TILT Biotherapeutics advances cancer immunotherapy clinical trial achieving primary end point in the first cohort
Second dose escalation site approved in Nantes, France
HELSINKI, March 15, 2021 /PRNewswire/ -- TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, announces that it has achieved the primary endpoint of safety in its phase I trial with the first dose of its dual cytokine armed oncolytic adenovirus, TILT-123, at Herlev hospital in Denmark. No serious adverse events (SAEs) were observed in the trial for TILT-123 as a monotherapy or in combination with tumour infiltrating lymphocytes (TILs). The company has received regulatory approval to open a second clinical trial site at CHU Nantes, France, with 15 patients in total to be enrolled across the two sites. The clinical trial will now proceed to the second (of five) dose levels and expects interim data by the end of this year.
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. 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.
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 our first-in-human phase 1 trial in metastatic melanoma has successfully met its primary clinical endpoint of safety at the initial dose and is now progressing steadily to the next dose level. I am grateful for the excellent work by the team at Denmark's prestigious National Center for Cancer Immune Therapy and look forward to continuing this and also working with the team in Nantes. Overall, the trial has the potential to increase the efficacy of adoptive T-cell therapy, remove the need for pre- and post-conditioning regimens, and deliver the combined anti-tumor benefits of armed oncolytic viruses and T-cell therapy."