Transgene and BioInvent Report Positive Phase Ia Data on Oncolytic Virus BT-001 in Solid Tumors

Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB, a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announce positive Phase Ia data on the oncolytic virus BT-001 for the treatment of solid tumors.

Treatment with single-agent BT-001 in 18 patients has now been completed with no safety concerns reported. Patients had at least one accessible superficial lesion and were studied in three dose-escalating cohorts. BT-001 stabilized the injected lesions in eleven patients in total: two at the 106 pfu dose (n=6), five at 107 pfu (n=6) and four at 108 pfu (n=6). Furthermore, objective antitumor activity, defined as decrease of injected lesion size of 50% or more, was observed in one patient in the 106 pfu cohort (n=6) and one patient in the 107 pfu cohort (n=6).

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO® platform encoding BioInvent’s anti-CTLA-4 antibody to elicit a strong and effective anti-tumoral response. The drug is currently being evaluated in a Phase I/IIa clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab) against solid tumors. Previously reported Phase I data confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumor activity. Based on these results, the independent Safety Review Committee (SRC) has now approved initiation of the combination part of the trial with pembrolizumab. The first patient in this Phase I part B is expected to be enrolled in H2 2023.