BioInvent and Transgene announce positive phase 1a solid tumour trial data

James Spargo | May 25, 2023 | News story | Research and Development BioInvent, Oncology, Transgene, clinical trials, oncology, tumours 

Sweden-based BioInvent and French Transgene, both biotech companies, have reported positive phase 1a data from a trial studying BT-001 for the treatment of solid tumours.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its large-capacity VVcopTK-RR-oncolytic virus, which has been engineered to encode both a Treg-depelting human recombinant anti-CTLA-4 antibody, which was generated by BioInvent’s n-CoDeR/F.I.R.S.T platforms and the human GM-CSF cytokine.

By targeting the tumour microenvironment, BT-001 is expected to achieve a stronger and more effective antitumoural response.

The trial is an ongoing phase 1/2a (NCT04725331) multi-centre, open label, dose-escalation study evaluating BT-001 in patients with metastatic/advanced tumours as a single agent (phase 1a), and in combination with Keytruda (pembrolizumab) (phase 1b). Phase 1a has now been completed in 18 patients, where no safety concerns were reported. Data showed that BT-001 stabilised tumours in 11 patients and objective anti-tumour activity ‒ categorised as a decrease of tumour size by 50% or more ‒ was seen in two patients.

Martin Welschof, CEO of BioInvent and Dr Alessandro Riva, chairman of Transgene, commented: “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, antitumor effect and ultimately clinical benefit in combination with pembrolizumab. There were no safety concerns and anti-tumour activity was observed even at the lowest dose. We are looking forward to investigating BT-001 further in combination with pembrolizumab.”

James Spargo

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