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# Apexigen Orphan Status for Sarcoma Therapy
- URL: https://www.fdaweb.com/apexigen-orphan-status-for-sarcoma-therapy/
- Published: 2021-08-05T12:00:00.000Z
- Updated: 2026-09-14T17:09:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149874

FDA has granted Apexigen an orphan drug designation for APX005M (sotigalimab) for treating soft tissue sarcoma. Sotigalimab is described by the company as a CD40 agonist monoclonal antibody “with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability. In an ongoing Phase 2 clinical trial, sotigalimab is being evaluated in advanced soft tissue sarcoma in combination with doxorubicin, a chemotherapy that is currently considered standard-of-care treatment.” Previously, the agency granted the therapy an orphan designation for treating esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.