On June 18, 2020 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy (Press release, Linnaeus Therapeutics, JUN 18, 2020, View Source [SID1234561237]).
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Linnaeus is currently evaluating LNS8801 in a phase 1 clinical trial in patients with advanced cancer. The company expects to identify the recommended phase 2 dose this summer and to begin its phase 2 program evaluating LNS8801 as a monotherapy and in combination with targeted therapies in early fall.
LNS8801 is a first-in-class, orally bioavailable, small-molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Agonizing GPER both stops cancers from proliferating and makes them more visible to the immune system.
"Receiving Fast Track designation for LNS8801 is an important step in its clinical development as we near the end of our phase 1 dose-escalation study and advance LNS8801 into phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "We are pleased that the FDA recognizes the potential of LNS8801 to help patients with melanoma who have progressed after anti–PD-1/L1 therapy."
About Fast Track Designation
Fast Track designation is a process designed to facilitate the expedited development and review of new drugs that treat serious or life-threatening conditions and that have demonstrated the potential to fill an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.
A company with a drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with the FDA to discuss the drug’s development and ensure collection of the appropriate data needed to support drug approval
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About LNS8801
LNS8801 is an orally bioavailable and 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 shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies, chemotherapies, and immunotherapies. LNS8801 is currently in a phase 1/2 clinical trial in patients with advanced cancer at six comprehensive cancer centers in the United States.