Ligand licenses wider rights to oncology product to Sermonix
Sermonix Pharmaceuticals LLC, a privately held biotechnology company focused on the development and commercialization of female-specific oncology products, today announced it licensed worldwide rights to develop and commercialize oral lasofoxifene, its lead investigational drug, from Ligand Pharmaceuticals Inc. (NASDAQ: LGND). Sermonix initially licensed oral lasofoxifene rights from Ligand in February 2015, covering the U.S., Japan and other select territories.
Lasofoxifene, a third-generation selective estrogen receptor modulator (SERM), is one of the most-studied drugs in its category. Sermonix is currently focused on developing lasofoxifene for breast and ovarian cancer treatment, particularly in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.
“We are pleased to now have the ability to bring the lasofoxifene oncology program forward on a global level,” said David Portman, MD, Sermonix Chief Executive Officer. “Data recently identified and licensed from Duke University on lasofoxifene’s activity signal in mutations of the estrogen receptor and the potential to treat endocrine-resistant breast cancer, will allow Sermonix to pursue indications in this area of significant and growing unmet medical need. A global strategy fits into our clinical development plans, and creates significant opportunity and value for Sermonix.”
Lasofoxifene has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program. An 80% reduction in ER+ breast cancer was seen in a five-year PEARL osteoporosis trial of over 8,500 women. Reductions in the risk of vertebral and non-vertebral fractures, and benefits on vulvovaginal atrophy (VVA) have been demonstrated (Cummings SR et al New England Journal of Medicine 2010).
Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+ and there are an estimated three million breast cancer survivors in the U.S. (Breast Cancer Facts & Figures 2015-2016 American Cancer Society). Many breast cancer patients suffer with significant osteoporosis and VVA, side effects of current therapies. Lasofoxifene’s potential benefits in this regard may confer additional treatment advantages.
“Sermonix has had productive and ongoing conversations with U.S. and European regulatory agencies,” said Paul Plourde, MD, Vice President of Oncology Clinical Development at Sermonix. “Lasofoxifene has an extensive non-clinical program and a large, supportive clinical safety dataset. In the near future, we hope to move oral lasofoxifene into the clinic in a Phase 2 trial for the treatment of locally advanced and metastatic breast cancer.”