The clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, iOnctura founded in 2017, today announces that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, for the treatment of metastatic uveal melanoma by the 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 [1].
iOnctura’s mission is to uncover keys to unlocking difficult to treat tumours burdened by stroma- and immune-mediated resistance. They do this by simultaneously targeting multiple tumour survival mechanisms with a single drug, disrupting the dynamic interplay at the heart of the tumour-stroma-immune interface. 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. PI3Kδ inhibition in solid tumors has recently emerged as a novel approach to treating cancer because of its potential in targeting multiple tumor survival pathways. First-generation PI3Kδ inhibitors are used to treat haematological tumors, but safety concerns and limited target selectivity have curbed their clinical usefulness. These concerns are even more aggravated in patients with solid malignancies where rapid onset of toxicities have been observed. In contrast, roginolisib has a favorable toxicity profile with less than 5% Grade 3/4 toxicities at the biologically effective dose in clinical studies. Importantly, these toxicities have to-date been transient in nature without the need for dose reductions.
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.”
Clinical activity, including partial and complete responses, are being seen in patients with both solid and haematologic malignancies. Further details on clinical responses will be released at a future international clinical conference in 2023. Fourteen of 43 patients (including 12 of 28 uveal melanoma patients) are still on treatment, with two patients having been on treatment for more than 2 years. The one-year OS rate is currently 70%; median OS has not been reached. A research paper recently published in Cancer Research Communications highlights that roginolisib has immune-modulatory properties that can be exploited in solid tumours and further reinforced the conclusion that roginolisib inhibits regulatory T cell proliferation while having limited anti-proliferative effects on conventional CD4+ T cells and no effect on CD8+ T cells; both immune cell types key to a robust immune response to tumours [2].
Niche not only introduced the iOntura team to the ILAP initiative but also played a pivotal role in its delivery, this being the third successful submission we have worked on. Benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorisation Application assessment, rolling review and a continuous benefit-risk assessment.
References
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