Business
Iovance Biotherapeutics Reports First Quarter 2023 Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission Completed in March 2023 Commercial Readiness Activities on track to Support Potential Commercial Launch
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"First Biologics License Application (BLA) Submission Completed in March 2023 Commercial Readiness Activities on track to Support Potential Commercial Launch of Lifileucel in 2023 SAN CARLOS, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T-cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), today reported first quarter 2023 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Since the beginning of 2023, we have completed our first BLA for lifileucel in advanced melanoma, and continue to execute our commercial readiness activities to launch lifileucel in 2023, while advancing our immuno-oncology pipeline. We are also on track with our integration activities for the planned acquisition of Proleukin®, which will provide revenue, streamline our supply chain and logistics, reduce our future cost of goods and lower expenses for IL-2 used with TIL therapies. Our top priorities in 2023 are to gain FDA approval and successfully launch lifileucel, continue to develop our pipeline in multiple solid tumor indications and present new data from our clinical programs.” Recent and First Quarter 2023 Highlights and Corporate Updates Acquisition of Proleukin® Under a definitive agreement between Iovance and Clinigen Limited, Iovance will acquire worldwide rights to Proleukin® (aldesleukin), an interleukin-2 (IL-2) product with uses that include administration following TIL infusion to promote T-cell activity. Iovance expects the benefits of this transaction to include immediate and future revenue, securing the IL-2 supply chain and logistics surrounding TIL therapy administration, and lower cost of goods and clinical trial expenses for Proleukin® used with TIL therapies. The closing of this transaction is expected to occur in the second quarter of 2023, when all closing conditions and required regulatory approvals are achieved. Iovance TIL Therapy (Lifileucel) in Advanced Melanoma Regulatory highlights: A rolling BLA submission for lifileucel in post-anti-PD-1 advanced (metastatic or unresectable) melanoma was completed in March 2023.Site activation commenced for the randomized, registrational Phase 3 global TILVANC...