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Iovance Biotherapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission on Track to Complete in 1Q23 SAN CARLOS, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Iovance
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"First Biologics License Application (BLA) Submission on Track to Complete in 1Q23\nSAN CARLOS, Calif., Feb. 28, 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 fourth quarter and full year 2022 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “During 2022, we made considerable progress initiating our first BLA for lifileucel in advanced melanoma, preparing for launch, and advancing our immuno-oncology pipeline. As we prepare for commercialization and expand our pipeline, our planned acquisition of Proleukin® will provide an immediate source of revenue, streamline our supply chain and logistics, reduce our future cost of goods and lower expenses for IL-2 used with TIL therapies in commercial and clinical settings. Our top priorities in 2023 are to complete the BLA submission in the first quarter, receive FDA approval, then successfully launch lifileucel. We also continue to develop our pipeline in multiple solid tumor indications and look forward to presenting new data.” Recent and Full Year 2022 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 by the end of the first quarter of 2023 or early in the second quarter of 2023, when all of the 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 commenced in August 2022 and remains on track to complete in the first quarter of 2023.Iova...