iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, has been awarded the innovative medicine designation, the Innovation Passport, for roginolisib, for the treatment of metastatic uveal melanoma by the Medicines & Healthcare products Regulatory Agency (MHRA).
Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumour proliferation and breaks immune tolerance in patients with solid and haematological tumours. Read more about the research on DDW.
Catherine Pickering, Chief Executive Officer of iOnctura, said: “The Innovation Passport is an exciting step in the clinical development programme for roginolisib, a drug with a game-changing clinical safety and activity profile. 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.”