LGND Ligand Pharmaceuticals Incorporated

Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today announced that it had five abstracts accepted as poster presentations at the 2023 San Antonio Breast Cancer Symposium (SABCS), which will be held Dec. 5-9 at the Henry B. Gonzalez Convention Center in San Antonio.

Three posters delve into clinical data tied to Sermonix’s Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies. One assesses baseline genomic alterations and the activity of lasofoxifene, Sermonix’s investigational novel endocrine therapy, and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib during the ELAINE-2 study. A second poster addresses pharmacokinetics of lasofoxifene as a monotherapy and in combination with abemaciclib. The third poster is a trial-in-progress update on ELAINE-3, which is studying the efficacy and safety of lasofoxifene in combination with abemaciclib in treating locally advanced or ER+/HER2- mBC with an ESR1 mutation.

The other two posters address the results of Sermonix’s third ESR1 and Quality of Life Survey (EQUALS 3), which was developed to help inform practicing oncologists about patients’ understanding of ESR1 mutations and the quality of life for metastatic breast cancer (mBC) patients. One poster addresses patient-provider communication challenges with respect to side effects of mBC treatments, and the second discusses how minimizing treatment toxicity and side effects impacts quality of life for ER+/HER2- mBC patients.

“Sermonix looks forward to updating our peers at SABCS 2023 about our growing understanding of lasofoxifene as a monotherapy and combination therapy, our initiated ELAINE-3 study, and our continuing work to learn more about how metastatic breast cancer impacts patient quality of life,” said Dr. David Portman, Sermonix founder and chief executive officer. “We are committed to investigating lasofoxifene’s efficacy in combating metastatic breast cancer, as well as observing its impacts on vaginal and sexual health, all issues that affect patients greatly.”

Poster sessions details are as follows:

• Poster Title: Baseline genomic alterations and the activity of lasofoxifene (LAS) plus abemaciclib (Abema) in patients with ER+/HER2- metastatic breast cancer (mBC): the ELAINE-2 study
  • Poster ID: P02-14-09
  • Date: Wednesday, Dec. 6, 2023
  • Time: 5-7 p.m. CT

• Poster Title: Pharmacokinetics (PK) of lasofoxifene (LAS) monotherapy and combined with abemaciclib (Abema)
  • Poster ID: P03-18-05
  • Date: Thursday, Dec. 7, 2023
  • Time: 12-2 p.m. CT

• Poster Title: Trial in progress: Open-label, randomized, multicenter, phase 3, ELAINE-3 study of the efficacy and safety of lasofoxifene plus abemaciclib for treating locally advanced or ER+/HER2- metastatic breast cancer with an ESR1 mutation
  • Poster ID: P01-18-12
  • Date: Wednesday, Dec. 6, 2023
  • Time: 12-2 p.m. CT

• Poster Title: Patient (pt)-provider communication challenges about side effects/ from metastatic breast cancer (mBC) treatments]
  • Poster ID: P03-12-05
  • Date: Thursday, Dec. 7, 2023
  • Time: 12-2 p.m. CT

• Poster Title: Minimization of treatment toxicity/side effects and their impact on quality of life (QoL) in patients (pts) with ER+/HER2- metastatic breast cancer (mBC)
  • Poster ID: P03-12-06
  • Date: Friday, Dec. 8, 2023
  • Time: 12-2 p.m. CT

To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit https://sermonixpharma.com. For more information about the ELAINE studies, visit https://elainestudy.com/.

About LasofoxifeneLasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), 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 novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

About SermonixSermonix 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.

Sermonix Contact:
Elizabeth Attias
Sermonix Chief Strategy and Development Officer
EAttias@sermonixpharma.com
(973) 723-7832