On February 17, 2021 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cancer and auto-immune disease, reported a financing and co-development collaboration with SFJ Pharmaceuticals to support the development of Bempegaldesleukin (BEMPEG), an investigational CD122-preferential IL-2–pathway agonist. SFJ Pharmaceuticals is a global drug development company backed by Abingworth and Blackstone Life Sciences (Press release, Nektar Therapeutics, FEB 17, 2021, View Source [SID1234575224]).
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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 Nektar Therapeutics. "SFJ’s global drug development and clinical trial management expertise, coupled with a track record of success in accelerating and advancing late-stage development programs for global pharmaceutical companies, make them an ideal partner."
Under the terms of the new agreement, SFJ will fund up to $150 million for the Phase 2/3 study until its completion. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years, which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for BEMPEG and will begin following completion of the head and neck study that is projected to be in 2024. If BEMPEG does not receive regulatory approval for one or more of the specified indications, Nektar will not owe any future payments linked to an indication that is not approved.
"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."
Morgan Stanley & Co. LLC acted as the sole structuring agent to Nektar on the transaction.
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 $1.45 billion in regulatory filing and approval milestones for BEMPEG. Nektar will book revenue for worldwide sales of BEMPEG and the companies will split global profits for BEMPEG with Nektar receiving 65% and Bristol-Myers Squibb 35%. The agreement allows Nektar to develop BEMPEG with other checkpoint inhibitor therapies in tumor types outside of the Nektar-Bristol-Myers Squibb joint clinical development program for BEMPEG plus NIVO.
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 Vaccibody in the DIRECT-01 study in combination with VB10.NEO in squamous cell carcinoma of the head and neck (NCT03548467).
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 The Global Cancer Observatory. The incidence of SCCHN continues to rise and is expected to increase by about 40% by 2040. According to data from the SEER registry, 5-year survival rate was estimated to be 66% for patients diagnosed with SCCHN and 40% for patients with metastatic disease, during the period 2010-2016.