ein spin-off des berlin- t-cell europe gmbh brandenburg ... · brandenburg centers für...
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Ein Spin-off des Berlin-Brandenburg Centers für Regenerative Therapien
Dr. Claudia Ulbrich CEO
September 22, 2013
T-CELL EUROPE GMBH COMPANY PRESENTATION
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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THE PROBLEM
► Graft rejection by host´s immune system after transplantation
► Need for permanent immunosuppressive therapy with drugs causing
massive side effects
► Only symptomatic treatment - no curative approach
► High post-transplantation treatment costs due to livelong
immunosuppression and therapy of side effects
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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THE SOLUTION
► Instead of suppressing all immune cells (both “good” and “bad”), as in therapies up until now (immunosuppression), selectively strengthens the effect of “good” cells (immunoregulation)
► Naturally occurring regulatory T cells (Treg) serve as a brake on overreac-tion by the immune system
► Under this novel therapy, Treg cells are used to control the body’s immune response following transplantation so that the foreign kidney is accepted as one’s own
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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AT A GLANCE
Corporate Objective: „t-cell Europe is aiming to become the world‘s technology leader in
the application of t-cell based therapies and diagnostics for transplantation medicine.”
► Company was founded in 2010 as a spin-off of the Berlin Brandenburg Center for Regenerative Therapies (BCRT)
► Headquarter in Potsdam / Laboratories at Charité, Berlin
► CEO: Dr. med. Claudia Ulbrich, degrees in medicine and health economics
► 6 employees
► Close partnership with the BCRT, scientific and medical advice by Prof. Dr. Hans-Dieter Volk and Prof Dr. Petra Reinke, Charité Universitätsmedizin Berlin
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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OVERVIEW ON OUR THREE TECHNOLOGY PLATFORMS AND PIPELINE
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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PT 1: THERAPEUTIC TREG-CELLS
Business Model: • Pre-clinical & clinical development until PoC (kidney). Then: Licensing to biopharma-partner
• Treg cell therapy for GvHD and autoimmunity will be exclusively developed within a cooperation
PT I is aiming at reshaping alloreactivity following solid organ transplantation • First indication: kidney transplants – aiming at minimization of immunosuppression
• Current status: end of pre-clinical phase, finalisation of cell manufacturing process, start of phase I/
IIa clinical trial is scheduled for 2014, key IP licensed in
• Future indications: liver, lung, heart, pancreas/islet, intestinal transplantations;
GvHD after hematopoietic stem cell transplantation, autoimmunity
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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OUR PRE-CLINICAL RESULTS
► Our development of a clinically relevant transplant model assures a comparable situation of patient´s immune-system and laboratory rat
► The pre-clinical results strongly indicate the full transferablity of the method to the patient in phase I/IIa
>1/1,000 alloreactive memory T
donor-reactive memory T before kidney Tx
normal rat under SPF housing = low immune challenge
<1/20,000 alloreactive memory T
>1/1,000 alloreactive memory T
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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ADOPTIVE TREG THERAPY CAN REPLACE PERMANENT CNI THERAPY FOR CONTROLLING DONOR-SPECIFIC T MEMORY
T-cell depl(>90%).
35 d
LIP
d-7 or d-150
Tmem 1/1,000
1x d5-20
Treg
allospec. T-Ly : - naive - Treg - memory/ effector T-cell depl.(>90%)
>150 d
LIP DA
LEW
T-cell depl(>90%).
<10 d
LIP
d-7 or d-150
Tmem 1/1,000
T-cell depl(>90%).
>150 d
LIP
d-7 or d-150
Tmem 1/1,000
1x d5-20
CNI 10-20d Treg
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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1 2 3 UNIQUE SELLING POINTS
World’s only transplant support therapy based on
Treg cells
Success of patient treatment can be monitored with
biomarker profiling
Addresses clear medical needs in multi-billion-euro
markets
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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BENEFITS FOR PATIENTS, PHYSICIANS AND INSURERS
Patients ► Improved quality of life and greater life expectancy by avoiding side
effects associated with lifelong immunosuppressive therapy ► Longer lifespan of transplanted organ reduces need for replacement
operations
Physicians ► Novel therapeutic approach enables superior patient care
Health insurance providers ► Potential for conclusive treatment (rather than ongoing treatment) ► Reduced costs through elimination of immunosuppressive therapy
and treatment of resulting side effects
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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SALES POTENTIAL OF NEW THERAPY
Projected sales (autologous therapy)
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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STRATEGY TO HIT THE MARKET
► Production – Transfer of the exis.ng GMP cer.fied produc.on for Inves.ga.onal
Medicinal Products to a CMO partner for commercial scale – Globally distributed produc.on with 2-‐3 produc.on hubs per con.nent – Enhancement of exis.ng bioreactor technology
► Market access – Access to key opinion leaders by strong academic network of founders – Key account model targe.ng big transplant centers
► Sales strategy – Partnering: Big Pharma (preferred), alterna.vely: Hospital Model
► Therapeutic Options – Allogeneic therapy approach (donor ≠ recepient) will be developed in
parallel to autologous therapy (donor = recepient) to simplify logis.c processes (towards off-‐the-‐shelf-‐products)
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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KEY SUCCESSES TO DATE KEY SUCCESSES TO DATE
► First-round financing agreement signed for EUR 1 million (seed capital)
► EUR 445,000 in government R&D funding from Brandenburg state development bank (ILB) for initial development and testing of therapy in autotransplantations (autologous therapy)
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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REQUIRED INVESTMENT CAPITAL
in order to: • Complete phase I/IIa study on T-cell-based kidney transplantation
Total study costs for 16 patients: 710k€ COGs: 10k€/ patient Clinics/ Lab et al.: 20k/patient CRO Overhead: 230k€
• Validate t-cell Europe platform technology PTI+III
million 5.5
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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INVESTMENT HIGHLIGHTS - SUMMARY
► Attractive market
► Experienced and highly regarded team
► Exclusive, patent-protected technology
► Growth-oriented, scalable business model
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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Dr. Claudia Ulbrich, CEO
MANY THANKS FOR YOUR INTEREST
t-cell Europe GmbH Zeppelinstr. 189 14471 Potsdam GERMANY
T + 49 331 27975690 F + 49 331 27975698 M + 49 172 4557632 [email protected] www.t-cell.de
Company Presentation t-cell Europe GmbH Dr. Claudia Ulbrich, CEO 22.09.13
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DISCLAIMER
This presentation may contain forward-looking statements and information which may be identified by formulations using terms such as “expects”, “aims”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates” or “will”. Such forward-looking statements are based on our current expectations and certain assumptions which may be subject to a variety of risks and uncertainties. The results actually achieved by t-cell Europe GmbH may substantially differ from these forward-looking statements. t-cell Europe GmbH assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.