On March 15, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported 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 (Press release, Iovance Biotherapeutics, MAR 15, 2022, View Source [SID1234610092]).
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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."
A poster highlighting preclinical activity, clinical-scale manufacturing process development, and characterization of IOV-4001 will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting. In the AACR (Free AACR Whitepaper) abstract, anti-tumor activity of IOV-4001 was superior to non-edited TIL, as well as non-edited TIL in combination with anti-PD-1, in a murine model.
About the TALEN Research Collaboration and Exclusive Worldwide Licensing Agreement
In January 2020, Iovance Biotherapeutics and Cellectis entered into a research collaboration and exclusive worldwide license agreement whereby Iovance licensed certain TALEN technology from Cellectis. The worldwide exclusive license enables Iovance to use certain TALEN technology addressing multiple gene targets to modify TIL for therapeutic use in several cancer indications. Iovance plans to initiate a clinical study of the first TALEN-edited TIL therapy, IOV-4001 (PD-1 inactivated TIL), in 2022. In addition, Iovance has a burgeoning preclinical pipeline of TALEN-edited TIL therapies, including double-knock out programs.