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Iovance Biotherapeutics Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Corporate Update
SAN CARLOS, Calif., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Feb. 25, 2020 (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 year-end 2019 financial results and provided a corporate update.\n “During 2019 we made tremendous progress in advancing Iovance TIL and PBL products,” said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. “We conducted two planned pivotal programs for lifileucel in melanoma and LN-145 in cervical, initiated patient dosing in earlier lines of therapy and received clearance from FDA on a new IND to proceed to dose patients with our PBL product, IOV-2001. In anticipation for commercialization of Iovance TIL, we are building our internal manufacturing capability and expanding our commercial team and infrastructure. With the first potential cell therapy in solid tumors, as well as a broad TIL platform, Iovance is poised to become the leader in development, manufacturing, and commercialization of TIL cell therapy for solid tumors.” 2019 Highlights and 2020 Updates Clinical Initiation and completion of patient dosing in the pivotal melanoma program, cohort 4 in the C-144-01 trial: Patient dosing in the pivotal cohort 4 of the C-144-01 study was initiated in March 2019 and completed in January 2020, three months ahead of schedule. Iovance intends to submit a biologics license application (BLA) to FDA subsequent to consultation with the agency in 2020.Presentation of data for lifileucel in metastatic melanoma and LN-145 for metastatic cervical cancer at major medical meetings: Several clinical data presentations continued to demonstrate efficacy and safety of lifileucel in metastatic melanoma (from C-144-01 study) and LN-145 in recurrent, metastatic, or persistent cervical cancer (from C-145-04 study). -- Melanoma update - The data for the C-144-01 study in melanoma demonstrated a 36.4% ORR by investigator as presented at ASCO.1 - In a recent data cut for the C-144-01 study, a median duration of response (DOR) was not reached at 15.5 months of median study follow up (Jan. 2020).2Expansion of TIL treatment to earlier lines of therapy for melanoma, head and neck, and non-small cell lung cancer (NSCLC) patients. Patient dosi...