GE Healthcare and SOFIE Biosciences Partner on FAP Radiopharmaceuticals Shown to Be Highly Prognostic in Cancer Studies
GE Healthcare and SOFIE Biosciences have entered into a global licensing agreement for the development and commercialization of two investigational radiopharmaceutical diagnostics targeting fibroblast activation protein (FAP): [68Ga]FAPI-46 and [18F]FAPI-74. FAP is an enzyme highly expressed in cancer-associated fibroblasts (CAFs), which play a pivotal role in the tumor microenvironment, supporting the growth and spread of cancer cells across various tumor types. The development of FAP-targeted diagnostics has potential in the field of oncology as well as other applications including applications in inflammation, fibrosis, and arthritis.
Under the agreement, GE Healthcare will assume global rights for [68Ga]FAPI-46 and outside-U.S. rights for [18F]FAPI-74, both of which are currently in Phase II clinical trials in the U.S. SOFIE Biosciences will retain clinical development and commercialization rights for [18F]FAPI-74 in the United States, continuing its current ongoing clinical development and commercialization program.
The collaboration aims to leverage GE Healthcare’s capabilities and resources to advance the development of FAP imaging products through clinical trials, regulatory submissions, and potential commercialization in various regions. SOFIE and GE Healthcare will collaborate on these processes through a joint steering committee. Financial terms of the agreement have not been disclosed.
A recent study published in June in Cell Communication and Signaling discusses the potential of FAP as a prognostic biomarker in cancer. The study discusses how FAP is highly expressed in cancer-associated fibroblasts (CAFs) and has been associated with poor patient prognosis in various cancer types. In lung adenocarcinoma, stromal FAP overexpression is linked to worse prognosis. High-grade serous ovarian cancer with FAP overexpression exhibits poor overall survival, progression-free survival, and advanced disease stages. FAP also correlates with tumor aggressiveness and poor survival in clear renal cell carcinoma and glioblastoma. FAP overexpression has been observed in gastrointestinal tumors, including pancreatic ductal adenocarcinoma, gastric cancer, esophageal squamous cell carcinoma, and hepatocellular carcinoma. High FAP expression in these cases is associated with factors like poor survival, tumor development, angiogenesis, lymph node metastasis, and aggressive disease stages.
FAP has perhaps been most studied in colorectal cancer. FAP’s overexpression in colorectal cancer is linked to tumor microenvironment remodeling, immunosuppression, and adverse clinical outcomes. Studies have shown that FAP overexpression in colorectal cancer is associated with more aggressive disease, metastasis, and recurrence, making it a promising target for therapeutic interventions.
The exclusive expression of FAP in tumor stroma also makes it a potential therapeutic target as well. Various approaches are being explored to target FAP, including Chimeric Antigen Receptor (CAR) T-cell therapy, cancer vaccines, antibody-drug conjugates, prodrugs, and nano-drugs. These therapies aim to enhance anti-tumor immune responses, inhibit tumor growth, and improve overall patient outcomes.
GE Healthcare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents, and supports approximately 100 million procedures annually, with a focus on cardiology, neurology, and oncology applications.
GE Healthcare’s Usankar Thiru, Strategy & Evaluation Director for Pharmaceutical Diagnostics, emphasized the company’s commitment to working with partners like SOFIE to expand its innovation pipeline and provide size, scale, and unique perspective to drive innovation in healthcare.