Starton Therapeutics Bolsters Clinical Strategy After Successful ASCO 2024 Advisory Meeting

Starton Therapeutics Inc., a clinical-stage biotechnology company, recently held a successful Scientific Advisory Board meeting during the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. This significant event was led by Starton's Scientific Board members and Chief Medical Officer and attended by esteemed experts and key opinion leaders in oncology. The meeting yielded critical insights that will shape Starton's research and development efforts in Chronic Lymphocytic Leukemia (CLL) and Multiple Myeloma (MM).

Dr. Jamie Oliver, the Chief Medical Officer at Starton, expressed that the feedback from the Advisory Board greatly enhanced their study design and introduced innovative ideas likely to drive the clinical development of STAR-LLD in oncology. As the company advances into the early stages of its STAR-LLD Phase 2 clinical trials, the unbiased third-party information received has been invaluable.

Pedro Lichtinger, Starton's Chairman and CEO, added that the support from leading hematological cancer experts has reinforced the scientific rationale for pursuing the clinical development of STAR-LLD. This backing positions the company to initiate preparatory measures for their Phase 2 trials confidently.

The Advisory Board consisted of 11 distinguished members from diverse backgrounds within hematological oncology. Following the ASCO meeting and the release of early Phase 1b data in multiple myeloma, the advisors expressed strong support for the continued development of STAR-LLD. They provided valuable feedback on optimizing future clinical trial designs, patient selection criteria, biomarker utilization, and endpoint determination. These recommendations aim to enhance the robustness and efficiency of Starton's clinical development programs, underscoring the company's commitment to pioneering breakthrough treatments for MM and CLL patients globally.

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 significant results: 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. Additionally, the study showed a 100% overall response rate (ORR) using continuous delivery LLD, with 20% of animals 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.

Moreover, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid® demonstrated that Starton's drug is well tolerated and over 91% bioavailable via the subcutaneous route. It was also observed that the maximum concentration (Cmax) is lower by more than 90% with STAR-LLD than with oral Revlimid®. Recently, the company announced interim, top-line data from its STAR-LLD Phase 1b clinical trial, where a 100% partial response or better was achieved in MM patients.

Starton Therapeutics is dedicated to transforming standard-of-care therapies with its proprietary continuous delivery technology. The goal is to enable cancer patients to receive continuous treatment, thereby improving their quality of life and extending their lifespan. Starton's transdermal technology aims to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use.