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- Iovance Biotherapeutics (NASDAQ:IOVA) is trading ~9% higher premarket after it acquired worldwide rights for Proleukin from Clinigen Limited for about £208.4M.
- Under the agreement, Iovance will pay an upfront payment of £166.7M, a £41.7M milestone payment will be paid upon first approval of lifileucel in advanced melanoma, and double-digit Proleukin global sales royalties.
- Iovance is financing the acquisition with existing cash.
- Proleukin is an interleukin-2 (IL-2) product used to promote T-cell activity following tumor infiltrating lymphocyte infusion.
- The company also reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 TILVANCE-301 trial of lifileucel in combination with Merck's cancer drug, Keytruda (pembrolizumab), in frontline advanced melanoma.
- The TILVANCE-301 trial will randomize 670 patients and will investigate lifileucel in combination with pembrolizumab compared with pembrolizumab monotherapy.
- The rolling BLA submission for lifileucel in post-anti-PD-1 advanced melanoma is on track to complete during the first quarter of 2023.