Study of lasofoxifene versus fulvestrant in patients with metastatic breast cancer will include seven precision-medicine Exactis Network study locations
COLUMBUS, Ohio, Sept. 30, 2020 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, today announced a collaboration with Exactis Innovation, a pan-Canadian Network of Centres of Excellence (NCE) in precision medicine, expanding a Phase 2 clinical trial of Sermonix’s lead investigational drug, lasofoxifene, into Canada.
The NCE is a Canadian government initiative that funds partnerships between universities, industry, government and not-for-profit organizations to create large-scale research networks integrating precision oncology across Canada.
With the recent Health Canada agreement to proceed, the open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study will now include Exactis Network sites in Quebec, Ontario, Nova Scotia and New Brunswick. The study, which began U.S. enrollment in September 2019, is assessing the efficacy 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 and progression-free survival as the primary endpoint.
“Sermonix is honored to collaborate with Exactis Innovation, a truly esteemed international center of excellence in precision medicine,” said David Portman, Sermonix founder and chief executive officer. “Our ELAINE trials are solely focused on women with ESR1 mutations, for whom there is such great need of targeted treatments that potentially can prolong and enhance their lives. Working with Exactis furthers that mission.”
With exclusive global rights to develop and commercialize lasofoxifene in the oncological arena, Sermonix is also adding ELAINE 1 study sites in Israel, further providing important international data as the company looks to fulfill its global mission of addressing the unmet needs of women with metastatic breast cancer.
Personalize My Treatment
Personalize My Treatment (PMT) is Exactis’ active pan-Canadian, Research Ethics Board-approved cancer patient registry that collects clinical and molecular patient data to match sub-populations in precision oncology research. Exactis will utilize its PMT registry, pre-screening patients to identify ESR1 mutations to both inform genomic cancer profiling during the patient’s treatment journey and potentially identify candidates for the ELAINE trial participation.
Exactis Chief Medical Officer Dr. Gerald Batist will work closely with Sermonix on the PMT/ELAINE collaboration. Dr. Batist is currently professor and former chair of the Department of Oncology at McGill University and is director of both the McGill Centre for Translational Research in Cancer and the Segal Cancer Centre at Sir Mortimer B. Davis-Jewish General Hospital in Montreal.
“The synergy between Sermonix’s precision medicine focus – through its ELAINE 1 study of lasofoxifene – and the Exactis network and PMT registry creates an ideal collaborative opportunity,” said Dr. Batist. “We look forward to identifying and enrolling Canadian women into this trial, extending the frontier of research in the ESR1-mutated breast cancer arena and offering Canadian patients participation in this very promising clinical trial.”
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally 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 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 potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.
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. Sermonix Pharmaceuticals 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. 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, has many decades of experience in the oncology drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in SERM biology. 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 https://sermonixpharma.com/.
David Portman, MD
CEO and Founder, Sermonix Pharmaceuticals