Date: 2015-05-11
Type of information: Licensing agreement
Compound: ABTL0812 (sodium 2-hydroxylinoleate)
Company: Ability Pharmaceuticals (Spain) SciClone Pharmaceuticals (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing development commercialisation
Action mechanism: kinase inhibitor/mtTOR inhibitor. ABTL0812 is a first-in-class Akt/mTOR signaling pathway inhibitor with 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 studies, ABTL0812 have shown efficacy in pancreatic cancer as single agent and synergistic effect (by 8 to 90 times) in combination with taxanes, platinum compounds and gemcitabine, with induction of tumor regression without increasing the toxicity associated with chemotherapy.
Disease:
Details: * On May 11, 2016, Ability Pharmaceuticals announced that the company has entered into an agreement with SciClone Pharmaceuticals granting SciClone an exclusive license to develop and market the novel anticancer ABTL0812 in China and some adjacent territories. Under the terms of the agreement, AbilityPharma has granted SciClone exclusive rights to develop, promote, market, distribute and sell ABTL0812 in China, as well as Hong Kong, Macau, Taiwan and Vietnam, getting access to follow-up compounds.
AbilityPharma has completed a Phase 1/1b clinical trial of orally administered ABTL0812 in 29 advanced cancer patients with solid tumors and presented the study results at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Vidal et al.) in Boston in November 2015. This first-in-humans clinical study was designed to explore ABTL0812’s safety and efficacy profile. Outstanding safety and tolerability with several long-term disease stabilizations were demonstrated in patients progressing after previous chemotherapy lines, two of them stabilized over one year. The study showed the inhibition of the PI3K/Akt/mTOR pathway based on biomarkers, with correlation with ABTL0812 plasma levels. A full Phase 2 clinical program has been designed in several advanced tumor indications including endometrial and lung cancer.
Financial terms: AbilityPharma will receive an upfront payment and research funding as well as development, regulatory and sales milestone payments, potentially totaling more than $20 million; AbilityPharma will also be eligible to receive royalties on sales. SciClone will be responsible for all aspects of development, product registration and commercialization in the partnered regions, having access to data generated by AbilityPharma.
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