Ability Pharmaceuticals announces positive Phase 1/1b study results of ABTL0812 in cancer patients with advanced solid tumors

Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, today announced positive results from the Phase 1/1b first-in-humans clinical trial with ABTL0812 in patients with advanced solid tumors.

ABTL0812 is a first-in-class Akt/mTOR signaling pathway inhibitor for oral administration with a novel mechanism of action and high in vitro and in vivo efficacy in different tumor settings, including resistant cancer models.

The results from this first-in-humans clinical trial indicate clinical activity with several long-term disease stabilizations in patients previously treated with different chemotherapy lines, additionally showing up to 90% inhibition of blood biomarkers that correlated with ABTL0812 plasma levels. The study also indicate that, as anticipated, ABTL0812 is extremely safe and well tolerated.

Overall 29 patients with advanced solid tumors, divided in four escalation cohorts and one expansion cohort, were treated at Hospital Clinic Barcelona (Principal Investigators: Dr. Laura Vidal and Dr. Pere Gascon) and at Institut Català d’Oncologia-Hospital Duran i Reynals (Principal Investigator: Dr. Marta Gil-Martin), two leading Hospitals in Catalonia. One patient with endometrial cancer bearing mutations in Akt1 and PIK3CA had disease stabilization for over 14 months; three patients had stable disease for more than 4 months and one patient with cholangiocarcinoma is currently stable, being treated after more than 10 months. Given the extremely high safety profile of ABTL0812 the maximum tolerated dose (MTD) was not achieved (no dose-limiting toxicities -DLT- appeared) and the recommended phase 2 dose was determined based on pharmacokinetic and pharmacodynamics analysis.

Data obtained in this trial “are very encouraging” said Marc Cortal, MD, Director of Clinical Research at Ability Pharmaceuticals, “We have observed long-term disease stabilizations in patients that did not respond to previous chemotherapy lines”. “Novel drugs with a differentiated mechanism of action are needed to improve the expectations of cancer patients” said Jose Alfón, Director of Research and Development at Ability Pharmaceuticals. “We are excited to continue the clinical development of our first candidate, and we are going to start Phase 2 clinical trials with selected solid tumor types with altered PI3K/Akt/mTOR signaling at the beginning of 2016.” commented Carles Domenech, PhD, Chief Executive Officer of Ability Pharmaceuticals.

The results of this study will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics that will take place in Boston in November 2015:

“First-in-Human Clinical Trial of ABTL0812, a Compound that Inhibits PI3K/Akt/mTOR Pathway by Upregulating TRIB3, in Patients with Advanced Solid Tumors.” Late-Breaking Poster Session C, Session Title: Clinical Trials, Abstract Number: LB-C18, Sunday Nov 8, 2015, 12:30-15:30, Location: Exhibit Hall C-D.

About ABTL0812

ABTL0812 is an investigational small molecule which inhibits the Akt/mTOR signaling pathway by a novel mechanism of action, fully differentiated from other PI3K/Akt/mTOR pathway inhibitors under development, and with cell death mediated by autophagy. In preclinical models ABTL0812 has shown activity similar or higher than reference compounds, but with higher safety. Additionally, ABTL0812 potentiates the antitumor effect of several standards of care chemotherapeutic agents, while still maintaining its safety profile. Moreover ABTL0812 keeps its potency and efficacy in tumor cells that have become resistant to standard chemotherapy or targeted therapies, with superiority over other PI3K/Akt/mTOR inhibitors.

About Ability Pharmaceuticals

Ability Pharmaceuticals (www.abilitypharma.com) is a research-based biopharmaceutical company established in 2009 with headquarters in Bellaterra (Barcelona, Catalonia, Spain) at the Research Park of the Autonomous University of Barcelona. In addition to ABTL0812, the company has another candidate, ABTL0815 in preclinical development.

Current shareholders include the biotech venture firm Inveready Seed Capital, its founders and private investors, and has the financial support from ACCIO (Government of Catalonia), CDTI and MINECO (Government of Spain).

Ability Pharmaceutics is currently raising funds in a Series A financing round.