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New G1 Trials Target Breast Cancer

G1 Therapeutics, a clinical-stage oncology company based in Research Triangle Park, is expanding its search for new anti-cancer weapons by launching three clinical trials targeting breast cancer patients.

The move by G1, a spinout from the University of North Carolina at Chapel Hill, comes a month after the company announced a partnership with biotech pioneer Genentech on a clinical trial involving patients with small-cell lung cancer who are receiving chemotherapy.

Privately held G1 is developing novel therapies that address significant unmet needs in people with various cancers. The company was bootstrapped with $500,000 in loans from the North Carolina Biotechnology Center in 2011 and 2012 and has since raised $95.5 million in venture capital.

In the recent launches, G1 will be testing its promising drug candidate trilaciclib (G1T28) as well as two of its other therapies: G1T38 and G1T48.

G1 is enrolling a Phase 2 study of intravenous trilaciclib in patients with triple-negative breast cancer (TNBC), and a Phase 1b/2a study of its oral G1T38 in patients with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer. In addition, G1 said it is advancing G1T48 so it can begin a Phase 1 trial in the fourth quarter of 2017.

“The expansion of our pipeline into breast cancer is the next step in our goal of building a fully integrated oncology company with novel products that address multiple indications,” said CEO Mark Velleca, M.D., Ph.D.

Trilaciclib is a potential first-in-class, short-acting intravenous inhibitor of CDK4 and CDK6, two proteins involved in cancer formation. Inhibiting these proteins temporarily stops desirable healthy cells from dividing, making them resistant to damage from chemotherapy drugs that target dividing cells. That helps cancer patients’ bodies strengthen immune system function during chemotherapy.

“Our CDK4/6 inhibitors have generated compelling clinical data, and we are thrilled to expand our pipeline to breast cancer, an area of significant need that still lacks adequate treatment options,” said Raj Malik, M.D., G1’s chief medical officer.

G1 and Genentech said in a joint news release in December 2016 they will conduct a Phase 2 trial to evaluate the combination of Genentech’s FDA-approved cancer-immunotherapy drug Tecentriq (atezolizumab) with G1’s Trilaciclib to treat lung cancer.

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