Team:Munich/Entrepreneurship

Entrepreneurship

Product idea

We successfully demonstrated the proof-of-concept of our analytic method. Now we want to bring ALIVE closer to the diagnostic benchmark.

We are currently expanding ALIVE with a stable and novel RNA based biomarker for transplanted cells, e.g., beta cells and CAR-T cells

This innovative product, which is in the patenting process, has the potential to increase patients' safety and reduce treatment costs. This is done to consolidate the monitoring of different transplanted cells to one reliable minimal-invasive and cost-efficient biomarker. We considered the value of our product, potential competitors, and funding options for the progression of our project, while also preparing a possible exit strategy under the consulting of our advisory board.

Advisory Board

For our end-user orientated product development we have united an advisory board with high-ranking experts. They are either versed in the treatment of T-cell or beta-cell therapy as well as their generation or the establishment of start-ups. Based on their personal consulting, we have developed our business model.

Field of Research: Molecular Imaging

Curriculum vitae

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• Took over the professorship for molecular imaging at the Technical University Munich in 2012


• Researched at MIT from 2005 until 2012


• Absolved parts of his clinical training at Harvard Med School


• Studied medicine in munich

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Prof. Dr. Gil Westmeyer

Host of iGEM Team Munich - Professor of Molecular Imaging at Technical University of Munich

"Given the growing success in organoid generation, immune cell engineering, and regenerative medicine, 'Alive' can provide a powerful complement to conventional molecular imaging approaches for monitoring cellular therapies."

Field of Research: Development of cellular therapies

Curriculum vitae

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• Operational leader and qualified person of TUMcells since 2011


• W3 professor for stem cell transplantation at the medical university Hannover from 2009 to 2011


• Hematology and oncology at the Helios Klinikum Berlin-Buch from 2002 to 2009


• Medical specialist for internal medicine and blood transfusion medicine at Charite Medical University Berlin from 1996 to 2002


• Assistant doctor at University Berlin

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Prof. Dr. Martin Hildebrandt

CEO of TUMCells - Expert for development of cellular therapies

"The Alive project could be used in the future for in vivo monitoring with non-destructive analysis methods and could help improving cell quality control in the field of regenerative medicine, which is becoming an important market with lots of growth potential."

Field of Research: CAR - T cell therapy

Curriculum vitae

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• Director of the Institute for Medical Microbiology, Immunology and Hygiene at the Technical University Munich since 2009.


• Leading the focus group "Clinical Cell Processing and Purification" at the TUM Institiute of Advanced Study.


• Finished his professional training at the Technical University Munich in 2005


• Absolved parts of his consequent training at Yale University from 1996 until 1999.


• Studied medicine in Mainz and Freiburg

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Prof. Dr. Dirk Busch

Director of the Institute for Medical Microbiology, Immunology and Hygiene at Technical University of Munich - T-cell therapy expert

"Most exciting about ALiVE is the possibilty of monitoring therapeutic cells non-invasively"

Field of Research: Biophysics

Curriculum vitae

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• Working on commercializing the 2018 iGEM project Phactory


• Supervised the 2018 iGEM Team Munich


• joined the working group Physics of Synthetic Biological Systems


• Finished his M.Sc. in Biophysics at the Technical University Munich in 2016

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Kilian Vogele

Founder Invitris after iGEM 2018 - M.Sc. Biophyiscs

"I see great potential for non-destructive and time-resolved monitoring of the same cell in various fields."

Position: Business Advisor

Curriculum vitae

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• Director of Operations EnTech, Bioengineering and Digital Health Helmholtz Center Munich since 2019


• Venture Partner Medical Valley Ventures since 2018


• Chief Business Officer / Chief Technology Officer faceALS since 2018


• Business Development Director ZFHN Zukunftsfonds Heilbron 2013-2017


• Senior Investment Manager BayernLB Capital Partner Munich 2001-2013


• Neuroscience and Information Science grades from the University of Konstanz 1990-2001

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Dr. Heiko Ott

Venture Partner and Director of Operations EnTech, Bioengineering and Digital Health

"The ingenious platform pioneered by ALiVE envisions first-of-their-kind longitudinal monitoring applications."

Field of Research: iPSC derived beta cells

Curriculum vitae

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• Editorial Board member of Stem Cells and Stem Cell Reports


• Coordinator of the collaborative EU FP7 project HumEn from 2014 to 2017.


• Head of the Section for Strategic Translational Stem Cell Research and Therapy from 2011 until 2016


• Co-Founder and scientific advisor within Cellartis AB


• Part of a collaboration between Lund University, Novo Nordiska/S and Cellartis/Cellectis from 2008 to 2013

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Prof. Dr. Henrik Semb

Professor of Human Stem Cell Biology at the University of Copenhagen - Director of the Institute of Translational Stem Cell Research at Helmholtz Center Munich

"I can see the potential for longitudinal omics-monitoring with respect to quality control and deployment of cell replacement therapy"

Value Proposition

Every 9 minutes
someone in the US dies from blood cancer

Leukemia, lymphoma and myeloma are expected to cause the deaths of an estimated 56,770 people in the US in 2019.¹

80% Success rate
are shown by CAR-T cell therapies

Over 80% of patients who recieved one of the two FDA approved CAR-T cell therapies in clinical trials had either a complete or partial response.²

$4,700,000,000
predicted target market volume

Based on the current CAR-T cell market of $295.1 million in 2018 and a predicted CAGR of 32,5% over the next 10 years.³

Blood cancers are expected to be the cause for 9.4% cancer deaths in 2019. CAR-T cell therapies are a new field of therapies, using modified T-cells to eliminate blood cancer cells. Current data shows success rates of over 80% with these therapies, with longterm success still being unclear due to the novelty of the therapy and limited longterm monitoring methods.² CAR-immunotherapies are being tested in clinical trials all over the world, with the United States and China leading the chart.³

The monitoring of CAR-T cells after the cancer´s inital regression is still a big problem. Currently, the monitorng methods are based on indirect approaches like B-cell counts or antibody screenings, dependent on the treated cancers.

This is where we and our advisory board, that is experienced with CAR-T cell therapy, see the market for our system. ALiVE in combination with our biomarker allows longterm monitoring of the remaining CAR-T cell population, giving new insights into the therapy while presenting a cost efficient and cancer-indipendent alternative to current methods.

$60,000,000
expected penetrable market

After a successfull CAR-T cell therapy the patient needs to be monitored annually. This is the market we want to penetrate by offering a cheaper and universal option. We calculated the market conservatively assuming every patient will be monitored only once a year, with patient numbers starting at 10.000 annually, according to our advisory board. We then applied the same growth rate as used before with the addition that every patient will be a long-term user, increasing the growth rate even further.⁴

State of the Art

Therapy-specific blood tests
Costs: avg $100

Therapy-specific blood tests, e.g. white blood cell counts or unconventional antibody screenings on average cost between $50 and $150 inside the laboratory.⁵

ALiVE

Universal biomarker
Costs: $24.17

Our biomarker can be used therapy-indipendently for any transplanted cell. The costs calculations are described here

SWOT Analysis

One by many companies commonly applied method to evaluate the market potential of a product is SWOT analysis. SWOT means “Strengths Weaknesses Opportunities and Threats” and helps us to evaluate the position of the product for potential market potential. We started with an internal analysis of the strengths and weaknesses of our product to improve our competitive market position. After that, an external analysis based on the criteria opportunities and threats gains inside into the cost benefit ratio of the project.

Protection of Intellectual Property (IP)

To increase funding opportunities and safe-guard our product we are in the process of patenting the novel RNA based biomarker. The submission is planed over the European Patent Office and then further registered in the currently most relevant markets, e.g., USA, GER and UK. Thus giving us a better position for the commercial exploitation of our system, which we are uniquely positioned to pursue.

Creation of Value

To assess whether we can compete with the current post-therapeutic monitoring methods, we calculated the costs for a single biomarker screening. Herefore we neglected the costs of necessary lab equipment. Furthermore, for the work, we used the average salary for a technical lab assistant in the USA of $15 per hour.⁵

Cost break down:Based on kits used during iGEM and standart sanger sequencing.^{6 7 8}

75 % cost reduction on average compared to current methods.

Interaction with Stakeholders

During our project we actively sought out experts in the field of translational medicine to evaluate our economic and scientific position. Here we found overwhelmingly positive feedback regarding ALiVE´s potential to improve the field of regenerative medicine as a diagnostic tool. Prof. Dr. Hildebrandt, the CEO of TUMcells, a company developing modern therapeutics based on living cells, discussed ALiVE with us extensively. Prof. Hildebrandt emphazised the importance of ALiVE´s key goals for the field of regenerative medicine, which he summarized in a Letter of Intent.

Current Competing Methods

Cell monitoring can be characterized over multiple categories. The most relevant ones in our opinion are the combination of longitudinal measurement in combination with Gene-of-interest (GOI)-specific monitoring.

While transcriptomics and proteomics are high throughput methods, they require cell lysis, making them destructive endpoint methods. In CAR-T cell therapy, cell counting and antibody screenings are currently state-of-the-art. These methods require cell extraction and are very limited in informational content, according to our advisory board. Classical biomarkers like insulin allow noninvasive monitoring, but they are celltype-dependent, and therefore require a variety of assays. Furthermore, these markers are not adjustable to the GOI, limiting the monitoring possibilities. Due to our specific exportable biomoarker that can be used iniversally, ALiVE overcomes theses problems.

Funding Strategy and Distribution

Access to capital for biotech start-ups in Europe is a highly competitive, in particulare in the pre-seed stage. Therefore, the EU, governments, and states provide non-dilutive programs to support the development of early stage projects toward start-up creation. Located within Germany's largest biotech network in Munich, first customer relationships are established and non-dilutive funding options like for example VIP+, (1,5 Mio Euro, 3 years), m4Award (one round of funding, 500.000 Euro, 2 years) or Exist (300.000 Euro, 8-36 months) are under preparation.

The following distribution is calculated with VIP+.

fields of expenses	Amount of funding
Postdoc	$80.000
2 PhDs	2 * $48.000
Technical Assistant	$40.000
Economic Advisor	$50.000
Consulting	$20.000
Running Costs	$64.000
Advanced Laboratory Equipment	$150.000
Patenting	$0 *
Laboratory Space	$0 *
Basic Laboratory Equipment	$0 *
Total	$500.000 per year

*The Chair of Prof. Westmeyer and the Helmholtz Center Munich are bearing these costs.

Exit Strategy

We are already thinking about the right exit strategies to achieve a successful and carefully-arranged business model. Thus we are ideally achieving a trade-sale exit, to contribute our product to a world-leading pharmaceutical company while generating profit.

Timeline

Vision

We have identified and separated the field of applications into three major areas: We are currently at the beginning of ALiVE´s potential. The closest application to achieve is the fundamental research area. Here, researchers can use ALiVE in their mammalian cell lines for non-invasive analysis of gene expression over time.
The applications in the foreseeable future are the second area of applications we identify for ALiVE. Here we are talking about cell therapies like CAR T-cell therapy as well as simple cell replacement therapies like beta-cell transplants. This field of therapeutic medicine is what we want to focus on during the development of ALiVE.
The third field of applications we envision for ALiVE is more future-oriented. The area of transplantation medicine is slowly moving towards synthetic organs.⁹ This entails growing organs inside a laboratory, making human organ donors obsolete. We envision ALiVE to be a powerful analytic tool during the growth of the organs as well as a monitoring system after the organ´s transplantation.

Want to cooperate with us?

If we have picked your interest with our novel product idea please contact us directly (igem.munich@gmail.com). We are always happy to supply you with information about ALIVE, e.g. our pitch deck. Please bear in mind that, due to patenting, discussions about the RNA biomarker might include signing a university set NDA (non-disclosure agreement).

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