Starton Therapeutics Announces Notice of Allowance for U.S. Patent Application 17/518,930 “Continuous Delivery of Lenalidomide and Other Immunomodulatory Agents” Including Transdermal Administration

• Significantly expands scope of patent coverage for Company’s proprietary drug delivery systems to now include transdermal delivery
• Patent expected to issue from the pending application will have term extending to 2040, excluding any patent term adjustments or patent term extensions that may provide additional protection
• STAR-LLD is being developed for use in hematological malignancies which includes multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and others.

PARAMUS, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/518,930, covering STAR-LLD, the Company’s continuous delivery lenalidomide program.

The notice of allowance for U.S. Patent Application No. 17/518,390, entitled, “Continuous Delivery of Lenalidomide and Other Immunomodulatory Agents,” includes claims directed to the delivery of immunomodulatory imide compounds including lenalidomide, pomalidomide, iberdomide, or a combination thereof with a transdermal delivery system. The Company’s previously granted U.S. Patent No. 11,197,852, covered drug delivery systems utilizing parenteral delivery by subcutaneous infusion. The allowed claims in this patent application significantly expands the scope of patent coverage by now including drug delivery systems that utilize transdermal delivery systems for continuous low-dose delivery profile of lenalidomide.

“We are delighted to receive this notice from the USPTO, further expanding the protection of our continuous delivery lenalidomide program,” stated Pedro Lichtinger, the Company’s Chairman and CEO. “The transdermal delivery system that is the subject of the allowed patent application demonstrates our unique approach to lowering drug exposure and AUC (area-under-the-curve) to potentially improve efficacy and safety and demonstrate superiority.”

The Company’s transdermal delivery system administers the immunomodulatory imide compound at a dose rate that is 10-75% of the daily dose of the oral and achieves blood levels of the compound that is equivalent to the blood level at a time point from 8 hours to 18 hours obtained from once daily oral dose. The transdermal application in the allowed claims of lenalidomide and other IMiDs is expected to obtain suitable blood levels which would equate to the continuous and low-dose levels of the subcutaneous administration in an easy to apply drug product.

Once granted, the patent expected to issue from the pending application will have a term extending to 2040, excluding any patent term adjustments or patent term extensions that may provide additional protection. Starton retains full global ownership of the patent applications and granted patents with the technology and methodology being developed internally.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD and 20% of animals in this cohort were tumor-free after 100 days, compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1 bioavailability study in healthy men comparing subcutaneous STAR-LLD to Revlimid^® demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid^®.

About Starton Therapeutics

Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit www.startontx.com.

Forward Looking Statements

All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially from those included within the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements and, except as required by law, the Company undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.

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