Date: 2015-03-31
Type of information: Licensing agreement
Compound: ABC294640
Company: Redhill Biopharma (Israel) Apogee Biotechnology (USA - PA)
Therapeutic area: Cancer - Oncology - Gastrointestinal diseases - Digestive diseases
Type agreement: licensing
Action mechanism: enzyme inhibitor/sphingosine kinase-2 (SK2) inhibitor. ABC294640 is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting a number of potential inflammatory, oncology and gastrointestinal indications. By inhibiting the SK2 enzyme, ABC294640 blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. ABC294640 has completed multiple successful pre-clinical studies in inflammatory, GI, radioprotection and oncology models, as well as a Phase I clinical study in cancer patients with advanced solid tumors.
Disease:
Details: * On March 31, 2015, RedHill Biopharma, an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and Apogee Biotechnology announced that they have entered into an exclusive worldwide license agreement under which RedHill has acquired the rights to the Phase II drug candidate ABC294640 and additional intellectual property rights. ABC294640 is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal (GI) and oncology indications. Apogee received cumulative funding exceeding $14 million to support the development of ABC294640, primarily through grants and contracts from U.S. federal and state government agencies such as the NIH Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) program, including funding from the National Cancer Institute (NCI), the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the Department of Defense (DoD), the FDA Office of Orphan Products Development and the Pennsylvania Department of Health. With this funding Apogee has completed numerous successful pre-clinical studies with ABC294640 in GI-inflammation, radioprotection and oncology models, as well as a successful Phase I clinical study in cancer patients with advanced solid tumors. The open-label, dose-escalation Phase I clinical study demonstrated the drug’s safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors. A Phase Ib/II clinical study with ABC294640 for refractory/relapsed diffuse large B cell lymphoma (DLBCL) is planned to commence in the second quarter of 2015 and will be funded by a $1.5 million grant awarded by the National Cancer Institute under the NIH SBIR/STTR program to Apogee in conjunction with the Louisiana State University Health Science Center. The study will include approximately 30 patients and is intended to assess the tolerability of ABC294640 within the DLBCL population, as well as provide a preliminary evaluation of efficacy. A second Phase II clinical study of ABC294640 for the treatment of multiple myeloma is planned, subject to funding by a pending grant from the National Cancer Institute. A third Phase II clinical study is being planned by RedHill in order to evaluate ABC294640 as a radio-protectant and radiation enhancer in cancer patients undergoing radiotherapy. Furthermore, multiple pre-clinical studies funded by the NIH (BARDA) and the DoD have demonstrated activity of ABC294640 against gastrointestinal injury from accidental acute radiation exposure. Therefore, a possible additional indication of protection against accidental radiation exposure may qualify as a medical countermeasure under the Animal Rule, under which no human efficacy studies would be required for FDA approval. In addition to the three ongoing Phase III studies in GI indications (RHB-105 for H. pylori infection, BEKINDA™ (RHB-102) for gastroenteritis, and RHB-104 for Crohn’s disease), RedHill\'s pipeline now includes three proprietary, Phase II-stage, orally-administered, first-in-class small molecule drug candidates intended to treat gastrointestinal and other solid tumor cancers, as well as other potential indications: Mesupron®, a urokinase-type plasminogen activator (uPA) inhibitor, RP101 (under an option-to-acquire), a heat shock protein 27 (Hsp27) inhibitor, and the newly-acquired SK2 inhibitor, ABC294640.
Financial terms: Under the terms of the agreement, RedHill has acquired the exclusive worldwide development and commercialization rights to ABC294640 and additional intellectual property for all indications. RedHill will pay Apogee an upfront payment of $1.5 million, as well as an additional $4 million in potential milestone payments, and potential tiered royalties starting in the low double-digits.
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