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Tilt Biotherapeutics Nabs $2M DoD Award for Ovarian Cancer Study

NEW YORK – Tilt Biotherapeutics on Wednesday said it has received a $2 million grant from the US Department of Defense for a three-year project to study its oncolytic adenovirus TILT-123 as a treatment for ovarian cancer.

In the open-label Phase I trial, Tilt researchers will evaluate the safety and preliminary efficacy of TILT-123 with Merck's checkpoint inhibitor Keytruda (pembrolizumab) in about 29 patients with platinum-resistant or refractory ovarian cancer. In the trial, the firm will also look for biomarkers that may identify a best-responder population.

"In early clinical stage, unless you are using a highly specific molecule (such as monoclonal antibodies), the biomarker search is rarely straightforward or prospective," Victor Cervera-Carrascon, VP of business development at Helsinki-based Tilt, said in an email, adding that in the ovarian cancer program for TILT-123, the firm will explore blood-based proteins, changes in immune cell populations at the systemic compartment, and tumor signatures as potential biomarkers of response.

TILT-123 is designed to stimulate tumor-infiltrating lymphocyte activity by delivering tumor necrosis factor alpha (TNFα) and interleukin-2 (IL-2) to the tumor microenvironment.

Tilt is evaluating TILT-123 in four other clinical trials. The company in December reported results from a Phase I trial of TILT-123 with a tumor-infiltrating lymphocyte cell therapy in 16 patients with metastatic melanoma demonstrating safety and signs of efficacy. In early results from other ongoing Phase I studies, Tilt investigators have reported changes in the profile of systemically circulating immune cells and local infiltration at injected and non-injected tumor sites.

"We designed TILT-123 to improve the response rates in those many patients that are not responsive to current treatments," Tilt CEO Akseli Hemminki said in a statement. "Our international clinical trials are progressing well through Phase I, and this significant grant is another key step in progressing these new therapies to reach patients in this [area of] high unmet medical need."