Medigene AG. (10/19/20). "Press Release: Medigene and Cytovant Enter into Service Agreement for DC Vaccine Manufacturing Process Development". Planegg-Martinsried.

	Organisation	Medigene AG (FSE: MDG1, Prime Standard)
	Group	Medigene (Group)
	Organisation 2	Cytovant Sciences HK Ltd.
	Group	Roivant (Group)
	Product	contract manufacturing (biologicals)
	Product 2	DC vaccine (dentritic cell vaccine)
	Person	Pinkernell, Kai (Medigene 201602– CMO before Miltenyi Biotec + Cytori Therapeutics)

Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, has concluded a service agreement with Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant), to support process development activities for the manufacturing of dendritic cell (DC) vaccines.

The service agreement builds on Medigene's license and cooperation agreements with Roivant/Cytovant which cover three TCR projects and Medigene's DC vaccine program targeting WT-1 and PRAME in acute myeloid leukemia (AML) for Greater China, South Korea and Japan. In January 2020, Medigene published positive final topline results from the open-label Phase I/II trial with its DC vaccine in 20 AML patients and Roivant/Cytovant is continuing the development of this program as CVT-DC-01 in its licensed territories in Asia.

Under the service agreement, Medigene will use its expertise to support Roivant/Cytovant in establishing processes for the manufacturing of the DC vaccine and further develop these towards an automated manufacturing process in the future. Financial terms of the service agreement were not disclosed.

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer (CMO/CDO): "We are delighted to build further on the collaboration with Roivant/Cytovant which is proceeding well on multiple programs. Following the positive final data from our DC trial, we are pleased to see our partners take the next steps to move the vaccine into further clinical development in Asia. Reliable manufacturing processes are crucial to ensure that the DC vaccines can be produced in compliance with all appropriate standards and we are pleased to provide our support."

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About Medigene's DC vaccines

In addition to Medigene's development focus on T cell-receptor modified T cells (TCR-Ts), the Company has developed a new generation of antigen-tailored dendritic cell (DC) vaccines.

Dendritic cells (DC) can take up antigens, process them and present peptides on their surface in a form that can induce antigen-specific T cells to mature and proliferate. In this way, T cells recognize and eliminate tumor cells which bear the same antigen peptide on their surface. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The scientific team of Medigene has developed new, fast and efficient methods for generating autologous (patient-specific) mature dendritic cells which have the relevant characteristics to generate very strong T cell and NK cell immune responses. The dendritic cells can be loaded with various tumor antigens to treat different forms of cancer. Since an immune response builds up over the total time of administration of the DC vaccine, this form of therapy is particularly designed for patients who suffer from a tumor disease which has been reduced to such an extent by chemotherapy that the prevention of the recurrence of the tumor disease is the main goal.

About Roivant/Cytovant

Cytovant Sciences HK Limited, owner of Cytovant Sciences Co., Ltd and affiliate of Roivant Asia Cell therapy Holdings Ltd, is a clinical-stage biopharmaceutical company focused on developing innovative cellular therapeutics in Asia. Roivant/Cytovant's mission is to become Asia's premier cell therapy company by discovering, developing, and commercializing new medicines that are uniquely suited to Asian patients.

For more information, please visit www.cytovant.com

About Medigene

Medigene AG (FSE: MDG1, Prime Standard, ISIN DE000A1X3W00) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

For more information, please visit www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene
Dr. Gary Waanders, Dr. Anna Niedl
Phone: +49 89 2000 3333 01
e-mail: investor@medigene.com

LifeSci Advisors
Mary-Ann Chang
Phone: +44 7483 284 853
e-mail: mchang@lifesciadvisors.com

Record changed: 2023-06-05