Sermonix Receives FDA Fast Track Designation for Investigational Drug Lasofoxifene

Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products, today announced that its lead investigational drug, lasofoxifene, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Sermonix is currently engaged in a Phase 2 clinical study of lasofoxifene in estrogen receptor-positive (ER+) metastatic breast cancer.

Fast Track designation allows companies to "get important new drugs to the patient earlier," according to the FDA. It is designed to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The Fast Track designation will allow Sermonix more frequent interactions with the FDA during Phase 2 and for the potential to obtain breakthrough designation and priority review of a New Drug Application.

"Lasofoxifene’s Fast Track designation highlights the significant unmet medical needs of women who have estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation," said Sermonix Chief Executive Officer Dr. David Portman. "Fast Track will allow us to more quickly complete our development program and, if successful, make lasofoxifene available to patients sooner."

Sermonix’s open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study will assess 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. ESR1 mutations are commonly found in women with ER+ metastatic breast cancer progressing after prior endocrine treatment and confer poorer prognosis. A liquid biopsy test will be utilized to identify women for inclusion in the ELAINE study.

"We are very encouraged to receive Fast Track designation, a recognition of lasofoxifene’s potential promise as a precision medicine for women with ER+ metastatic breast cancer," said Sermonix Chairman Dr. Anthony Wild.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. and 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 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 SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine 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’s lead product is 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 [(R)] and Faslodex [(R)]. Barry Komm, Ph.D., chief scientific officer, is former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee [(R)] . 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.

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