Duality Biologics has expanded its licensing collaboration with BioNTech to include the Trop2 antibody-drug conjugate (ADC) DB-1305.
As part of the agreement, Duality Bio will receive upfront development and milestone-based payments, along with tiered royalties on net drug sales.
DB-1305 is a third-generation ADC built using Duality Bio’s duality immune toxin antibody conjugates (DITAC) platform. The drug has demonstrated efficacy in pre-clinical models of non-small cell lung cancer (NSCLC) and other solid tumours, according to Duality Bio.
The ADC is currently being investigated for safety and efficacy in an open-label, non-randomised Phase I/II trial (NCT05438329) for the treatment of advanced solid tumours.
The latest collaboration expands on an existing one involving two other drug candidates, DB-1303 and DB-1311, which are topoisomerase-1 inhibitor-based ADCs that target human epidermal growth factor receptor 2 (HER2) in HER2-expressing cancers. The agreement provides BioNTech with the rights to market the three Duality Bio drugs globally, except in mainland China, Hong Kong and Macau, where the latter retains the commercial rights.
DB-1303 is currently being investigated in an open-label, non-randomised Phase II trial (NCT05150691) for the treatment of HER2-expressing malignant solid tumours. It has also been granted a fast track designation from the US Food and Drug Administration (FDA)
BioNTech has reported a sharp decline in revenue in H1 2023, generating only €1.44bn ($1.59bn) in the six months compared to €9.57bn ($10.5bn) generated in the comparative period in 2022. This was mainly attributed to the decline in Covid-19 vaccine sales compared to last year. BioNTech’s market cap currently stands at $25.66bn.
Despite declining Covid-19 vaccine sales, the German-based company recently announced a $3.2bn contract with the US Government to supply its Omicron-adapted Covid-19 vaccines, developed in conjunction with Pfizer. The contract is contingent on FDA approval of the vaccine.