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FDA Clears Global Phase III Trials for Osemitamab


The gastric/gastroesophageal cancer treatment is produced by Transcenta.

Transcenta Holding Limited announced that FDA granted clearance for it to proceed with the global Phase III trial for osemitamab.

The trial will test the treatment in conjunction with nivolumab and chemotherapy, according to a press release. osemitamab is a treatment for gastric or gastroesophageal adenocarcinoma.

In a press release, Transcenta executive vice president of global medicine development and chief medical officer Dr. Caroline Germa said, “We are delighted with the positive outcome of the EOP2 meeting. The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. Securing FDA endorsement on critical program elements represents a pivotal milestone in advancing our Phase III trial in the U.S."

Osemitamab is described as a second-generation humanized CLN18.2 targeting antibody with CLDN18.2 binding affinity. It has demonstrated anti-tumor activities in preclinical tumor models.

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