Biond Biologics Ltd., a private clinical-stage biopharmaceutical company, has entered a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, to evaluate its immunotherapy agent BND-35 in combination with Merck KGaA’s anti-EGFR monoclonal antibody cetuximab (Erbitux) in a Phase 1 clinical trial (BND-35-001, NCT06274437) for the treatment of patients with unresectable or metastatic solid tumors.
 
Under the agreement, Merck KGaA will supply Biond Biologics with cetuximab to support Biond’s Phase 1 clinical trial, aimed at evaluating the safety and efficacy of BND-35 in combination with cetuximab. Enrollment in the BND-35 dose-escalation monotherapy arm has already begun, and several patients have already been dosed.
 
BND-35 is a novel anti-ILT3 (LILRB4) antibody that inhibits the interaction between ILT3 and various extracellular matrix ligands, including fibronectin, a major component of many tumor microenvironments (TME). ILT3 is expressed on myeloid suppressive cells and contributes to a pro-tumorigenic TME. Additionally, ILT3 reduces the effectiveness of targeted antibody therapies that leverage antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), immunological mechanisms known to eliminate tumor cells. BND-35 reprograms the suppressive TME to a more pro-inflammatory one and reverses the inhibitory effects of ILT3 on ADCC and ADCP mechanisms.
 
“We are thrilled to partner with Merck KGaA, Darmstadt, Germany to secure the supply of cetuximab for our clinical trial and thank Merck KGaA, Darmstadt, Germany for their interest in BND-35,” said Tal Sines, VP of Business Development at Biond Biologics. “Our preclinical data show that BND-35 can synergize with therapies such as cetuximab, that promote ADCC and ADCP activities. It could provide a potential new treatment option for patients with solid tumors.”