RE: Cohort 3 2W6 Aug 2024 20:39
Note the three areas of interest between between the asterisks:
RNS 23.5.24
"The sub-study through partnership with SOFIE utilising baseline [18F]FAPI-74 PET scanning in the AVA6000 Phase 1 trial has commenced and is designed to better characterise in a subset of patients the ***whole-body tumor expression of the target of the pre|CISION™ molecule and levels of fibroblast activation protein ("FAP") expression, an enzyme present in high concentrations in many solid tumors. These data will inform on various indications for further efficacy studies. *** This sub-study represents an ongoing collaboration between Avacta and SOFIE, in the use of [18F]FAPI-74 PET as a complementary diagnostic. [18F]FAPI-74 PET is currently in clinical development and for investigational use only."
Also
CC "The introduction of a new diagnostic approach of [18F]FAPI-74 -PET scanning into the programme will help to better characterize the FAP expression among patients, potentially assisting in indication selection."
"We're excited to be working with our investigators to integrate these tools to accelerate our efforts to optimise indications, dosing and schedule, as we bring this promising program through clinical studies."
++++
From
https://sofie.com/2023/10/11/sofie-and-ge-healthcare-enter-licensing-agreement-to-develop-fap-pet-radiotracers/
"Chalfont St Giles, UK – 11 October, 2023: 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)[2] and [18F]FAPI-74 (***NCT05641896***)[3]). SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74 in the U.S."
++++
From NCT05641896 - https://clinicaltrials.gov/study/NCT05641896
"Study Overview
Brief Summary
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients ***diagnosed with Gastrointestinal cancers***, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer."
++++
SOFIE's Phase 2 study is Gastro only.
The sub-study with Avacta is whole body.
++++
Is this to give assurance where all the cancer cells are in Avacta patients prior to beginning of treatment - whole body,
and are SOFIE trying out their system for whole body not just GI.