Radiopharmaceuticals firm Theragnostics has been awarded an Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its THG-009 iodine-123 poly (ADP-ribose) polymerase inhibitor (PARPi) radiotherapeutic agent.
Theragnostics is developing the I-123 PARPi agent for treating primary and recurrent glioblastoma multiforme (GBM). The vendor said that its early nonclinical data showed promising results, supporting the progression of I-123 PARPi into a phase I clinical study for treating recurrent GBM.
The Innovation Passport, provided under the MHRA's Innovative Licensing and Access Pathway, is awarded by the agency to companies developing therapeutics for life-threatening or seriously debilitating conditions, Theragnostics said. In the next step of this regulatory pathway, a target development profile document will be prepared by the MHRA, the National Institute for Health and Care Excellence, and the Scottish Medicines Consortium.
![Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/05/body-comp.XgAjTfPj1W.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
