• One poster examines baseline vaginal and vulvar symptoms in ESR1-mutated, ER+/HER2- metastatic breast cancer
  • Second poster shares survey results examining vaginal and sexual health in ER+/HER2- metastatic breast cancer patients

COLUMBUS, Ohio, June 29, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today announced it will present two posters, addressing sexual and urogenital health of metastatic breast cancer patients, at The Menopause Society (formerly North American Menopause Society, or NAMS) 2023 Annual Meeting, to be held Sept. 27-30 at the Downtown Marriott in Philadelphia.

“Quality of life, which includes sexual and overall genitourinary health, is a constant concern for the vast majority of women confronted with metastatic breast cancer,” said Dr. David Portman, founder and chief executive officer of Sermonix. “Our lead investigational drug, lasofoxifene, has demonstrated potential benefit with respect to vaginal and sexual health, and we are excited to continue investigating this vitally important aspect of disease management during our upcoming Phase 3 study. We look forward to engaging with our peers at The Menopause Society 2023 Annual Meeting and sharing our most recent findings.”

Sermonix will share its two posters Thursday, Sept. 28, from 6:15-7:15 p.m. ET. They are:

  • “Vaginal and vulvar symptoms in patients with ESR1-mutated, ER+/HER2- metastatic breast cancer by baseline characteristics”
    The objective of this analysis was to evaluate the effects of patient characteristics on baseline vaginal/vulvar symptoms in the Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1) study assessing the efficacy and safety of oral lasofoxifene versus intramuscular fulvestrant.
  • “Vaginal and sexual health in patients with ER+/HER2- metastatic breast cancer (mBC)”
    This poster analyzes the results of the 50-question, online EQUALS 2 (ESR1 QUAlity of Life Survey 2) survey, whose objective was to better understand vaginal and sexual health concerns of women with ER+/HER2- metastatic breast cancer.

“The theme of this year’s meeting is ‘Midlife Women’s Health in the Era of Precision Medicine,’” said Dr. Lisa Larkin, president-elect of The Menopause Society board of trustees. “Sermonix’s efforts in the precision medicine women’s oncology space is significant and its investigation of targeted therapy lasofoxifene’s impact on vaginal and sexual health is much needed in an arena that is currently so underserved. We look forward to Sermonix’s participation in The Menopause Society Annual Meeting and as a member of our 2023 Corporate Liaison Council.”

Sermonix in March initiated ELAINE-3, a registrational Phase 3 study of 400 patients assessing the efficacy of lasofoxifene and abemaciclib. Enrollment will begin soon.

To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit https://sermonixpharma.com. To learn more about the ELAINE studies, visit https://elainestudy.com/.

About Lasofoxifene
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 a CDK4/6 inhibitor 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 ER+ breast cancer.

About Sermonix
Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking 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.

Sermonix Contact:

Monica Kozlowski, MSPH
Sermonix Product Manager