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CELLMED & PROCURE®: AT A GLANCE

  • CELLMED Research GmbH1:
    Austrian life science company founded in 2006
  • CLINICAL COMPANY:
    Phase I/IIa in ovarian cancer successfully completed with USD 20 million being raised currently for upcoming phase IIb
  • PROCURE®:
    Patented unique double loaded dendritic cell therapy maximizing magnitude of efficacy directly activating both arms of the immune system without restrictions proven by striking phase I/IIa results
    - Highly significant immune responses in 100% of patients treated
    - Indication of zero material negative side effects
    - Cancer recurrence delayed by >163% compared to control (interim data)
    - Applicable to many indications other than ovarian cancer (current indication)

Patents are granted in the EU and Japan and pending in the US.

  • SUPERIOR TARGETS:
    Two universal tumor antigens Survivin & TERT, pivotal for development of most tumor types
    - Maximize efficacy, minimize side effects
    - Platform technology for a broad spectrum of therapeutic indications
  • MANUFACTURING:
    Robust and of reproducible high quality with off the shelf antigens and potency release assay
  • COMMERCIALIZATION:
    Manufacturing automation and cost reduction concept ready for scale-up
  •  IN-HOUSE:
    GMP production technology, logistics, distribution and strong long-term management competence team

 

CELLMED is reshaping the future of cancer treatment by focusing on the clinical development of its lead product PROCURE®. By supporting the rise of personalized medicine and cellular immunotherapy CELLMED aims to provide a better treatment for patients.

Important criteria for dendritic cell therapy have been recently identified and established providing for the reduced risk and significant upside potential for CELLMED. Autologous cell therapy has almost no side effects but a very complicated mechanism of action. Many mistakes were made previously, resulting in ambiguous clinical data concerning dendritic cell vaccine efficacy as a treatment for cancer and notable corporate failures. Early clinical results suggest CELLMED's science has overcome these prior errors and its phase IIb protocols will provide stronger evidence of such.

Cellular Immunotherapy Therapy

CELLMED board of directors

  • Gerhard Huber
  • Gerhard Nidetzky
  • Rudolf Zelenka
  • Thomas Zivny

Cellmed's Technology

PROCURE® is a vaccine manufactured from cells isolated from the individual patient. Precursor cells collected from the patient via leukapheresis are differentiated into dendritic cells, loaded with two universal tumor antigens, TERT mRNA and Survivin peptide, via the MHC I & II pathways. This unique dual antigen loading technology of PROCURE® is designed to elicit both short- and long-term anti-tumor immune responses and targets two fundamental and well characterized structures essential for tumor progression and development.

After passing stringent release criteria at the GMP laboratories, PROCURE® is stored frozen until the thawed vaccines are administered intradermally to the patient, in compliance with a pre-defined treatment scheme. CELLMED’s innovative cellular immunotherapy represents a technology platform applicable for the treatment of all solid tumors in general. Besides targeting ovarian cancer PROCURE® can be developed in additional cancer indications with potential for further pipeline products.

Cell life for long life

Development Plan

A phase I/IIa study with 15 patients randomized in two treatment arms to confirm the safety and immunological proof of concept of PROCURE® was conducted with last patient out in December 2012 and final report in June 2013. All results of the phase I/IIa trial confirmed product safety and results of specific T cell responses of all evaluable patients exhibit a striking 100% rate of positive immune responses with high significance1.

The median of progression free survival (PFS) as of July 2015 is already more than 26 months longer (interim data) which means a >163% improvement compared to the historical control group. Further data will be collected. It should be noted that Avastin, an angiogenesis inhibitor for the treatment of cancer, has received the EU approval based on results of two studies with improvement in PFS in the range of 14%-39% though substantial side effects.

Market and Competitors

Cancer is one of the leading causes of death in the industrialized world and one of the most prominent areas of research and development in the pharmaceutical industry. Certain cancers cannot be cured and improvements based on new therapies mostly focus on overall survival, often neglecting the patient ́s quality of life.

Today’s demography and modern way of life have led to a significant increase of cancer. In the EU alone, 2.5 million new cases of cancer are diagnosed annually. According to the Institute for Healthcare Informatics (IMS) cancer product sales constitute a USD 100 bn market, in which CELLMED is positioning itself with its immunotherapy technology.

Considerable market potential in solid tumor indications

GLOBAL CANCER INCIDENCE IN ‘000

  • 48,0 % Asia
  • 24,5 % Europe
  • 20,5 % America
  • 6,0 % Africa
  • 1,0 % Australia / New Zealand

Structure and Team

CELLMED was founded in 2006. Today the CELLMED-group consists of the subsidiaries Life Research Technologies GmbH and Cellpro Danube GmbH. Currently the consolidation and simplification of the corporate structure are in progress.
Wolfgang Huber, MD, MBA - CEO at CELLMED Marianne Imhof, PhD, MA  - CSO at CELLMEDGerda Plajer, MA - interim CFO at CELLMED Bettina Praschinger, MA - CFO at CELLMEDGerhard Stvarnik, PhD - Consultant at CELLMED

Financial Planning

Financial planning & Exit strategy

Up to now, CELLMED has raised more than USD 18.7 million for its project. Now CELLMED is aiming for another USD 20.0 million equity round for its clinical phase IIb study, manufacturing automation and scale-up, and a move of operations to the US. An IPO at NASDAQ is planned for 2016; at the latest the phase IIb proof of concept data should lead to an exit point (M&A or IPO) within around 3.5 years after funding.

Investment Considerations and Risk Factors

The investor shall thoroughly evaluate the following risk factors and considerations.

Cell life for good life

Letter from the CEO

CEO of CELLMED - Wolfgang Huber, MD, MBA

Dear Investor!

In 2006 a group of scientists, medical doctors and investors were inspired by the vision to develop a cellular immunotherapy against cancer and founded CELLMED, a biotech company focusing on oncological cell therapy. To find a cancer therapy that would support the human body's own defense mechanisms against cancer and would not cause such severe side effects, usually associated with cancer therapy, seemed a goal to invest eight years of hard work and USD 18.7 million thus far.

Contact

CELLMED Research GmbH

Schönlaterngasse 11/13
1010 Wien
AUSTRIA

office@cellmed.eu
www.cellmed.eu

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 Teaser ASP Executive Summary Letter of the CEO Brief des CEO (German) Executive Summary (German)