COLUMBUS, Ohio, Feb. 8, 2023 — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, today announced that it had an abstract accepted as a Discussed E-poster Presentation at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2023. The conference takes place March 3-5 in St. Louis.
The poster, “Vaginal/vulvar symptoms with lasofoxifene versus fulvestrant in ESR1-mutated, ER+/HER2- metastatic breast cancer patients,” will be presented Saturday, March 4, at the Marriott St. Louis Grand. Presentation details are as follows:
- Session: E-poster Session 10 – Cancer & Chronic Medical Illness
- Date/time: Saturday, March 4, 2023; 2:50 p.m. – 3:20 p.m. CST
- Presenter: Shari B. Goldfarb, M.D., Assistant Attending Physician, Memorial Sloan Kettering Cancer Center
The poster shares results from the open-label randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study, which began U.S. enrollment in September 2019. Top-line data were revealed in September at the European Society for Medical Oncology (ESMO) Congress 2022. ELAINE 1 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.
The objective of the abstract to be shared at the ISSWSH Annual Meeting was to evaluate an exploratory endpoint of patient-reported vaginal/vulvar symptoms with lasofoxifene versus fulvestrant in ELAINE 1 participants.
Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), 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 novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced HR+ breast cancer.
Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific and patient-centric oncology products and has currently completed two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com.
Managing Director, Investor Relations Corporate Communications