ABL Bio Confirms Possibility of FDA Accelerated Approval for Zivastomig

Novabridge Holds Meeting with FDA
"Application to Be Filed Using ORR Data as Primary Endpoint"

ABL Bio announced on March 17 that its partner, Novabridge Biosciences, has confirmed the possibility of accelerated approval for Zivastomig (ABL111), which is being developed as a treatment for gastric cancer, during a meeting with the US Food and Drug Administration (FDA).

The company explained that this meeting was based on positive data from the Phase 1b clinical trial evaluating the combination therapy of Zivastomig, the PD-1 inhibitor nivolumab, and chemotherapy.

Novabridge held a Type B meeting with the FDA and subsequently received a written meeting summary containing an agreement on the accelerated approval process for Zivastomig. ABL Bio and Novabridge plan to use objective response rate (ORR) as the primary endpoint for Zivastomig's accelerated approval, based on the discussions from this meeting.

Zivastomig is a bispecific antibody that targets both Claudin18.2 and 4-1BB, and is one of the pipeline assets being co-developed by ABL Bio and Novabridge. ABL Bio and Novabridge are aiming to initiate the registrational Phase 3 clinical trial for the accelerated approval application in the fourth quarter of this year.

ABL Bio CEO Lee Sanghoon stated, "Through close collaboration with Novabridge, we will accelerate the development of Zivastomig and become a leader in the Claudin18.2 therapeutics market."

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