AbilityPharma (www.abilitypharma.com) is a clinical-stage biopharmaceutical company committed to develop first-in-class therapies that address unmet medical needs in the oncology space. ABTL0812, the most advanced asset, is a drug candidate in phase 2 clinical trials in lung cancer (squamous-NSCLC) and endometrial cancer.
Development and marketing rights for Greater China granted to SciClone Pharmaceuticals, Inc. in a territorial license agreement signed in April 2016.
A Fully Differentiated Anti-Cancer Agent causing Cancer Cell Death through Autophagy
ABTL0812 is a first-in-class fully differentiated oral targeted anticancer compound causing cell death by autophagy through binding to the nuclear receptors PPARα/γ. It induces TRIB3 overexpression which blocks Akt activation, the central kinase of the PI3K/Akt/mTOR pathway, thus blocking this pathway, and induces PPAR-dependent Endoplasmic Reticular Stress (ER-stress). The combination of TRIB3-mediated inhibition of the PI3K/Akt/mTOR pathway and the ER-Stress induction results in autophagy-mediated cancer cell death. Its unique mechanism of action was published at Clinical Cancer Research in May 2016.
In animal cancer models ABTL0812 is efficacious as single agent with an excellent safety profile in a broad spectrum of cancer types: lung, endometrial and pancreatic cancer and neuroblastoma. In these models, the compound has also synergistic effect with chemotherapy (taxanes, platinum compounds and gemcitabine) and radiotherapy without increasing its toxicity. ABTL0812 is also active on cells resistant to other targeted therapies, on tumor stem cells and inhibits metastasis formation. Preliminary results show promising immunomodulatory effects.
Phase 1/1b First in Human Clinical Trial
In the first in human phase 1/1b clinical trial (29 patients with advanced solid tumors), ABTL0812 showed the best safety and tolerability compared to other pathway inhibitors. The efficacy in patients was comparable to the best inhibitors of the pathway in similar clinical trials. Remarkably 2 patients had disease stabilizations over one year (endometrial cancer 14 months and cholangiocarcinoma 18 months). Additionally, ABTL0812 showed high efficacy on biomarkers with PK/PD correlation. Due to its extremely low toxicity, the recommended phase 2 dose (RP2D) was determined by PK/PD, without reaching any dose limiting toxicity.
Phase 1/2a Clinical Trial
AbilityPharma is conducting the phase 1/2a clinical trial (80 patients) with ABTL0812 (at RP2D) as first-line therapy in endometrial cancer and in squamous NSCLC in combination with paclitaxel and carboplatin, the standard first-line regime. After the chemotherapy cycles, the patients remain treated with ABTL0812 chronically. The basis for selecting this design is the high incidence of mutations in the PI3K/Akt/mTOR pathway in both cancer types together with ABTL0812 synergistic effect with both chemotherapy agents.
The clinical trial includes the leading institutions Vall d’Hebron Institute of Oncology VHIO (Barcelona), Institut Gustave Roussy IGR (Paris), Institut Català d’Oncologia ICO (L’Hospitlalet, Girona and Badalona), Centre Léon Bérard (Lyon), Hospital Clínic Valencia INCLIVA (València), Hospital Universitario Virgen del Rocio (Sevilla) and Institut Paoli-Calmettes (Marselle).
CTA approved in Spain and in France.
IND opened at FDA. Protocols for clinical trials in endometrial, lung and pancreatic cancer approved in USA.
- Area of Activity
- Respiratory and pulmonary system
- Drug discovery
- Drug development
- Company type
- Health Biotechnology
Edifici Eureka – Campus de la UAB
Bellaterra, Barcelona 08193, ES
P: +34 935 868 977
F:+34 935 868 836
Avinguda Parc Tecnològic, 3 Centre d’Empreses de Noves Tecnologies
Cerdanyola, Barcelona 08290 , ES
AbilityPharma has an experienced management team with great success in the management of biotech companies, research and development of drugs, establishment of licensing agreements with multinational companies, specifically in China and Japan, and in obtaining approval of medicines by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company is also supported by a highly qualified team of advisors, not only in the medical or scientific area, but also in IP, legal or strategic field.
Carles Domenech, PhD
Co-founder and General Director
Carles is a biologist graduated from the Autonomous University of Barcelona and a PhD in cell biology from the same university, working as a post doc at the Memorial Sloan-Kettering Cancer Center in New York. After his experience as a researcher, he held positions in Almirall, SA as Head of Business Development and Licensing for 12 years and in Lacer, SA as Director of Business Development and Licensing. He also has 4 years of experience in biotech venture capital and business angels associations.
José Alfón, PhD,
VP, Research and Development
José has a degree in pharmacy from the Hebrew University of Jerusalem and a PhD in pharmacology from the University of Barcelona. José has more than 20 years of experience in drug development, working in J. Uriach y Cia, SA (and later in his spin-off Palau Pharma, SA), leading the Discovery Department and Drug Development programs.
Directora de Asuntos Clínicos y Regulatorios
Gemma has a degree in Pharmacy from the University of Barcelona and a master's degree in European Regulatory Affairs from the Autonomous University of Barcelona. In 2004, she became Director of Regulatory Affairs for Spain and Portugal of Procter & Gamble, subsequently assuming additional responsibilities for all European countries. Later, Gemma was appointed head of Regulatory Affairs at Bayer Hispania, SL, from 2012 to 2014, also assuming responsibilities in clinical trials.
Directora de Administración y Finanzas
Vanessa obtained a bachelor's and master's degree in economics at the Universitat Pompeu Fabra in Barcelona. He specialized in business administration. Before joining the company, for 2 years she was the financial director of Sevibe Cells.
Marc Cortal , MD
Director de Investigación Clínica
Marc obtained a degree in Medicine and Surgery at the University of Barcelona in 1993. He began his medical activities as a volunteer in the former Yugoslavia and then moved to London to perform different clinical practices and in 1996 he moved to Switzerland, entering the International Committee of the Red Cross. In 1998 he moved to Barcelona to perform different jobs as a doctor in the Public and Private Health Services. He also pursued different programs in organizing clinical trials to develop new therapies in oncology as a clinical researcher.
Héctor Pérez-Montoyo, PhD
Director de Proyectos Biològicos
Héctor graduated in Biology in 2005 and obtained a PhD in Biology in 2010 at the University of Alicante. He moved to the University of Texas Southwestern Medical Center in Dallas (USA), to start his career developing new therapeutic antibodies under the supervision of Dr. Sally E. Ward. After obtaining his PhD, he combined two postdoctoral grants in Barcelona with the Metastasis and Transformation Group at the Biomedical Research Center of Bellvitge - IDIBELL, and in Valencia with the Autoimmune Pathology Group at the Prince Felipe Research Laboratory.
Maria Jesús Guerrero
Directora de Proyectos
Mª Jesús has extensive experience in a multinational companies as a manager in the area of Information Systems, in the food sector. In 1991 he joined Nabisco, as Project Manager. In 1997, she was appointed Director of Systems for Iberia. In 2001 United Biscuits acquired Nabisco's business in Iberia and she joined United Biscuits as IS Southern Europe Director. In 2006 Kraft acquired the Iberia business and Mª Jesús directed the integration.
Marc Yeste, PhD
Director de Investigación Translacional
Marc obtained a bachelor's and a master's degree in experimental biochemistry and a doctorate in molecular biology from the University of Barcelona (2002 - 2008). He later moved to London to work as a postdoctoral research associate at the Barts Cancer Institute (Queen Mary University of London), where he began his career in cancer research. He studied the molecular mechanisms involved in the development of prostate and testicular cancer in collaboration with Takeda Oncology. He then moved to the industry to work as a principal scientist at Vasgen Ltd., where he developed monoclonal antibodies and their potential therapeutic use in cancer.
Target Product Profile (TPP): First-line therapy in combination with chemotherapy and maintenance as single-agent after chemotherapy.
Unique Selling Point: Increase the response rate to chemotherapy and delay the relapse.
Objective: To turn cancer into a chronic disease not mortal.
Sales potential over €2.5 billion in 2025, with a market share over 20% in selected cancer types.
The product has potential in several cancer types as first-line and maintenance therapy including lung, endometrial, pancreatic, breast, head and neck cancer, glioblastoma, cholangiocarcinoma and the pediatric cancer neuroblastoma.
Orphan Drug Designation for neuroblastoma and pancreatic cancer was granted by US FDA and Europe EMA. ODD application planned for cholangiocarcinoma
‐ First in class targeted cancer therapy
‐ Cell death caused through autophagy
‐ Fully differentiated from inhibitors of the PI3K/Akt/mTOR pathway
‐ Outstanding safety profile in patients, with highest safety and tolerability
‐ Clinical efficacy in advanced cancer patients with PK/PD correlation in biomarkers in the PI3K/Akt/mTOR pathway
‐ Suitable as monotherapy or as a first-line therapy in combination with chemotherapy
‐ Patient-friendly use: oral administration
‐ Synergy with taxanes, platinum compounds and gemcitabine without increasing its toxicity
‐ Active on resistant cells
‐ Active on tumor stem cells
‐ Inhibition of metastasis formation
‐ Potential immunomodulatory effects
‐ Potential patient selection in future trials