TetraLogic Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, will acquire Shape Pharmaceuticals, a privately held biotechnology company developing suberohydroxamic acid phenyl ester (SHAPE), a novel, tissue-targeted HDAC inhibitor in a topical gel formulation to treat stage IA-IIA Cutaneous T-Cell Lymphoma (CTCL), adding a second clinical-stage oncology compound to the TetraLogic portfolio.
TetraLogic will acquire Shape for an upfront cash payment of $13 million. TetraLogic also is responsible for future development and commercialization milestones, as well as tiered royalties on product sales.
SHAPE is designed to be rapidly degraded in plasma, thus avoiding systemic exposure. In a randomized phase I trial, promising early activity with SHAPE was observed, with responses seen after only 28 days of administration. SHAPE was generally well-tolerated in this study with no dose-limiting toxicities observed.
The company believes the gel formulation provides concentrated local effect and the molecule itself is designed to avoid systemic absorption and related toxicities. The company expects to commence a phase II trial of SHAPE for early-stage CTCL in the fourth quarter of 2014.
SHAPE's composition of matter patent extends until at least 2028; in addition, SHAPE has been granted Orphan Drug Designation for CTCL by the FDA. TetraLogic has acquired worldwide development and commercialization rights to SHAPE for all indications.