BioInvent receives Investigational New Drug approval for monoclonal antibody BI-1910

James Spargo | June 2, 2023 | News story | Research and Development BioInvent, NSCLC, Oncology, monoclonal antibody 

Swedish clinical stage biotech company BioInvent has announced that it has received Investigational New Drug (IND) approval for its monoclonal antibody, making it the second of its anti-tumour necrosis factor receptor 2 (TNFR2) programmes to enter clinical development.

BI-1910 is a differentiated agonist approach compared to BioInvent’s first-in-class anti-TNFR2 antibody BI-1808, which is currently in a phase 1/2a trial. Both programmes were chosen from a large family of binders generated through BioInvent’s F.I.R.S.T technology platform. A surrogate of BI-1910 was used in experimental models, allowing the company to research more deeply the pharmacodynamic biomarkers.

BioInvent will conduct a phase 1/2a clinical trial across US and Europe for BI-1910, with exploratory cohorts planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). The drug will also be tested by itself and in combination with pembrolizumab.

Martin Welschof, CEO of BioInvent, stated: “I am very excited to be moving BI-1910 into clinical trials to explore the potential of this differentiated anti-TNFR2 approach. We have built up a strong understanding of the biology of TNFR2 and this means we can move forward with two different monoclonal antibodies against this promising target. BI-1910 becomes the fifth product in clinical development, in six different trials, reflecting the productivity of the BioInvent technology platform and its potential to radically intervene on the tumour microenvironment and significantly improve treatment for cancer patients.”

James Spargo

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