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Nektar Submits IND for NKTR-214 to Treat Solid Tumors

Zacks Equity Research
Updated

Nektar Therapeutics NKTR announced the submission of an Investigational New Drug application (IND) to the FDA for NKTR-214.

A phase I/II study in patients with solid tumor malignancies is expected to be initiated by year end. Along with evaluating the safety, tolerability and efficacy of NKTR-214, the study will include expansion cohorts to evaluate the candidate, both as a monotherapy and in combination with a checkpoint inhibitor.

In addition to the phase I/II program, Nektar is looking to conduct translational research in collaboration with MD Anderson Cancer Center to identify predictive biomarkers that can be used for future development of NKTR-214.

Initial data from the study is expected by the second half of 2016.

Meanwhile, Nektar continues to progress on its pipeline candidates. Currently, a biologics license application for Adynovate for the treatment of hemophilia A has been filed by Nektar’s partner Baxalta Incorporated BXLT. Baxalta plans to launch Adynovate later in 2015, upon approval. Other pipeline candidates include NKTR-181 (phase III) for the treatment of chronic pain conditions, Amikacin Inhale (phase III) as an adjunctive treatment for intubated and mechanically ventilated patients with gram-negative pneumonia and, NKTR-171 (phase I) for the treatment of peripheral neuropathic pain.

We remind the investors that Nektar currently has only one marketed product, Movantik, approved for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The company has a license agreement with AstraZeneca plc AZN for the development and commercialization of Movantik. Early last month, Nektar announced that it has received a milestone payment of $40 million from AstraZeneca for the first commercial sale of Movantik in the EU.

Nektar carries a Zacks Rank #5 (Strong Sell). A better-ranked stock in the health care sector includes Nexvet Biopharma Public Limited Company NVET, sporting a Zacks Rank #1 (Strong Buy).

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