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

SAN CARLOS, CA, USA I March 15, 2022 I 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.”

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) 2022 Annual Meeting. In the AACR 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.

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit

About Cellectis

Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 22 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). For more information, visit Follow Cellectis on social media: @cellectis, LinkedIn and YouTube.

SOURCE: Cellectis

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