BARCELONA, Catalonia, Spain - February 19th, 2018 – Ability Pharmaceuticals SL, a biopharmaceutical company announced today that the United States Food and Drug Administration (FDA) has approved a phase 1/2 study to assess the efficacy and safety of ABTL0812 in combination with gemcitabine and nab-paclitaxel in patients with advanced metastatic pancreatic cancer at first line therapy and as maintenance therapy after chemotherapy. This milestone comes after FDA approval of the Investigational New Drug (IND) for endometrial cancer or squamous non-small cell lung cancer last December, which validated the protocol of the Phas 1/2 study with ABTL0812 currently ongoing in Spain and France.  
 
In preclinical studies, ABTL0812 has shown efficacy in pancreatic cancer models as single agent, and in combination with nab-paclitaxel and gemcitabine, with synergistic effect, with induction of tumor regression without increasing the toxicity associated with chemotherapy. First-line therapy with ABTL0812 in combination with chemotherapy could greatly improve the treatment outcome.
 
Carles Domènech, PhD, Chief Executive Officer said: “FDA approval of the phase 1/2 trial in pancreatic cancer with ABTL0812 is an important step forward in the development of our novel drug with the potential to become a transformational therapy for patients affected with this cancer”. “ We are now working with the medical community to start the clinical development of ABTL0812 in this condition” Carles Domènech added.
 
 
About ABTL0812
 
ABTL0812 causes cell death by autophagy through the overexpression of TRIB3, an endogenous Akt regulator. It is a first-in-class fully differentiated oral targeted anticancer compound inhibiting the PI3K/Akt/mTOR pathway without being a direct kinase inhibitor. Its unique mechanism of action was published at Clinical Cancer Research in 2016.
 
In preclinical cancer models ABTL0812 is efficacious as single agent with an excellent safety profile in a broad spectrum of cancer types: lung, endometrial and pancreatic cancers, and neuroblastoma. In these models the compound has also synergistic effect with chemotherapy (taxanes, platinum compounds and gemcitabine) without increasing its toxicity.
 
In Europe, ABTL0812 is currently in phase 2 as first line therapy in combination with chemotherapy in patients with endometrial or squamous lung cancer. The study includes centers in Spain and France.
 
In the phase 1/1b clinical trial (29 patients with advanced solid tumors), ABTL0812 showed the best safety and tolerability compared to other inhibitors of the pathway; no dose-limiting toxicities were identified. The efficacy in patients was comparable to the best PI3K/Akt/mTOR inhibitors in similar clinical trials. Remarkably 2 patients had extremely long disease stabilizations over one year (14 and 18 months). Additionally, ABTL0812 showed high efficacy on biomarkers of the pathway with dose-response effect.
 
 
About Ability Pharmaceuticals
 
Ability Pharmaceuticals (www.abilitypharma.com) is a clinical-stage biopharmaceutical company focused on creating the future of oncology by developing innovative therapies that address unmet medical needs. Established in 2009 and with two drug candidates in development: ABTL0812, a targeted therapy already in phase 2 clinical trials and ABTL0815 in preclinical development, AbilityPharma is positioning itself as one of the fast growers in the Catalan and Spanish biotech sector.
 
In April 2016, AbilityPharma signed a territorial license agreement for ABTL0812 with the NASDAQ US company SciClone Pharmaceuticals, Inc. to develop and market the product in Greater China.
 
Ability Pharmaceuticals has headquarters in Cerdanyola del Vallès (Barcelona, Catalonia, Spain) at Parc Tecnològic del Vallès and Parc de Recerca UAB. Current shareholders include the biotech venture firms Inveready and SODENA, its founders and private investors, and has the financial support from ACCIO (Government of Catalonia), CDTI, ENISA and MINECO (Government of Spain).