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This Women Health Startup will Develop Unique Breast Cancer Drug with Duke University

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Female-specific oncology based startup Sermonix Pharmaceuticals signed an exclusive agreement with Duke University to in-license the intellectual property related to the use of lasofoxifeneSermonix’s lead investigational drug for the treatment of endocrine-resistant breast cancer.

sermonix-pharma-logoThe deal with Duke University will provide an opportunity to further investigate oncological uses of lasofoxifene, beyond its already demonstrated benefits on osteoporosis and vulvovaginal atrophy (VVA). Currently, Sermonix is developing lasofoxifene for breast and ovarian cancer treatment, particularly in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.

Duke will receive an undisclosed upfront payment from Sermonix, as well as future equity and milestone payments. Recently, Sermonix raised more than $2 million in a preferred seed funding round.

lasofoxifene_structure

Lasofoxifene structure

As per estimations of American Cancer Society, nearly every 2 out of 3 cases of breast cancer are hormone receptor-positive. Approximately 80% of all breast cancer is ER-positive and 65% of the patients are progesterone receptor-positive or PR-positive.

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

Lasofoxifene is a unique third-generation, non-steroidal selective estrogen receptor modulator (SERM) and is one of the thoroughly studied drugs of the category. More than 15000 women were tested in comprehensive global Phase I-III studies such as PEARL, OPAL, GARNET and other trials. The drug proved efficacious in vertebral fractures, non-vertebral fractures, positive impact on VVA and significant reduction in ER+ breast cancer in women with osteoporosis.

Sermonix is aimed to develop lasofoxifene for the treatment of breast and ovarian cancer, more specifically in ER+ endocrine-resistant breast cancer.

Many patients develop resistance to presently available therapies on account of mutations of the estrogen receptor. Sermonix believes the drug will be able to provide benefit to the patients against such mutations as well as against the side effects of the current therapies such as osteoporosis and VVA.

Dr. Anthony H. Wild, Sermonix Chairman said, “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”.

The privately held biotech was founded by Dr. David Portman, MD, a leading clinical researcher and expert in women’s health, menopause and SERM therapy, in 2014. The company signed exclusive development and commercialization license agreement in 2015 with US-based drugmaker Ligand Pharmaceuticals for the company’s lead product oral lasofoxifene in the US and Japan.

Lasofoxifene is marketed in Europe under the brand name Fablyn for the prevention and treatment of osteoporosis and for the treatment of vaginal atrophy.

Sermonix plans to file for an FDA approval for the use of oral lasofoxifene for the treatment of several women’s health indications, including breast and ovarian cancer.

Featured Image Credit: Bigstockphoto

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