Entrepreneurship
Overview
Assemblase is a highly adaptable product that can be used across any biochemical reaction where rate limiting barriers are creating vast inefficiencies in yield. Currently we are using Paclitaxel manufacturing as a case study to showcase how Assemblase can enter and dominate the cancer drug development market. There are plans however, to expand into different industries such as high value therapeutics, food industry and consumer good production. The business plan has been created from the business plan template created by our team. We have consulted a total of 9 companies ranging from venture capital firms to pharmaceutical companies. Additionally, we have attracted interest from a private investor to invest $100,000 pre seed.
Currently there is no commercially available protein scaffold this is due to the novel nature of this science1. Additionally, there are attempts to improve multi-step reaction inefficiencies however this appears to be limited in a commercial setting. We realised Assemblase could provide a novel solution to solve this well-documented problem2.
Our goal is to improve the manufacturing of multi enzyme reactions. Through applying Assemblase we can put two enzymes closely together, increasing the probability that the product of one enzyme will enter as the substrate for the next in a multi-enzyme reaction . We have decided to use Paclitaxel as a case study due to its renown nature. Additionally, we can combine Assemblase to two pathways in Paclitaxel this in conjunction with the application using FRET3 acts a proof of science to show Assemblase is in fact adaptable and multimodular.
Customer Discovery
We determined our addressable market by conversations with academics, pharmaceutical companies, government agencies and investors all whom are key stakeholders. To find out more visit our Integrated Human Practices page.
Protein scaffolds will play an integral role to improve biochemical manufacturing processes.
Dominic Glover
Senior Lecturer, UNSW
Paclitaxel will continue to have a role (in chemotherapy). It is established in too many diseases for it to disappear in the next two to three decades.
Gilberto Lopez
Editor-in-Chief, Journal of Global Oncology
There is a need for improvement in cancer treatment. This could be done through improving the manufacturing process of drugs freeing up money for better patient treatment.
Josie Rutovitz
Oncologist, Northern Hematology Oncology Group
Pharmaceutical companies are looking for products that have a diverse range of applications. Assemblase being adaptable will play a pivotal role in dominating the enzyme market.
Peter Grudzinkas
Ex-Marketing Manager, Abbott Products
That's 70% of the total cancer market, with $1.8 billion out of pocket.
Additionally, 48,8406 will die each year of Cancer accounting for 28.1% of all deaths within Australia.
60-70% of chemotherapy patients will require the use of Paclitaxel at least once throughout their treatment process.
Dr Peter Gunning
Global
Aus
A monthly dose still costs $800 in America8.
The enzyme market is $5.8 billion annually estimated to reach $6.4 Billion by 202010.
| Industry | Enzyme | Use |
|---|---|---|
| Baking | Xylanase | Dough conditioning |
| Dairy | Acid proteinase | Milk coagulation |
| Brewing | Pullulanase | Starch saccharification |
| Detergent | Lipase | Fat stain elimination |
| Cosmetics | Laccase | Hair dye |
Cost
Through reducing loss to diffusion reactions with Assemblase require less input.Sustainability
The use of multienzyme steps allows for inclusion of sustainable pathways that use waste products.Time
Through reducing the rate limiting step reactions occur faster with Assemblase.| Key Stakeholders | Description |
|---|---|
| Australian Paclitaxel Manufacturer | Pfizer Australia Pty Ltd (anzatax) |
| Australian Paclitaxel Manufacturer | Juno Pharmaceuticals Pty Ltd (paclitaxel ACT) |
| Australian Paclitaxel Manufacturer | Accord Healthcare Pty Ltd (paclitaxel accord) |
| Australian Paclitaxel Manufacturer | Sandoz Pty Ltd (paclitaxel ebewe) |
| Australian Paclitaxel Manufacturer | Fresenius Kabi Australia Pty Limited (paclitaxel Kabi) |
| Australian Paclitaxel Manufacturer | Teva Pharma Australia Pty Limited (paclitaxin) |
| Australian Government | Public Benefits Scheme |
| International Insurance agencies | Healthcare Insurance Companies |
Assemblase
| Adaptable | Apply to a variety of pathways |
|---|---|
| Self-assembling | Requires no intervention, machines, or chemicals to assemble |
| Stable | Work at a range of pH and temperature |
| Sustainable | Use multiple times through filtration |
| Multimodal | Use 2 to 3 unrelated enzymes |
| Co-localisation | Make reactions occur in a single area |
Without Assemblase
With Assemblase
Assemblase makes Paclitaxel synthesis 6x more efficient, demonstrated through modelling
| Our Baccatin III pathway is environmentally friendly. | |
| F2 PBS Status ensures all manufactures will incorporate Assemblase. | |
| Paclitaxel is used to create other pharmaceuticals such as Abraxane, Taxoprexin, Opaxio. | |
| Assemblase production method recycles waste products. |
Other Considerations
Patents
During the initial years Assemblase will be sold a trade secret with patenting not being an issue until global expansion.Legal Structure
Assemblase has a Proprietary Limited legal structure this allows for the initial founders to retain ownership whilst easily bringing in outside funding parties.Compliance
Assemblase is compliant with the Office of Gene Technology Regulator.
| ProSci13 | Deltagen14 | Enzyme Solutions15 | Novozymes16 | |
|---|---|---|---|---|
| About | A leader in its field, ProSci’s priority is to provide the highest quality monoclonal, polyclonal, and single domain antibody services in the industry. | Originally producers of high-grade enzymes for the wine and brewing industry, over the past two decades Deltagen has developed a position as a key supplier of food flavours, colours and processing aids to the food and beverage manufacturers of Australia. | Enzyme Solutions is involved in sales and distribution of Enzymes for many industries including Baking, Brewing, Cleaning, Dairy, Ethanol, Fruit Juice & Olive Oil Production, Grain Processing, Nutraceuticals Paper, Protein Processing, Specialty Enzymes, Textiles, Waste Treatment & Wine. | The company’s focus is the research, development and production of industrial enzymes, microorganisms, and biopharmaceutical ingredients. |
| Founded | 1998 | 1983 | 1997 | 1925 |
| Strength | Provides a wide array of services and goods within therapeutics. | Provides both enzyme production as well as distribution and packaging services. | Provides a highly personalise service with education on how to use the enzyme as well as safety requirements and what enzyme is worthwhile. | Provides a wide range of enzymes across many industries leveraging long standing experience. |
| Weakness | Quite niche in the therapeutics market predominately established in the US. | Only provides products in food and beverage. | An international presence and established market presence have not been ensued to diverse product range. | Currently not employing novel scaffolding methods as well as less tailored service due to size of customer base. |
- The initial step involves client sending either sourcing an enzyme or receiving a sequence of the enzyme from the client which will then be attached to the Assemblase scaffold.
- The components of Assemblase scaffold will then be produced by the Assemblase team.
- The different components will then be sent in a biologically compliant storage device by Assemblase’s distributor.
- The customer can then distribute their product to the end user.
- The Assemblase team will provide information into the recovery process prior to bead immobilisation.
- The user will then add the Assemblase components to their reaction.
Minimum Viable Product
The minimum viable product for the Assemblase scaffold is a protein scaffold that could increase reaction rate by a minimum amount of 10% this would ensure that consumer need is met. Assemblase must be able to self-assemble and be stable and unreactive with undesired elements of customer reaction process. Additionally, the Assemblase scaffold must not alter or create any by-products that could hinder or to a reasonable level inconvenience current production method.
Future Commitments & Funding
BLACKBIRD VENTURES
One of Australia’s largest venture capital firms.
BIOSCIENCE MANAGERS
An international healthcare investment firm that finances and enables innovative science and technology .
ONE VENTURES
One of Australia’s largest venture capital firms holding one of the largest venture healthcare funds.
AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH
Oversees the running of Australia's health system.
TEVA
A Multinational pharmaceutical specialising in generic pharmaceuticals.
UNSW FOUNDERS
A leading accelerator supporting students, staff and alumni.
CICADA INNOVATIONS
An Australian incubator that supports science-based innovations.
ALLEN PARTNERS
A boutique investment bank specialising in capital raising.
CSIRO
An independent Australian federal government agency responsible for scientific research.
Assemblase requires a large amount of capital for operations. Through funding capital expenditure on equipment and R&D will be facilitated. The funding schedule will be accompanied with coveats specific to each round ensuring a stable cash flow prior to establishing a network of customers.
| Round | Who | Amount | Investment to Date | Tranches | Date |
|---|---|---|---|---|---|
| Pre-seed | University, government, accelerator, family and friends | $100,000 | $100,000 | Subordinate | H1 2020 |
| Seed VC | Venture Capital Fund | $2,000,000 | $2,100,000 | Senior | H2 2020 |
| VC | Institutional | $10,000,000 | $12,100,000 | Senior | H1 2022 |
We were lucky enough to pitch to venture capital firms, accelerators and fund managers. Through pitching we gained valuable perspective into the market understanding the market demand for Assemblase. We used the following to accompany each pitch:
Business Plan
We created a business plan adapted from the UNSW business scaffold. This enabled us to consider and understand how to bring and integrate Assemblase into the market.
Market Strategy
Entrepreneurship Criteria
Customer Discovery - Has the team interviewed a representative number of potential customers for the technology and clearly communicated what they learned?
Through interviewing a diverse range of stakeholders, we understood the problem surrounding biochemical manufacturing processes. This in conjunction with market research allowed us to come to the conclusion that there were no commercially available protein scaffolds. Our stakeholder analysis ensured that all individuals in the value chain were considered such as; Pharmaceutical companies, investors and end users. Our customer analysis demonstrated that the Assemblase Scaffold must be; adaptable, self-assembling, stable, sustainable and multimodal. This will ensure the commercial success of Assemblase improving biochemical manufacturing pathways.
Based on their interviews, does the team have a clear hypothesis describing their customers' needs?
Through consulting stakeholders, we created a clear hypothesis, “Currently there are vast inefficiencies in multienzyme reactions causing high prices for manufacturers and consumers”. We will meet the customers’ needs by reducing costs and time of production whilst, improving the sustainability of the biochemical processes.
Does the team present a convincing case that their product meets the customers' needs?
Through consulting all key stakeholders, we were able to create a protein scaffold that meet their needs. Our scaffold exhibits the core components that make it vastly adaptable and multimodal. These characteristics in conjunction with our MVP ensure our product exceeds customer’s needs. e
Has the team demonstrated a minimum viable (MVP) product? And does the team have customers to commit (LOI, etc.) to purchasing it / using it?
Our team has created the criteria for a minimum viable product. This will provide the user with utility improving their biochemical manufacturing process. Additionally, we have pitched our idea to a variety of stakeholders who have expressed interest. This has ultimately culminated in a $100,000 commitment invest by a private investor.
Does the team have a viable and understood business model/value proposition to take their company to market?
We have created a business model which has been outlined in our business plan. This business plan allows us to map out the next 36 months for Assemblase. The business plan also shows key consideration for establishing Assemblase as a viable business. Additionally, the pitchbook and slidedeck has allowed us to engage with investors, demonstrating the value proposition Assemblase brings to the community.
References
- Horn AH, Sticht H. Synthetic protein scaffolds based on peptide motifs and cognate adaptor domains for improving metabolic productivity. Frontiers in bioengineering and biotechnology. 2015 Nov 23;3:191.
- Britton J, Raston CL. Multi-step continuous-flow synthesis. Chemical Society Reviews. 2017;46(5):1250-71.
- Sekar RB, Periasamy A. Fluorescence resonance energy transfer (FRET) microscopy imaging of live cell protein localizations. The Journal of cell biology. 2003 Mar 3;160(5):629-33.
- Goldsbury D, et al. Health services costs for cancer care in Australia: Estimates from the 45 and Up Study. PLOS ONE [Internet]. 2018 [cited 9 October 2019];13(7):e0201552. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0201552
- Cancer statistics | Cancer Australia [Internet]. Canceraustralia.gov.au. 2019 [cited 9 October 2019]. Available from: https://canceraustralia.gov.au/affected-cancer/cancer-statistics
- Cancer in Australia [Internet]. Cancer.org.au. 2019 [cited 13 October 2019]. Available from: https://www.cancer.org.au/about-cancer/what-is-cancer/facts-and-figures.html
- Newman DJ, Cragg GM, Kingston DG. Natural products as pharmaceuticals and sources for lead structures. InThe Practice of Medicinal Chemistry 2008 Jan 1 (pp. 159-186). Academic Press.
- Force RW, Pugmire BA, Culbertson VL. Comparing medical cost of care for patients with metastatic breast cancer receiving taxane therapy: claims analysis. American health & drug benefits. 2010 Jul;3(4):276.
- Price Disclosure [Internet]. Pbs.gov.au. 2019 [cited 9 October 2019]. Available from: http://www.pbs.gov.au/info/industry/pricing/price-disclosure-spd
- Singh R, Kumar M, Mittal A, Mehta PK. Microbial enzymes: industrial progress in 21st century. 3 Biotech. 2016 Dec 1;6(2):174.
- Robinson PK. Enzymes: principles and biotechnological applications. Essays in biochemistry. 2015 Nov 15;59:1.
- Rowinsky EK, Donehower RC. Paclitaxel (taxol). New England journal of medicine. 1995 Apr 13;332(15):1004-14.
- ProSci Antibodies [Internet]. Prosci-inc.com. 2019 [cited 13 October 2019]. Available from: https://www.prosci-inc.com/products/
- Deltagen [Internet]. Deltagen. 2019 [cited 13 October 2019]. Available from: https://deltagen.com.au/
- Enzyme Solutions [Internet]. Enzyme Solutions. 2019 [cited 13 October 2019]. Available from: https://www.enzymesolutions.com.au/
- Novozymes [Internet]. Novozymes. 2019 [cited 13 October 2019]. Available from: https://www.novozymes.com/en