Pursuant to the terms of the agreement, Shape Pharma will be acquired by TetraLogic Pharma for an upfront cash payment of $13m. TetraLogic will also be responsible for future development and commercialization milestones, as well as tiered royalties on product sales.
Shape Pharmaceuticals is currently developing suberohydroxamic acid phenyl ester (SHAPE), a tissue-targeted HDAC inhibitor in a topical gel formulation to treat stage IA-IIA cutaneous T-cell lymphoma. The company has designed SHAPE to be rapidly degraded in plasma, thus avoiding systemic exposure.
TetraLogic president and CEO Kevin Buchi noted the company is pleased to have augmented its oncology pipeline with this acquisition.
"We are encouraged with SHAPE’s clinical data to date, specifically the response rate and early onset of action, and we expect to advance it into Phase II trials later this year with a goal of evaluating the 6 month efficacy of SHAPE in Stage IA-IIA CTCL patients," Buchi added.
In a Phase I double-blind, dose-escalating clinical trial, SHAPE has showed promising early activity. In the randomized, placebo-controlled clinical trial 15 patients were administered SHAPE, BID for 28 days, while three patients were administered placebo.
Of the 15 patients who were administered SHAPE, four patients demonstrated PRs (clinical improvement of lesions) by Composite Assessment of Index Lesion Severity or CAILS score, while the patients on placebo demonstrated no significant improvements.
PK data indicated minimal systemic exposure, and PD data demonstrated local dermal acetylation. No significant safety events were observed in the study.
In this study, SHAPE was generally well tolerated with no dose limiting toxicities observed.
Shape Pharma expects to initiate a Phase II trial of SHAPE for early-stage CTCL in the fourth quarter of 2014.
The company believes that the gel formulation provides concentrated local effect and the molecule itself is designed to avoid systemic absorption and related toxicities.
SHAPE’s composition of matter patent extends until at least 2028.Additionally, SHAPE has been granted US orphan drug designation for CTCL.
TetraLogic has acquired worldwide development and commercialization rights to SHAPE for all indications.