Linnaeus Therapeutics Announces Presentation of Positive Clinical Data of LNS8801 in Metastatic Melanoma at 2024 ESMO Annual Meeting

HADDONFIELD, N.J., Sept. 16, 2024 /PRNewswire/ -- Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, today announced the presentation of clinical data at the 2024 ESMO Annual Meeting from its dose-expansion cohort of LNS8801 as a monotherapy in patients with metastatic cutaneous melanoma who could not tolerate immunotherapy due to prior immune-related adverse events.

The poster is entitled "Efficacy of LNS8801 in melanoma patients with prior immune-related adverse events from immune-checkpoint inhibitors" (Abstract 1137P).

LNS8801 given alone was tolerable without unanticipated toxicities and demonstrated encouraging antitumor activity in patients with metastatic cutaneous melanoma who had prior severe immune-related adverse events on immune checkpoint inhibitor therapies. LNS8801 monotherapy treatment resulted in a disease control rate of 100% in biomarker-positive patients, with a preliminary progression-free survival of over 6 months. This includes a patient that has been on treatment for over 4.5 years with resolution of all soft-tissue lesions and no evidence of active disease in the residual bone-associated target lesion or elsewhere.

"We are extremely pleased to showcase these data at ESMO," commented Patrick Mooney, MD, CEO of Linnaeus. "The data from this study demonstrate that LNS8801 is extremely safe and well tolerated and shows very promising signs of efficacy. Given that patients with prior irAEs are often prevented from receiving further immunotherapy, these patients represent a large unmet need. We look forward to generating more data in this patient population and in unresectable treatment refractory melanoma."

Linnaeus anticipates initiating a randomized controlled clinical trial in unresectable, treatment-refractory cutaneous melanoma in Q4 of this year. This study will randomize 135 biomarker-positive patients to receive LNS8801 monotherapy; LNS8801 and pembrolizumab; or physician's choice therapy. The study will assess median progression-free survival and overall survival among the groups.

About LNS8801
LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified.

About Metastatic Cutaneous Melanoma
Although there has been progress in the treatment of metastatic cutaneous melanoma, most patients will progress on standard of care therapies and need further treatment. According to the American Cancer Society, almost 8,000 patients die each year in the United States, highlighting the need for safe and effective therapies in the treatment-refractory setting. 

About Linnaeus
Linnaeus Therapeutics, Inc. is a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics that target G protein-coupled receptors. The company was formed and launched in partnership with the UPstart incubator at the University of Pennsylvania's Penn Center for Innovation (PCI).

SOURCE Linnaeus Therapeutics, Inc.