Center launches first global clinical trial of Silexion’s KRAS-targeting therapy for pancreatic cancer

ISRAEL—Tel Aviv Sourasky Medical Center has become the first hospital in the world to begin recruiting patients for a clinical trial evaluating an experimental therapy designed to target KRAS mutations in pancreatic cancer.

The study, launched in partnership with Israeli biotechnology company Silexion Therapeutics, marks an important step in the development of new treatment options for one of the deadliest forms of cancer.

Investigational therapy targets KRAS mutations

The clinical trial will assess SIL204, an investigational treatment developed by Silexion using small interfering RNA (siRNA) technology.

The therapy is designed to suppress the activity of mutated KRAS genes inside tumor cells, potentially slowing or preventing cancer growth.

KRAS mutations occur in about 90% of pancreatic cancer cases and are widely recognized as a major driver of tumor development and disease progression.

Despite decades of research, scientists have struggled to develop therapies capable of effectively targeting these mutations, making KRAS one of the most challenging cancer targets.

Pancreatic cancer also remains one of the most aggressive malignancies because it is often diagnosed only after it has reached an advanced stage, limiting treatment options and reducing survival rates.

Trial design and patient enrollment

Under the study protocol, clinicians will administer SIL204 directly into the tumor while patients continue to receive standard systemic treatment.

Researchers aim to determine whether silencing the mutated KRAS gene can reduce tumor growth in patients with locally advanced pancreatic cancer that cannot be removed through surgery.

The first phase of the study will enroll approximately 18 patients and will primarily evaluate the safety of the investigational therapy.

If successful, the trial will expand to additional medical centers across Israel, Germany, and other countries, with total enrollment expected to reach about 166 patients.

Prof. Ravit Geva, Director of the Oncology Institute and Gastrointestinal Oncology Center at Tel Aviv Sourasky Medical Center, will lead the study at the hospital.

“Pancreatic cancer treatment is undergoing a significant transformation,” Geva said.

“We are proud to be the first center worldwide to lead this Israeli-developed approach, which combines direct intratumoral administration of the investigational treatment with systemic therapy in patients with locally advanced, unresectable disease.”

Geva added that the study brings together specialists in oncology, gastroenterology, surgery, imaging, and clinical research to ensure comprehensive patient care throughout the trial.

Company marks clinical milestone

Silexion Therapeutics, which is listed on the Nasdaq stock exchange under the ticker SLXN, described the launch of patient recruitment as a major milestone following years of research, product development, and clinical preparation.

“The initiation of the study at Tel Aviv Sourasky Medical Center marks SIL204’s transition from years of development and clinical preparation into an active clinical program,” said Silexion Chairman and Chief Executive Officer Ilan Hadar.

Hadar noted that the study is expected to evaluate whether broad and targeted silencing of KRAS mutations could provide a new therapeutic option for patients with pancreatic cancer.

SIL204 remains an investigational treatment, and its safety and effectiveness have not yet been established through clinical testing.