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Notable Labs announced Wednesday that its artificial intelligence (AI)-powered platform will be used to characterise patient response to fosciclopirox, an experimental drug for acute myelogenous leukaemia (AML), in a Phase Ia/IIb clinical trial. The effort is part of a co-development deal it struck with CicloMed, the company behind fosciclopirox.
Prior to this deal being sealed, the two parties had worked together under a research collaboration to assess the feasibility of selecting AML patients for treatment using Notable's Predictive Precision Medicine platform. Thomas Bock, CEO of Notable, told FirstWord HealthTech that the results of that study had shown the platform's ability to identify differing degrees of sensitivity to fosciclopirox using patient peripheral blood or bone marrow samples.
This open-label Phase Ia/IIb trial is conducted at the University of Kansas Cancer Center and is enrolled relapsed/refractory AML patients. The objectives are to determine efficacy and safety of fosciclopirox, as well as to determine the performance of Notable’s platform in identifying patients that respond to treatment.
The Notable platform is designed to replicate a patient's clinical response to cancer treatments with "high fidelity," by integrating biological assay conditions, dynamic signal analysis and AI-driven in-silico translation into predictive algorithms. The technology has the "potential to develop cancer treatments precisely for the patients predicted to respond," commented Bock, and these precision medicines in turn allow for "smaller clinical trials and…[expedited] development timelines."
Splitting commercialisation costs
Under the co-development agreement, Notable will focus on optimising its predictive precision medicine platform, while CicloMed will handle clinical trial operations. Both companies will be responsible for research and commercialisation costs associated with the AML clinical development programme.
On regulatory approval of fosciclopirox, Ciclomed will retain commercialisation and distribution rights for the drug as a therapeutic while Notable retains all rights for the companion diagnostic used to determine patient sensitivity to fosciclopirox.
Notable recently sublicensed worldwide rights to volasertib, another AML treatment candidate originally developed by Boehringer Ingelheim and licenced to Oncoheroes.
Bock said Notable aims to develop multiple treatment candidates within one disease, "knowing that therapies that work for one patient may not work for another." "For example, using our predictive precision medicine platform, we envision testing all AML patients for responsiveness to an array of potential treatments - including treatments being developed at Notable and available standard of care drugs - and matching the best treatments to each patient."
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