Linnaeus Therapeutics Awarded Its Fourth Competitive SBIR Award by the National Cancer Institute Bringing Total SBIR Funding to $8.3 Million

$2,000,000 Direct-to-Phase 2 Award Funds Study of LNS8801 in the Treatment of Melanoma

HADDONFIELD, N.J., March 26, 2025 /PRNewswire/ -- Linnaeus Therapeutics, Inc. ("Linnaeus"), a privately held biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, today announced it has been awarded its fourth competitive Small Business Innovation Research ("SBIR") Award by the National Cancer Institute ("NCI") of the National Institutes of Health ("NIH").

This $2,000,000 SBIR award was granted to the company after yet another highly competitive peer-review process. The award will help fund the clinical development of its lead compound, LNS8801, which targets a G protein-coupled receptor (GPER), for the treatment of metastatic cutaneous melanoma as a monotherapy in patients who cannot tolerate immunotherapy.

"This award marks the fourth time that Linnaeus has received a competitive award from NCI for LNS8801 development and brings the total non-dilutive contribution by NCI to LNS8801 development to $8.3 million. NCI's continued support provides a strong peer-reviewed validation of the core science that is the basis of LNS8801, its target GPER, and the clinical data seen in LNS8801-treated patients with cancer," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "This award will allow us to further advance LNS8801 as a potentially safe and effective oral therapeutic for the treatment of melanoma and will augment the data seen from our ongoing clinical studies of LNS8801. We thank the NCI and NIH for their ongoing support of LNS8801 to help patients with cancer."

Linnaeus anticipates initiating a randomized controlled clinical trial in unresectable, treatment refractory cutaneous melanoma in Q2 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 progression-free survival and overall survival between 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 durable clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified.

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.