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news.Radius Health has entered into a worldwide clinical collaboration with Novartis Pharmaceuticals to evaluate the safety and efficacy of combining investigational agent RAD1901, a novel oral selective estrogen receptor degrader (SERD), with investigational agent LEE011 (ribociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor.
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Preclinical studies of RAD1901 have shown consistent and robust single agent anti-tumor activity in multiple wild type and ESR1-mutant breast cancer models and tumor regression when combined with targeted agents such as CDK 4/6 inhibitors in pre-clinical models.
The parties also intend to conduct pre-clinical studies to evaluate the effects of RAD1901 in combination with BYL719 (alpelisib), an investigational phosphoinositide 3-kinase (PI3K) inhibitor, with the goal of initiating future clinical trials.
Radius Health president and CEO Robert Ward said: "We are pleased to begin work with Novartis to explore the potential clinical benefits of RAD1901 in combination with these promising investigational agents for breast cancer, the second most common cancer in the world and the most prevalent cancer in women.
"This collaboration will evaluate the potential of combination therapies to generate improved clinical results, as compared to single agents alone, and to address the needs of these underserved patient populations."
Under the agreement, Radius and Novartis will each contribute resources and supply compound material necessary for the studies to be conducted under the collaboration and will share third party out-of-pocket research and development expenses.
The agreement is non-exclusive and each party will solely own all rights to any invention or discovery solely related to its respective product and/or compound. The parties will jointly own all data and inventions related to the combination use of investigational drug RAD1901 with investigational drugs LEE011, BYL719 or another compound arising under the collaboration.
LEE011 was developed by the Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals.