On December 3, 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 that it will share a poster and audio presentation at the virtual San Antonio Breast Cancer Symposium (SABCS) 2020 on the Phase 2 clinical study 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, DEC 3, 2020, View Source [SID1234572124]).

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The abstract reviews the design of the study, which was announced in July and began dosing patients in October. As of Nov. 16, four of 13 U.S. centers are now enrolling and four subjects have begun study treatment.

Presentation Details:

Title: An Open-Label, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination with Abemaciclib for the Treatment of Pre and Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2− Breast Cancer and Have an ESR1 Mutation
Presenters:
Senthil Damodaran, M.D., Ph.D., assistant professor of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center
Paul V. Plourde, M.D., vice president of oncology clinical development, Sermonix Pharmaceuticals
Debu Tripathy, M.D., professor and chair of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center
Simon Jenkins, Ph.D., vice president of operations, Sermonix Pharmaceuticals
David Portman, M.D., founder and chief executive officer, Sermonix Pharmaceuticals
Date and time: The poster will be made available online at SABCS.org on Wednesday, Dec. 9, at 8 a.m. Central Time
Session: Ongoing Trials Poster Session (OT9-01)
The study is Sermonix’s second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study and known as ELAINE 2. It is assessing the safety and tolerability of lasofoxifene in combination with abemaciclib for treating women with locally advanced or metastatic ER+/HER2- breast cancer and an ESR1 mutation. Sermonix is partnering with Tempus, a data-driven, precision-medicine technology company, to identify and enroll ELAINE 2 participants through genomic biomarker testing.

"Sermonix is delighted to share a poster at SABCS 2020 highlighting the study in our collaboration with Eli Lilly and Company," said Dr. Paul Plourde. "Combination therapy is an important treatment option in the ER+/HER2- breast cancer setting, yet there is currently no approved therapy in the presence of ESR1 mutations. This safety study allows us to continue the effort toward addressing this area of significant unmet medical need."

Preclinical models of invasive breast cancer at the University of Chicago have identified synergy between lasofoxifene, a selective estrogen receptor modulator (SERM), and a CDK 4 and 6 inhibitor, palbociclib, in the presence of ESR1 mutations.

"The ELAINE 2 trial is a critical step toward confirming the efficacy of this combination in a larger study," said Dr. Senthil Damodaran. "It is important we continue the work of investigating combinations in the setting of ESR1 mutations, and making progress toward improving the prognosis for women with metastatic breast cancer."

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.