SOFIE submits IND for [18F]-FAPI-74 in Phase 2 study of Gastrointestinal Cancers

Dulles, VA – October 31, 2022 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has submitted the IND for [ 18 F]FAPI-74, fluorine 18 labelled radiopharmaceutical targeting Fibroblast Activation Protein (FAP) to the FDA. The clinical protocol for this IND is a Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [ 18 F]FAPI-74 PET in Patients with Gastrointestinal Cancers. The filing, which continues SOFIE’s FAPI clinical development efforts, follows the IND activation and clinical trial launch for [ 68 Ga]FAPI-46, the lead 68 Ga labelled product of the FAPI family of compounds. Sherly Mosessian, Ph.D , SOFIE’s Chief Scientific Officer, stated, “We are proud of the work that has gone into enabling this critical milestone for a new and much needed 18F labelled radiopharmaceutical for targeting FAP. This allows us to address an unmet diagnostic need in gastrointestinal cancers, in addition to providing a strong companion diagnostic for radioligand and non-radioligand therapies targeting FAP and the tumor microenvironment.” While the FDA conducts its 30-day IND review, SOFIE is engaging in site feasibility and vendor selection efforts in preparation for clinical trial activation.

The release as fetched from its publisher. sofie.com ↗