FAPI-74 / Novartis - LARVOL DELTA

SOFIE and GE HealthCare Enter Licensing Agreement to Develop FAP PET Radiotracers (GE healthcare Press Release) - "GE HealthCare today announced an exclusive global licensing agreement with SOFIE Biosciences (SOFIE), a Virginia, U.S.-based company, to develop, manufacture and commercialize SOFIE’s Gallium-68 and Fluorine-18 labelled diagnostics targeting fibroblast activation protein (FAP). Financial terms were not disclosed. Based on this agreement, GE HealthCare will take on global rights for [68Ga]FAPI-46 and outside-US rights for [18F]FAPI-74, originally developed at Heidelberg University in Germany, and both currently in Phase II clinical trials in the U.S. ([68Ga]FAPI-46 (NCT05262855) and [18F]FAPI-74 (NCT05641896). SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74 in the U.S."

Licensing / partnership • Oncology

Molecular theranostics for metastatic prostate cancer: PSMA, FAPI, or both? Levinneen eturauhassyövän teranostiikka: PSMA, FAPI vai molemmat? (clinicaltrialsregister.eu) - P2 | N=40 | Ongoing | Sponsor: Heikki Minn

Metastases • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FAP

Potential Value of FAPI PET/CT in the Detection and Treatment of Fibrosing Mediastinitis: Preclinical and Pilot Clinical Investigation. (PubMed, Mol Pharm) - "Through a fibrosis rat model, F-FAPI-74 was used for lesion imaging and Lu-FAPI-46 was utilized to investigate the potential therapeutic effect on FM in vivo...In conclusion, F-FAPI-46 PET/CT can be a potentially valuable tool for the diagnosis of FM. Of note, Lu-FAPI-46 may be a novel and safe radiolabeled reagent for the integration of diagnosis and treatment of FM."

Journal • Preclinical • Cardiovascular • Fibrosis • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • FAP

Head-to-Head Intra-Individual Comparison of Biodistribution and Tumor Uptake of [F]FAPI-74 with [F]FDG in Patients with PDAC: A Prospective Exploratory Study. (PubMed, Cancers (Basel)) - "To the best of our knowledge, this is the first, prospective, intra-individual investigation comparing [F]FAPI-74 with [F]FDG imaging in PDAC with encouraging results. These pivotalresults supporta larger, multicentric, prospective study to determine the value of [F]FAPI-74 in detecting and staging PDAC in comparison with current standard of care imaging."

Head-to-Head • Journal • Gastrointestinal Cancer • Hepatology • Oncology • Palliative care • Pancreatic Cancer • Solid Tumor • FAP

Activated fibroblasts in muscle sarcoidosis revealed by [F]FAPI-74 PET. (PubMed, Eur J Nucl Med Mol Imaging) - No abstract available

Journal • Immunology • Sarcoidosis

Initial Evaluation of [F]FAPI-74 PET for Various Histopathologically Confirmed Cancers and Benign Lesions. (PubMed, J Nucl Med) - "[F]FAPI-74 PET is a promising novel diagnostic modality for various tumors, especially for precise staging before treatment, including characterization of tumor lesions before surgery. Moreover, F-labeled FAPI ligand might serve a higher demand in clinical care in the future."

Journal • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thymoma • Thymus Cancer • FAP

First Patient Imaged in SOFIE's 18F-FAPI Phase 2 trial (PRNewswire) - "SOFIE Biosciences...has dosed and imaged the first patient with [18F]FAPI-74 in its US Clinical Trial of flourine-18 labeled Fibroblast Activation Protein Inhibitor (FAPI). This study is a Phase 2, Multicenter, Non-randomized Study of [18F]FAPI-74 PET for imaging patients with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer (NCT05641896)."

Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Monitoring FAP CAR T Cell Therapy with PET Imaging (ASGCT 2023) - "FAP is a cell surface serine protease that is highly expressed by cancer associated fibroblasts in the TME that participate in the generation of the immunosuppressive stromagenic response in solid tumors...In this study, we utilized the 18F-radiolabeled FAP inhibitor (FAPI), [18F]AlF-FAPI-74, to image FAP in two different mouse tumor models...PET imaging is a powerful tool that can have may applications. PET imaging of FAP could be a highly useful approach to stratify patients prior to FAP CAR T therapy, as well as to monitor the pharmacodynamic response for FAP-targeted therapies."

CAR T-Cell Therapy • IO biomarker • Lung Adenocarcinoma • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SOFIE granted IND for 18F-FAPI in Phase 2 study (PRNewswire) - "SOFIE Biosciences...has received Investigational New Drug (IND) clearance to proceed with clinical study of [18F]FAPI-74, its lead fluorine-18 labelled Fibroblast Activation Protein Inhibitor (FAPI) product. The study accepted as part of the FDA IND review is for a Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in patients with Gastrointestinal Cancers."

IND • Gastrointestinal Cancer • Oncology • Solid Tumor

Subclass Analysis of Malignant, Inflammatory and Degenerative Pathologies Based on Multiple Timepoint FAPI-PET Acquisitions Using FAPI-02, FAPI-46 and FAPI-74. (PubMed, Cancers (Basel)) - "Multiple timepoint FAPI-PET/CT is a promising innovative imaging technique that provides additional imaging information compared to single timepoint imaging. Differences in the kinetic behavior of malignant and benign pathologies can facilitate the interpretation of FAPI-positive lesions."

Journal • Gastrointestinal Cancer • Hepatology • Immunology • Inflammation • Oncology • Pancreatic Cancer • Pancreatitis • Solid Tumor • FAP

Monitoring Therapeutic Response to Anti-Fibroblast Activation Protein (FAP) CAR T Cells using [18F]AlF-FAPI-74. (PubMed, Clin Cancer Res) - "This non-invasive imaging approach to interrogate the tumor microenvironment represents an innovative pairing of a diagnostic PET probe with solid tumor CAR T cell therapy and has the potential to serve as a predictive and pharmacodynamic response biomarker for FAP as well as other stromal cell-targeted therapies."

CAR T-Cell Therapy • Journal • Hematological Disorders • Hematological Malignancies • Lung Cancer • Oncology • Solid Tumor • FAP

Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Tadashi Watabe

New trial • Oncology • Solid Tumor

Repetitive early FAPI-PET acquisition comparing FAPI-02, FAPI-46 and FAPI-74: methodological and diagnostic implications for malignant, inflammatory and degenerative lesions. (PubMed, J Nucl Med) - "Additionally, considering clinical feasibility, acquisition at 30 to 40 min p.i. could be a reasonable compromise. Different FAPI tracer variants show significant differences in their time-dependent biodistributional behaviour and should be selected carefully depending on the clinical setting."

Journal • Oncology • Pancreatic Cancer • FAP

Fibroblast activation protein targeted therapy using [Lu]FAPI-46 compared with [Ac]FAPI-46 in a pancreatic cancer model. (PubMed, Eur J Nucl Med Mol Imaging) - "This study suggested the possible application of FAPI radioligand therapy in FAP-expressing pancreatic cancer. Further evaluation is necessary to find the best radionuclide with shorter half-life, as well as the combination with therapies targeting tumour cells directly."

Journal • Preclinical • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • FAP

FAPI-CRC1: FAPI PET/CT for Lymph Node Staging in Colorectal Carcinoma (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: The Netherlands Cancer Institute

New trial • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MRI

One-pot and one-step automated radio-synthesis of [F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. (PubMed, EJNMMI Radiopharm Chem) - "We established a one-pot one-step automated synthesis method using a CFN-MPS200 synthesizer that provided high radioactivity and stable radiochemical purity for possible clinical applications."

Journal • Oncology • FAP

F-labeled tracers targeting fibroblast activation protein. (PubMed, EJNMMI Radiopharm Chem) - "[F]AlF-labeled FAPI derivatives represent powerful tracers for PET. Owing to an excellent performance in PET imaging, FAPI-74 can be regarded as a promising precursor for [F]AlF-based FAP-imaging."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • DPP4 • FAP

Diagnostic comparison of 18F-FDG with 18F-FAPI-74 in Thyroid Cancer patients with TENIS Syndrome Συγκριση της απεικονιστικής ικανότητας μεταξύ του 18F-FDG και 18F-FAPI-74 σε ασθενείς με καρκίνο θυρεοειδούς με σύνδρομο TENIS (clinicaltrialsregister.eu) - P2; N=20; Ongoing; Sponsor: GERMAN ONCOLOGY CENTER

New P2 trial • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Clinical translational evaluation of AlF-NOTA-FAPI for fibroblast activation protein-targeted tumour imaging. (PubMed, Eur J Nucl Med Mol Imaging) - "The AlF-NOTA-FAPI probe was successfully fabricated and applied in fibroblast activation protein-targeted tumour PET/CT imaging, which showed excellent imaging quality and tumour detection efficacy in U87MG tumour-bearing mice as well as in cancer patients."

Clinical • Journal • Oncology • FAP

Fully automated production of the fibroblast activation protein radiotracer [ F]FAPI-74. (PubMed, J Labelled Comp Radiopharm) - "The radiochemical purity was greater than 95% for [ F]FAPI-74, obtained from both modules. Overall, the protocol reliably provides a sterile and pyrogen-free good manufacturing practice (GMP) compliant product of [ F]FAPI-74 suitable for clinical PET imaging."

Journal • FAP

Novartis expands targeted radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP) (GlobeNewswire) - "Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74...The agreement also includes co-exclusive rights for Novartis to develop imaging applications for these assets...'We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. We believe working across multiple approaches is the key to reimagining cancer care...'"

Licensing / partnership • Oncology