Nektar Therapeutics Secures $150M From SFJ Pharma For New Study With BEMPEG/Pembrolizumab Combo In Head & Neck Cancer

Nektar Therapeutics (NASDAQ: NKTR) announces a financing and co-development collaboration with privately-held SFJ Pharmaceuticals to develop Bempegaldesleukin (BEMPEG) CD122-preferential IL-2–pathway agonist.
The collaboration between SFJ and Nektar will support a new Phase 2/3 registrational study of BEMPEG plus Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) in patients with head and neck cancer whose tumors express PD-L1.
Under the terms of the agreement, SFJ has agreed to fund up to $150 million to support the study until its completion. Nektar will be the sponsor of the Phase 2/3 study planned to start in the second half of 2021.
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.
Nektar will conduct the Phase 2/3 study, which is expected to enroll 500 patients. The Phase 2 portion of the study will include an interim analysis of the overall response rate (ORR) after the first 200 patients enrolled have a minimum follow-up of 4 months. Suppose the ORR passes a prespecified futility boundary. In that case, the study will continue, and the remaining 300 patients will be enrolled for the Phase 3 portion of the study with primary endpoints of ORR and overall survival; progression-free survival is a secondary endpoint.
Price Action: NKTR gained 13.1% at $25.4 in premarket trading on the last check Wednesday.