Lead cancer immunotherapy candidate granted EU orphan drug designations

July 20, 2016

London, UK– July 20, 2016. Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and viral infections, has received European Commission orphan drug designations for CMD-003 (baltaleucel-T) as a treatment for extranodal NK/T-cell lymphoma, nasal type, and post-transplant lymphoproliferative disorder.

CMD-003 is comprised of the patient’s immune cells which have been activated to kill malignant cells expressing antigens associated with the oncogenic Epstein Barr virus (EBV). The product has the potential to address a range of EBV-associated lymphomas, nasopharyngeal carcinoma and gastric cancer. The EU designation follows the U.S. Food and Drug Administration (FDA) orphan drug designation for CMD-003 as a treatment for all EBV-associated non-Hodgkin lymphomas.

With the EU orphan designation, Cell Medica can obtain regulatory and financial incentives for developing and marketing CMD-003, along with a ten-year period of marketing exclusivity within the EU after product approval. Cell Medica can also receive protocol assistance from the EMA during product development as well as direct access to the centralized authorization procedure.

Gregg Sando, Chief Executive Officer of Cell Medica said:

“CMD-003 is a novel cellular immunotherapy with the potential to transform the way we treat patients with EBV-associated lymphomas. We are now testing this product in our CITADEL Phase II trial for patients with advanced extranodal NK/T cell lymphoma and look forward to completion of the study next year.”

For further information, please contact:

Gregg Sando
Chief Executive Officer
Cell Medica Limited
+44 (0)20 7554 4070

About Cell Medica

Cell Medica develops, manufactures and markets cellular immunotherapy products for the treatment of cancer and infections. The Company employs leading-edge technologies to develop cell-based therapies with the potential to transform the lives of cancer patients in the years ahead. The Company’s lead oncology product, baltaleucel-T, is aimed at a range of cancers associated with the oncogenic Epstein Barr virus (EBV), including non-Hodgkin lymphomas, Hodgkin lymphoma and nasopharyngeal carcinoma. This novel cancer immunotherapy is currently under study in an international Phase II clinical trial (CITADEL) for the treatment of advanced NK/T cell lymphoma. Cell Medica is working in collaboration with the Baylor College of Medicine on the development of baltaleucel-T with funding provided in part by the Cancer Prevention and Research Institute of Texas. Cell Medica recently announced an important expansion of its collaboration with Baylor College of Medicine to include the development of next-generation cellular immunotherapies incorporating chimeric antigen receptor (CAR) with genetically enhanced potency for the treatment of cancers that do not respond to conventional therapies. In addition to its oncology programmes, Cell Medica is marketing Cytovir CMV for the treatment of cytomegalovirus infections and developing Cytovir ADV for the treatment of adenovirus infections. Both products are for the treatment and prevention of viral infections in patients who are profoundly immunosuppressed following a bone marrow transplant. Additional information can be found at www.cellmedica.co.uk.

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