TILT Biotherapeutics has announced 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).

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.

“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,” says TILT Biotherapeutics’ CEO, Akseli Hemminki.

The TUNINTIL and the TUNIMO trial

The ‘TUNINTIL’ clinical trial 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.

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