New peer-reviewed collaborative publication

Treatment of advanced gastrointestinal cancer with genetically modified autologous mesenchymal stem cells: Results from the phase 1/2 TREAT‐ME‐1 trial Autors: Jobst Christian von Einem, Christine Guenther, Hans‐Dieter Volk, Gerald Grütz, Daniela Hirsch, Christoph Salat, Oliver Stoetzer, Peter J. Nelson, Marlies Michl, Dominik P. Modest, Julian W. Holch, Martin Angele, Christiane Bruns, Hanno Niess, Volker Heinemann International Journal of Cancer, first published 23 February 2019

New peer-reviewed collaborative publication

Human Stem Cells Promote Liver Regeneration After Partial Hepatectomy in BALB/C Nude Mice Simon Wabitsch, MD,a,* Christian Benzing, MD,a Felix Krenzien, MD,a Katrin Splith, PhD,a Philipp Konstantin Haber, MD,a Alexander Arnold, MD,b Maximilian Nösser,a Can Kamali,a Felix Hermann, PhD,c Christine Günther, PhD,c Daniela Hirsch, PhD,c Igor M. Sauer, MD,a Johann Pratschke, MD,a and Moritz Schmelzle, MDa a Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité Universitätsmedizin, Berlin, Germany b Department of Pathology, Campus Charité Mitte and Campus Virchow-Klinikum, Charité Universitaetsmedizin, Berlin, Germany c Apceth Biopharma GmbH, Munich, Germany Journal of Surginal Research, July 2019,Volume 239, Pages 191–200 To the article:

Hitachi Chemical Co. Ltd. to acquire apceth Biopharma GmbH

Munich, Germany, January 31, 2019. apceth Biopharma GmbH, a leading contract manufacturing organization in the field of cell and gene therapy, announces today that Hitachi Chemical Co., Ltd. will enter into an agreement to acquire all shares of apceth Biopharma GmbH. This acquisition is expected to close in April 2019. Founded 2007, apceth is a pioneer in cell and gene therapy and has developed into a leading European contract development and manufacturing organization (CDMO) for Advanced Therapy Medicinal Products (ATMPs). The company has state-of-the-art facilities located in Munich, Germany, which are fully compliant with all current EU ATMP regulations, BSL2 and ICH guidelines. With the acquisition of apceth, Hitachi Chemical will be expanding its business presence footprint in Europe―the world’s second-largest market for regenerative medicine after the United States. “We are very pleased to become part of Hitachi Chemical. Our combined strengths within Hitachi Chemical will allow us to manufacture complex cell and gene therapies for clients in North America, Asia, and Europe. This will allow our clients to supply patients around the world with highly needed innovative and high-quality cell and gene therapies”, said Christine Guenther, MD, CEO of apceth Biopharma. “apceth had been built by a great team and strong support of its shareholders into Europe’s leading independent cell therapy manufacturer. We are very proud that these joint efforts resulted in apceth Biopharma now being chosen as Hitachi Chemical’s hub for cell therapy in Europe,” commented Manfred Ruediger, PhD, Chairman of the Board of apceth. “We are proud having been able to accompany apceth on its successful journey from its foundation in 2007 until today. We are very pleased to have found an excellent partner for apceth’s future endeavors with Hitachi Chemical,” said Helmut Jeggle, Managing Director of Santo Holding (Deutschland) GmbH, majority shareholder of apceth. “The addition of apceth Biopharma to Hitachi Chemical will strengthen our presence in the second-largest cell and gene therapy market in the world, and enable us to offer a truly harmonized global operation, providing our customers with ready access to new markets and maximizing the value we bring to the industry,” said Robert A. Preti, PhD, CEO and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector.   About Hitachi Chemical Hitachi Chemical Co., Ltd. (TSE:4217), is headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2017 (ended March 31, 2018) totaled 669 billion yen (5.4 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at *The conversion rate is 1 euro = 124 yen.   About apceth Biopharma GmbH apceth Biopharma is a pioneering company in regenerative medicines and a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent.   Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email:   Press release as pdf: German and English

Phacilitate 2019

Miami, USA, Jan 22-25, 2019: Phacilitate Leaders World & World Stem Cell Summit 2019. Meet apceth at the world’s largest advanced therapies partnering event – visit us at booth no. 13.