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# Alteogen Gains Orphan Status for Cancer Therapy
- URL: https://www.fdaweb.com/alteogen-gains-orphan-status-for-cancer-therapy/
- Published: 2018-08-06T12:00:00.000Z
- Updated: 2026-09-15T00:23:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142042

FDA has granted Alteogen an orphan drug designation for ALT-P7 and its use in treating gastric cancer. The antibody-drug conjugate (ADC) uses a trastuzumab (Genentech’s Herceptin) variant form of an antibody. ALT-P7, which is being investigated for treating gastric and breast cancers, utilizes the company’s NexMab platform technology, a proprietary next-generation site-specific conjugation methodology, Alteogen says. It is currently undergoing a first-in-humans Phase 1 clinical trial for breast cancer patients in Korea, and a Phase 2 clinical trial for breast cancer patients is expected to begin in 2019.