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 http://www.hitachi-chem.co.jp/english/ *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: contact@apceth.com www.apceth.com   Press release as pdf: German and English

apceth Biopharma GmbH manufactures DCprime’s cell-based cancer vaccine for phase II clinical study

Munich, Germany, November 16, 2018. apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, has started supplying clinical batches of DCprime’s cell-based cancer vaccine DCP-001 to a phase II clinical study for the treatment of Acute Myeloid Leukemia (AML). AML is a haematological cancer characterized by high risk of relapse, even after initial response to chemotherapy. Cancer vaccination with dendritic cells could be a successful strategy to boost the patient’s immune system and result in lasting disease control. DCprime announced yesterday that the first patient has been treated with the product DCP-001 at the Amsterdam University Medical Center (UMC). “We are proud to be the manufacturing partner of DCprime for DCP-001, the first off-the shelf dendritic cell vaccine in a cancer indication with high unmet medical need”, explained Dr Christine Günther, CEO of apceth Biopharma. “Our long-term collaboration with DCprime has always been constructive and cooperative, from technology transfer to the large-scale manufacturing process.” Dr Erik Manting, CEO of DCprime, commented: “Based on the recently published encouraging results of the phase I trial with our lead product DCP-001, we aim to confirm these results in the phase II ADVANCE-II trial and we are happy with the enrollment of the first patient. We would like to thank the apceth Biopharma team for their important contribution to the manufacturing of our product.” About apceth Biopharma GmbH apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors. apceth Biopharma is also 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. Press release as pdf (English) Press release as pdf (German) Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com www.apceth.com

apceth to manufacture first potential one-time gene therapy for transfusion dependent β-thalassemia

Munich, Germany, Oct 5th, 2018 – apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, congratulates its partner bluebird bio on the acceptance and validation of its market authorization application (MAA) by the European Medicines Agency (EMA). bluebird bio has applied for market authorization of its investigational LentiGlobin™ gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. “We congratulate our partner bluebird bio on this recent success”, commented Dr Christine Guenther, CEO of apceth Biopharma. “These are exciting times also for apceth, as we are now in the position to become one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use.” apceth has supported and will continue to support bluebird bio for obtaining the market authorization for LentiGlobin™. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for LentiGlobin, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy.   Press release as pdf (English)  or pdf (German) Press release from bluebird bio     About apceth Biopharma GmbH apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors. apceth Biopharma is also 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 (MSC), 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 (iPSCs) 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: contact@apceth.com www.apceth.com

apceth Biopharma receives an extended general manufacturing authorization for cell and gene therapeutics

Munich, Germany, Aug 7, 2018 – apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, announced today that it has received an extended general manufacturing authorization by the District Government of Upper Bavaria. This manufacturing authorization for cell and gene therapeutics is now regulated on an activity-related and no longer product-related basis. The previously obligatory inspection by the regulatory authority becomes optional. “We are very pleased with the trust and confidence shown by the regulatory authority”, commented Dr Christine Guenther, CEO of apceth Biopharma. “I am very proud of the entire apceth team, which has successfully completed every inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute since the foundation of the company. This kind of regulatory approval is rarely found for cell and gene therapeutics.” The extended general manufacturing authorization includes the clinical as well as commercial supply of cell products with different manufacturing techniques. It allows the production of cell therapeutics from various starting materials, for example bone marrow and umbilical cord blood, the production of native and genetically modified cells as well as the autologous or allogeneic administration. “This gives us more flexibility, streamlines the manufacturing approval process and shortens the timelines for our new customers”, explains Dr Andreas Schmiede, head of the Contract Development and Manufacturing department (CDMO). In 2018, apceth has also expanded its manufacturing capacities with two new class B clean rooms and is continuously strengthening its Manufacturing and Quality Control teams. “Due to the high demand for capacity for the CDMO business, we are significantly enhancing our capabilities to meet the growing need of our customers”.   About apceth Biopharma GmbH apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors. apceth Biopharma is also 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 (ISO 5, ISO 7, ISO 8, BSL2 cleanrooms) 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 (MSC), 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 (iPSCs) 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: contact@apceth.com www.apceth.com Download the  press release (pdf, English or German)

apceth Biopharma to Present at EHA-SWG Scientific Meeting

apceth Biopharma is proud to announce that it will be presenting its latest results on apceth-201 in graft-vs-host-disease (GvHD) during the European Hematology Society (EHA)-SWG Scientific Meeting in Amsterdam on November 23-25, 2017. apceth’s presentation will take place on November 24, 2017 between 16:00 – 17:00. For more information, please consult the full press release. Download Press Release_EHA-SWG Meeting

apceth Biopharma Appoints a New Supervisory Board

apceth Biopharma is proud to announce the appointment of a new Supervisory Board. The Supervisory Board will be responsible for advising and supporting the company on its corporate and business strategies. The Board is composed of highly experienced members with successful track records in the pharma and biotech industry. For more information, please consult the full press release: Download Press Release_Supervisory Board

DCPrime and apceth Biopharma GmbH announce manufacturing partnership

apceth Biopharma is proud to announce a new manufacturing partnership with DCPrime. The collaboration involves clinical batch production and the development of a commercial scale manufacturing process of cancer vaccines based on DCPrime’s technology platform DCOne®. The companies also announce that apceth has recently successfully passed an inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute for the manufacturing license for production of DCP-001, DCPrime’s lead program. This will enable DCPrime to enter into a Phase II Proof of Concept study in Acute Myeloid Leukemia. For more information, please consult the full press release: Download Press Release_DCPrime and apceth Biopharma

apceth Biopharma appoints Dusan Kosijer as Chief Financial Officer

apceth Biopharma GmbH (www.apceth.com), a cell therapy company with a proprietary portfolio of genetically modified mesenchymal stem cell therapeutics for the treatment of inflammatory diseases and cancer, and a successful Contract Development and Manufacturing Organisation (CDMO) for cell and gene therapy products, announced today the appointment of Mr Dusan Kosijer as new Chief Financial Officer, effective immediately. Download Press Release ENG (PDF)

bluebird bio and apceth Biopharma Establish Commercial Drug Product Manufacturing Agreement

bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer and apceth Biopharma GmbH (www.apceth.com), the global innovator and leader in the development of engineered mesenchymal stem cell (MSC) therapeutics and a successful and established contract development and manufacturing organization in the field of cell and gene therapy, announced today that they have entered into a strategic manufacturing agreement providing for the future European commercial production of bluebird bio’s Lenti-D™ product candidate for cerebral adrenoleukodystropy and its LentiGlobin™ product candidate for transfusion-dependent β-thalassemia. Downolad Press Release ENG, DE (PDF)