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Sermonix signs licensing deal to further explore lasofoxifene for breast cancer treatment

Published 08 December 2016

Sermonix Pharmaceuticals has signed a licensing agreement to gain exclusive rights to Duke University intellectual property related to the use of lasofoxifene, its lead investigational drug, in the treatment of endocrine-resistant breast cancer.

Duke will receive an undisclosed upfront payment from Sermonix, as well as future equity and milestone payments.

Sermonix also announced that it secured more than $2 million in a preferred seed funding round, which closed November 10.

The licensing agreement creates the opportunity for Sermonix to further investigate oncological uses of lasofoxifene, beyond its already demonstrated benefits on osteoporosis and vulvovaginal atrophy.

David Portman MD, Sermonix Chief Executive Officer, said: "This agreement presents a great opportunity for the Sermonix development program.

"By using newly acquired technologies to identify additional uses for lasofoxifene, particularly in endocrine-resistant cancer settings, we have the opportunity to contribute significantly to a precision medicine approach to breast cancer."

Sermonix is currently focused on developing lasofoxifene for breast and ovarian cancer treatment, particularly in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer. Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+. Many in the metastatic setting develop resistance to current therapies due to mutations of the estrogen receptor.

Lasofoxifene, a potent selective estrogen receptor modulator (SERM) with activity against such mutations, may hold promise for many patients in this area of unmet medical need.

There are an estimated three million breast cancer survivors in the U.S., including 160,000 women living with stage IV breast cancer. Many of these women suffer with significant osteoporosis and VVA, side effects of current therapies, and may benefit from lasofoxifene in this regard as well.

"Data generated to date suggest that lasofoxifene may have the potential to become a viable treatment option for patients with breast or gynecologic cancers that have developed resistance to endocrine therapy as a result of prior treatment with aromatase inhibitors," said Stéphanie Gaillard, MD, PhD, Assistant Professor in Medical Oncology at the Duke Cancer Institute. "If ultimately approved for this use in the United States, lasofoxifene could potentially represent an opportunity to personalize treatment based on individual tumor characteristics." 

Sermonix plans to seek FDA approval for the use of oral lasofoxifene to treat several women's health indications, including breast and ovarian cancer. 

Lasofoxifene, a third-generation SERM, is one of the most well-studied drugs in its category. It has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL and other trials, showing a positive impact on vulvovaginal atrophy (VVA) in addition to a reduction in vertebral and non-vertebral fractures and an 80% reduction in the incidence of ER+ breast cancer in women with osteoporosis.

"While there have been tremendous advancements in the treatment of women with breast cancer, much work remains," said Dr. Anthony H. Wild, Sermonix Chairman.

"Lasofoxifene has the potential to play an important role in such breakthroughs, and the licensing agreement announced today and new intellectual property are enormous steps forward for Sermonix. Our recent funding round also puts the company in a good financial position to execute its goals."

Source: Company Press Release