The Company - Ability Pharma

ABOUT

AbilityPharma

"We are committed to creating the future of oncology by developing innovative therapies inducing autophagy to address unmet medical needs"

AbilityPharma

AbilityPharma is a clinical-stage biopharmaceutical company focused on developing first-in-class fully differentiated oral targeted anticancer compounds that produces autophagy-mediated cytotoxicity selectively in cancer cells.

The first drug candidate, ABTL0812, is currently in phase 2b/3 clinical trials in pancreatic cancer in Spain, USA, France, and Israel. The product has also completed with positive results a phase 2a trial in endometrial cancer and squamous non-small cell lung cancer in Spain and France.

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 phase 2a trial in endometrial cancer and lung cancer was conducted in Vall d’Hebron Institute of Oncology (VHIO, Barcelona), Institut Gustave Roussy (Paris), Centre Léon-Bérard (Lyon), Institut Català d’Oncologia (ICO, L'Hospitalet, Badalona and Girona), INCLIVA (Valencia), Institut Paoli-Calmettes (Marseille) and Hospital Universitario Virgen del Rocío (Sevilla)

ABTL0812 showed efficacy and an outstanding safety and tolerability profile in the first in humans phase 1/1b clinical trial with 29 patients with advanced cancer.

In Europe pancreatic cancer is the 3th leading cause of death by cancer and only 4% of pancreatic cancer survive after 5 years.

AbilityPharma has the aproval of the FDA (US) and the AEMPS (Spain) to start a phase 2b/3 clinical trial with ABTL0812 in patients with pancreatic cancer.

Orphan drug designation (ODD) has been granted to ABTL0812 for pancreatic cancer treatment from the EMA in Europe and the FDA in the US.

Lung cancer and endometrial cancer together cause almost 30% of all cancer deaths. More specifically, only 17.7 % of the patients with lung cancer survive after 5 years.

AbilityPharma has concluded positively a phase 2a clinical trial with as first-line therapy for endometrial cancer and for squamous NSCLC in combination with chemotherapy, followed by maintenance therapy.

The investigational new drug (IND) is also approved in the US by the FDA for endometrial and lung cancer.

AbilityPharma is also committed to improve the outcome of children with cancer with an improvement of their quality of life. Both the FDA and the EMA granted orphan drug designation ODD to ABTL0812 for treatment of the pediatric cancer neuroblastoma.

Approval in pediatric cancer could award AbilityPharma with a FDA priority review voucher.

AbilityPharma has an experienced management team with outstanding success in getting drugs approved by both the FDA and the EMA, and licensing them to big-pharma. The company is also supported by a highly-qualified team of advisors, not only in the medical or scientific area, but also with the IP, legal or strategic issues. Together, we build an excellent team to lead our projects to success.