BT-001 encodes a differentiated regulatory T-cell depleting human recombinant anti-CTLA4 antibody as well as granulocyte-macrophage colony-stimulating factor (GM-CSF).
The drug is currently in a Phase I/IIa clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor Keytruda (pembrolizumab) against solid tumours. Keytruda for the trial is provided by MSD (Merck & Co).
The ongoing Phase 1/2a (NCT04725331) study is a multicentre, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with the anti-PD-1 treatment, Keytruda.
The Phase I is divided into two parts. In part A, patients with metastatic/advanced tumours receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with Keytruda.
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According to the companies report, the BT-001 single agent treatment was completed in 18 patients and no safety concerns were reported. BT-001 stabilised the injected lesions in eleven patients in total: two out of six at the 106 pfu dose, five out of six at 107 pfu and four out of six at 108 pfu.
Additionally, objective antitumor activity, which is defined as decrease of injected lesion size of 50% or more, was observed in two patients – one each of the 106 pfu cohort and the 107 pfu cohort.
The independent Safety Review Committee has now approved initiation of the combination part of the trial with pembrolizumab. The first patient in this combination cohort is expected to be enrolled in H2 2023.
According to GlobalData analysts oncolytic viruses are a key immuno-oncology development trend to watch in future. Analysis estimates that the oncolytic virus market will reach $1 billion by 2026.
Transgene and BioInvent are co-developing the virus under 50:50 costs and revenue collaboration agreement in oncolytic virus development.
BioInvent has another pipeline drug as combination therapy with Keytruda for solid tumour therapy. The BI-1206 is also under Phase I/IIa of development (NCT04219254).
Transgene will be presenting new data at ASCO 2023 for its therapeutic cancer vaccines TG4001, in Phase II study in patients with HPV16-positive anogenital tumours (NCT03260023), and TG4050, Phase I study in head and neck cancers (NCT04183166).