AbilityPharma announces FDA approval of IND for Phase 2 Trial of ABTL0812 in patients with endometrial cancer or squamous non-small cell lung cancer

Ability Pharmaceuticals SL, a biopharmaceutical company announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application which validates the phase 1/2a clinical trial of ABTL0812, its autophagy PI3K/Akt/mTOR pathway inhibitor, in patients with endometrial cancer or squamous non-small cell lung cancer, in combination with paclitaxel and carboplatin as first-line therapy. AbilityPharma submitted its IND on October 31, 2017.

The trial is ongoing in Europe, where a total of 80 patients will be enrolled. Since November 2016, patients are being included in Vall d’Hebron Institute of Oncology VHIO (Barcelona), Institut Català d’Oncologia ICO (L’Hospilatet, Badalona and Girona in Catalonia), INCLIVA (València) and Hospital Universitario Virgen del Rocío (Sevilla). In early 2018 the trial will start recruiting patients in Institut Gustave Roussy (Paris), Centre Léon Bérard (Lyon) and Institut Paoli-Calmettes (Marseille), following the Clinical Trial Application (CTA) approval by the French Agency for Medicines in October 2017.

Carles Domènech, Chief Executive Officer said: “FDA clearance of our IND application is an important milestone for AbilityPharma, which recognizes our efforts to start clinical development in the US during 2018”. Gemma Fierro, Vice President of Clinical and Regulatory Affairs of AbilityPharma, stated: “After this major achievement, we are continuing with enthusiasm the preparations of additional INDs and CTAs with new clinical trials in both Europe and the US”. José Alfón, VP, Research & Development said: “We have already received positive indications of interest from key investigators and clinical institutions to progress with the development of ABTL0812”.

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 2015.

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).