Tel Aviv Sourasky Medical Center will become the first medical center worldwide to recruit patients for a clinical trial of an experimental treatment targeting KRAS mutations in pancreatic cancer, the hospital and Israeli biotechnology company Silexion Therapeutics announced.
The trial will evaluate SIL204, a treatment developed by Silexion that uses small interfering RNA molecules, known as siRNA, to suppress the expression of mutated KRAS genes inside tumor cells.
KRAS mutations are found in approximately 90% of pancreatic cancer patients and are considered one of the main mechanisms driving tumor growth and the spread of the disease. Developing therapies capable of targeting KRAS has historically proved difficult.
Pancreatic cancer remains among the most lethal forms of cancer, in part because it is frequently diagnosed only after reaching an advanced stage.
Under the trial protocol, SIL204 will be administered directly into the tumor and combined with standard systemic treatment. Researchers will examine whether silencing mutated KRAS can inhibit tumor growth in patients with locally advanced pancreatic cancer that cannot be surgically removed.
Initial trials enroll 18 patients, test safety before expanding to Europe
The initial phase will enroll approximately 18 patients and focus primarily on the treatment’s safety. The study is later expected to expand to additional medical centers in Israel, Germany, and other countries, with total enrollment potentially reaching approximately 166 patients.
Prof. Ravit Geva, director of the Oncology Institute and Gastrointestinal Oncology Center at Tel Aviv Sourasky Medical Center, will serve as the study’s lead investigator 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 said the study required cooperation among experts in oncology, gastroenterology, surgery, and imaging, as well as the hospital’s clinical research teams.
Silexion opens trial after years of development, clinical preparations
Silexion, which trades on Nasdaq under the ticker SLXN, described the opening of the trial as an important milestone following years of development and clinical preparations.
“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,” Silexion chairman and CEO Ilan Hadar said.
The trial would help determine whether broad and targeted silencing of KRAS could eventually offer another treatment option for pancreatic cancer patients, Hadar said.
The treatment remains investigational, and its safety and effectiveness have yet to be established through the clinical trial.
