Method-of-use patent strengthens STAR-LLD’s long-term patent portfolio
PARAMUS, N.J., OCTOBER 4, 2021 – Starton Therapeutics Inc., a clinical stage biotechnology company transforming standard of care therapies with proprietary dermal technologies, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 16/854,810, covering STAR-LLD, the Company’s continuous delivery lenalidomide program. The allowed patent application, entitled, “Continuous Delivery of Lenalidomide and Other Immunomodulatory Agents,” includes claims directed to using continuous delivery of immunomodulatory imide compounds including thalidomide and its derivatives. Surprisingly, this method of continuous delivery improved anti-cancer activity or anti-inflammatory activity of the drug with reduced toxicities (such as neutropenia) when compared with a standard pulsatile dosing regimen.. The patent that issues will have a base patent term extending to 2040, excluding any patent term adjustments or patent term extensions which may provide additional protection.
Pedro Lichtinger, Chairman and Chief Executive Officer, said, “We are pleased to receive this notice from the USPTO, confirming broad protection of our continuous delivery lenalidomide program. This method of use takes advantage of our unique approach to lowering drug exposure and AUC (area-under-the-curve) to potentially improve efficacy and safety. The technology covered by the patent is broad and includes all forms of continuous administration of thalidomide and its derivatives via subcutaneous infusion from an external drug supply.”
A Notice of Allowance is issued after the USPTO makes a determination that a patent should be granted from an application. Starton Therapeutics retains full global ownership of this patent, with the technology and methodology being developed internally.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with oral lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg continuous LLD vs. 0% ORR with active control and 20% tumor elimination at 144 mcg continuous LLD vs. 0% tumor elimination with daily pulsatile dosing.
STAR-LLD SC is expected to enter clinical studies in Q1 2022. Starton has completed a pre-IND meeting for STAR-LLD SC and all IND-enabling studies.
Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID(r).
About Starton Therapeutics
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use.To learn more, visit www.startontx.com
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