SAN FRANCISCO, CA, USA I April 9, 2014 I Nektar Therapeutics (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.
NKTR-102 Presentation
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.
NKTR-214 Presentation
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:
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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
http://www.nektar.com/pdf/pipeline/NKTR-102/NKTR-102_AACR_Poster_01Apr2014.pdf
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
http://www.nektar.com/pdf/pipeline/2014_NKTR-214_AACR_poster.pdf
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About Nektar
Nektar Therapeutics (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.
SOURCE: Nektar Therapeutics
Post Views: 85
SAN FRANCISCO, CA, USA I April 9, 2014 I Nektar Therapeutics (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.
NKTR-102 Presentation
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.
NKTR-214 Presentation
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
http://www.nektar.com/pdf/pipeline/NKTR-102/NKTR-102_AACR_Poster_01Apr2014.pdf
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
http://www.nektar.com/pdf/pipeline/2014_NKTR-214_AACR_poster.pdf
|
About Nektar
Nektar Therapeutics (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.
SOURCE: Nektar Therapeutics
Post Views: 85
