iOnctura awarded UK's MHRA Innovation Passport for roginolisib

28 March 2023

Netherlands-based iOnctura today announced that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, a potential treatment for metastatic uveal melanoma by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA).

The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP) which aims to accelerate time to market and thereby patient access to novel treatments in the UK. Reserved for innovative therapies for life-threatening or seriously debilitating conditions, ILAP provides applicants with a toolkit to support all stages of the design, development, and approval process.

Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumor proliferation and breaks immune tolerance in patients with solid and hematological tumors.

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