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COLUMBUS, Ohio, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative targeted therapeutics to specifically treat ESR1 -mutated metastatic breast and gynecological cancers, today broadly shared two poster presentations initially released at the 2022 San Antonio Breast Cancer Symposium (SABCS). The presentations discussed exploratory analyses evaluating mutant allele frequencies (MAF) of ESR1 (mut ESR1 ) in circulating tumor DNA (ctDNA) from patients who participated in each of Sermonix’s Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) Phase 2 studies.
Using the Sysmex Inostics OncoBeam or SafeSeq assays, ELAINE 1 assessed the efficacy and safety of Sermonix’s lead development candidate, oral lasofoxifene, versus the current standard of care, intramuscular fulvestrant, in postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer (mBC) and an ESR1 mutation. ELAINE 2, which used the SafeSeq assay, evaluated lasofoxifene in combination with the CDK 4 and 6 inhibitor abemaciclib in a heavily pre-treated ESR1 mutation positive patient population.
“The ELAINE studies are biomarker driven, with patients selected for treatment utilizing liquid biopsy detection of ESR1 mutations,” said Dr. David Portman, Sermonix chief executive officer. “The results confirm robust target engagement with decrease and clearance of ctDNA seen with lasofoxifene as both monotherapy and when combined with abemaciclib, and associated with improved progression-free survival (PFS) and clinical benefit. Future studies may help clarify the role of molecular response in optimizing clinical outcomes and we look forward to exploring this further in our upcoming Phase 3 program.”
ELAINE 1 data demonstrated that targeted lasofoxifene more effectively decreased or cleared mut ESR1 than fulvestrant. Further, mut ESR1 MAF decreases on lasofoxifene were associated with prolonged progression-free survival of 8 months, whereas fulvestrant patients with a decrease in MAF achieved a median PFS of 4.5 months. These data indicate lasofoxifene results in robust mut ESR1 target engagement. Taken together, the data suggest mut ESR1 as a potential biomarker for predicting response to lasofoxifene in mut ESR1, endocrine-resistant mBC patients.
In ELAINE 2, 81% of patients had decreased/cleared mut ESR1 after 4 weeks of lasofoxifene plus abemaciclib, which correlated with clinical benefit. All mut ESR1 variants detected appear targeted with this therapy. High sensitivity and favorable positive predictive value were observed in patients with undetectable MAF at 4 weeks, indicating that ESR1 liquid biopsy evaluation may be a potential molecular biomarker for monitoring patients on this treatment if confirmed in a larger randomized study.
ELAINE 1 RESULTS:
“The use of ctDNA is dramatically improving our understanding about the molecular evolution of breast cancer, particularly with regards to endocrine resistance,” said Dr. Massimo Cristofanilli, a chief of breast oncology in New York and past president of the International Society of Liquid Biopsy. “The information allows us to evaluate the targeted endocrine agents and monitor not only the clinical response, but also the impact of such therapies on the molecular patient journey, especially in light of variants of the ESR1 mutation that are known to confer the worst outcomes.”
ELAINE 2 RESULTS:
About Lasofoxifene
Lasofoxifene is an investigational targeted endocrine treatment and next-generation 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 Sermonix
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. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. 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 SermonixPharma.com.
Contact information:
Glenn Garmont
LifeSci Advisors
Managing Director, Investor Relations Corporate Communications
ggarmont@lifesciadvisors.com
646-876-5521