AbilityPharma is a clinical-stage biopharmaceutical company focused on developing first-in-class causing autophagy molecules by the overexpression of TRIB3 and inhibiting the PI3K/Akt/mTOR pathway, to treat multiple cancers. ABTL0812 has completed the first in humans phase I/Ib clinical trial with excellent safety and efficacy signals and the phase 2 started in September 2016 in sqNSCLC and endometrial cancer as first-line therapy, in top institutions in Spain and France.
The Phase I/Ib has shown:
• ABTL0812 has the best safety and tolerability among all inhibitors, with mild adverse events and no DLT observed
• It has better activity on biomarkers than most PI3K/Akt/mTOR inhibitors with lineal inhibition of Akt phosphorylation (90% in expansion cohort)
• Its efficacy in patients is comparable to the best PI3K/Akt/mTOR inhibitors at initial phases of development in similar clinical trials, with five long term disease stabilizations lasting up to 18 months (5/29)
• Recommended Phase 2 dose identified based on PK/PD
Preclinical models of ABTL0812 have shown:
• Activity in a broad range of human cancer cell lines and in human cancer models (xenografts)
• Efficacy in resistant and non-responder cell lines
• Superiority over selected PI3K/Akt/mTOR pathway inhibitors in resistant cancer cells
• Decreases cancer stem cell population
In 2015 ABTL0812 was granted ODD for the pediatric cancer neuroblastoma by EMA and FDA, and in December 2016 for pancreatic cancer by the FDA.
In April 2016 AbilityPharma signed a license agreement with SciClone Pharmaceuticals to develop and commercialize ABTL0812 in China, Hong Kong, Macau, Taiwan and Vietnam.