On August 25, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that top-line data from its Phase 2 study of lasofoxifene, its lead investigational drug, versus fulvestrant was accepted for a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, which is being held September 9-13, 2022, in Paris (Press release, Sermonix Pharmaceuticals, AUG 25, 2022, View Source [SID1234618708]).

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The open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study, which began U.S. enrollment in September 2019, assessed the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

Details of the presentation are as follows:

Title: Open-label, randomized study of lasofoxifene (LAS) vs fulvestrant (Fulv) for women with locally advanced/metastatic ER+/HER2- breast cancer (mBC), an estrogen receptor 1 (ESR1) mutation, and disease progression on aromatase (AI) and cyclin-dependent kinase 4/6 (CDK4/6i) inhibitors

Presenter: Matthew P. Goetz

Date, Time and Location: September 10 at 3:05 p.m. CEST, 7.2.E – Évry Auditorium

Session: Mini Oral Session: breast cancer, metastatic

Presentation Number: LBA20

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.