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Imperial Innovations Pumps $26.5 Million into Cell Medica


7/23/2012 6:53:14 AM

London, UK – 23 July 2012: Cell Medica, a leading cell therapeutics company, today announced it has secured a £17 million ($26.5 million) equity investment to launch new operations in Texas focussing on cancer immunotherapy and to continue development of its immune reconstitution cell therapies in Europe. The financing includes new investment from Invesco Perpetual and Imperial Innovations alongside a previously announced Commercialisation (Relocation) Award from the Cancer Prevention and Research Institute of Texas (CPRIT). Contemporaneous with the financing, the Wellcome Trust will become a shareholder in the Company through conversion of a loan security into equity.

The equity capital will finance a significant build-up of the Company’s operations in both the United States and Europe. As part of this strategy, existing director Dr. Thomas Hecht will assume the Chairman’s role while the current Chairman Nigel Burns will carry on as a non-executive Director. Dr. Hecht brings significant experience to the role of Chairman through his involvement in other early stage biotech companies and his previous role as a senior executive in Amgen’s European Operations.

The CPRIT investment, previously announced at $15.3 million, will fund the Texas-based clinical development of a promising cancer immunotherapy technology (CytorexTM EBV) which the Company has licensed from the Center for Cell and Gene Therapy at Baylor College of Medicine in Houston, The Methodist Hospital and Texas Children’s Hospital in Houston, Texas (BCM CAGT). Cytorex EBV represents a novel approach to treating cancers associated with the oncogenic Epstein Barr Virus (EBV). To execute the US cancer immunotherapy plan, Cell Medica will establish commercial operations in Texas and relocate a substantial part of its headquarters to the Texas-based company. In Europe, the additional investment will finance Cell Medica’s commercialisation programme focussing on its immune reconstitution products including CytovirTM CMV and Cytovir ADV. Comprised of specific immune cells referred to as T cells, the Cytovir product family prevents viral infections by reconstituting natural cell-mediated immunity in patients who are profoundly immunosuppressed after bone marrow transplantation. Treating viral infections through immune reconstitution represents a unique benefit of the Cytovir cell therapy approach which cannot be matched by antiviral drugs. The market launch of Cytovir CMV is targeted for 2013 following completion of the first of two Company-sponsored randomised controlled trials ongoing in the UK. The Cytovir ADV clinical development programme will be initiated with a Phase I/II trial later in 2012.

Dr. Thomas Hecht, newly-appointed Chairman said, “I am very pleased to take on the role of Chairman as Cell Medica enters this very exciting phase of international growth and development. We have brought together a very special group of investors who are supporting an expert team and well considered plan to realise the significant clinical potential of patient-specific cell therapeutics.”

Gregg Sando, CEO and Founder of Cell Medica, said, “The launch of our US cancer immunotherapy operations represents a key step in the execution of Cell Medica’s business plan and we are very fortunate to have CPRIT as a core investor supporting the operations being set up in Texas. We will be expanding our management team both in the US and Europe to deliver on our current product programmes and to secure a leadership position in cell therapeutics for cancer and infectious diseases.”

About Cell Medica

Cell Medica is a cell therapeutics company engaged in the development, manufacture, marketing and distribution of cell-based products for immune reconstitution and cancer. The Company’s Cytovir product family for immune reconstitution targets the prevention and treatment of infections caused by latent viruses in immunosuppressed patients following allogeneic haematopoietic stem cell (bone marrow) transplant. In the field of cancer immunotherapy, Cell Medica is targeting a range of cancers associated with the oncogenic Epstein Barr Virus (EBV).

Cell Medica is currently sponsoring two ground-breaking randomised controlled clinical studies to investigate the use of Cytovir CMV to prevent and treat cytomegalovirus (CMV) infection following bone marrow transplantation. The CMV~IMPACT Study is funded by a Translation Award by the Wellcome Trust and the CMV~ACE/ASPECT Study which is funded, in part, by a grant to the University of Birmingham from Leukaemia Lymphoma Research. The Chief Investigator of both studies is Dr Karl Peggs, University College London Hospital. Cell Medica’s commercialisation plan for Cytovir CMV follows academic research from members of its Scientific Advisory Broad and others which has shown the safety and efficacy of adoptive cell therapy based. Cytovir CMV is comprised of immune cells, specifically T cells, which are purified from the donor who provided the bone marrow tissue (haematopoietic stem cells). Following the bone marrow transplant, Cytovir CMV is infused into the patient to reconstitute immunity to CMV. 1,2,3 Cytovir ADV is for the treatment of adenovirus (ADV) infections in paediatric patients following bone marrow transplantation. For high risk paediatric patients undergoing transplant from unrelated or mismatched donors, adenovirus infection causes mortality in up to 30% of cases. There is no approved antiviral treatment for adenovirus infections in this patient group. Cytovir ADV is comprised of ADV-specific T cells selected and expanded from the donor providing the bone marrow tissue (haematopoietic stem cells) to the patient. The cell therapy is administered post transplant to reconstitute immunity against adenovirus infection. The Cytovir ADV development programme will be initiated in 2012 with the launch of a Phase I/II Trial conducted at the Great Ormond Street Hospital for Children in London and is funded by the Technology Strategy Board through its “Developing Therapeutics” research programme.

Cell Medica’s cell-based cancer technology has been under development for over 15 years by the senior team at the Center for Cell and Gene Therapy at Baylor College of Medicine (BCM CAGT), The Methodist Hospital and Texas Children’s Hospital. Published data from the World Health Organisation indicates that up to 18% of all cancers are associated with infection from pathogens, including cervical cancer (Human Papilloma Virus), hepatocellular carcinoma (Hepatitis B and C Virus) and a range of cancers including lymphoma, nasopharyngeal carcinoma and gastric carcinoma which are associated with the Epstein Barr Virus (EBV). Following primary infection which is usually easily controlled in individuals with healthy immune systems, EBV remains in the body in a latent state within specific cell populations including lymphocytes and epithelial cells of the nasopharynx region. When malignancies occur within cells harbouring EBV on a latent basis, the cancerous cells will express EBV antigens which can be used as biomarkers for a targeted cancer therapy. Cell Medica and BCM CAGT have together developed Cytorex EBV which is a commercial version of a prototype academic product comprised of activated, antigen-focused and expanded EBV-specific T cells which can be produced from a single patient blood sample. When re-infused into the patient, Cytorex EBV selectively targets malignant cells expressing EBV antigens4. Building on BCM CAGT’s long record of academic clinical research, Cell Medica will undertake a development programme aimed at regulatory approval for this cell therapy in patients with extranodal NK/T cell lymphoma (ENKTL). Current chemotherapy regimens for patients with advanced ENKTL are associated with high levels of toxicity and limited efficacy.

Additional information can be found on the Company’s website: www.cellmedica.co.uk

About Dr. Thomas Hecht

Dr Hecht was previously Vice President Marketing at Amgen Europe, Lucerne, Switzerland. An experienced manager and industry professional, he has held various positions in clinical development, medical affairs and marketing at Amgen between 1989 and 2002. Prior to joining the biopharmaceutical industry, he qualified in internal medicine and served as Co-Head of the Program for Bone Marrow Transplantation, University of Freiburg, Germany. Today, he provides services to the pharmaceutical industry in clinical development/marketing and licensing strategies through HHC, a biopharmaceutical consulting company founded in 2002. He also serves as Chairman of the Boards of Delenex, Affimed Therapeutics AG, Cytos Biotechnology AG and of the supervisory council of SuppreMol GmbH. With the acquisition by Alcon, he stepped down from the Chairmanship of ESBATech AG.

About CPRIT

Texas voters overwhelmingly approved a constitutional amendment in 2007 establishing CPRIT and authorizing the state to issue $3 billion in bonds to fund groundbreaking cancer research and prevention programs and services in Texas. CPRIT’s goal is to expedite innovation and commercialization in the area of cancer research and to enhance access to evidence-based prevention programs and services throughout the state. CPRIT accepts applications and awards grants for a wide variety of cancer-related research and for the delivery of cancer prevention programs and services by public and private entities located in Texas. More information about CPRIT is available on its website, www.cprit.state.tx.us

About Invesco Perpetual

Invesco Perpetual is part of Invesco Ltd, a leading independent global investment manager, dedicated to helping investors worldwide achieve their financial objectives. By delivering the combined power of our distinctive investment management capabilities, Invesco provides a wide range of investment strategies and vehicles to our retail, institutional and high net worth clients around the world.

About Imperial Innovations

Innovations creates, builds and invests in pioneering university technologies addressing global problems in healthcare, energy, engineering and the environment. It combines deep understanding of science and technology with commercial acumen and strong investment expertise.

Innovations supports scientist-entrepreneurs in the commercialisation of their ideas by:

• leading the formation of new companies and providing facilities in the early stages

• providing significant investment and encouraging co-investment to accelerate the transition from R&D to products

• providing operational expertise

• helping to recruit high-calibre industry figures and experienced entrepreneurs as executive management and Board members

Innovations invests in companies based on technologies from or associated with four universities: Imperial College London; and Cambridge University, Oxford University, and UCL supported by its collaborations with Cambridge Enterprise, OSEM and UCL Business. These are the UK’s leading research intensive universities, measured by research income.

By raising £140 million in January 2011, Innovations has been able to accelerate the making of, and increase the size of its investments. In the year to 31 July 2011, Innovations invested £35.1 million (2010: £14 million) in 23 ventures, and launched six new companies.

In its current portfolio of 78 companies, Innovations’ most advanced assets include Circassia, which develops innovative vaccines for the treatment of a wide range of allergies; and Nexeon, a battery materials and licensing company which develops silicon anodes which extend the life and increase the capacity of lithium-ion batteries.

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.

Scientific References

1Walter E, Greenberg P, Gilbert M, Finch R, Watanabe K, Thomas E and S Riddell. Reconstitution of cellular immunity against cytomegalovirus in recipients of allogeneic bone marrow by transfer of T cell clones from the donor. N. Engl. J. Med. 1995; (333): pp1038-1044.

2Peggs KS, Verfuerth S, Pizzey A, Chow S-LC, Thomson K, Mackinnon S. Cytomegalovirus-specific T cell immunotherapy promotes restoration of durable functional antiviral immunity following allogeneic stem cell transplantation. Clinical Infectious Diseases 2009; 49 (15 December):pp1851-60

3Mackinnon S, Thomson K, Verfuerth S, Peggs K, Lowdell M. Adoptive cellular therapy for cytomegalovirus infection following allogeneic stem cell transplantation using virus-specific T cells. Blood Cells, Molecules, and Diseases 40. 2008: pp63-67

4Bollard CM, Gottschalk S, Leen AM, Weiss H, Straathof KC, Carrum G, Khalil M, Wu M, Huls MH, Chang C, Gresik MV, Gee AP, Brenner MK, Rooney CM, Heslop HE. Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood. 2007 110: 2838-2845

For more information, please contact:

Gregg Sando

CEO

Cell Medica Limited

Gregg.Sando@cellmedica.co.uk

+44 (0)20 7554 4070



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