Starton Therapeutics Inc. (“Starton”), a clinical-stage biotechnology company employing standard-of-care therapies with proprietary continuous delivery technologies, announced today that it has signed a clinical trial agreement with the Stanford School of Medicine to evaluate Starton’s lead candidate STAR-LLD, in combination with a novel CAR-T cell therapy for the treatment of multiple myeloma (MM).
The planned study will investigate the safety and preliminary efficacy of STAR-LLD administered in combination with the Stanford Medicine investigational CAR-T therapy in patients with relapsed or refractory multiple myeloma. The collaboration aims to explore whether STAR-LLD may enhance therapeutic responses and improve clinical outcomes when used alongside advanced cellular immunotherapies. It will also be assessing correlative biomarkers to characterize the immune effects of STAR-LLD at various doses to confirm the PK/PD relationship.
“We are excited to collaborate with Stanford Medicine and advance the evaluation of STAR-LLD,” said Pedro Lichtinger, Chairman and CEO. “This agreement represents an important step in our strategy, as we believe this combination has the potential to improve CAR-T cell expansion and persistence, while minimizing the known toxicity of immunomodulatory imide drugs (IMiD).”
“The use of lenalidomide in combination with CAR-T cell therapy has demonstrated an improvement in outcomes, however, is associated with significant increases in severe or life-threatening toxicities. Lenalidomide has shown potent effect on immune cell fitness, production of a favorable tumor microenvironment, and mitigation of T cell exhaustion all of which may have a positive effect on CAR-T’s long-term persistence,” said Jamie Oliver, Starton’s Chief Medical Officer. “By providing low-dose continuous delivery of lenalidomide we may decrease the concomitant toxicity observed with current lenalidomide oral formulations while maintaining the immunologic activity observed with the IMiD class of drugs.”
“We look forward to exploring how the combination of STAR-LLD with our novel BCMA directed CAR-T therapy might impact outcomes,” added Lekha Mikkilineni, MD, MA, Assistant Professor of medicine at Stanford Medicine. “We intend to present the data from this study for publication in scientific forums.”
While Stanford Medicine is solely responsible for the protocol and conduct of the study, Starton anticipates using the data to support a Phase 2 IND in combination with BCMA CAR-T’s in MM.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide (LLD) in development seeking 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 Phase 1b clinical 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.
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