Key Takeaways
- Cascade Prodrug and Uneedle are advancing development of CPD100, a hypoxia-targeted investigational therapy for wet AMD, using the Bella-Vue suprachoroidal microneedle delivery system
- Preclinical in vitro findings suggest CPD100 selectively targets endothelial cells in hypoxic conditions while preserving retinal cell viability, supporting its potential anti-angiogenic mechanism
Cascade Prodrug and Uneedle are expanding their collaboration to evaluate CPD100, Cascade's first-in-class hypoxia-targeted therapeutic candidate, for the treatment of wet age-related macular degeneration (AMD).
The companies are pairing CPD100 with Uneedle's Bella-Vue suprachoroidal microneedle system, which is designed to deliver therapies directly to the choroid, where angiogenic processes associated with wet AMD originate. Uneedle plans to present details of the collaboration and initial development progress publicly for the first time at the OIS 9th Retina Innovation Summit on July 14 in Montreal, Canada.
CPD100 is designed to preferentially activate in hypoxic disease environments. According to the companies, in vitro studies conducted under hypoxic conditions demonstrated that low concentrations of the investigational therapy induced cell-cycle arrest and apoptosis in endothelial cells while preserving retinal cell viability. Those findings suggest the potential for a targeted anti-angiogenic effect in hypoxic regions of the macula.
"Cascade is excited to work with Uneedle as we advance CPD100 toward clinical development in wet AMD," Allan Cochrane, President of Cascade Prodrug, said in a statement. "By combining CPD100's hypoxia-targeted mechanism of action with Uneedle's Bella-Vue suprachoroidal microneedle system, we believe we can create a compelling therapeutic approach designed to address pathological angiogenesis while preserving retinal integrity."
"CPD100 represents a highly differentiated therapeutic approach for wet AMD, and we are pleased that Cascade has selected Bella-Vue to support targeted delivery to the suprachoroidal space," said Jeroen Wissink, CEO of Uneedle. "This collaboration reflects our commitment to enabling partners with a precise, validated microneedle platform for the next generation of ophthalmic therapeutics."
Uneedle said its Bella-Vue platform has been evaluated in multiple preclinical and clinical studies, including a phase 1 study in patients with wet AMD, demonstrating the feasibility, safety, and accuracy of suprachoroidal delivery. The companies added that initial in vivo tolerability data from Cascade's first suprachoroidal administration study using Bella-Vue support continued development in an ongoing preclinical proof-of-concept study.
Looking ahead, Cascade and Uneedle plan to complete the current proof-of-concept program and support an initial INTERACT meeting with the FDA during the fourth quarter of 2026. Cascade is also seeking funding to complete chemistry, manufacturing and controls (CMC) activities and nonclinical Good Laboratory Practice (GLP)-enabling studies needed to support an investigational new drug (IND) application and future clinical development.