Press release

ABILITY PHARMACEUTICALS awarded a 1.2 million euros grant to develop its Lipid Analog ABTL0812 for Lung and Pancreatic Cancer
The grant will fund the first-in-man phase Ib clinical trial in advanced cancer patients with refractory solid tumor
The program will be presented at the 2013 ASCO Meeting and involves the Autonomous University of Barcelona and the research institute IDIBAPS
Bellaterra (Barcelona, Spain), February 5, 2013.- Ability Pharmaceuticals, a privately held biopharmaceutical company, announced today that it was awarded a 36 month 1.2 Million Euros grant under the INNPACTO-2012 Collaborative Program from the Ministry of Economy and Competitiveness of the Government of Spain. A substantial part of the grant will be devoted to finance the first-in-man phase Ib clinical trial for ABTL0812, a Lipid Analog Therapeutic molecule that is nearing the end of preclinical development, with anticipated IMPD/CTA filing in April 2013. Ability Pharmaceuticals is the leader of this collaborative program that involves other Catalan companies and research institutions, including the Autonomous University of Barcelona, the University of Barcelona and the IDIBAPS research institute in Barcelona. The consortium has been funded with 2.2 Million Euros.

“We are very satisfied of the non-diluting financing we have been granted by the Ministry of Economy and Competitiveness –said Dr. Carles Domènech, CEO and co-founder of Ability Pharmaceuticals-, because it will allow us to start the clinical development of ABTL0812, our first drug candidate, and to offer cancer patient a new experimental therapeutic candidate that has shown significant advantages in the pre-clinical setting compared to conventional chemotherapy: high efficacy in lung and pancreatic cancer, very low toxicity, few adverse events and oral administration”. A program overview will be presented by Dr. José Alfon, Vice-President of Research and Development at the American Society of Clinical Oncology (ASCO) 2013 Meeting in Chicago, May 31-June 4.

About ABTL0812

ABTL0812 is a Lipid Analog Therapeutic compound that shows significant advantages compared to conventional chemotherapy in preclinical setting: high efficacy, low toxicity and oral administration. In animal models of immunosuppressed mice with lung and pancreatic cancer xenografts, after a 4 weeks treatment the molecule reduced tumor growth by 70% and complete tumor growth arrest was observed in 10% of treated mice. ABTL0812 has shown efficacy equal or superior to standards of care, such as docetaxel, erlotinib and gemcitabine, with lower toxicity and fewer adverse events.

ABTL0812 interferes with key processes related with cell proliferation and survival. It affects two key cellular processes: i) the inhibition of akt and the mTORC1 and mTORC2 pathways which are involved in protein synthesis and cell survival, and ii) DNA synthesis through the inhibition of the gene expression of dihydrofolate reductase (DHFR), needed for cell proliferation. By blocking these two key cellular functions, tumor cells finally die by Autophagy. These targets are clinically validated by the use of specific blockbuster drugs (i.e. pemetrexed - Alimtatm and everolimus - Affinitortm). The advantage of the dual targeting strategy is that by simultaneously affecting both targets, an increased efficacy and lower appearance of resistances could be attained. The first results on the characterization of the mechanism of action were presented at the 2012 Meeting of the American Association for Cancer Research (AACR) in Chicago, and extended at the 2012 Meeting of the European Association for Cancer Research (EACR) in Barcelona.

ABTL0812 is completing preclinical development, which is showing high safety with a wide therapeutic window, high oral bioavailability, lineal pharmacology, PK/PD correlation and once-daily administration. The Phase Ib clinical trial will start in spring 2013 in advanced cancer patients with refractory solid tumors.

About Ability Pharmaceuticals

Ability Pharmaceuticals is a drug research and development biopharmaceutical company founded in 2009 with headquarters in Bellaterra (Barcelona, Catalonia, Spain) at the Research Park of the Autonomous University of Barcelona, with a planned US development office in Boston, Massachusetts in 2013. The current shareholders of Ability Pharmaceuticals include the reference specialized biotech venture capital firm Inveready Capital Company, based in Barcelona, its founders and private investors.

Ability Pharmaceuticals develops highly a differentiated innovative new class of cancer drugs, with a novel mechanism of action, called Lipid Analog Therapeutics. The company has two drug candidates in development: ABTL0812, which is completing preclinical development, with planned Phase Ib Clinical Trial in advanced cancer patients with refractory solid tumors starting in spring 2013; and ABTL1014, expected to start preclinical development in 1Q 2013.
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