Research Project
9677216
Inhibikase Therapeutics is a clinical stage, bio-pharmaceutical company that has developed a novel prodrug formulation for the popular anticancer agent Gleevec®. Gleevec® treatment is commonly accompanied by significant, burdensome gastrointestinal side effects, fatigue and myalgias that erode therapy success due to poor patient compliance. Inhibikase's prodrug of Gleevec®, IkT-001Pro (001Pro), completely blunts these side effects in comparative toxicology testing in non-human primates. Analysis of the relative anti-tumor activity of 001Pro in K562 and in human patient derived liquid tumor models has revealed that the prodrug more efficiently delivers imatinib to the target tissue, enabling up to 1/3 oral dose reduction to achieve the same total drug exposure in the body and the same tumor control. This unexpected finding portends an even greater safety benefit for patients because the Adeverse Event (AE) frequency and severity varies linearly with oral dose for Gleevec®. If the observed oral dose reduction to achieve the same Area Under the Curve (AUC) is realized in human patients, then significantly less imatinib will be administered to achieve the same therapeutic effect and will result in a substantial reduction in AE frequency and severity. This suggests that a Gleevec® prodrug could substantially benefit patients undergoing treatment for stable-phase Chronic Myelogenous Leukemia. Given that Gleevec® is now generic, there is little commercial motivation to introduce innovations into the treatment landscape for this devastating disease, which now afflicts more than 100,000 patients in the U.S. The prodrug could be approved in 12 months from initiation of the single clinical trial agreed to between the FDA and Inhibikase Therapeutics under the 505(b)2 regulation. Thus, a simple alteration to a well-established generic anti-cancer agent could bring urgently needed relief from adherence related side effects to these critically ill patients in a short-period of time. Commercial success is likely given that the generic Gleevec® market has experienced gross sales > $1 billion USD in the U.S. market.
