#Israel #Sheba Medical #Tel Hashomer #Entolimod #Valion Bio

Groundbreaking Clinical Trial at Sheba Medical Center

Sheba Medical Center in Israel, ranked as the world's seventh-best hospital, has embarked on an innovative clinical trial to evaluate Valion Bio's Entolimod in cancer patients. This decision marks an essential step in researching the potential benefits of Entolimod beyond its current applications targeted towards Acute Radiation Syndrome (ARS).

Independent Validation and Opportunity Expansion

The selection of Entolimod for a clinical evaluation highlights its potential efficacy in reducing radiation-induced neutropenia, a common and serious side effect of cancer treatments involving high doses of radiation. Neutropenia can lead to infections and treatment delays, making this research vital for enhancing patient care during radiation therapy.

This initiative not only paves the way for a second clinical application of Entolimod, expanding its reach into supportive oncology care, but it also opens a significantly larger commercial market for Valion Bio. The collaboration implies that Sheba Medical Center is willing to invest its resources to fund and conduct the trial, which is a testament to the hospital’s belief in Entolimod's therapeutic potential. Valion Bio anticipates that this could create a productive opportunity to derive independent clinical data without incurring substantial additional costs.

Clinical Trial Details

The trial aims to enroll up to ten adult patients undergoing treatment for a rare form of cancer. The research will assess whether Entolimod can effectively preserve bone marrow function, thereby reducing neutropenia and improving treatment outcomes. Given that cancer patients often face challenges in completing their therapy due to this condition, success in this trial could lead to significant advancements in oncology treatment protocols.

The timeline for this clinical trial includes several key milestones:

• - Institutional Review Board approval is anticipated in Q3 2026.
• - First patient enrollment is expected during the fourth quarter of 2026 into the first quarter of 2027.
• - Initial data readout is expected in early 2027, followed by topline data later in the year.

Each phase presents significant opportunities to validate Entolimod's clinical and market potential, along with a chance to increase shareholder value for Valion Bio.

About Sheba Medical Center

Sheba Medical Center, with its state-of-the-art facilities and experienced team, is the largest medical center in the Middle East and is highly regarded for its oncology services. The Benjamin Davidai Department of Radiation Oncology will spearhead the trial, leveraging its expertise to ensure comprehensive and rigorous evaluation of Entolimod.

Valion Bio's Vision

Valion Bio, Inc. is recognized for its commitment to developing innovative immunotherapeutics, positioning Entolimod as a first-in-class treatment aimed at mitigating the side effects of radiation exposure in medical settings. Currently, this drug is being advanced under the FDA's Animal Rule for Acute Radiation Syndrome and holds Fast Track and Orphan Drug designations.

Conclusion

The collaboration between Valion Bio and Sheba Medical Center represents a significant advancement in medical research and patient care in oncology. As the trial unfolds, the results will be closely watched, with hopes of improving outcomes for cancer patients facing the challenges of radiation therapy. Should Entolimod prove successful, it could become a cornerstone in the treatment protocol for managing radiation-induced neutropenia, thus solidifying its role in modern cancer treatment strategies.