Swedish biotech firm BioInvent International has signed a clinical trial partnership and supply agreement with Merck (MSD) to assess its BI-1808 plus Keytruda for the treatment of solid tumours.
BI-1808 is an antibody that targets tumour necrosis factor receptor 2 (TNFR2) while Merck’s Keytruda is an anti-programmed cell death protein 1 (anti-PD-1) drug.
The collaboration, which is the second such agreement between the companies, involves a Phase I/IIa clinical trial of lung cancer and ovarian cancer patients.
BioInvent International CEO Martin Welschof said: “We are very pleased we have reached a second collaboration with MSD that supports the expansion of the clinical trial programme with our anti-TNFR2 antibody BI-1808.
“We are excited about the potential synergistic activity of BI-1808 in combination with pembrolizumab and this agreement supports the strong interest elicited by our broadening pipeline of anti-cancer antibodies.”
The Phase I/IIa trial is designed to evaluate BI-1808 as a monotherapy and in combination with Keytruda for the treatment of non-small cell lung cancer and ovarian cancer patients.
In the Phase I segment, for which enrolment is ongoing, subjects will be given BI-1808 as a single agent while the Phase II segment will analyse the combination.
Separately, the Phase IIa portion will test BI-1808 as monotherapy for cutaneous T cell lymphoma.
The trial will be conducted in the US, Denmark, Hungary, the UK and Russia. Participant recruitment is underway in multiple countries in Europe.
BioInvent has three drug candidates in four clinical programmes in Phase I/II studies to treat haematological cancer and solid tumours, respectively.
BI-1808 is part of the company’s tumour-associated regulatory T cells (Treg)-targeting programme, which builds on its F.I.R.S.T platform technology that detects targets and antibodies at the same time.
The platform can generate potential new therapy candidates to act on the tumour microenvironment.
In May 2021, BioInvent and its partner Transgene obtained approval from the US Food and Drug Administration for their Phase I/IIa trial of the oncolytic virus, BT-001, to treat solid tumours.