CLIN.L Regulatory News (CLIN)

14 January 2020

Clinigen signs agreement with Iovance Biotherapeutics to supply Proleukin® (aldesleukin) for use in Tumor Infiltrating Lymphocyte (TIL) Clinical R&D

Proleukin is the first and only FDA approved IL-2 being used indevelopment of T-Cell treatments

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has signed a supply agreement with Iovance Biotherapeutics, Inc., (NASDAQ: IOVA, 'Iovance'), a late-stage biotechnology company developing novel T-cell-based cancer immunotherapies.

Iovance is undertaking pivotal studies of its Tumor Infiltrating Lymphocytes ('TIL') technology for the treatment of metastatic melanoma and advanced cervical cancer. In addition, Iovance's TIL therapy is being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. Proleukin is part of the TIL therapy treatment regimen being studied.

Proleukin will be made available by Clinigen in bulk supply over the course of a two-year period, with the first shipment under the agreement supplied in December 2019 and ensuring that Iovance has uninterrupted access to Proleukin to continue ongoing clinical trials. No financial details were disclosed.

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.clinigengroup.com. IL-2 is being studied in clinical development programs as a component of cell immunotherapies, including TIL therapy, and is critical to their clinical application and potential commercialisation.

Clinigen acquired the rest of world rights to Proleukin in July 2018 and subsequently acquired the US rights in April 2019. It is Clinigen's second biologic and its largest product, with its acquisition diversifying the Commercial Medicines portfolio and creating the foundation from which to expand Clinigen's existing footprint in the higher value US market. Proleukin may have a future role in combination therapies in various types of cancer treatment and certain autoimmune diseases, clinical investigation is underway.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"The agreement with Iovance is a first significant step in the revitalisation of Proleukin and demonstrates our global commitment to fully understanding the role it can play as an immunotherapy treatment for cancer. Proleukin is the only approved IL-2 in the US and Europe that is currently being used in TIL therapy development and is an inherent component of these programs. This is a product that is involved in over 80 clinical trials in the US alone, which presents other similar opportunities for us to pursue.

"Clinigen is committed to getting the right medicine to the right patient at the right time. This agreement demonstrates our unwavering commitment to our mission for patients while also bringing synergistic opportunities to other businesses within the Clinigen Group - in this case, to Clinical Services as we supply Proleukin for use in Iovance's future clinical trials."

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About Iovance Biotherapeutics, Inc

Iovance Biotherapeutics aims to improve patient care by making T-cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack cancer. TIL cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the company's TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovance's T-cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is being initiated. For more information, please visit www.iovance.com.

About Clinigen Group

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

Cautionary statement

This announcement contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Clinigen Group plc. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Except as required by law, Clinigen undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

The information contained in this statement has not been audited and may be subject to further review.