Linnaeus Therapeutics Announces FDA Clearance of Investigational New Drug Application for LNS8801

Haddonfield NJ, September 24, 2019–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 that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for LNS8801, a small molecule agonist of the G protein-coupled estrogen receptor (GPER). Linnaeus is developing LNS8801 for the treatment of solid and hematologic cancers.

“The FDA clearance of the IND allows Linnaeus to begin human testing of LNS8801 and represents the culmination of a tremendous effort by our research and development team,” commented Patrick Mooney, MD, chief executive officer of Linnaeus. “LNS8801 is a potent and highly selective small molecule agonist of GPER. Based on the epidemiological evidence and the strong preclinical data, we believe that LNS8801 has very real potential to provide meaningful and lasting clinical benefit for patients with cancer. We are excited to enroll our first patient in the coming weeks.”

FDA allowance of the IND enables Linnaeus to initiate its planned phase 1/2 clinical trial in patients with advanced cancers. The phase 1 dose-escalation portion of the trial will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of LNS8801. After a recommended phase 2 dose is established, dose expansion cohorts are anticipated. Linnaeus expects the first patient to be enrolled in the trial in October 2019.

About LNS8801
LNS8801 is an orally bioavailable, highly specific, agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has significant antitumor activity, including complete responses that are immune to rechallenge. LNS8801 also has combinatorial effects with targeted therapies and immunotherapies. Preclinical toxicology studies have established a wide safety margin.

About Linnaeus

Linnaeus Therapeutics, Inc. is a privately held biopharmaceutical company focused on the development and commercialization of novel, small molecule oncology therapeutics that target a novel G protein-coupled receptor, known as GPER, or GPR30. The company was launched through the UPstart incubator at the University of Pennsylvania’s Penn Center for Innovation (PCI) Ventures. Its lead molecule, LNS8801, is in the final stages of preclinical development. The Company expects to begin its phase 1 clinical program in the summer of 2019. In addition to developing GPER agonists, Linnaeus is also currently focusing on developing small molecules that activate other G protein-coupled receptors to engage tumor-suppressive cellular signaling pathways.