On June 9, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that it will host a virtual update on its ELAINE Phase 2 clinical programs on Wednesday, June 15 at 10:00 a.m. EDT (Press release, Sermonix Pharmaceuticals, JUN 9, 2022, View Source [SID1234615825]).
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The event will feature presentations from Key Opinion Leaders (KOLs) Sarah Sammons, M.D. (Duke University) and Senthil Damodaran, M.D., Ph.D. (The University of Texas MD Anderson Cancer Center) who will discuss lasofoxifene, Sermonix’s investigational treatment for metastatic breast cancer with an acquired estrogen receptor 1 (ESR1) mutation.
Dr. Sammons will provide an overview of the ELAINE-1 study, an open-label, randomized, multicenter study evaluating the activity of lasofoxifene versus fulvestrant (the current standard of care) in patients who have progressed following treatment with an aromatase inhibitor (Al), including in combination with a CDK 4/6 inhibitor.
Dr. Damodaran will then provide an analysis of efficacy and safety data from the ELAINE-2 study, an open-label multicenter study evaluating lasofoxifene in combination with Lilly’s CDK 4/6 inhibitor abemaciclib (VERZENIO), which was provided by Eli Lilly and Co for the study.
Following Dr. Damodaran and Dr. Sammons’ presentations, the Sermonix leadership team will provide a company overview and update.
Interested participants are required to register in advance for the event and may do so here.
Key Opinion Leader Biographies
Sarah Sammons, M.D.
Sarah Sammons, M.D. is currently an assistant professor of medicine at Duke University/Duke Cancer Institute. Her clinical focus is in breast medical oncology and she has expertise in treating patients with all subtypes of metastatic breast cancer. She serves as assistant director of breast cancer clinical research at Duke Cancer Institute and as breast leader for the Centers of Brain Metastases and the Cancer Immunotherapy Research.
Her research focuses on the development of novel therapies for the treatment of metastatic breast cancer. She has designed and implemented several institutional, national and international clinical trials in advanced breast cancer. She also has a translational focus on understanding breast tumors that may respond to immunotherapeutic strategies and how to enhance them.
Senthil Damodaran, M.D., Ph.D.
Senthil Damodaran, M.D., Ph.D. is a medical oncologist/physician scientist with expertise in breast cancers, cancer genomics and development of novel targeted therapies. Dr. Damodaran serves as assistant professor in breast medical oncology with a joint appointment in investigational cancer therapeutics at MD Anderson Cancer Center.
He focuses on 1) genomics-driven clinical trials, 2) application of genomics for target discovery in breast cancers, and 3) characterization of secondary drug resistance mechanisms. At MD Anderson, he led their department’s genomic-directed clinical/translational efforts.
Dr. Damodaran is actively involved in several National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) initiatives. He serves as the chair for the NCI MATCH (Molecular Analysis for Therapy Choice) trial (Sub-protocol Z1F) and co-chair for upcoming ComboMATCH studies. He also serves as PI for genomically matched NCI-ETCTN study evaluating copanlisib in combination with trastuzumab and pertuzumab in HER2 +ve MBC with PIK3CA or PTEN alterations. Additionally, Dr. Damodaran serves as PI for the INTERACT study, which employs real-time ctDNA monitoring to identify secondary ESR1 alterations as well as genomically targeted study of futibatinib (TAS120) in MBC patients with FGFR amplifications. He also serves as the co-lead for post-mortem tissue collection protocol for metastatic breast cancer, a first of its kind at MD Anderson. In addition, he serves on the ABIM/ASCO Breast Question Writing group and the ASCO (Free ASCO Whitepaper) biomarker expert panel.
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.