Biond Biologics has dosed the first subjects in the sub-part of Phase I clinical trial of BND-22 (SAR444881) plus Keytruda (pembrolizumab) or with Erbitux (cetuximab) in advanced solid tumour patients.

A humanised IgG4, antagonist antibody, BND-22 acts on the Ig-Like Transcript 2 (ILT2) receptor. It is being developed for treating solid tumours.

The antibody showed to possess a wide-ranging anti-tumour effect in preclinical studies by acting on ILT2-mediated ‘do not eat me’ signals in macrophages and by stimulating NK and CD8+ lymphocytes.

The first-in-human, open-label, dose escalation and expansion trial will analyse the safety, tolerability, pharmacokinetics (PK), anti-tumour activity and exploratory biomarkers for BND-22 activity in subjects with selected advanced solid tumours. It is enrolling subjects in medical centres in the US and Israel.

Biond Biologics Clinical Development vice-president Itay Friedman said: “While approved immunotherapies and tumour targeting antibodies have transformed cancer care, an urgent need to develop new approaches for the treatment of advanced cancer patients remains.

“Concurrently targeting different immune pathways, dysregulated in tumours may result in an enhanced anti-tumour effect.

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“We are excited to initiate the next part of BND-22’s Phase I trial exploring the inhibition of ILT2 in combination with potentially complementing therapeutics.”

The company entered an exclusive global licence agreement with Sanofi in January last year to develop and market BND-22.

As per the deal, Biond agreed to oversee the Phase I trial of the antibody to assess its safety and tolerability as a monotherapy and along with approved cancer treatments.

Furthermore, the company will investigate the link between the anti-tumour activity of BND-22 and select tumour and blood-based biomarkers.

Sanofi will oversee the further clinical development and marketing of BND-22.