Starton Therapeutics Announces 100% Partial Response or Better in Multiple Myeloma Patients in Interim, Top-line Data from STAR-LLD Phase 1b Clinical Trial

• 100% of patients enrolled achieved a partial response or better
• Milder and less frequent drug-related adverse events were observed compared to those associated with Revlimid^®
• No grade 3 or greater adverse events in neutropenia, thrombocytopenia, or diarrhea reported

PARAMUS, N.J., June 21, 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 positive interim top-line data from its low-dose lenalidomide STAR-LLD Phase 1b clinical trial in multiple myeloma (MM). The study, designed to assess the safety, pharmacokinetics, and efficacy of the Company’s STAR-LLD in combination with dexamethasone and bortezomib (Velcade^®), met the primary objective of safety and tolerability while being administered by continuous subcutaneous (SC) infusion. All six patients achieved a partial response (PR) or better within 1-3 cycles.

“These interim results are encouraging,” stated Dr. Jamie Oliver, Starton’s Chief Medical Officer. “To date, lenalidomide is a cornerstone in treating MM. As a standard of care, Revlimid^® is widely used due to its effectiveness in combination with other therapies. However, its toxicity profile is unbearable for some, leaving a notable percentage of patients’ intolerant to lenalidomide. STAR-LLD is demonstrating lower toxicity at therapeutic doses, which could potentially improve lenalidomide’s use in MM.”

“Lenalidomide intolerance adversely affects treatment efficacy and overall survival, often leading to dose modifications or treatment discontinuation. By successfully demonstrating continuous delivery at a tolerable dose, we are directly addressing the needs of patients and their loved ones,” stated Pedro Lichtinger, Starton’s Chairman and CEO.

Tolerance measures a patient’s ability to endure minimal adverse effects from a certain drug. Severe intolerance may lead to discontinuity of treatment. The most common side effects associated with Revlimid^® during continuous maintenance treatment and contributing to intolerance include neutropenia (79%), thrombocytopenia (72%), anemia (21%), and gastrointestinal issues (40%). The hematologic adverse events lead to treatment interruptions in approximately 30% of patients. By contrast, Starton’s Phase 1b study resulted in no grade 3 or greater adverse events of neutropenia or thrombocytopenia. Although diarrhea was reported by 33% of the patients in Starton’s Phase 1b study at grades 1 and 2 adverse events, this was favorable compared to oral Revlimid^®, where diarrhea was observed in approximately 50% or more patients, of which close to 20% of those patients experienced grades 3 or 4 toxicity. Half of the Phase 1b patients reported a confined rash at the injection site, and one patient reported a rash with grade 3, which was treated. Nausea and fatigue were reported at grades 1 and 2. The majority of events reported in the study were not drug-related.

The Company will prepare a summary of data on safety and activity for the U.S. Food and Drug Administration (FDA) while patients continue treatment for efficacy endpoints. Phase 2 studies in MM and chronic lymphocytic leukemia (CLL) are planned for 2025.

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 STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, grew 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 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 with STAR-LLD than with 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 and adversely 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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