Barcelona (Catalonia, Spain), May 30, 2019. AbilityPharma (Ability Pharmaceuticals, SL) a biopharmaceutical company developing oncology drugs, announced today that the company will release the first results of the currently ongoing phase 1/2a clinical trial evaluating ABTL0812 in combination with carboplatin and paclitaxel in patients with endometrial cancer or non-small cell lung cancer. The results correspond to the phase 1 part of the phase 1/2a clinical trial.
 
The results will be presented by investigators of the trial during 2019 ASCO Annual Meeting taking place at Chicago, at the session “Developmental Therapeutics and Tumor Biology (Nonimmuno)”, that takes place on Saturday June 1, from 8:00 to 11:00h (Poster Board: #81, Abstract 3089).
 
The study has confirmed that the combination with carboplatin and paclitaxel, followed by ABTL0812 as maintenance after chemotherapy, is safe and well tolerated and efficacy signals were observed. ABTL0812 plasma levels and the surrogated biomarkers TRIB3 and CHOP confirmed the drug activity.
 
This study has been performed in leading cancer hospitals in Spain, including Hospital Vall d’Hebron in Barcelona, Institut Català d’Oncologia in L’Hospitalet, Badalona and Girona, INCLIVA in Valencia and Hospital Virgen del Rocío in Seville.
 
About ABTL0812
ABTL0812 is currently in phase 2 clinical trial in Europe in patients with endometrial cancer or squamous cell lung cancer, as a first-line treatment in combination with chemotherapy followed by maintenance treatment after chemotherapy. The study is being conducted in leading cancer hospitals in Spain and France.

This same phase 2 study was also approved by the US FDA in December 2017. In addition, the FDA approved the protocol for a phase 2 study in pancreatic cancer in January 2018.

ABTL0812 has also received Orphan Drug Designations (ODD) for pancreatic cancer, biliary cancer and the pediatric cancer neuroblastoma by the FDA in the USA and by the EMA in Europe.

A phase 1/1b clinical trial was previously conducted 29 patients with advanced solid tumors, in which ABTL0812 showed great safety and tolerability and no dose-limiting toxicities were identified. There were signs of efficacy, and notably two patients had long-term disease stabilizations, for more than one year (14 and 18 months).

ABTL0812 is an oral first-in-class small molecule, that binds to the nuclear receptors PPARα and PPARγ blocking Akt activation, the central kinase of the PI3K/Akt/mTOR pathway, and induces PPAR-dependent Endoplasmic Reticular Stress (ER-stress). The combination of inhibition of the PI3K/Akt/mTOR pathway and the ER-stress induction results in autophagy-mediated cancer cell death.

In preclinical cancer models, ABTL0812 is effective as a single agent with an excellent safety profile in a broad spectrum of cancer types, including NSCLC, endometrial cancer, pancreatic cancer, neuroblastoma and glioma. Likewise, it also synergizes with chemotherapy (taxanes, platinum compounds and gemcitabine) without increasing its toxicity.
 
About Ability Pharmaceuticals
Ability Pharmaceuticals (www.abilitypharma.com) is a biopharmaceutical company with a lead compound, ABTL0812, in phase 2 clinical trials, focused on improving the future of oncology by developing innovative therapies that address unmet medical needs.
 
In April 2016, AbilityPharma signed a territorial license agreement for ABTL0812 with SciClone Pharmaceuticals (Hong Kong) Development Co.  Limited to develop and market the product in China.
 
Ability Pharmaceuticals is headquartered in Parc Tecnològic del Vallès and Parc de Recerca UAB (Cerdanyola del Vallès, Barcelona, Catalonia, Spain). 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), and CDTI, ENISA and MINECO (Government of Spain).