Additional patent application filed for novel parenteral formulation in development for Chronic Lymphocytic Leukemia (CLL)
PARAMUS, N.J., January 11, 2021 – 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
This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as “may,” “should,” “plan,” “intend,” “potential,” “continue,” “believe,” “expect,” “predict,” “anticipate” and “estimate,” the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the Company’s control and involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the Company’s beliefs, assumptions and expectations of future performance, taking into account information currently available to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, the Company’s business, financial condition, liquidity, results of operations, plans and objectives may vary materially for from those expressed in the aforementioned forward-looking statements.