MHRA designation involves entry into innovative licensing and access pathways.
iOnctura – a company developing treatments for patients with cancer – has announced that the innovative medicine designation, known as the ‘Innovation Passport’, has been awarded for its roginolisib drug by the Medicines and Healthcare products Regulatory Agency (MHRA).
The therapy treats patients with metastatic uveal melanoma and is a non-ATP-competitive, allosteric modulator of PI3Kδ which prevents tumor proliferation and breaks immune tolerance in patients with solid and hematological tumors.
The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP). This initiative aims to accelerate the time it takes for a product to reach the market, thereby boosting patient access to novel treatments across the UK.
Furthermore, ILAP is reserved for innovative therapies involving life-threatening or seriously debilitating conditions. It also provides applicants with a toolkit to support every level of the design, development and approval processes.
Catherine Pickering, chief executive officer of iOnctura, reflected: “The Innovation Passport is an exciting step in the clinical development program for roginolisib, a drug with a game-changing clinical safety and activity profile.”
She added: “Being awarded this 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 to roginolisib.”
PI3Kδ inhibition in solid tumors has emerged as a novel approach to treating cancer because of its potential in targeting multiple tumor survival pathways. First-generation inhibitors are used to treat hematological tumors, but limited target selectivity and safety concerns and have stalled their clinical usefulness.
Such concerns are even more prevalent among patients with solid malignancies where the rapid onset of toxicities has been witnessed. Roginolisib, in contrast, has a sound toxicity profile with less than 5% grade 3/4 toxicities at the biologically effective dose observed during clinical trials.
Clinical activity – including partial and complete responses – is still being seen in patients with both hematologic and solid malignancies. Meanwhile, 14 of 43 patients are still on treatment, with two patients having been on treatment for more than two years.
