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nektar therapeutics (NKTR) Details

Nektar Therapeutics, a clinical-stage biopharmaceutical company, develops drug candidates that utilize its PEGylation and polymer conjugate technology platforms in the United States. Its product pipeline comprises drug candidates in therapeutic areas, including oncology, pain, anti-infectives, and immunology. The company’s drug candidates in clinical development stage comprise naloxegol, an opioid antagonist, which has completed Phase III clinical trial for treating opioid-induced constipation; BAY41-6551 that is in Phase III clinical trial to treat gram-negative pneumonias; NKTR-181, which has completed Phase II clinical trial for chronic pain; and NKTR-171 that is in Phase I clinical trial to treat neuropathic pain. Its other product candidates comprise etirinotecan pegol, a topoisomerase I inhibitor, which is in Phase III clinical trial for metastatic breast cancer and in Phase II clinical trial for second-line metastatic colorectal cancer; and in combination with 5-fluorouracil/leucovorin to treat metastatic colorectal cancer that has completed Phase I clinical trial. In addition, the company offers preclinical drug candidates comprising opioid/NKTR-118 to treat chronic pain; NKTR-192 to treat acute pain; and NKTR-214, a cytokine immunostimulatory therapy to treat oncology. Nektar Therapeutics has collaboration with Bayer Healthcare LLC to develop BAY41-6551, which is an inhaled solution of amikacin, an aminoglycoside antibiotic; and a license agreement with AstraZeneca AB to develop and commercialize naloxegol and naloxegol fixed-dose combination program. Further, it has license, manufacturing, and supply agreements with Amgen Inc.; MAP Pharmaceuticals, Inc.; Merck & Co., Inc.; Ophthotech Corporation; Pfizer, Inc.; F. Hoffmann-La Roche Ltd (Roche), Regado Biosciences, Inc.; and UCB Pharma. The company was founded in 1990 and is headquartered in San Francisco, California.

445 Employees
Last Reported Date: 02/27/14
Founded in 1990

nektar therapeutics (NKTR) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $831.2K
Chief Financial Officer and Senior Vice Presi...
Total Annual Compensation: $524.3K
Senior Vice President, General Counsel and Se...
Total Annual Compensation: $504.2K
Chief Scientific Officer and Senior Vice Pres...
Total Annual Compensation: $459.7K
Compensation as of Fiscal Year 2013.

nektar therapeutics (NKTR) Key Developments

US FDA Advisory Committee Recommends No Cardiovascular Outcomes Trial for Peripherally-Acting Mu-Opioid Receptor Antagonist (PAMORA) Class Including Movantik

Nektar Therapeutics reported that partner AstraZeneca announced that the majority of US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes MOVANTIK(TM) (naloxegol oxalate), an investigational treatment for opioid-induced constipation (OIC) for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12, 2014. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is September 16, 2014. MOVANTIK was designed using Nektar's proprietary oral, small molecule polymer conjugate technology. MOVANTIK is part of the exclusive worldwide licence agreement announced in September 2009 between AstraZeneca and Nektar. Opioids play an important role in chronic pain relief by binding mu-receptors in the brain, but they also bind mu-receptors in the bowel. That is why patients taking opioids for chronic pain can develop OIC. In fact, the incidence of OIC can be as high as 81% in patients taking opioids. There is a significant unmet need for safe, effective treatment options for patients with OIC. An estimated 235 million prescriptions for opioids are written in the US each year, of which 20% are for chronic pain. For patients taking prescription opioids for chronic pain, constipation is one of the most common side effects and one not adequately relieved by laxatives. In addition to the U.S., AstraZeneca has also submitted regulatory filings for MOVANTIK with health agencies in the European Union and Canada.

Nektar Announces Positive Preclinical Data for NKTR-214, a Novel Cancer Immunotherapy

Nektar scientists conducted a series of studies using preclinical models of breast tumors (EMT6) and colon tumors (CT26) to assess both single agent and combination dosing of NKTR-214 with checkpoint inhibitors, either an anti-PD-1 therapy or an anti-CTLA-4 therapy. The studies also compared NKTR-214 single agent and combination dosing regimens with single agent and combination dosing regimens of anti-PD-1 and anti-CTLA-4 therapies. In both the breast and colon tumor models, the combination dosing regimens of NKTR-214 therapy with anti-PD-1 therapy or anti-CTLA-4 therapy resulted in significant tumor growth inhibition. In the aggressive EMT6 breast tumor model where activity with single-agent anti-PD-1 therapy or single-agent anti-CTLA-4 therapy was not observed, pre-dosing of NKTR-214 followed by anti-PD-1 demonstrated better efficacy (tumor growth inhibition of 74%) as compared to a concomitant dosing regimen of anti-CTLA-4 and anti-PD-1 therapies (tumor growth inhibition of 23%). NKTR-214 was also very well-tolerated when co-dosed with either antibody. NKTR-214 is a selective immune stimulator, which is designed to stimulate the patient's own immune system to kill tumor cells. The molecule uses Nektar's targeted polymer conjugate technology to enable selective activation of immunostimulatory IL-2 receptors, which is a novel mechanism of action in immunotherapy. Existing IL-2 therapy activates both immunosuppressive as well as immunostimulatory receptors, which has limited its utility in clinical settings. The design of NKTR-214 enhances CD8+ memory effector T cells (tumor-killing cells) in the tumor without increasing regulatory T cells (immune suppressor cells). In addition, the polymer conjugate structure of NKTR-214 increases the exposure of NKTR-214 to the tumor by 500-fold compared to existing IL-2 therapy, allowing, for the first time, antibody-like dosing frequency of a cytokine with a favorable tolerability profile. NKTR-214 is currently undergoing further IND-enabling studies.

Nektar Therapeutics Announces Positive Data from Phase 2 Trial of NKTR-102 in Patients with Avastin-Refractory High-Grade Glioma

Nektar Therapeutics announced new data from an investigator-sponsored Phase 2 study of NKTR-102 (etirinotecan pegol) in patients with Avastin-refractory high-grade glioma conducted at Stanford Cancer Institute under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigator Seema Nagpal, M.D., Clinical Assistant Professor of Neurology and Neurological Sciences, Stanford School of Medicine. The trial enrolled 20 patients with high-grade glioma from August 2012 to May 2013. Patients had a median KPS of 70 and had received a median of three lines of prior therapy, including recurrence following treatment with Avastin. Avastin-refractory was defined as progression by RANO criteria within 60 days of prior Avastin (bevacizumab) treatment. 90% of patients in the trial had glioblastoma. Patients received a median of three cycles (1-22) of NKTR-102 once every three weeks as monotherapy. Six-week progression-free survival in at least 25% of the patients was needed to reject the null hypothesis for the primary endpoint. The primary endpoint was met and exceeded with 55% (95% CI: 31%-75%) of patients in the study achieving six-week progression-free survival. Response and disease progression were assessed by RANO criteria in the trial. Three patients, or 15%, achieved partial responses with NKTR-102 monotherapy with maximum percent reductions in tumor area of 86%, 72%, and 59%. An additional eight patients, or 40%, achieved stable disease as best response. Two of the three patients with RANO responses experienced a long duration of response of 14 and 20 months. Secondary endpoints include median progression-free survival (2.2 months), median survival from time of first NKTR-102 infusion (4.5 months) and median overall survival from date of pathologic diagnosis or confirmation of high-grade glioma (17.1 months). NKTR-102 monotherapy was well-tolerated in patients with Avastin-refractory high-grade glioma with low toxicity in spite of being heavily pre-treated and neurologically symptomatic. Only one patient (5%) had Grade 3 toxicity (diarrhea with dehydration) attributable to NKTR-102 as a result of not taking anti-diarrheal medication. Hematologic toxicity was mild. As of May 31, 2014, there is one patient in the study who is continuing on NKTR-102 monotherapy.


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