TILT Biotherapeutics has dosed the first patient in a Phase I trial of its oncolytic adenovirus igrelimogene litadenorepvec (TILT-123). The candidate is being investigated in combination with avelumab in squamous cell carcinoma of head and neck (SCCHN).

The Phase I trial is a multi-centre, open-label, dose-escalation study that will evaluate TILT-123 in combination with avelumab in squamous cell carcinoma of head and neck (SCCHN). It will also evaluate melanoma in patients with advanced solid tumors who did not respond to anti-PD(L)1.

The trial (NCT05222932) is part of a collaboration between the Helsinki, Finland-based biotech company and the Merk-Pfizer alliance. The European trial is taking place at the Docrates Cancer Center in Helsinki, Finland, with the company expecting to open a US site in the latter half of 2023. According to TILT, further clinical trials are planned for 2023, including a Phase II trial in ovarian cancer.

TILT-123 is a 5/3 chimeric serotype adenovirus delivered intravenously or intratumorally. The addition of human cytokines boosts immune response in patients and works synergistically with immune checkpoint inhibitors.

“Our lead asset, TILT-123, has been administered as monotherapy or in combination to about 50 patients in four international TILT-sponsored trials with promising initial efficacy responses observed in some of the patients,” said TILT Biotherapeutics CEO, Akseli Hemminki.

“We believe it has the potential to increase the response rate of immune checkpoint inhibitors to deliver synergistic benefits to patients who have failed to benefit from immune checkpoint inhibitors, or where immunotherapy has become an ineffective treatment option.”