The biopharmaceutical company Ability Pharmaceuticals SL announced today that it has been awarded €5 million blended financing from the Horizon Europe, European Innovation Council (EIC) Accelerator Pilot Program. The grant will fund a phase 2b clinical trial in advanced pancreatic cancer patients to investigate ABTL0812 in combination with the standard-of-care chemotherapy.
The EIC Accelerator (former SME Instrument) is a highly competitive program of the European Commission offering funding, coaching and business acceleration services to innovative small or medium-sized businesses with global ambitions. In this second call of the program, only 2,4% of applications submitted have been funded.
The program provides grant-only support as well as support in the form of blended finance (combining grant and equity). In fact, for AbilityPharma, received ca. 2,5M € as grant, and ca. 2,5M € as equity and managed by the European Investment Bank.
AbilityPharma’s objectives for this project are to conduct a phase 2 multicenter double-blind placebo controlled clinical trial in pancreatic cancer to investigate ABTL0812 in combination with the FOLFIRINOX. It will include leading centers in Spain, France, Israel and other European countries. After finishing the clinical trial, a partnership (licensing deal) with a big pharma partner will be stablished to further develop ABTL0812 to make it available to pancreatic cancer patients. Top Key Opinion Leaders in pancreatic cancer clinical research in Barcelona, France, Israel and the USA have endorsed the project and will lead the clinical trial in their territories.
Carles Domenech, Executive Chairman and CSO of AbilityPharma said “Today marks an important milestone in AbilityPharma’s history. ABTL0812 has strong potential for treating pancreatic cancer, and this funding is crucial to address this urgent unmet medical need by providing a safe and efficacious treatment to these patients.” , Maribel Berges CEO of AbilityPharma added “This grant is the result of the hard work performed by the highly qualified team of AbilityPharma, and it strengthens our balance sheet to continue developing our clinical candidate ABTL0812”. The whole AbilityPharma team and its investors are extremely satisfied to be able to try to bring solutions to pancreatic cancer patients, where only 2% of all cancer research funds are devoted.
ABTL0812 is a first-in-class fully differentiated oral targeted anticancer compound causing cell death by autophagy (self-digestion).
ABTL0812 is currently in phase 2a open-label clinical trials in Europe in patients with endometrial cancer or squamous cell lung cancer, as a first-line treatment in combination with chemotherapy and as a maintenance treatment after the chemotherapy cycles. 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). In addition, ABTL0812 showed activity on biomarkers with dose-response.
The mechanism of action of ABTL0812 is unique and novel. ABTL0812 is a targeted therapy drug that kills cancer cells through the induction of robust cytotoxic autophagy. ABTL0812 binds and activates the transcriptional activity of the nuclear receptors PPARα and PPARγ, leading to the induction of endoplasmic reticular stress (ER-Stress), and to the blockade of Akt activation, the central kinase of the PI3K/Akt/mTOR pathway. This dual action of ER-Stress activation and Akt/mTOR axis blockade converge to strongly induce autophagy, which results in cancer cell death. The mechanism of action was published partially in Clinical Cancer Research in May 2016, and additional information will appear in Autophagy in a short time (manuscript accepted in March 2020).
In preclinical cancer models, ABTL0812 is effective as a single agent with an excellent safety profile in a broad spectrum of cancer types, including lung, endometrial and pancreatic cancer, neuroblastoma and glioma. Likewise, it also enhances chemotherapy (taxanes, platinum compounds and gemcitabine) with a synergistic effect without increasing its toxicity.
About Ability Pharmaceuticals
Ability Pharmaceuticals (www.abilitypharma.com) is a biopharmaceutical company with a product, 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, Fitalent 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).