Focus on FAPI Newsletter – October 2022

We are excited to launch our FAPI newsletter with the aim of keeping our FAPI user community informed, engage new users and create a community to share research and development advances in FAP targeting efforts. This quarterly newsletter will feature FAPI publication highlights, updates on SOFIE’s FAPI clinical and regulatory development efforts, the latest from our FAPI global outreach program, and any other important news.

In this newsletter we are highlighting the first patient imaged as part of our [⁶⁸Ga]FAPI-46 Phase 2 Pancreatic Ductal Adenocarcinoma study at NYU Langone, in addition to our IND filing for [¹⁸F]FAPI-74 for a Phase 2 study in Gastrointestinal Cancers.

At SOFIE we look forward to expanding our partnership with academic leaders to explore the full potential of the FAPI family of compounds, along with partnerships with industry FAPI-46/FAPI-74 serving as a companion diagnostic tool as a predictive biomarker and therapy response measurement in FAP or stroma targeted therapeutics.

We hope you enjoy this newsletter, and welcome your feedback on how we can better keep you informed.

– Sherly Mosessian, Ph.D., Chief Scientific Officer

The first patient has been dosed and imaged with [⁶⁸Ga]FAPI-46 at NYU Langone in SOFIE’s Phase 2, Multicenter, Non-randomized Study of [⁶⁸Ga]FAPI-46 PET for imaging patients with Pancreatic Ductal Adenocarcinoma (PDAC).

NYU Langone and Mayo Clinic are the first two sites activated in support of this study, with additional sites expected to join in the coming months. Special thanks to NYU Langone Health (PI: Elcin Zan, MD) and Mayo Clinic’s clinical trial team (PI: Ajit H. Goenka, MD) and investigators in support of this study.

In addition to the efforts on the [⁶⁸Ga]FAPI-46 PET clinical development, SOFIE has submitted its IND for [¹⁸F]FAPI-74 for a Phase 2 study in Gastrointestinal Cancers at the end of October. This submission comes following a successful pre-IND meeting with the FDA in support of this study.

SOFIE is currently in the process of performing site feasibility assessment of clinical trial sites for this study. Once the IND has been granted, SOFIE will move forward with activating clinical trial sites, in addition to working with investigators who are interested in performing investigator initiated studies with [¹⁸F]FAPI-74 and providing access to use of the IND through a letter of cross reference.