On May 4, 2020 Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company reported that presentation of results from the Phase I trial "Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in non -small cell lung cancer (NSCLC) (Press release, Clinigen Group, MAY 4, 2020, View Source [SID1234556970])." Ben C. Creelan MD, MS from the Thoracic Oncology, Immunology Program of the Moffitt Cancer and Research Institute presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual annual meeting on April 28, 2020. Eligibility criteria described in trial registry (NCT03215810).
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The objectives of the study were to evaluate the safety and efficacy of TIL therapy in metastatic NSCLC (mNSCLC) after evidence of progression on nivolumab*. The authors concluded that the Cy/Flu/TIL/IL-2 therapy has manageable toxicity and sustained activity in PD-1 experienced mNSCLC. It also was speculated that TIL may be a promising therapeutic option for certain mNSCLC patients.
Adoptive cellular therapy is a novel treatment which typically includes select lymphodepleting agents, autologous tumor infiltrating lymphocytes and Proleukin. This therapy currently is being studied in a range of tumors.
Shaun Chilton, Group Chief Executive Officer, Clinigen said:
"We applaud the Moffitt Cancer Center, Dr Creelan and co-investigators on this study and their work looking at this novel treatment in a cancer with such high unmet medical need. At Clinigen, we strive for solutions to improve people’s lives and are pleased with the role Proleukin is playing in the development of these emerging TIL therapies."
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Notes to Editors
About TIL therapy
Adoptive cell therapy (ACT) using tumor-infiltrating lymphocytes (TIL) is a personalized cancer treatment based on the infusion of autologous CD4+ and CD8+ T lymphocytes expanded in-vitro from tumors in the presence of interleukin-2 (IL-2) 2 alone, or in combination with IL-7, IL-15, and/or IL-21. 3,4,5 The treatment may include high-dose lymphodepleting chemotherapy, the infusion of the expanded and activated T cells and interleukin-2 (IL-2) injections to increase survival of the T cells. 6 TIL therapy currently is being studied in a wide range of tumors.
About Proleukin
Proleukin is the first and only approved recombinant IL-2 indicated for the treatment of adults with metastatic renal cell carcinoma (mRCC) or metastatic melanoma (mM) by the US Food and Drug Administration (FDA). For further information, specific to the US product dosing and administration please visit www.proleukin.com. IL-2 is being studied in clinical development programs as a component of cell immunotherapies, including TIL therapy.