Iovance Biotherapeutics Announces First Patient Dosed with PD-1 Inactivated Tumor Infiltrating Lymphocyte (TIL) Therapy

First Genetically Modified (TALEN^®-edited) Iovance TIL Therapy with Inactivated PD-1 Expression

SAN CARLOS, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced that the first patient was dosed, and completed the safety observation period, in the trial of Iovance’s genetically modified, PD-1 inactivated TIL therapy, IOV-4001. IOV-GM1-201 is a Phase 1/2, first-in-human study investigating the safety and efficacy of IOV-4001 in patients with previously treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers.”

To inactivate the gene coding for the PD-1 protein, IOV-4001 utilizes 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. This single genetic modification in IOV-4001 may enhance the antitumor activity of the TIL mechanism to directly target and kill tumor cells.

Jason Chesney, M.D., Ph.D., Director and Endowed Professor, UofL Health – Brown Cancer Center, University of Louisville, and an IOV-GM1-201 principal investigator, stated, “I am excited about the potential for gene-editing to open new doors for TIL therapy in patients with solid tumor cancers that do not respond well to current treatment options. As the first multicenter clinical trial to investigate a genetically modified TIL therapy, the IOV-GM1-201 trial may pave the way for a promising new treatment approach to cancer.”

PD-1 is a checkpoint protein found on T cells that normally acts as an “off switch” to help to prevent T cells from attacking other cells in the body. It works by binding to PD-L1, a protein found on both normal and cancerous cells, thereby shutting down an attack by a T cell. As a TIL therapy that is genetically modified to remove 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 on preclinical data was presented at the American Association for Cancer Research (AACR) 2022 Annual Meeting.

IOV-GM1-201 is actively enrolling adult participants with advanced NSCLC or unresectable or metastatic melanoma. For more information, eligibility criteria, and trial locations, please visit (NCT05361174) or contact .

About Iovance Biotherapeutics, Inc.

aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell 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 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 .

Forward-Looking Statements

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CONTACTS

Iovance Biotherapeutics, Inc:

Sara Pellegrino, IRC

Senior Vice President, Investor Relations & Corporate Communications

650-260-7120 ext. 264

Jen Saunders

Director, Investor Relations & Public Relations

267-485-3119

TALEN^® is a trademark owned by Cellectis