Business
Iovance Biotherapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Updates
Expanding TIL Platform in Multiple Solid Tumors and Treatment Settings SAN CARLOS, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc.
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"Expanding TIL Platform in Multiple Solid Tumors and Treatment Settings\nSAN CARLOS, Calif., Feb. 24, 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 fourth quarter and full year 2021 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Throughout 2021, we continued to build upon the strength of clinical data for Iovance TIL therapy in multiple solid tumor types and treatment settings. Highlights included long-term clinical data for one-time treatment with lifileucel in metastatic melanoma, the potential to increase response rates for TIL therapy in combination with pembrolizumab as an earlier treatment for melanoma, cervical and head and neck cancers, as well as an important proof-of-concept for Iovance TIL therapy in non-small cell lung cancer. We also advanced our genetically modified TIL pipeline and expect to initiate our first clinical study of a gene-edited TIL product candidate later this year. Our top priority remains our ongoing work to address feedback from the U.S. Food and Drug Administration (FDA) regarding the potency assays for lifileucel to support our planned biologics license application (BLA) submission in the first half of this year. We remain increasingly confident in the broad potential for TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need.” Full Year 2021 Highlights and Recent Corporate Updates Regulatory Potency assays for lifileucel: Following FDA feedback regarding the potency assays for lifileucel, Iovance has continued ongoing work developing and validating its potency assays and has engaged in discussions with the FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for the first half of 2022. Resolution of the potency assay for lifileucel in melanoma is also a key step towards regulatory plans in other indications.U.S. FDA Fast Track Designation for lifileucel in combination with pembrolizumab in metastatic melanoma: The FDA granted fast track designation for lifileucel in combination with pembrolizumab for the treatme...