Barcelona (Catalonia, Spain), February 4, 2019. AbilityPharma (Ability Pharmaceuticals, SL) a biopharmaceutical company developing oncology drugs, announced today that its partner in China, SciClone (SciClone Pharmaceuticals (Hong Kong) Development Co. Limited.), has obtained the approval from the Chinese medicine agency NMPA (National Medical Products Administration) to start clinical trials in China with the anticancer product ABTL0812.
 
The clinical trial approved is a phase 1/2a study with ABTL0812 as first-line therapy in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer, followed by maintenance therapy with ABTL0812 after chemotherapy completion. AbilityPharma obtained the approval of the same protocol by the FDA in the USA in January 2018.

This important milestone is the result of the collaboration between AbilityPharma and SciClone, which started in May 2016 with the signature of a licensing agreement, valued more than 20 million dollars, in which AbilityPharma granted an exclusive license to SciClone to develop and market ABTL0812 in China, Taiwan, Hong Kong, Macao and Vietnam.

Currently, AbilityPharma is conducting in Europe (Spain and France) a phase 2 clinical study with ABTL0812 as a first line treatment in patients with endometrial cancer and squamous cell lung cancer, in combination with chemotherapy and as maintenance therapy after chemotherapy. In the future, the company plans to also start clinical studies in pancreatic cancer in the USA.

"The approval by the NMPA to conduct a clinical study in pancreatic cancer with ABTL0812 is a very important step that shows the great work done in the collaboration between AbilityPharma and SciClone", said Dr. Carles Domènech, Managing Director of AbilityPharma, who added "This milestone achieved by SciClone in pancreatic cancer allows us to expand the validation of the efficacy of our product beyond the indications that are currently being evaluated in Europe, endometrial and lung cancer."
 
About ABTL0812
ABTL0812 is a first-in-class fully differentiated oral targeted anticancer compound causing cell death by autophagy (self-digestion).

ABTL0812 is currently in phase 2 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. It induces the overexpression of TRIB3 that blocks Akt activation, blocking the Akt/mTORC1 axis of the PI3K/Akt/mTOR pathway, and induces Endoplasmic Reticular Stress (ER Stress). The combination of both effects produces cancer cell-death mediated by a robust autophagy. The mechanism of action was published in Clinical Cancer Research in May 2016.

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 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).

AbilityPharma has recently launched a financing round of 3-5M euros.
 
About SciClone
SciClone Pharmaceuticals (www.sciclone.com) is a pharmaceutical company with a substantial commercial business in China, where it has a portfolio of products covering oncology, infectious diseases and cardiovascular disorders. The main product originated by SciClone, ZADAXIN® (timalfasin), is approved in around 20 countries and is used in the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain types of cancer, and also as a vaccine adjuvant. SciClone has successfully licensed and marketed products with the potential to become future market leaders and drive the long-term growth of the company Management GP Limited. In the past, SciClone was a US company based in Foster City (CA) listed on NASDAQ.
 
Contact information:
Carles Domenech, PhD
CEO Ability Pharmaceuticals
email: media.relations@abilitypharma.com
Tel..: +34 935 824 411
 www.abilitypharma.com