Sermonix Announces FDA Acceptance of IND Application; Will Begin Phase 2 Trial of Lasofoxifene for Targeted Treatment of Women With ESR1 Mutations in Metastatic Breast Cancer

Study, set to commence in early 2019, will evaluate activity of oral lasofoxifene versus IM fulvestrant for treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation

COLUMBUS, Ohio, Dec. 10, 2018 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application, indicating that Sermonix may proceed directly to a Phase 2 clinical study in the personalized medicine arena involving its lead investigational drug, lasofoxifene.

The open-label, randomized, multi-center study is expected to begin enrollment in early 2019 and 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.

“We are delighted the IND application was favorably reviewed by the FDA and brings us ever closer to delivering a novel endocrine treatment option for these women in great need,” said Sermonix Chairman Dr. Anthony Wild. “This marks an important milestone in Sermonix’s effort to develop lasofoxifene as a precision medicine for women with advanced breast cancer.”

A large amount of clinical data from earlier non-oncology development, along with new, compelling preclinical data have enabled Sermonix to commence directly into the Phase 2 study. The study will include postmenopausal women with ESR1 mutations, identified using a liquid biopsy clinical trial assay, who have progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy. ESR1 mutations occur in up to 40 percent of women with metastatic breast cancer and may confer a worse prognosis and poor response to currently available endocrine treatments1.

“As ESR1 mutations are highly prevalent in ER+ metastatic breast cancer, we look forward to demonstrating lasofoxifene’s potential promise in this area of significant unmet medical need,” said Dr. David Portman, Sermonix founder and chief executive officer. “Acceptance of the IND application allows us to maintain momentum in the important effort to bring lasofoxifene to patients who desperately need more options for this incurable disease, so we are thrilled to receive this news from the FDA.”

1 Chandarlapaty S et al, JAMA oncology 2016 Oct 1;2(10):1310-1315)

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 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.

About Sermonix

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 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 http://sermonixpharma.com.