Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company powering continuous delivery of approved drugs in novel indications, announced today that it has selected a subcutaneous lenalidomide formulation as the lead formulation candidate for its continuous subcutaneous delivery system (STAR-LLD SC) for chronic lymphocytic leukemia (CLL) and other hematologic malignancies.
“Lenalidomide is an exceptionally challenging molecule to formulate,” said Andy Rensink, Chief Manufacturing Officer. “By using unique and novel technology we are thrilled to have successfully developed a stable solution for use in the STAR-LLD SC delivery system and are excited to move this product closer to benefitting patients.”
Starton has filed a provisional patent application based on the novelty of the formulation, which is being co-developed and co-manufactured in collaboration with a large international FDA-compliant contract manufacturing partner. Any IP generated from co-development and co-manufacturing will be solely owned by Starton Therapeutics. STAR-LLD SC clinical trial materials are expected to be shipped in Q2 2021 for initiation of Phase 1/2 clinical studies for CLL in the second half of 2021. The studies are expected to use an open-label design with arms in multiple indications in CLL, with each target indication using different sub-population characteristics. Starton believes that this strategy provides multiple shots on goal with at least one indication with the potential for FDA breakthrough therapy designation.
STAR-LLD SC is the first delivery system in the STAR-LLD continuous delivery platform. Starton is also developing a once-weekly transdermal delivery patch system, which is also rapidly progressing in formulation development. STAR-LLD SC will use an ambulatory pump to infuse low-dose lenalidomide continuously, based on Starton research showing that low-dose continuous delivery may have superiority in survival and complete response rates. STAR-LLD is expected to offer a new mode of action for CLL patients and be the first IMiD (immunomodulatory drug) available for this patient population.
About Starton Therapeutics
A clinical-stage biotechnology company focused on transforming standard of care therapeutics. Starton uses proven continuous delivery technology with proprietary drivers to obtain new indications or develop on-label superiority for patients with hematological malignancies. To learn more, visit www.startontx.com