Tumour treatment among all phase 1a cohorts in were concluded with no safety concerns

Transgene – a company focusing on cancer immunotherapeutics and BioInvent International AB, which concentrates on the discovery of antibodies, have announced positive phase 1a data related to the oncolytic virus BT-001. The therapy has been developed for treating solid tumours.

Incorporating single agent BT-001 as a treatment among 18 patients has now reached its conclusion, with no safety concerns reported.

Individuals in the patient group had at least one superficial lesion and all were studied in three dose-escalating cohorts.

Candidate BT-001 duly stabilised the injected lesions in eleven patients – two at the 106 plaque-forming units (pfu) dose, five at 107 pfu and four at 108 pfu.

Meanwhile, objective antitumour activity – defined as a decrease of injected lesion size of 50% or above – was witnessed in one patient within the 106 pfu cohort and one patient in the 107 pfu group.

Transgene and BioInvent have collaborated to develop BT-001 – an oncolytic virus developed using Transgene’s Invir.IO platform; encoding BioInvent’s anti-CTLA-4 antibody to deliver an effective anti-tumoural response.

The therapy is currently being evaluated during a phase 1/2a clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor Keytruda, for the treatment of solid tumours.

Following the release of the data, the independent safety review committee has now approved initiation of the combination element of the study. An initial patient in this phase 1 part B is anticipated later in 2023.

Martin Welschof, chief executive officer of BioInvent, reflected: “This data is a further positive indication of the efficacy of BT-001 against solid tumours. 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, antitumour effect and ultimately clinical benefit in combination with pembrolizumab.”

He concluded: “There were no safety concerns and antitumour activity was observed even at the lowest dose. We are looking forward to investigating BT-001 further in combination with pembrolizumab.”