AstraZeneca, BioInvent ink pact to evaluate BI-1206 in combo with rituximab, Calquence

Under the terms of the supply agreement, AstraZeneca will provide Calquence, a selective inhibitor of Bruton's tyrosine kinase (BTK), for use in combination with BI-1206 and rituximab in the ongoing Phase 1/2a clinical study (NCT03571568) for the treatment of patients with follicular lymphoma who have progressed or are refractory to rituximab.

"Having already shown the benefits of combining BI-1206 with rituximab, we believe the addition of Calquence for a triplet combination could further improve clinical outcomes for patients with non-Hodgkin's lymphoma, including follicular lymphoma and mantle cell lymphoma, " said Dr. Martin Welschof, CEO of BioInvent. “We are extremely pleased to be entering into this supply agreement with AstraZeneca that allows us to explore a potential new, chemo-free, treatment option for these patients. "

The Phase 1 part - intravenously (IV) administered BI-1206 - has been completed with impressive early signs of clinical efficacy. The Phase 2a IV dose expansion cohort is currently enrolling patients, and it will look to enroll patients to be treated with the triplet. A subcutaneous (SC) formulation is being developed in parallel to the IV and it is expected to bring a great deal of convenience to the treatment. The Calquence expansion cohort is expected to enroll approximately 30 patients at sites in Sweden, Spain, the US, and Brazil.

BI-1206 is one of BioInvent’s most advanced drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab, drugs with combined global sales of approximately USD 23 billion annually.

The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin’s lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. Two delivery formulations (intravenous (IV) and (subcutaneous (SC) of BI-1206 are being evaluated in parallel.