Aduro's Drug Gets Clearance by the FDA for Solid Tumors

NVS MRK

Aduro Biotech, Inc. announced that the FDA has cleared the Investigational New Drug application (IND) for its pipeline candidate ADU-S100 (MIW815). This candidate will be evaluated in combination with Novartis’ (NVS - Free Report) investigational anti-PD-1 checkpoint inhibitor- PDR001, for the treatment of advanced/metastatic solid tumors or lymphomas.

Aduro’s shares underperformed the Zacks classified Medical-Biomedical and Genetics industry year to date. Shares of Aduro declined 13.6% during the period, while the industry witnessed an increase of 1%.

Moving ahead, Aduro, an immunotherapy company, in collaboration with Novartis is also planning to initiate a phase Ib trial of ADU-S100 in combination with anti-PD1 in the second half of 2017. The phase Ib trial is designed to assess the safety and efficacy of ADU-S100 administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas.

We remind investors that in May 2016, Aduros initiated a phase I, multicenter, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ADU-S100 in patients with cutaneously accessible metastatic solid tumors or lymphomas. This study is currently ongoing and the company expects to expand into viscerally accessible lesions in the second half of 2017.

We also remind investors that in Mar 2017, Merck & Co., Inc. ‘s (MRK - Free Report) anti-PD-1 therapy, Keytruda, received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (cHL).

 

Zacks Rank and Stocks to Consider

Aduro carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes VIVUS, Inc. sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.

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