MHRA awards Innovation Passport to Theragnostics' Glioblastoma product

Life sciences company Theragnostics has been awarded an Innovation Passport by the Medicines and Healthcare products Regulatory Agency (MHRA) for its product targeting the treatment of primary and recurrent Glioblastoma Multiforme (GBM).

Theragnostics’ therapeutic agent I-123 PARPi (THG-009) is currently being developed as a treatment for patients diagnosed with primary and recurrent GBM. The company states that the therapy has so far demonstrated promising results and is now looking to progress it towards a phase I clinical trial in recurrent GBM.

Glioblastoma has a high rate of recurrence in patients of approximately 90% and has a poor overall prognosis of survival of less than two years in most patients.

The Innovation Passport has been designed for companies developing therapeutics for conditions that are life-threatening or seriously debilitating and has the potential to offer significant benefits to patients. It’s designed to act as a gateway to enter the MHRA’s Innovative Licensing and Access Pathway (ILAP) which was launched in January 2021 to accelerate development and access to innovative medicines in the UK.

The next step in the pathway is the preparation of a target development profile (TDP) document by the MHRA, National Institute for Health and care Excellence (NICE) and the Scottish Medicines Consortium (SMC). The TDP is a ‘living document’ which sets out the regulatory and development milestones, finds potential pitfalls and creates a roadmap to achieving early patient access in the UK. The TDP can aid pharmaceutical companies with clinical trial design and evidence generation.

Dr Greg Mullen, chief executive officer of Theragnostics, said: “The Innovation Passport will allow us to work closely with the MHRA and its partner agencies to chart out a roadmap for regulatory and key development milestones with the primary goal of achieving early patient access for the treatment of glioblastoma.”