Iovance Biotherapeutics and MaSTherCell Announce New Manufacturing Services Agreement in Europe

SAN CARLOS, CA and GOSSELIES, BELGIUM  – October 18, 2018 – Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor infiltrating lymphocyte (TIL) technology, and  MaSTherCell S.A. a subsidiary of Orgenesis Inc. (NASDAQ: ORGS) through Masthercell Global Inc., a cell therapy-dedicated Contract Development and Manufacturing Organization (CDMO) today announced that the two companies have entered into a new three-year Manufacturing Services Agreement. MaSTherCell will manufacture TIL for Iovance’s European late-stage clinical trials in its commercial-ready cGMP manufacturing suites.

“We are pleased to be expanding our clinical and manufacturing capacity in Europe through this new collaboration with MaSTherCell. We have been dosing patients with lifileucel in Europe for the treatment of metastatic melanoma and LN-145 for the treatment of cervical cancers. As part of our global development plan for our TIL product, we are initiating the IOV-COM-202 trial in Europe as well and have received approval from Medicines and Healthcare products Regulatory Agency (MHRA). This newly established relationship with MaSTherCell will add additional commercial-ready capacity to support our ongoing and upcoming trials,” said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. “MaSTherCell specializes in clinical and commercial manufacturing of cell therapy as well as process development which brings valuable expertise and capabilities to our development program. We look forward to working with them to deliver our TIL product to patients with solid tumors across Europe.”

“We are glad that Iovance called on our expertise to accelerate the development of their TIL products. By addressing the unmet needs for solid tumor treatment, the outcome of this project could represent an enormous hope for a considerable number of patients,” commented Dr. Denis Bedoret, General Manager of MaSTherCell. “MaSTherCell is really pleased to welcome Iovance in its new commercial plant for advanced cell therapy manufacturing.”

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The company’s lead product candidate is an adoptive cell therapy using TIL technology being investigated for the treatment of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck, recurrent, metastatic or persistent cervical cancer and locally advanced or metastatic non-small cell lung cancer. For more information, please visit http://www.iovance.com.

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