Sotigalimab (APX005M) Receives Orphan Drug Designation From US FDA

Release Date: 21-Sep-2021

US FDA has granted the orphan drug designation to sotigalimab (APX005M) for the treatment of soft tissue sarcoma. Sotigalimab is planned to stimulate antitumor immune response and to target CD40, which is a key co-stimulatory receptor that helps to activate innate and adaptive immune systems. Sotigalimab, when binds to CD40 on antigen-presenting cells, it induces a multifaceted immune response that gets numerous components of the immune system collected to attack the cancer.


In Phase 2 clinical trial the safety and efficacy of the agent in combination with standard-of-care doxorubicin is being evaluated in patients with advanced soft tissue sarcomas, which is estimated to enroll a total of 27 participants. The initial objective of the trial is objective response rate, and secondary objectives comprise of determining the recommended dose for the combination, examining progression-free survival, and evaluating the adverse effects (AEs) that occur with the regimen.


Sotigalimab is also being considered in phase 2 clinical trials as a powerful treatment for patients with melanoma, esophageal and gastro esophageal junction cancers, rectal cancer, and sarcoma in multiple combinations with radiation therapy, immunotherapy, chemotherapy, or a cancer vaccine.

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