On March 31, 2022 TILT Biotherapeutics, a clinical-stage biotechnology company developing oncolytic immunotherapy for enabling therapies based on T cells, such as immune checkpoint inhibitors and adoptive cell therapies, reported that positive interim progress and safety data from its phase 1 clinical trials in metastatic melanoma (T215 – the ‘TUNINTIL’ trial) and solid tumors (T115 – the ‘TUNIMO’ trial) (Press release, TILT Biotherapeutics, MAR 31, 2022, View Source [SID1234611203]). These two trials, with patients in Denmark, France, and Finland, are of the company’s oncolytic immunotherapy asset TILT-123, designed to stimulate T-cells to better fight cancer.
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TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and cancer clinician who has personally treated almost 300 patients with ten different oncolytic viruses, said, "We are delighted that our phase 1 trial in solid tumors (T115), which consists of a total of 11 patients being treated to date, is progressing at pace. Our first-in-human melanoma (T215) trial is showing equally positive results, with 10 patients being treated and some now being treated under an extension protocol. I am thankful for the excellent work by the clinical teams. We are showing that the treatment is well tolerated, has prominent biological effects on tumors, and has the potential to increase the efficacy of immunotherapies, and deliver the anti-tumor benefits of armed oncolytic viruses."
The ‘TUNINTIL’ clinical trial (1) is a phase 1, open-label, dose-escalation study of the company’s oncolytic adenovirus coding for Tumor Necrosis Factor Alpha (TNF alpha) and Interleukin 2 (IL-2), known as TILT-123. A total of about 15 metastatic melanoma patients receive TILT-123 as an initial monotherapy over one month, followed by up to two administrations of tumor infiltrating lymphocytes (TILs) in the second month as well as ongoing consecutive doses of TILT-123, for up to 24 months.
The ‘TUNIMO’ clinical trial (2) is also a phase 1 trial of TILT-123. A total of 15-20 patients with solid tumors receive TILT-123 as a monotherapy over a three-month period, and, as with the TUNINTIL protocol, followed up by a 24- month extension period.
The primary objective of both trials is to evaluate the safety of TILT-123 and to deliver insights about the behavior of TILT-123 in humans, such as systemic tumor transduction following intravenous delivery and virus replication in the tumor, as well as immunological responses.
To date, most frequent adverse events across both trials have been fever, chills, and fatigue, consistent with the administration of an oncolytic adenoviral immunotherapy, with no treatment related serious adverse events.
The heart of TILT’s innovative approach revolves around the use of armed oncolytic adenoviruses, using cytokines and other molecules to boost the patient’s immune response to better enable it to find and destroy cancer cells. The company is advancing its pipeline of other assets and programs with TILT-123 towards further clinical trials, including in combination with the immune checkpoint inhibitors (3) (4).