Nektar Initiates PROPEL Clinical Study To Evaluate Combination Of NKTR-214, A CD122-Biased Agonist, With TECENTRIQ (Atezolizumab) Or KEYTRUDA (Pembrolizumab)
Published: Sep 12, 2017
SAN FRANCISCO, Sept. 12, 2017 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that it has begun dosing in the PROPEL clinical study which will evaluate the efficacy and safety of NKTR-214, the company's lead immuno-oncology candidate in combination with approved checkpoint inhibitors, TECENTRIQ® (atezolizumab) and KEYTRUDA® (pembrolizumab). NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor microenvironment and increase expression of PD-1 on these immune cells.
Atezolizumab is a monoclonal antibody designed to bind with programmed death-ligand 1 (PD-L1). Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.
"NKTR-214 directly increases the numbers of tumor infiltrating lymphocytes (TILs) in vivo and its unique mechanism is designed to have synergy with all mechanisms of checkpoint inhibition, including the PD-1/PD-L1 pathway," said Mary Tagliaferri, M.D., Senior Vice President of Clinical Development at Nektar Therapeutics. "The PROPEL study is intended to show the synergies of NKTR-214 when combined with either atezolizumab or pembrolizumab and it complements our ongoing PIVOT clinical program which combines NKTR-214 with nivolumab in eight different cancer indications. Many patients fighting cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies and we believe the combination of NKTR-214 with these agents could expand treatment options for patients in multiple tumor settings."
NKTR-214 targets CD122 specific receptors found on the surface of cancer-fighting immune cells in order to stimulate their proliferation and activation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
The Phase 1/2 PROPEL study is a Nektar-sponsored trial that will enroll patients into two separate arms concurrently. The first arm will evaluate an every three-week dose regimen of NKTR-214 in combination with atezolizumab in up to 30 patients in approved treatment settings of atezolizumab, including patients with non-small cell lung cancer or bladder cancer. The second arm will evaluate an every three-week dose regimen of NKTR-214 in combination with pembrolizumab in up to 30 patients in approved treatment settings of pembrolizumab, including patients with melanoma, non-small cell lung cancer or bladder cancer.
Nektar Therapeutics is a research-based, development-stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. 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.
TECENTRIQ is a registered trademark of Roche and KEYTRUDA is a registered trademark of Merck & Co., Inc.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "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-214, both alone and in combination with one or more other agents (such as anti-PD1 and anti-PD-L1 agents), the synergistic activities of combinations of active agents (such as NKTR-214 in combination with anti-PD1 and anti-PD-L1 agents), the anticipated timing of reporting data for our clinical studies, 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) our statements regarding the therapeutic potential of NKTR-214 are based on findings and observations from preclinical findings and ongoing clinical studies; (ii) NKTR-214, both alone and in combination with other agents (such as anti-PD1 and anti-PD-L1 agents), is in early stages of clinical development and the risk of failure remains high and failure can unexpectedly occur due to efficacy, safety or other unpredictable factors prior to regulatory approval for numerous reasons, including negative safety and efficacy findings even after positive findings in previous clinical and preclinical studies; (iii) the timing of the commencement or end of clinical studies and the availability of clinical data 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; (iv) 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-214) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (v) patents may not issue from our patent applications for our drug candidates including NKTR-214, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2017. 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.
For Investors and Media:
Jennifer Ruddock of Nektar Therapeutics
Jodi Sievers of Nektar Therapeutics
- Charych, D., et al., Clin Can Res; 22(3) February 1, 2016
- Diab, A., et al., Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):P369
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SOURCE Nektar Therapeutics