SAN FRANCISCO, Nov. 6, 2018 /PRNewswire/ — Nektar Therapeutics (NASDAQ:NKTR) announced that it has entered into an oncology clinical collaboration with Pfizer Inc. (NYSE:PFE) to evaluate several combination regimens in multiple cancer settings, including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN). The collaboration will evaluate Nektar’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214 with avelumab, a human anti-PD-L1 antibody in development by Merck KGaA, Darmstadt, Germany, and Pfizer; talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor developed by Pfizer; or enzalutamide, an androgen receptor inhibitor in development by Pfizer and Astellas Pharma Inc.
“We are excited to partner with Pfizer to evaluate the potential benefit of the combination of NKTR-214 with agents targeting multiple mechanisms in the Company’s portfolio for patients with a diagnosis of prostate and head and neck cancer,” said Mary Tagliaferri, M.D., Chief Medical Officer and Senior Vice President of Clinical Development at Nektar. “Importantly, this new clinical collaboration will allow us to understand how we might access multiple immuno-oncology and targeted modalities simultaneously to treat cancer in complementary and novel ways.”
Under the new collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and NKTR-214 and separately avelumab, enzalutamide and NKTR-214. Nektar, Pfizer and their respective partners will each maintain global commercial rights to their respective medicines.
“We are looking forward to combining Nektar’s unique CD122-biased agonist with a number of agents with distinct mechanisms,” said Chris Boshoff, M.D., Ph.D., Senior Vice President of Immuno-Oncology, Early Development and Translational Oncology at Pfizer. “We hope to achieve our goal of improving the care of patients with difficult-to-treat cancers with unique immunotherapy-based regimens.”
NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. NKTR-214 is being evaluated in multiple clinical trials in cancer patients. It has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
About Metastatic Castration-Resistant Prostate Cancer
Other than skin cancer, prostate cancer is the most common cancer in American men and is the second leading cause of death for American males. The American Cancer Society estimates over 164,000 new cases of prostate cancer are projected in 2018, with approximately 29,000 expected deaths. mCRPC is an incurable disease and is usually associated with poor prognosis. The five-year survival rate for mCRPC is approximately 29%.1
About Squamous Cell Carcinoma of the Head and Neck
Squamous cell carcinomas of the head and neck (SCCHN) are usually only diagnosed at an advanced stage and thus have a relatively poor prognosis. One cause may be human papillomavirus (HPV), but the main cause is tobacco smoking and excessive consumption of high-percentage alcohol.
About Nektar Therapeutics
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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains uncertain or forward-looking statements which 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 potential therapeutic potential of NKTR-214, the therapeutic potential of NKTR-214 in combination with other drug compounds, the timing and likelihood of advancement into the clinic for NKTR-214 in combination with other compounds, future clinical development plans for NKTR-214, and the potential of 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 and 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 and you should not rely on such statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include: (i) pre-clinical and clinical study outcomes remain very unpredictable and it is possible that a study could fail; (ii) NKTR-214 is in early-stage clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety and efficacy findings; (iii) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying NKTR-214 with new drug compounds is uncertain and unpredictable and one or more development programs may fail; (iv) 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 negative safety and efficacy findings even after positive findings in previous preclinical and clinical studies; (v) the commencement or end of studies and the availability of study data may be delayed or unsuccessful; (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-Q for the quarter ended June 30, 2018 filed with the Securities and Exchange Commission on August 9, 2018. 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.
Jennifer Ruddock of Nektar Therapeutics
Dan Budwick of 1AB
1. American Cancer Society, 2018