On June 28, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, reported that enrollment has been completed for its 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, JUN 28, 2021, View Source [SID1234584406]). Sermonix expects initial data from the trial to be available in the first half of 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Combination therapy in the metastatic setting is becoming quite commonplace and the potential to pair a well-tolerated endocrine therapy with a CDK 4/6 inhibitor in women with an ESR1 mutation is important from a clinical perspective, thus it is vital to assess safety and tolerability of these agents used concomitantly to optimize progression-free survival," said Dr. David Portman, Sermonix founder and chief executive officer. "We are delighted to have promptly completed enrollment and thank our participants, their families and clinical centers for supporting our efforts."

The open-label, multi-center study is evaluating 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 ofLasofoxifene inESR1 Mutations (ELAINE) study and is known as ELAINE 2.

Sermonix partnered with Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, to assist in identifying and enrolling patients in the ELAINE 2 study. Leveraging Tempus’ AI capabilities and the TIME Trial program, Sermonix was able to find patients in real-time, especially eligible ESR1+ patients who are treated in the community setting.

Preclinical models of invasive breast cancer at the University of Chicago – recently published in the journal Breast Cancer Research – identified synergy between lasofoxifene, a selective estrogen receptor modulator (SERM), and a CDK 4 and 6 inhibitor in the presence of ESR1 mutations.

"The completion of ELAINE 2 enrollment marks an important preparative step toward conducting a larger efficacy study of lasofoxifene in combination with a CDK 4/6 inhibitor," said Dr. Paul Plourde, Sermonix vice president of clinical development. "We are delighted with the fast study enrollment – particularly given the challenges of the pandemic – and the momentum of lasofoxifene and our ELAINE program as we look to share initial data early in 2022."

For more information about the ELAINE studies, visit View Source

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.