SAN FRANCISCO, April 9, 2014 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technologies, today announced that preclinical data for NKTR-102 and NKTR-214 were presented at the 2014 Annual Meeting of the American Association of Cancer Research (AACR) being held in San Diego, California.
Positive preclinical data was presented for NKTR-102 (etirinotecan pegol), a novel, next-generation topoisomerase I inhibitor, which is currently in Phase 3 development for the treatment of advanced breast cancer. In a model of triple-negative breast cancer with brain metastases (MDA-MB-231Br cell line), NKTR-102 reduced the size and number of brain metastases and also prolonged survival as compared to both placebo and irinotecan, a first-generation topoisomerase-I inhibitor.
"Brain tumors resulting from metastatic breast cancer are notoriously difficult to treat because of the inability to achieve effective concentrations of standard anti-cancer agents in these tumors," said Paul R. Lockman, PhD., Chair of the Department of Basic Pharmaceutical Sciences, and the Associate Center Director for Translational Research in the Mary Babb Randolph Cancer Center. "These remarkable preclinical data for NKTR-102 clearly demonstrate that the drug's extended half-life combined with its unique molecular design allow NKTR-102 to penetrate through leaky brain tumor vasculature and concentrate in metastasized tumors, which results in significant tumor reduction and prolonged survival."
NKTR-102 is currently being evaluated in the BEACON study, which is a Phase 3, open-label, randomized, multicenter study of NKTR-102 that enrolled 852 women with locally recurrent or metastatic breast cancer, who have previously been treated with ATC. More than one million women worldwide are diagnosed with breast cancer globally every year. (1) The chance of developing invasive breast cancer at some time in a woman's life is a little less than one in eight (12%). There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year. (2) Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body.
Positive preclinical data was also presented for NKTR-214, a novel immunocytokine therapy that is engineered using Nektar's polymer conjugate technology to selectively target the beneficial IL-2 receptor complex. Preclinical data reported in murine colon and breast tumor models showed that pre-dosing with anti-CTLA 4 followed by NKTR-214 produced complete responses in a majority of the animals with fewer side effects than dosing either agent alone or the combination concomitantly.
"NKTR-214 specifically enhanced CD8+ memory T cells without increasing regulatory T cells when dosed following anti-CTLA4 therapy, which resulted in durable complete responses in aggressive and resistant preclinical models," said Stephen Doberstein, Ph.D., Senior Vice President and Chief Scientific Officer of Nektar Therapeutics. "The synergy of NKTR-214 when dosed with an anti-CTLA4 therapy shows promise for this combination in further activating the immune system to fight tumors."
Preclinical data presentations made at the 2014 AACR can be downloaded from Nektar's website:
Abstract #4592: "Etirinotecan pegol accumulates in breast cancer brain metastases and prolongs survival in an experimental model of brain metastases of human triple negative breast cancer", Nounou et al.
Presentation Time: Tuesday, April 8, 2014, 1:00 pm - 5:00 pm Pacific Time
Location: Hall A-E, Poster Section 33
Abstract 5032: "Synergy between an engineered cytokine, NKTR-214, and CTLA-4 blockade in murine colon and breast tumor models", Lee, S., et al.
Session Date and Time: Wednesday April 9, 2014, 8:00 AM - 12:00 PM
Location: Hall A-E, Poster Section 10
Nektar Therapeutics (NASDAQ: NKTR) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has been filed for regulatory approvals in the U.S., Europe and Canada as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-171, a new sodium channel blocker being developed as an oral therapy for the treatment of peripheral neuropathic pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian, colorectal, lung and brain cancers. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development.
Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.
Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
(1) American Cancer Society, 2007 Global Cancer Facts and Figures Report.
(2) American Cancer Society, 2009 Global Cancer Facts and Figures Report.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-102, NKTR-214 and the potential of our technology and drug candidates in our research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) positive preclinical efficacy findings, such as those for NKTR-102 and NKTR-214 reported in this press release, are subject to inherent scientific and medical uncertainties typical for this early stage of drug development and may not be confirmed in subsequent preclinical studies or in clinical trials, if any; (ii) NKTR-214 is in early stage research and there are a number of hurdles, including the successful completion of preclinical toxicology studies, prior to the potential commencement of clinical studies for NKTR-214; (iii) our drug candidates and those of our collaboration partners are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval for numerous reasons including safety and efficacy findings even after positive findings in previous preclinical and clinical studies; (iv) the timing of the commencement or end of clinical trials and the commercial launch of our drug candidates may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-102 and NKTR-214) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; and (vi) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2014. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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