Transgene and BioInvent report positive Phase Ia data on oncolytic virus BT-001 in solid tumors

Transgene and BioInvent report positive Phase Ia data on oncolytic virus BT-001 in solid tumors

Treatment of all Phase Ia cohorts in monotherapy completed with no safety concerns

Stabilization of injected lesions in 11/18 patients

An independent Safety Review Committee has approved initiation of the combination trial with pembrolizumab

Strasbourg, France, and Lund, Sweden, May 25, 2023, 7:30 am CEST – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), 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.

“These data are a further positive indication of the efficacy of BT-001 against solid tumors. While the advanced disease setting of this first in human trial did not allow long-term monitoring of patients, the effect on injected lesions has the potential to translate into the induction of a systemic immune response, antitumor effect and ultimately clinical benefit in combination with pembrolizumab. There were no safety concerns and antitumor activity was observed even at the lowest dose. We are looking forward to investigating BT-001 further in combination with pembrolizumab,” commented Martin Welschof, CEO of BioInvent and Dr. Alessandro Riva, Chairman of Transgene.