Ambrx’s ARX788 gets FDA orphan drug status for gastric cancer treatment

Ambrx has announced that its antibody drug conjugate (ADC) ARX788 has been granted orphan drug designation by the US Food and Drug Administration for the treatment of patients having HER2-positive gastric cancer.

The orphan drug designation for ARX788, announced in March 2021, for gastric cancer gives Ambrx with benefits such as inclusion of an exemption to FDA prescription drug user fees and also tax credits for qualified clinical trials.

Besides, it grants eligibility for seven years of market exclusivity to the gastric cancer drug candidate, which will be subject to getting approval from the FDA.

Ambrx’s ARX788 gets FDA orphan drug status for gastric cancer treatment

Feng Tian – President and CEO of Ambrx said: “The ongoing Phase 1 ACE-Gastric-01 trial has shown promising anti-tumor activity in HER2-positive advanced gastric patients who have been previously treated with trastuzumab and chemotherapy in the metastatic setting.

“Receiving orphan drug designation from the FDA is an important milestone in our ongoing efforts to develop ARX788 for a wide range of HER2-positive cancers. We are proud to be targeting a rare disease that is currently severely underserved by advancing ARX788 into additional clinical trials.”

Ambrx expects the release of additional data from the phase 1 ACE-Gastric-01 trial by the end of this year. In the second half of 2021, the California-based clinical stage biopharma company will also look to launch the global phase 3 ACE-Gastric-02 trial for assessing ARX788 in HER2-positive gastric cancer.

The ACE-Gastric-02 clinical trial is presently intended to be a randomized trial of ARX788 in comparison to physician’s choice of treatment in second line HER2-positive gastric cancer and also HER2-positive cancer at the gastroesophageal junction.