Linnaeus Therapeutics, Inc. (Linnaeus) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for LNS8801 for the treatment of patients with metastatic cutaneous melanoma.
| HADDONFIELD, N.J., Jan. 19, 2023 /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 that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for LNS8801 for the treatment of patients with metastatic cutaneous melanoma.
The FDA’s Office of Orphan Drug Products grants orphan drug status to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including market exclusivity upon FDA approval, exemption of FDA application fees, and tax credits for qualified clinical trials. “We are extremely pleased to have received orphan drug designation for cutaneous melanoma from the FDA. This is an important milestone that has emerged from the very promising data we have seen in biomarker-defined patients with metastatic cutaneous melanoma in our dose-expansion cohorts,” commented Patrick Mooney, MD, CEO of Linnaeus. “We look forward to further opening a randomized controlled study in patients with treatment-refractory cutaneous melanoma to explore the promising results we have already seen with LNS8801 alone and also in combination with pembrolizumab.” Having completed dose escalation, Linnaeus is currently testing LNS8801 in its phase 1/2 adaptive-design clinical trial as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in various cancers and patient populations. 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 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. |
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