Posters to be displayed at Dec. 4-8 conference address introduction of Phase 2 study of investigational drug lasofoxifene, its effect on breast cancer and lung and liver metastasis in an in vivo model, and oncologists’ perceptions of ESR1 mutations and biomarker testing.
COLUMBUS, Ohio, Nov. 14, 2018 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, today announced the acceptance of three posters for presentation at the 2018 San Antonio Breast Cancer Symposium (SABCS). The accepted presentations demonstrate Sermonix’s continued momentum toward realizing the potential of its lead investigational drug, lasofoxifene, as an oral targeted treatment for women with ESR1 mutations in metastatic breast cancer.
The Dec. 4-8 meeting at the Henry B. Gonzalez Convention Center in San Antonio will include the following posters:
- An open-label, randomized, multi-center Phase 2 study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2 – breast cancer (MBC) with an ESR1 mutation
- Presenting author Matthew Goetz, M.D., Mayo Clinic
- Poster Session OT (OT1-01-02); Wed., Dec. 5, 5pm-7pm
- A preliminary assessment of knowledge, attitudes, and awareness surrounding ESR1 mutations and biomarker testing amongst medical oncologists
- Presenting author Shari Goldfarb, M.D., Memorial Sloan Kettering Cancer Center
- Poster Session 5 (PD5-11-11); Fri. Dec. 7, 5pm-7pm
- Lasofoxifene decreases breast cancer lung and liver metastasis in a mammary intraductal (MIND) xenograft model of mutant ER-alpha+ breast cancer
- Presenting author Muriel Lainé, Ph.D., University of Chicago
- Poster Session 7 (PD7-09); Fri., Dec. 7, 7am-9am
One poster introduces a Phase 2 trial of oral lasofoxifene, evaluating its activity versus intramuscular fulvestrant for the treatment of postmenopausal women who have locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 (estrogen receptor gene) mutation. Another poster, selected for a spotlight session on endocrine resistance, is Sermonix-sponsored research from the University of Chicago Ben May Department for Cancer Research in a MIND xenograft model of mutant ER+ breast cancer. The third poster will share results of a study on medical oncologists’ knowledge, awareness and perceptions of precision medicine and liquid biopsy biomarker testing specific to breast cancer and ESR1 mutations.
“Lasofoxifene’s potency and newly discovered activity in ESR1 mutations may hold promise for patients who have acquired resistance in an area of significant unmet medical need,” said David Portman, M.D., Sermonix founder and chief executive officer. “We look forward to presenting exciting data at this year’s San Antonio Breast Cancer Symposium as we move lasofoxifene forward as a targeted therapy for women with advanced breast cancer.”
“Clinical data have shown a significant reduction in the incidence of ER+ breast cancer in postmenopausal women with osteoporosis who were treated with lasofoxifene,” said Paul Plourde, M.D., Sermonix vice president of clinical development. “Further non-clinical and clinical study results provide a strong rationale for pursuing a Phase 2 clinical trial comparing lasofoxifene to fulvestrant, a current widely used injectable medication for advanced breast cancer.”
“Lasofoxifene’s ability to reduce primary tumor weights and inhibit metastasis of ER-mutated breast cancer xenografts in a mouse mammary intraductal (MIND) model was reported at the Annual Meeting of the American Society of Clinical Oncology in June this year,” said Geoffrey Greene, Ph.D., chair of the Ben May Department for Cancer Research and co-director of the Ludwig Center for Metastasis Research at the University of Chicago. “We look forward to sharing new data on lasofoxifene’s impact on lung and liver metastases in breast cancer xenografts that express mutant ER.”
Muriel Lainé, a senior research professional in Greene’s lab, will serve as presenting author for the Spotlight Session in San Antonio.
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 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 Astra-Zeneca, 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. 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.