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


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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


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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


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OVERVIEW ON OUR THREE TECHNOLOGY PLATFORMS AND PIPELINE


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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


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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


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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


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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


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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


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SALES POTENTIAL OF NEW THERAPY

Projected sales (autologous therapy)


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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)


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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)


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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


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INVESTMENT HIGHLIGHTS - SUMMARY

► Attractive market

► Experienced and highly regarded team

► Exclusive, patent-protected technology

► Growth-oriented, scalable business model


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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


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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.

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