Ability Pharma Announces The Approval From The French Medicines Agency ANSM To Initiate A Phase I/IIa Clinical Trial With ABTL0812 To Treat Patients With Endometrial Cancer Or Squamous Lung Cancer As First-Line Therapy In France

Published: Oct 05, 2017

BARCELONA, Catalonia, Spain - October 5th, 2017 – Ability Pharmaceuticals, SL announced today that the company has received the Clinical Trial Application (CTA) approval from the Ethical Committee and the French Medicines Agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) to initiate a Phase 1/2a Clinical Trial with its novel anticancer agent ABTL0812, in combination with paclitaxel and carboplatin to treat 80 patients with advanced endometrial cancer or squamous non-small cell lung cancer as first-line therapy in France. The trial is ongoing since November 2016 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). Following the CTA approval in France, the trial will include patients at Institut Gustave Roussy (Paris), at Centre Léon Bérard (Lyon) and at Institut Paoli-Calmettes (Marseille). Gemma Fierro, Vice President of Clinical and Regulatory Affairs of AbilityPharma stated: “We are very happy having reach this important regulatory step with the first international approval to conduct clinical trials outside of Spain. Carles Domènech, PhD, Chief Executive Officer and co-founder said: “We look forward to working closely with three French leading cancer centers. Expanding the clinical trial in France will accelerate the evaluation of ABTL0812, accelerating the development of important new cancer therapeutics to patients with high unmet medical needs”. 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. 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 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). Contact information: Carles Domènech, PhD CEO Ability Pharmaceuticals email: media.relations@abilitypharma.com Tel.: +34 935 824 411 www.abilitypharma.com

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