On October 13, 2020 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, reported the enrollment and dosing of the first patient into the Phase 2 clinical trial collaboration of its lead investigational drug, lasofoxifene, in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib (Press release, Sermonix Pharmaceuticals, OCT 13, 2020, View Source [SID1234568478]).
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The open-label, multi-center study will evaluate the safety of lasofoxifene in combination with abemaciclib for the treatment of pre- and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2- breast cancer and an ESR1 mutation. It is Sermonix’s second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study and is known as ELAINE 2.
Preclinical models of invasive breast cancer at the University of Chicago identified synergy between lasofoxifene, a selective estrogen receptor modulator (SERM), and palbociclib, a CDK 4 and 6 inhibitor, in the presence of ESR1 mutations.
"Combination therapy with a CDK 4/6 inhibitor and an endocrine backbone will likely continue to be widely utilized for women with metastatic breast cancer, and our positive preclinical data encouraged us to pursue further safety data with a lasofoxifene and abemaciclib combination in collaboration with Eli Lilly," said Dr. Paul Plourde, Sermonix vice president of clinical development. "It’s an important step toward conducting a larger study, so we are pleased to be in the clinic, continuing our research and our momentum."
Recruitment Through Tempus
Sermonix is partnering with Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, for ELAINE study recruitment. The first ELAINE 2 patient was enrolled at one of Tempus’s TIME Trial Network sites. Tempus, with the world’s largest library of clinical and molecular data, uses innovative, proprietary software to match patients to clinical trials in real-time. For Sermonix, it is helping to identify and enroll eligible patients who have an ESR1 mutation.
"We’re thrilled to have Sermonix leveraging our real-time clinical trial network, which is focused on harnessing genomic and clinical data to rapidly match patients to these kinds of biomarker-driven trials," said Dr. Kim Blackwell, MD, Tempus chief medical officer. "Both companies share a mutual vision of advancing precision medicine through targeted therapeutics."
ELAINE 1, which began enrollment in September 2019, will continue to assess 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 delighted to begin ELAINE 2 enrollment, in line with our initially anticipated timeline," said Dr. David Portman, Sermonix founder and chief executive officer. "Tempus has a state-of-the-art approach in identifying eligible patients at the point of care, providing both agility and speed, and we are certain this innovative collaboration in the precision medicine arena will prove fruitful in expediting our clinical trial enrollment efforts in both of our clinical programs."
Both ELAINE 1 and ELAINE 2 are actively enrolling patients. To learn more about the trials, visit www.sermonixpharma.com.
About Lasofoxifene
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.
About Abemaciclib
Abemaciclib (trade name Verzenio) is a CDK4 and 6 inhibitor and the first and only oral tablet of its kind that can be taken every day for the treatment of HR+, HER2– metastatic breast cancer. It is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer, in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; in combination with fulvestrant for women with disease progression following endocrine therapy; or as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.