Sermonix Pharmaceuticals Inc., a leader in biopharmaceutical innovations, has achieved a significant milestone with the issuance of a new U.S. patent that broadens the application of its leading investigational drug, lasofoxifene. The patent, officially recorded as U.S. Patent No. 12,023,321 B2, introduces a novel method for treating estrogen receptor-positive (ER+) breast cancer that is resistant to aromatase inhibitors (AI), specifically in cases without ESR1 mutations.

Lasofoxifene’s efficacy against ER+ metastatic breast cancer (mBC) has been under study in the ongoing ELAINE trial series. Preliminary trials have shown promising results; ELAINE-1 reported lasofoxifene monotherapy offering a progression-free survival of 5.6 months, compared to 3.7 months with fulvestrant. ELAINE-2 further highlighted its effectiveness in combination with Eli Lilly’s CDK4/6 inhibitor, abemaciclib, reaching a median progression-free survival of about 13 months in patients who had previously undergone CDK4/6i treatments.

The research leading to this patent was spearheaded by Dr. Geoffrey Greene at the University of Chicago. His work in preclinical studies showcased lasofoxifene’s potential in AI-resistant, ER+ breast cancer models, setting the stage for broader clinical applications. This research has been crucial in guiding the development of lasofoxifene, especially for treating breast cancer patients with wild-type ER, who represent a significant portion of those who either relapse post-adjuvant therapy or progress during advanced treatments.

Dr. David Portman, CEO and founder of Sermonix, expressed optimism about the expanded applications of lasofoxifene, particularly its potential in earlier lines of therapy. “There is a great medical need for efficacious and well-tolerated new therapies for this large population of breast cancer patients,” stated Dr. Portman. The company is eagerly progressing with ELAINE-3, a global Phase 3 study, to explore the drug’s effectiveness further.

ELAINE-3 is currently enrolling participants across various regions including the U.S., Europe, Israel, and Canada. This study compares the efficacy of oral lasofoxifene and abemaciclib against fulvestrant and abemaciclib in treating 400 pre- and post-menopausal women and men with advanced ER+/HER2- breast cancer with an ESR1 mutation.

The expansion of lasofoxifene’s application could be a game-changer in breast cancer therapy, offering new hope to patients with hormone-treatment resistant forms of the disease.”

  Breast Cancer, breast cancer treatment, clinical trials, lasofoxifene, medical innovation, Sermonix Pharmaceuticals