Transgene and BioInvent International have obtained US Food and Drug Administration (FDA) approval for investigational new drug (IND) application of a new oncolytic virus, BT-001, to treat solid tumours.

With the approval, the companies can recruit US patients for their ongoing multi-centre, open-label, dose-escalation Phase I/IIa clinical trial of the drug candidate.

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BT-001 encodes a differentiated Treg depleting human recombinant anti-CTLA4 antibody as well as granulocyte-macrophage colony-stimulating factor (GM-CSF). Transgene and BioInvent are co-developing the drug candidate.

The Phase I/IIa trial is designed to assess BT-001 as a monotherapy and in combination with pembrolizumab, which is an anti-PD-1 drug. The Phase I portion is underway in Europe and is enrolling participants in multiple countries.

Transgene and BioInvent expect BT-001 to specifically target and modulate the tumour microenvironment to generate a strong and effective response against tumours.

The delivery of the drug candidate directly to the tumour is also intended to stimulate local Treg reduction and strong therapeutic action.

Furthermore, a decrease in systemic exposure could enhance the safety and tolerability of BT-001.

Transgene chairman and CEO Hedi Ben Brahim said: “We have designed BT-001 to significantly improve treatment for patients with solid tumours by restoring their immune response against cancer.

“Its capacity to induce long-lasting antitumor immune responses and abscopal effects has been demonstrated in several tumour models.”

The Phase I portion of the trial includes Part A, which will see up to 36 metastatic or advanced solid tumour patients who will be given intra-tumoral administrations of BT-001 as a monotherapy.

Meanwhile, Phase I Part B will evaluate the combination of intra-tumoral BT-001 plus the standard regimen of pembrolizumab in 12 patients.

The trial’s Phase IIa portion will analyse BT-001-based combination treatment in multiple patient cohorts with various types of tumours.

These expansion cohorts are meant to examine the treatment’s activity in malignancies that are not usually addressed with this type of therapy.

In March this year, the first patient in the trial was enrolled at the Institut Bergonié in France.