A WORD FROM OUR CHIEF SCIENTIFIC OFFICER

Dear FAPI Community,

We are looking forward to a fruitful 2024. SOFIE and GE Healthcare (GEHC) continue to work closely on the clinical development of Gallium-68 and Fluorine-18 Fibroblast Activation Protein Inhibitor (FAPI) radiopharmaceutical tracers. Last October, we entered a licensing agreement for GEHC to take on global rights for [68Ga]FAPI-46 and outside-US rights for [18F]FAPI-74, while SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74  in the U.S. We completed our first Joint Steering Meeting in person to kick start our strategic efforts on the FAPI program.

SOFIE’s Phase 2 prospective clinical trial with [18F]FAPI-74 is well underway with 4 sites activated and 2 more in progress. We have completed 40% of the study and anticipate completing patient recruitment by August 2024. More updates are in the Clinical Development section below.

SOFIE and GEHC are excited to participate jointly in the the 7th Theranostics World Congress, to be held March 22-24 in Santiago, Chile. This international conference is a forum to share the latest theranostic developments. I will be presenting, along with Paul Evans, PhD, from GE Healthcare on advancements in FAPI diagnostics. If you are planning to attend, I hope to see you there!

As always, thank you for reading our newsletter. We sincerely appreciate your input on how this can be a better resource for the FAPI community.

Sherly Mosessian, Ph.D.

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

FAPI CLINICAL DEVELOPMENT UPDATES

FAPI Pipeline 2024

PUBLICATION HIGHLIGHTS

Each newsletter will feature recent FAPI publications.

18F-FAPI-04 Outperforms 18F-FDG PET/CT in Clinical Assessments of Patients with Pancreatic Adenocarcinoma

J Nucl Med. 2024 Feb

Fibroblast Activation Protein α-Directed Imaging and Therapy of Solitary Fibrous Tumor  

J Nucl Med. 2024 Feb

68Ga-Labeled Fibroblast Activation Protein Inhibitor PET/CT for the Early and Late Prediction of Pathologic Response to Neoadjuvant Chemotherapy in Breast Cancer Patients: A Prospective Study

J Nucl Med. 2023 Dec

THERANOSTICS WORLD CONGRESS

7th Theranostics World Congress

The next Theranostics World Congress, another sign of our growing field, will be held March 22-24 in Santiago, Chile. The program features perspectives on cutting edge research, disease-specific targets, therapies, and patient access. SOFIE and GE Healthcare will be presenting on FAPI in a session on tumor microenvironment diagnostics.

FAPI OUTREACH PROGRAM

Join us in advancing the frontier of molecular imaging through the FAPI Outreach Program

SOFIE is continuing to accept applications for our FAPI Outreach Program. This program aims to raise awareness and foster collaboration in the field of molecular imaging, specifically focusing on Fibroblast Activation Protein Inhibitor (FAPI) studies. This program seeks to engage with healthcare professionals, researchers, and the broader community to share knowledge, advancements, and the potential impact of FAPI in diagnostic and therapeutic applications.

*GE Healthcare licensed products and regions will be ready for new application reviews in April.

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