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G1 Therapeutics to Test Cancer Therapy with Genentech

By Barry Teater, NCBiotech Writer

G1 Therapeutics, a clinical-stage oncology company based in Research Triangle Park, will team up with biotech pioneer Genentech on a cancer clinical trial in the new year.

G1 said in a news release it will conduct a phase two trial to evaluate the combination of Genentech’s FDA-approved cancer-immunotherapy drug Tecentriq (atezolizumab) with G1’s drug candidate trilaciclib (G1T28) as a first-line treatment for patients with small-cell lung cancer receiving chemotherapy.

Privately held G1 is developing novel, small-molecule therapies that address significant unmet needs in people with various cancers. The company, a spin-out from the University of North Carolina at Chapel Hill, 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.

“We are excited that this combination regimen of trilaciclib plus Tecentriq may benefit patients with small-cell lung cancer, a disease with tremendous unmet medical need,” said Mark Velleca, M.D., Ph.D., chief executive officer of G1. “Trilaciclib has demonstrated its ability to preserve the immune system from damage by chemotherapy and to enhance T cell activation, which may augment anti-tumor immunity and be a powerful complement to Tecentriq.”

Protection during chemotherapy

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 hematopoietic stem and progenitor cells from dividing, making them resistant to damage from chemotherapy drugs that target dividing cells. Trilaciclib is being developed to preserve hematopoietic stem cells and enhance immune system function during chemotherapy.

Tecentriq is a monoclonal antibody designed to bind to the protein PD-L1 expressed on tumor cells and tumor-infiltrating immune cells. It blocks the protein’s interactions with the receptors for both PD-1 and another protein, B7.1.

In combination, trilaciclib and Tecentriq have the potential to provide a powerful triple punch against small-cell lung cancer: anti-tumor activity, conservation of hematopoietic stem cells, and preservation or enhancement of immune system function.

Preliminary results from two ongoing phase one-b/two-a trials of trilaciclib in combination with chemotherapy in small-cell lung cancer have demonstrated anti-tumor activity, including a complete response and multiple partial responses, according to G1. The treatment has been well-tolerated with no febrile neutropenia, an abnormally low number of neutrophil granulocyte cells in the blood.

In preclinical studies, trilaciclib significantly increased efficacy and overall survival in combination with oxaliplatin and anti-PD-L1 in mouse-tumor models. Trilaciclib is being studied in two phase one-b/two-a proof-of-concept trials in patients with small-cell lung cancer: a study in newly diagnosed, treatment-naive patients, and a study in previously treated patients.

Financial terms of the non-exclusive collaboration between G1 and Genentech were not disclosed.

Genentech, a member of the Roche Group, was founded 40 years ago and was one of the first drug-development companies to use recombinant DNA technology. The publicly traded company, based in South San Francisco, discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.

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