Ability Pharmaceuticals, SA Information

Ability Pharmaceuticals is a clinical-stage biopharmaceutical company committed to develop first-in-class therapies that address unmet medical needs in the oncology space. AbilityPharma's is currently conducting, with ABTL0812, the most advanced asset, an international multi-center, double-blind, placebo-controlled phase 2b clinical trial in patients with metastatic pancreatic cancer to investigate ABTL0812 as first-lin therapy in combination with FOLFIRINOX chemotherapy. The study includes reference centers in Spain, France, United States and Israel. ABTL0812 has finished with very positive results a phase 2a clinical trial as first-line therapy in endometrial cancer and in squamous NSCLC in combination with paclitaxel and carboplatin. The study included leading institutions in Spain and France (Vall d’Hebron Institut d’Oncologia – VHIO, Institut Gustave Roussy, Centre Léon Bérard). ABTL0812 is the first cancer drug killing tumor cells through potent cytotoxic autophagy via inhibition of the Akt/mTOR axis, and the induction of robust endoplasmic reticular stress (ER Stress). Its unique mechanism of action was partially published at Clinical Cancer Research in December 2015 and fully characterized at Autophagy journal in May 2020. The compound has also immunomodulatory effects, turning "cold" immunogenic tumors into "hot" immunogenic. The compound is active as standalone treatment, it has synergy with chemotherapy, and it has synergy with anti PD1 therapies. The product has potential in several cancer types as first-line and maintenance therapy including lung, endometrial, pancreatic, breast, head and neck cancer, glioblastoma, cholangiocarcinoma and the pediatric cancer neuroblastoma. ABTL0812 has been granted Orphan Drug Designation for pancreatic cancer, neuroblastoma, and biliary tract cancer, by the US FDA and the European EMA. Development and marketing rights for Greater China granted to SciClone Pharmaceuticals, Inc.