AstraZeneca has sold worldwide development and commercialization rights to its polycystic ovary syndrome (PCOS) candidate AZD4901 to newly renamed Millendo Therapeutics for an undisclosed price.
Millendo—a three-year-old startup known until now as Atterocor—said today it will continue to develop the drug candidate under the name MLE4901 as part of a portfolio of treatments for orphan and specialty endocrine diseases.
To help build and develop that portfolio, Millendo said, it has secured $62 million in series B financing.
“We are committed to developing novel treatment options for patients with significant unmet medical needs and we believe that MLE4901, a first-in-class, first-in-disease, non-hormonal therapy, has tremendous potential in the treatment of PCOS, for which there are currently no approved therapies,” Millendo president and CEO Julia Owens said in a statement. “Our new company name reflects our vision to develop a robust pipeline of endocrine therapeutics.”
MLE4901 is a Neurokinin 3 receptor (NK3R) antagonist that is designed to diminish GnRH hyperpulsatility and luteinizing hormone (LH) pulse frequency in order to treat PCOS, the most common endocrine disease in women. In a Phase IIa trial, PCOS patients treated with MLE4901 showed significant reductions in LH and testosterone, Millendo reported.
Millendo acquired global rights to develop and commercialize MLE4901 in return for paying AstraZeneca an upfront payment, plus payments tied to development and commercial milestones. AstraZeneca is eligible to receive royalties on net product sales.
Under the companies’ licensing agreement, AstraZeneca took an undisclosed equity stake in Millendo.
MLE4901 was developed through AstraZeneca’s Open Innovation platform, designed to promote rapid clinical development of compounds that do not fall under the pharma giant’s R&D core focus areas. AstraZeneca finds partners to develop such compounds once studies generate results that suggest a breakthrough therapy for patients.
The $62 million financing was led by New Enterprise Associates (NEA) and included new investors Roche Venture Fund, Adams Street Partners, Altitude Life Science Ventures, Longwood Fund, and Renaissance Venture Capital Fund—as well as current Millendo investors Frazier Healthcare Partners, Osage University Partners, 5AM Ventures, and the Regents of the University of Michigan under the Michigan Investment in New Technology Startup Program.
In conjunction with the financing, Tracy Saxton of the Roche Venture Fund will join Millendo’s board of directors, and existing board member Carol Gallagher will shift her role from an independent board member to representing NEA.