Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)
Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy
First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression
Excerpt from the Press Release:
SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has allowed an Investigational New Drug Application (IND) to proceed for its first genetically modified TIL therapy, IOV-4001, for the treatment of unresectable or metastatic melanoma and stage III or IV NSCLC.
IOV-4001 leverages the gene editing TALEN® technology licensed from Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop potentially life-saving cell and gene therapies, to inactivate the gene coding for the PD-1 protein. By removal of this important barrier for T cells to attack cancer, IOV-4001 has the potential to become an optimized, next generation TIL therapy for several solid tumor cancers. A clinical study of IOV-4001 in patients with metastatic melanoma or stage III or IV NSCLC is expected to begin in 2022.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “IND allowance for IOV-4001 in two advanced cancers is an exciting milestone in the evolution of our TIL platform as we incorporate the gene editing TALEN® technology to develop next generation TIL therapies. IOV-4001 provides a significant opportunity to deliver the combination of TIL and immune checkpoint inhibition within a single genome-edited TIL therapy in multiple solid tumor types. We look forward to bringing IOV-4001 into the clinic and to advancing additional next generation TIL therapies.”
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?