Clinigen: IL-2 Plays Role in Emerging TIL Therapies

Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company acknowledges the 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).” 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) virtual annual meeting on April 28, 2020. Eligibility criteria described in trial registry (NCT03215810).

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.

About Clinigen

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and Asia Pacific.

Clinigen now has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 22 of the top 25 pharmaceutical companies; interacting with over 15,000 registered users across over 100 countries, shipping approximately 6.4 million units in the year.

For more information on Clinigen, please visit www.clinigengroup.com.

* Nivolumab is manufactured and distributed by Bristol-Myers Squibb Company under the trade name OPDIVO.

References:

1. Abstract #10617 Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in non-small cell lung cancer (NSCLC): a Phase I trial.
2. Yron I, Wood TA Jr, Spiess PJ, Rosenberg SA. In vitro growth of murine T cells. V. The isolation and growth of lymphoid cells infiltrating syngeneic solid tumors. J Immunol 1980; 125(1): 238–245.
3. Maeurer MJ, Walter W, Martin D et al. Interleukin-7 (IL-7) in colorectal cancer: IL-7 is produced by tissues from colorectal cancer and promotes preferential expansion of tumour infiltrating lymphocytes. Scand J Immunol 1997; 45(2): 182–192.
4. Meng Q, Liu Z, Rangelova E et al. Expansion of tumor-reactive T cells from patients with pancreatic cancer. J Immunother 2016; 39(2): 81–89.
5. Liu Z, Meng Q, Bartek J Jr et al. Tumor-infiltrating lymphocytes (TILs) from patients with glioma. Oncoimmunology 2017; 6(2): e1252894.
6. Gynecol Oncol. 2018 August; 150(2): 361–369. doi: 10.1016/j.ygyno.2018.05.024.
7. See ClinicalTrials.gov for more information.

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