Linnaeus Therapeutics to Present Positive LNS8801 Data in Metastatic Melanoma at 2024 ESMO Meeting

Linnaeus Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Haddonfield, N.J., announced the presentation of new clinical data at the 2024 ESMO Annual Meeting. This data emerges from a dose-expansion cohort study of their drug LNS8801, administered as a monotherapy to patients with metastatic cutaneous melanoma who experienced severe immune-related adverse events (irAEs) from previous immunotherapy treatments.

The study, featured in a poster titled "Efficacy of LNS8801 in melanoma patients with prior immune-related adverse events from immune-checkpoint inhibitors" (Abstract 1137P), indicated that LNS8801 was well-tolerated and did not result in unexpected toxicities. Moreover, the drug exhibited promising antitumor effects. Notably, in biomarker-positive patients, the treatment achieved a 100% disease control rate, with a preliminary progression-free survival period extending beyond six months. Remarkably, one patient has been on the treatment for over 4.5 years, with complete resolution of soft-tissue lesions and no active disease detected in the residual bone-associated target lesion or elsewhere.

Dr. Patrick Mooney, CEO of Linnaeus, expressed his enthusiasm about the results. He highlighted the significance of these findings, noting that patients who suffer from irAEs are often excluded from further immunotherapy, representing a substantial unmet need in the field. Dr. Mooney emphasized the company's commitment to further research in this patient population and in cases of unresectable, treatment-refractory melanoma.

Linnaeus plans to initiate a randomized controlled clinical trial in the fourth quarter of this year. The trial will involve 135 biomarker-positive patients with unresectable, treatment-refractory cutaneous melanoma. Participants will be randomized into three groups: LNS8801 monotherapy, a combination of LNS8801 and pembrolizumab, or a physician's choice therapy. The study aims to evaluate median progression-free survival and overall survival across these groups.

LNS8801 is an orally administered, highly specific, and potent agonist of G protein-coupled estrogen receptor (GPER). Its effectiveness depends on the expression of GPER, and it rapidly and durably reduces levels of c-Myc protein. Preclinical studies have shown that LNS8801 has potent antitumor activities across various tumor types, leading to rapid tumor shrinkage and the induction of immune memory.

In ongoing human clinical trials, LNS8801 has been found to be safe and well-tolerated. The drug has shown evidence of target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers. A predictive biomarker for the drug's effectiveness has also been identified.

Metastatic cutaneous melanoma remains a challenging condition to treat, despite advances in therapy. Many patients eventually progress beyond the reach of standard treatments and require additional options. According to the American Cancer Society, nearly 8,000 deaths occur annually in the United States due to this disease, underscoring the critical need for new and effective therapies.

Linnaeus Therapeutics is committed to addressing this need. Founded in partnership with the UPstart incubator at the University of Pennsylvania's Penn Center for Innovation, the company focuses on developing novel small-molecule oncology therapeutics that target G protein-coupled receptors. Their innovative approach aims to bring new hope to patients facing difficult-to-treat cancers.