The collaboration between SFJ and Nektar will support a new Phase 2/3 registrational clinical study of BEMPEG plus pembrolizumab in patients with head and neck cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). Under the terms of the agreement, SFJ has agreed to fund up to $150 million to support the study and manage clinical trial operations. Nektar will serve as the sponsor of the Phase 2/3 study.
"This innovative collaboration with SFJ provides Nektar with substantial non-dilutive funding to broaden the registrational program for BEMPEG," said Howard Robin, President and CEO of
Under the terms of the new agreement, SFJ will fund up to
"We are excited to be partnering with Nektar under this novel financing and co-development agreement," said Bob DeBenedetto, Chief Executive Officer of SFJ. "Based on the strength of the clinical data generated to date for BEMPEG in melanoma and other tumor types, and following an extensive diligence process conducted in conjunction with our partners at Blackstone Life Sciences and Abingworth, we believe that BEMPEG has great potential to help cancer patients. We look forward to supporting the Phase 3 study and working closely with the Nektar team."
About Bempegaldesleukin (BEMPEG; NKTR-214)
Bempegaldesleukin (BEMPEG: NKTR-214) is an investigational CD122-preferential IL-2–pathway agonist that leverages the clinically validated IL-2 pathway to stimulate an antitumor immune response.1 BEMPEG was engineered to deliver a controlled, sustained, and preferential IL-2 pathway signal, with the goals of stimulating an antitumor immune response while minimizing toxicity, thereby allowing for outpatient administration.1,2 In a phase 1 trial of BEMPEG in combination with the checkpoint inhibitor nivolumab (NIVO; PIVOT-02), the combination was well tolerated and produced durable responses that deepened over time in multiple advanced solid tumor types.3
In February of 2018, Nektar and Bristol-Myers Squibb entered into a global strategic development and commercialization collaboration for BEMPEG. Under the terms of the agreement, Nektar is eligible to receive
In July of 2019, Bristol-Myers Squibb and Nektar announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin in combination with nivolumab for the treatment of patients with previously untreated unresectable or metastatic melanoma.
The joint clinical development program for BEMPEG plus NIVO includes registrational and other studies of BEMPEG plus NIVO in melanoma, renal cell carcinoma or RCC, and bladder cancer. This includes a Phase 3 trial in first-line advanced melanoma (NCT03635983), a Phase 3 trial in adjuvant melanoma (NCT04410445), a Phase 3 trial in advanced RCC (NCT03729245), a Phase 3 trial in muscle-invasive bladder cancer (NCT04209114), a Phase 2 trial in cisplatin-ineligible urothelial carcinoma (NCT03785925), a Phase 1/2 trial in combination with a tyrosine kinase inhibitor in advanced RCC (NCT04540705) and a Phase 1/2 trial in children, adolescents and young adults with recurrent or treatment-resistant cancer (NCT04730349).
BEMPEG is also being evaluated separately in the PROPEL study in combination with pembrolizumab in patients with first-line metastatic non-small cell lung cancer (NCT03138889) and in collaboration with
About Head and Neck Cancer
Squamous cell carcinoma of the head and neck, which forms in the tissues of the moist, mucosal surfaces inside the mouth, nose and throat, is the sixth most common cancer worldwide. In 2020, there were more than 850,000 cases leading to 440,000 deaths, according to
About the SFJ Pharmaceuticals Group
SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world's top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ's mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve.
- Bentebibel S-E, et al. A First-in-Human Study and Biomarker Analysis of NKTR-214, a Novel IL2Rβγ -Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discovery 2019;9:711-21.
- Charych D, et al. Modeling the receptor pharmacology, pharmacokinetics, and pharmacodynamics of NKTR-214, a kinetically controlled interleukin-2 (IL2) receptor agonist for cancer immunotherapy. PLoS ONE 2017;12.
- Diab A, et al. Bempegaldesleukin (NKTR-214) plus nivolumab in patients with advanced solid tumors: Phase 1 dose-escalation study of safety, efficacy and immune activation (PIVOT-02). Cancer Discovery 2020
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will," "develop," "may," "provide," "deliver" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of bempegaldesleukin (BEMPEG) in combination with other agents (such as nivolumab and pembrolizumab), the availability of results from clinical studies, and the potential benefits of co-development collaborations. 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, 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 bempegaldesleukin are based on preclinical and clinical findings and the expected therapeutic potential for bempegaldesleukin is subject to change as research and development continue; (ii) bempegaldesleukin is in clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the indications being studied prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors that impact drug development; (iii) data reported from ongoing preclinical and clinical trials are necessarily interim data only and the final results will change based on continuing observations; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of potential new drug candidates (such as bempegaldesleukin) is therefore very uncertain and unpredictable; (v) 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, delays caused by our collaboration partners and the COVID-19 pandemic, and enrollment competition; (vi) projected costs for completing clinical trials are estimates only and the actual costs will vary and can be higher depending on a number of factors, such as unexpected changes in healthcare costs over time, the need to increase the number of clinical trial sites, and the length of time the trial is conducted; (vii) 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 (viii) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the
Vivian Wu of Nektar Therapeutics
Dan Budwick of 1AB
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