Biopharmaceutical company collaborated with Ben May Department for Cancer Research at University of Chicago to study efficacy of lasofoxifene
COLUMBUS, Ohio, March 04, 2019 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, today announced it will present a poster on the performance of its lead investigational drug, lasofoxifene, at ENDO 2019, the annual meeting of the Endocrine Society. The abstract, “Lasofoxifene Achieves Potent Anti-Tumor Activity in Y537S ESR1 Hormone-Resistant Breast Cancer Cells by Saturating ERα,” will be presented Sunday, March 24, in a 1-3 p.m. poster session at the Ernest N. Morial Convention Center in New Orleans.
Sermonix, which is currently enrolling patients in a Phase 2 clinical study of lasofoxifene, collaborated with researchers at the University of Chicago on the poster to be presented at ENDO 2019.
“Our laboratory has been looking for potent, effective inhibitors of tumor progression and metastases, especially in hormone-resistant tumors, so we were excited to observe the significant efficacy of lasofoxifene,” said Dr. Geoffrey Greene, Ph.D., chair of the Ben May Department for Cancer Research at the University of Chicago, and the poster’s senior author. “We look forward to detailing our findings at ENDO 2019.”
One of the primary goals of collaborating with the University of Chicago was to support Sermonix’s preclinical program – supplementing lasofoxifene’s well-characterized pharmacology – with further study of recently discovered activity in metastatic breast cancers harboring estrogen receptor mutations, according to Barry Komm, Ph.D., Sermonix chief scientific officer.
“This new data collection from Dr. Greene and team is helping us achieve that goal, continuing our momentum toward developing lasofoxifene as a potential novel precision medicine for women diagnosed with treatment-resistant metastatic breast cancer,” said Komm.
The U.S. Food and Drug Administration in December accepted Sermonix’s Investigational New Drug application, indicating the company could proceed directly to a Phase 2 clinical study of lasofoxifene. The open-label, randomized, multi-center study will evaluate the activity 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.
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (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 binding affinity 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 and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.
Sermonix Pharmaceuticals LLC is a biopharmaceutical company with a targeted focus on bringing female-specific oncology products through proof of concept, preclinical and clinical development, and regulatory approval. The company was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women’s health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene. The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. Paul Plourde, M.D., vice president of oncology clinical development, was previously with AstraZeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, Ph.D., chief scientific officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, M.M.Sc., Sc.D., vice president of business development, 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 roles at Wyeth and Pfizer across a range of therapeutic areas. 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 https://sermonixpharma.com.