Starton Therapeutics Inc., a clinical-stage biotechnology company, has announced a strategic collaboration with Bend Bioscience to advance development of STAR-LLD, a proprietary oral sustained-release formulation of lenalidomide designed to improve treatment outcomes for multiple myeloma patients. The partnership aims to address tolerability challenges associated with current lenalidomide therapy while maintaining or enhancing therapeutic efficacy.
Addressing Current Treatment Limitations
While lenalidomide remains a cornerstone treatment for multiple myeloma, the approved oral formulation is associated with hematologic side effects in some patients. STAR-LLD's continuous delivery approach may improve the therapeutic index of lenalidomide by delivering lower doses continuously, potentially allowing for better treatment outcomes with reduced toxicity.
"This oral formulation of STAR-LLD not only has the potential to demonstrate superior tolerability and efficacy but could also improve patient compliance and convenience," said Pedro Lichtinger, Chairman and CEO of Starton. "By giving less drug continuously, STAR-LLD may improve the therapeutic index of lenalidomide allowing for better treatment outcomes."
Promising Preclinical and Clinical Data
STAR-LLD has demonstrated compelling efficacy in preclinical studies. A proof-of-concept study showed that multiple myeloma tumors caused by human myeloma cells grew 25-fold if untreated and five-fold when treated with daily lenalidomide, but shrank by 80% with STAR-LLD over a single 28-day cycle. The study achieved a 100% overall response rate using continuous delivery lenalidomide, with 20% of animals remaining tumor-free after 100 days, compared to a 0% overall response rate in animals treated with a 70% higher dose of lenalidomide given in single daily doses.
Clinical validation came through a Phase 1b study involving six relapsed/refractory multiple myeloma patients, where all participants who received STAR-LLD achieved an objective response, including one complete response and five partial responses. Notably, no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 throughout up to 12 cycles of therapy.
Strategic Partnership Framework
The collaboration leverages Bend Bioscience's expertise in controlled release formulation, manufacturing process development, and analytical method development for solid oral dosage forms. Bend will develop an optimized oral STAR-LLD tablet by building upon Starton's intellectual property and clinical experience with continuous lenalidomide delivery from prior trials.
"Bend's proven expertise in formulation and manufacturing complements our innovation and understanding of how to reduce toxicity and improve efficacy of lenalidomide and we're eager to partner with them," said Andy Rensink, Starton's Chief Manufacturing Officer.
The partnership will focus on enhancing the product's performance and scalability, with Bend leading scale-up and commercial manufacturing efforts. Owen Murray, CEO of Bend, emphasized the collaboration's potential impact: "We are excited to be a part of Starton's story, and to see STAR-LLD potentially reach patients in need."
Expanding Treatment Applications
STAR-LLD is being developed to expand and potentially replace standard-of-care treatment for multiple myeloma and chronic lymphocytic leukemia. The continuous delivery technology represents Starton's broader platform approach to transforming standard-of-care therapies by increasing efficacy of approved drugs while making them more tolerable and expanding their potential applications.
