On September 23, 2019 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female-specific oncology products in the precision medicine metastatic breast cancer arena, reported the enrollment and dosing of the first patient into a Phase 2 clinical trial of its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, SEP 23, 2019, View Source [SID1234539705]).

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The open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE, NCT03781063) study will assess 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.

"To address this unique population, the landmark ELAINE study of women with advanced metastatic breast cancer is the first of its kind to select all patients for participation prospectively based on ESR1 mutation status," said Paul Plourde, M.D., vice president of clinical oncology development at Sermonix. "A potential targeted therapy for ER+/HER2- breast cancer patients could greatly advance our approach to this complex disease."

Assessment of ESR1 mutations is difficult in patients with advanced disease, as molecular heterogeneity can confound results and tissue biopsies of multiple tumor sites are impractical. To address this challenge, Sermonix partnered with Sysmex Inostics to identify appropriate study participants using the OncoBEAM ESR1 test. The liquid biopsy test has demonstrated proven clinical performance in screening patient plasma for ESR1 mutations.

"The OncoBEAM ESR1 technology allows us to determine if a mutation exists in the binding domain of the tumor’s estrogen receptor gene via a minimally invasive peripheral blood draw," said Dr. Plourde. "We are delighted to collaborate with Sysmex Inostics to quickly and accurately identify appropriate study candidates."

Sermonix’s mission to develop lasofoxifene as a precision medicine for women in great medical need is one important step closer to fruition with the initiation of the ELAINE study, according to Dr. David Portman, Sermonix founder and chief executive officer.

"The dosing of our first patient, which closely follows the completion of our Series A financing, marks a pivotal milestone and truly gratifying moment for Sermonix," said Dr. Portman. "ESR1 mutations are highly prevalent in ER+ metastatic breast cancer and confer a poor prognosis. We are encouraged to be able to offer women the opportunity to participate in the ELAINE study, and for Sermonix to deliver on the promise of demonstrating lasofoxifene’s potential as a novel endocrine treatment option in the fight against this incurable disease."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed 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 and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered at Duke University and Sermonix has exclusive rights to develop and commercialize it 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.