Starton Therapeutics Granted New U.S. Patent #12,390,457 Titled “Stable Solutions of Immunomodulatory Imide Compounds for Parenteral Use” a Formulation of STAR-LLD

• New U.S. patent provides IP coverage for the formulation to 2042
  
• Further expands Starton’s intellectual property portfolio surrounding its lead product candidate, STAR-LLD, Method of Use Patent #11,197,852 which provides IP coverage to 2040
  
  

PARAMUS, N.J., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary continuous delivery technologies, announced today the issuance of a patent by the United States Patent and Trademark Office (USPTO) covering claims related to Starton’s lead product candidate, STAR-LLD. STAR-LLD is currently in late-stage clinical development for the treatment of multiple myeloma (MM) and other possible indications.

U.S. Patent 12,390,457 B2 was issued on August 19, 2025, and is entitled “Stable Solutions of Immunomodulatory Imide Compounds for Parenteral Use.” The patent includes multiple claims covering stable formulations of immunomodulatory imide drugs (IMiDs), including Starton’s proprietary continuous low-dose formulation of lenalidomide (Revlimid^®), STAR-LLD, for parenteral delivery in the treatment of inflammatory disorders and cancer.

“We are pleased to announce the issuance of this new U.S. patent, which further expands our IP protections for our lead product candidate, STAR-LLD,” said Pedro Lichtinger, Chairman and CEO of Starton. “The granted claims in the newly issued ‘457 patent provide strong protections surrounding our proprietary, stable formulations of STAR-LLD, which represents the foundational science enabling Starton to deliver continuous, low-dose lenalidomide. We believe Starton, with a strong and growing number of U.S. patents covering STAR-LLD, has the potential to realize a significant commercial opportunity over the next several years, driven by our mission of improving treatment outcomes for cancer patients.”

Starton has been issued multiple U.S. patents covering the continuous delivery of lenalidomide and other immunomodulatory agents that extend out to 2040 and 2042. Starton’s IP strategy is led by Roy Waldron, Ph.D., JD, former Global VP of Intellectual Property at Pfizer and a current Starton Board member.

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 with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

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 live better, for longer. Starton’s proprietary 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, Starton undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.

Investor Relations Contact

Alex Starr
Managing Director
LifeSci Advisors
astarr@lifesciadvisors.com

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