Team:UCAS-China/Entrepreneurship


ENTREPRENEUR

Why do we need a plan of entrepreneur?

★ We believe our safety platform is of great potential to be applied in bacterial therapy pharmacy and aiming to let more people enjoy our products.

★ We hope view our project from another perspective which we indeed unfamiliar with but keeping trying new things and learning from it benefits us a lot.

★ We know that this plan of entrepreneur is really a untypical one. What we want to convey with it is that you can always scan your project in a new way which can inspire you a lot.


Product application and Current situation

★ We hope to provide our products in two ways: electronic capsule cPlus & bacteria strain with our platform ARK.micro

★ Currently there has been a lot of potential clinical drugs,which can be applied in various diseases, such as cancer(Metastatic, refractory or recurrent invasive carcinoma of the cervix; Prostate cancer......), neurodegenerative disease (Parkinson), intestine problems(Crohn's disease)......Estimated by the proportion of the completed, active and proposed clinical trials involving engineered live bacteria as therapeutics, we expected that 10-20 years following will be a extremely positive period for microbial therapy.

Clinicaltrials.gov ref number
Disease
Phase
Sponsor/Company
NCT00729872
Moderately active Ulcerative Colitis
IIA
ActoGeniX N.V. (Intrexon)
NCT00938080
Oral mucositis
IB
ActoGeniX N.V. (Intrexon)
NCT03179878
Hyper-ammonemia
I
Synlogic
NCT01598792
Human Papilloma Virus-related oropharyngeal cancer
I
University of Liverpool
NCT01116245
Cervical Intraepithelial Neoplasia
II
Advaxis, Inc.
NCT01266460
Persistent or recurrent cervical cancer
II
Gynecologic Oncology Group
NCT02399813
Anal and rectal cancer
II
Advaxis, Inc.
NCT02291055
Cervical, head and Neck cancer (HPV+)
I/II
Advaxis, Inc.
NCT00327652
Carcinoma and liver metastases
I
Anza Therapeutics, Inc (Aduro Biotech, Inc)
NCT02004262
Previously-treated metastatic adenocarcinoma of the pancreas
IIB
Aduro Biotech, Inc
NCT03006302
Metastatic pancreatic adenocarcinoma
II
Sidney Kimmel Comprehensive Cancer Center
Table 1. Part of completed, Active and Proposed clinical trials involving engineered live bacteria as therapeutics.[2]

Figure 2. Clinical Trails of Microbial therapies. Data from [2].

★ It is estimated that the global micro-ecological drug market space is expected to reach 10 billion US dollars in 2026.

Assumption:

1) We actively assume that the three microecological drugs currently in clinical phase III can be successfully listed;

2)The Seth Robey and Frank S. David model and the characteristics of the pharmaceutical market are expected to peak in 6 years of marketing; the penetration rate at peak is 10% to 20% (considering lactose intolerance can avoid dairy products and dairy products) Food to ease, the treatment rate is relatively low, conservatively expected to reach 5% to 10% by 2026);

Since the FDA has not approved the micro-ecological drugs listed on the market, we estimate the price of micro-ecological drugs to be 2000-3000 US dollars per course with reference to the pricing of its competing products. Generally, it is treated three times according to the upgrade treatment strategy, and the cost is 6000-9000 Dollar. (Difidd macrolide antibiotics are $3,360/10 days; Bbezlotoxumab monoclonal antibody is $3,000/dose, which prevents recurrence every 6-8 treatments).


Then: We expect the market space of global micro-ecological drugs to reach 10 billion US dollars in 2026.

1)It is estimated that ser-109, rbx2660, rp-g28 will have a global market space of 30 to 9.4 billion US dollars in 2026;

2)At present, there are more than ten incomplete statistics of LBPs and small molecule microecological regulators in clinical stage II. The indications include hepatic encephalopathy, infection, IBD, NASH, etc. The probability of successful listing is expected to be 20%, then 2026 There are also 2~4 new drugs successfully listed;

3)Fecal bacteria transplantation was included in the treatment guidelines for recurrent C. difficile infection in 2013. At present, there are 20,000 patients receiving fecal transplantation in the world. According to the upgrade treatment strategy, it is generally performed three times, and the fee is 6000 USD/time. With a scale of 170 million US dollars, there is still room for growth in the future.[1]

Figure 2. Analysis of current market situation.


What will them bring to you?

★ We have done a series of work to explore the potential of our platform ARK.micro and our hardware cPlus to enter the real market and clinically change the medication field. We evaluated the prospect of the microbial therapy, absorbing information from different perspectives and visiting real industrial line, we found the potential of our platform to promote the transformation of an academic result to be exploit into clinically also industrially microbial therapy. We made a comprehensive business plan, innovatively providing the business mode and objectively analysis its industrial prospect. We brought our project to participate in a national Innovation and Entrepreneurship Competition host by Chinese Academy of Sciences and won high reputation among sponsors. Many of our instructors expressed interest in offering support for the further development and industrialization of our project. We believe that our platform will change the whole medication world.


★ Handbook for users of cPlus. SEE MORE

How did we present our plan?

★ We took part in an innovation and entrepreneurship competition and was awarded with the third prize.


★ Our business plan. SEE MORE
























Figure 2. Part of our business plan.

★ We introduced our products to Tao Xu, academician of Chinese Academy of Sciences from Institute of Biophysics, Chinese Academy of Sciences. He showed great interest in our electronic capsule and willing to help us develop it further.


Something necessary to be mentioned

★ We can go to the department of transformation of scientific and technological achievements and ask for some advice. Maybe we can consult some lawyers who specialize in applying for a patent in biology. These things will of great importance to accelerate the commercialization of our project but they are not the most important.

★ The most difficult problem to be solved is to have a series of laws and regulations to make bacterial therapy, especially engineering bacteria normalize and put it under the protection of the policy.

★ Possible risks. Our project can promote the development of bacterial therapy but also depends on the development of bacterial therapy. The carrying out of clinical experiment and the efficacy of related medicine are also things we should track.


References:

[1] Guangzheng Hang Seng special report on microecological medicine 2018.11

[2] Riglar, D. T., & Silver, P. A. (2018). Engineering bacteria for diagnostic and therapeutic applications. Nature Reviews Microbiology, 16, 214.