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Iovance Biotherapeutics Reports Third Quarter and Year-to-Date 2022 Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission Initiated and on Track to Complete in 4Q22 SAN CARLOS, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Iovance
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"First Biologics License Application (BLA) Submission Initiated and on Track to Complete in 4Q22 SAN CARLOS, Calif., Nov. 03, 2022 (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 third quarter and year-to-date 2022 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Iovance has made tremendous progress year-to-date. With our rolling BLA submission for lifileucel and six active clinical trials of TIL therapy underway, we are executing our mission to innovate, develop and deliver TIL therapy for patients with cancer. We are on track to complete our BLA submission in the fourth quarter. As we prepare for our first potential FDA approval and commercial launch and advance our pipeline and technology platforms, we believe we have multiple opportunities to create significant value for patients with cancer as well as for our shareholders.” Third Quarter 2022 Highlights and Recent Corporate Updates Regulatory and Clinical Updates for Iovance TIL Therapy (Lifileucel) in Advanced Melanoma BLA Submission: A rolling BLA submission for lifileucel in advanced melanoma (post-anti-PD-1 therapy) commenced in August 2022 and is anticipated to complete in the fourth quarter of 2022.C-144-01 Trial Presentation and Poster at Society for Immunotherapy of Cancer (SITC): Iovance reported positive topline clinical data from Cohorts 2 and 4 of the C-144-01 clinical trial in advanced melanoma in the second quarter of 2022. A pooled analysis and additional results for Cohorts 2 and 4 will be presented during SITC’s 37th Annual Meeting as well as a Webcast on November 10, 2022. Phase 3 trial in frontline advanced melanoma: Iovance remains on track to begin the Phase 3 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma in late 2022. The Phase 3 trial is intended to expand the opportunity for lifileucel as an earlier treatment and serve as a confirmatory study.Poster at European Society for Medical Oncology (ESMO) Congress 2022: A poster at ESMO highlighted the potential for lifileucel in advanced melanoma patients who progress after anti-LAG-3 and an...