Problem and Solution

Problem Statement

B Cell engineering represents an exciting and emerging frontier in the treatment of diseases such as HIV, HBV, and various types of cancer and even Alzheimer’s disease. As with any pharmaceutical therapy, ensuring the safety and controllability of B Cells is crucial. While there are currently no FDA-approved B-cell therapies available, it is foreseeable that the need to exert precise control over these cells will arise. We want to tackle this problem by developing an On-/Off-switch for B cells.

By optimizing our independently researched activation- and kill-switch mechanisms, we aim to address this challenge by developing a mechanism that enables us to activate and deactivate B cells as needed. On one hand, this capability will prove invaluable when we want to activate B cells targeting endogenous structures, particularly in cases where T cell activation is insufficient. On the other hand, once a specific cancer has been temporarily defeated or an infection has been effectively dismantled, it is undesirable for B cells to continue producing the corresponding protein/antibody, since cancer targets are often expressed on healthy cells as well and antibodies can have severe side effects (e.g. brain bleeding after administration of antibodies against Alzheimer’s disease)¹ A temporary inactivation of B cells could prevent that.

Given the potential for cancer and infections to reoccur (up to 80% for glioblastoma²; overall estimation: 38% +/- 26%)³ , the ability to reactivate these cells becomes crucial. This reactivation feature not only allows us to respond promptly to reoccurring threats but also serves to mitigate the risk of severe side effects associated with the sustained production of therapeutic proteins/antibodies. With these benefits in mind, we anticipate that our technology will accelerate the development of safety and more effective B cell therapeutics.

B Cell Engineering

One of the key features of B cell engineering is the stable integration of genetic constructs. This process involves introducing antibody or protein constructs into the endogenous IgH (Immunoglobulin Heavy Chain) locus of B cells. This stable integration allows for the expression of engineered antibodies or proteins within B cells while maintaining the cell’s ability to undergo physiological mechanisms, such as somatic hypermutation (SHM) and isotype switching⁴. As a result, the engineered B cell can produce antibodies with specificity for a target antigen, mirroring the natural immune response. Therefore we decided to improve current problems in the B-cell therapy space, which is regulation of the B-cell activity.

Controlling B Cell Expression and Activity: The On/Off-Switch

Controlling the expression and activity of B cells is a significant challenge in the field of immunotherapy. An On/Off-Switch for B cells is analogous to a remote control for these cells, allowing us to activate or deactivate antibody expression as needed. This concept has been inspired by research in CAR T-cell therapy⁵, where the expression of Chimeric Antigen Receptors (CARs) can be controlled. In CAR T-cell therapy, researchers have achieved controlled CAR expression using lenalidomide, a medication that induces ubiquitination of CAR proteins. This ubiquitination leads to the degradation of CARs, effectively turning off their activity. Subsequently, when lenalidomide is no longer present, the CARs can be reactivated. Alternatively, lenalidomide can induce the dimerization or assembly of functional CARs, turning them on. This approach allows for reversible and precise control of CAR T-cell activity, as demonstrated in the study by Max Jan et al., published in Science Translational Medicine in 2021⁶. Importantly, this same principle can be applied to B cells, enabling us to control the expression of engineered antibodies. By using an On/Off-Switch mechanism, we can activate or deactivate antibody and therapeutic protein expression respectively within B cells as needed.

Synthetic Circuits for B Cells

Another intriguing development in B cell engineering comes from Audrey Page⁷, who has designed a synthetic circuit to express green fluorescent protein (GFP) upon antigen recognition via an artificial B cell receptor (BCR). The construct was introduced lentiviral and although this technology has to be adapted for the IgH locus, to allow B cell differentiation and self-enhancing mechanisms like SHM or isotype switching. A great addition would be the recognition of particularly morbid structure like the TME as well.

Market Opportunity

Market Analysis

The aim of iGEM Munich Team (BEE) is to make B-cell therapie safer and more flexible by developing an on/off switch that will enable a flexible regulation of protein titers produced by B-cells. By out-licensing our IPs or co-development of new B-cell therapeutics we are participating in the overall biologics market, specifically B-cell therapies market.

The overall biologics market is a major growth driver within the pharmaceutical industry and is expected to expand their market share to approximately 36.3% by 2027. Cell and gene therapies experienced a remarkable revenue growth, with a year-on-year increase of over 50% in 2022.

The key therapeutic segments that are projected to thrive include oncology, central nervous system, and infectious diseases, with cardiovascular disease (CVD) gaining momentum by 2027 ⁸.

With our enhanced technologies for B-cell therapies, BEE will be well-positioned to tap into these markets. The concrete co-development of B-cell therapies against a specific target is strongly dependent on our future partners and not to be disclosed yet. However we see great opportunities for B-cell therapy lie in the improvement of current antibody therapies. The size of the immunoglobulin market worldwide in 2019 was predicted to be 11.3 billion US Dollars and is predicted to double until 2030.⁹

The overall revenue for the antibody drug conjugates (ADCs) Therapeutics was 7.35 Billion US dollar and is expected to experience a compound annual growth rate of 25.4% until 2028. ¹⁰

Choice of Market

The Total Addressable Market (TAM) for global Immunotherapy is estimated at $200 billion with a Compound Annual Growth Rate (CAGR) of 11%.¹¹ The Serviceable Addressable Market (SAM) comprises $12 billion, exhibiting a significant CAGR of 29.8%.¹² As there are currently no approved B cell therapies, estimating the size of the Serviceable Obtainable Market (SOM) is a challenge. However, for reference, we estimate it at $3.82 billion, based on the current market size for CAR T cell therapy.¹³ This demonstrates how another novel and innovative cell therapy can establish itself in the market. Given that B cell therapy has the potential to replace certain antibody therapies, it’s worth considering the entire antibody therapy market, which is valued at $210 billion.¹⁴ Moreover, the applicability of an On-/Off-Switch for B cell therapies across the board where B cell therapies are on the rise solidifies the notion that there is a substantial, multi-billion dollar market for B cells and, by extension, B cell therapy enhancements like On-Off-Switches.

Competitor Analysis

There are several biotherapeutics companies that focus on B-cell therapeutics.

1. Walking Fish Therapeutics has several therapeutics in the pipeline. First, a rare disease/ replacement protein against fabry disease in IND enabling studies,a therapeutic protein in preclinical development, without disclosing the targets as well as a B-cell therapy against solid tumor which is also in preclinical development.

2. Immusoft has the first B-cell therapy against Hurler Syndrome(MPS1) in phase 1 clinical trials (NCT05682144) as well as another B-cell therapy against Hurler Syndrome (MPS2) in IND-Enabling. Immusoft is also looking into more therapeutic areas, but doesn’t disclose their specific targets.

3. BE Biopharma is a preclinical therapeutics company focusing on rare disease and oncology. Currently they are moving these programs toward the clinic.

4. Tabby Therapeutis is a seed stage start up focusing on B-Cell therapy against HIV.

5. Bespoke Biotherapeutics is a seed stage start up focusing on B-cell theapy against solid tumors. The have recetly raised $256,000 from the National Science Foundation.

Our competitive advantage lies in the novelty of our future intellecutial properties. By developing a on/off switch for B-cell therapies, we are enhancing existing B-cell therapies and increasing their therapeutic potential against a more diverse range of targets. Our main focus lies in reducing the drawbacks of B-cell Therapies by setting our main focus on R&D to develop novel solutions. Collaborations with biopharmaceutical companies are enabling us to capitalize on these novel targets. Out-licencing our technologies will accelerate the growth and acceptance of B-cell Therapies leading the way to a whole new class of revolutionaly therapeutics.

SWOT Analysis

Strength

Our biopharmaceutical company, strategically located in Munich, possesses several key strengths. First and foremost, our commitment to personalized treatment is a core advantage. This innovative approach tailors therapies to individual patients, enhancing treatment efficacy, and minimizing side effects. Furthermore, we specialize in treating diseases before symptoms manifest, a pioneering strategy that can revolutionize early-stage disease control. We offer one-time or limited treatments, promoting patient compliance and reducing the burden of long-term therapy. Our technology’s adaptability allows us to target a wide range of diseases when the specific antibody is known, providing avenues for diversification and expansion. Our proximity to various research groups in Munich facilitates collaborative innovation and knowledge exchange.

Weakness

Notwithstanding our strengths, several challenges must be addressed. The cost of developing and offering personalized therapies can be significant, potentially limiting accessibility for some patients. We acknowledge that our technology requires further optimization to mitigate potential inefficiencies, increased costs, or unforeseen side effects. The absence of patents exposes our innovations to potential intellectual property challenges or replication by competitors. As we scale and optimize our technology, substantial investments in research and development will be necessary. We also need to address any expertise gaps and key personnel needs to ensure the seamless advancement of our research and development, which may require strategic recruitment and partnerships.

Opportunities

Amidst these challenges, substantial opportunities exist in our business plan. The market potential for personalized treatments and pre-symptomatic therapies is vast, especially in areas with a high disease burden. Additionally, the evolving regulatory landscape, including the proposed elevation of the FDA’s Office of Therapeutic Products (OTP)¹⁵, is set to streamline the regulatory approval process for cell and gene therapies, potentially reducing time-to-market, The reauthorization of PDUFA provides a predictable source of funding for the FDA’s drug review process. Collaborating with small- to mid-size pharmaceutical companies and research groups to strengthen our pipeline aligns perfectly with our business strategy, enhancing our capabilities and resources. This approach mirrors the industry trend where biopharmaceutical companies are increasingly focusing on partnerships to fortify their portfolios.

The Inflation Reduction Act (IRA)¹⁶, which the US law passed in August 2022, is expected to bring about significant positive changes. It is likely to lead to higher sales, improved profitability, and substantial shifts in R&D strategies for pharmaceutical companies in 2023 and beyond. Consequently, there is a demand for advanced technologies to effectively tackle these challenges.

Innovative medicine continues to be the primary catalyst for pharmaceutical revenue.

Threats

In implementing our business plan, we must remain vigilant about potential threats. Competition from established therapies, such as Antibody, CAR-T and mRNA treatments, is a challenge as these treatments have already established regulatory approval. At the same time they come with known potential side effects that may influence the market’s perception of immunotherapy. It is essential to maintain a proactive stance by continuously monitoring and adapting to changes in FDA regulations and the competitive landscape, ensuring that our strategies remain nimble and adaptable to the evolving biopharmaceutical industry. This constant analysis and adaptation will ensure our business plan’s resilience and success in a dynamic market.

Financial Analysis

Brake-even analysis:

To perform a breakeven analysis, we need to estimate the following three parameters, fixed costs, variable costs, and the expected revenue per deal, in the case of licensing or co-development agreements).

Fixed Costs:

The estimated annual fixed costs range between $500,000 and $1.5 million. Details are provided in section 6.9 Cost Structure.

Variable Costs:

Estimated annual variable costs range between $10,000 and $100,000. Details are provided in section 6.9 Cost Structure. In addition, variable costs will vary with the number of deals closed, so we need to determine the cost of goods sold (COGS). For here, we assume the variable cost per deal (considering outreach, negotiations, etc.) is $5,000.

To do the break-even analysis, we’ll use the mid-points of these ranges:

Fixed costs = $1 million

Variable costs = $55,000

Revenue:

The revenue streams comprise of two sections: the licensing, and the co-development. Details are provided in section 6.10 Revenue Streams. Licensing deals might have upfront payments, milestones, and royalties, marker-exclusive buyout, while co-development deals might involve shared revenues from the sale of the co-developed product, which takes several years to have the co-developed drug to be approved. For simplicity, we will assume an average revenue of $100,000 per licensing deal.

With this information, the breakeven formula is:

Breakeven (in number of deals) = Fixed Costs / (Revenue per deal - Variable Cost per deal)

Based on the provided data and assumptions, we would need to close approximately 10.53 deals (rounding up, you’d need 11 deals) in a year to break even. This means that after securing 11 deals, every subsequent deal contributes to profit, after accounting for variable costs.

Below is a step-by-step breakdown.

Fixed Costs (FC) = $1,000,000

Variable Cost Per Deal (VC) = $5,000

Revenue Per Deal (R) = $100,000

Contribution Margin Per Deal (CM) = R−VC

CM = $100,000−$5,000 = $95,000

Breakeven Deals (BE) = FC/CM

BE = $1,000,000/$95,000 ≈ 10.53

Therefore, with the aforementioned assumptions, we will need to close 11 deals to achieve breakeven in a year.

Cashflow projections

To provide a more realistic projections of the financials with the fact that we may not be able to close any deals in the first 12 months, the cashflow projection here shows how much capital we will need to raise in other for us to get through the initial R&D phase that will not bring us any revenue.

To conduct the cashflow projections, again, we make several assumptions of the business.

1. Fixed costs are spread evenly throughout the year.
2. Variable costs are incurred at the time of each deal.
3. The revenue per deal (inflow) is $100,000.
4. No other inflows or outflows are considered.
5. The number of deals closed in year 2, 3, 4, and 5, are 2, 4, 8, 10, respectively.
6. The annual fixed costs and the annual variable costs are detailed in section Details are provided in section 6.9 Cost Structure and the in section 6.10 Revenue Streams.

To sustain operations for the full five years, the company should raise approximately $8,098,477. This amount will cover all the anticipated expenses and shortfalls in revenue over the five-year period, ensuring that the company remains operational and solvent throughout this time frame.

Assuming the capital to be raised equals 10% equity, that means initially, we have to create a business with a post-valuation of $80,098,477, which is feasible given our market analysis.

Risk Assessment

Risk Analysis

Multifaceted risks are integral to the pharmaceutical and biotechnology industry, which need to be monitored. One key dimension that we must address is the legislative and regulatory landscape, where adherence to stringent regulations is imperative. Failing to meet these requirements can result in delays in product development, financial penalties, or even the withdrawal of our products from the market. Additionally, safeguarding our intellectual property is paramount, as we must protect against patent infringement, trade secret leaks, and other challenges that may arise in our partnerships.

In the realm of economics and marketing, we must confront fierce competition. Our therapies will be contending with established players such as antibody therapies and mRNA treatments. To ensure our success, we need to be financially astute, as funding and capital risks are ever-present. Research and development, clinical trials, and scaling up production require substantial financial resources. Equally important is pricing and reimbursement, where we must strike the right balance between cost, market acceptance, and competition, while considering whether insurance can offset some of these expenses.

Our commitment to research and development brings its own set of challenges. We must address technological limitations to optimize our products ideally. The safety and effectiveness of our therapies are paramount, requiring rigorous evaluation to mitigate side effects, off-target effects, toxicity, and the potential development of resistance, particularly in cases where cancers mutate surface antigens. The clinical trials we undertake are both a significant investment and a potential risk factor.

On the network and management front, we understand the importance of collaborative partnerships and codevelopment ventures. We also acknowledge that engagement with larger pharmaceutical companies may not always be straightforward, as their interests may not align with ours. Moreover, our business requires a pool of experts and staff with diverse skills, ranging from patents to administration. Ensuring that we have the right talent and expertise is crucial to our business’s success.

Risk Management Plan

Team

The second most prominet reason why early stage start-ups fail is because of a wrong team ¹⁷. We wanted to mitigate this riks by reflecting about or stenghts and weakesses as a team as well as aligning our goals and values.

Business Model

Business Model Canvas

Key Activities

The company’s key activities are research and development (R&D), IP filing, and partnership. R&D is fundamental for developing our in-house expertise in B cell engineering and safety switches technology. Finetuning our technology to be easily adaptable to different antibody sequences will speed up the development of safer B cell therapeutics.

Another important activity is IP filing. To achieve the ability to out-license our technology, one of the critical components is the IP we own. Therefore, we prioritize IP generation as a critical activity. It involves identifying, securing, and managing the intellectual property rights for our innovations, ensuring their protection from potential infringements, and positioning us favorably in the competitive market landscape.

As the field of B cell therapeutics is just emerging, we rely on networking to keep ourselves updated on the current development pace of different therapeutics products before they enter clinical trials. As discussed, in our co-development approach, we will partner with research labs that are in the very early stages of drug development. These labs may not have a weak online or media presence, so developing a network for that is very crucial.

Value Propositions

Customer Segment

There are two ways of creating revenue for our company: Either by out-licensing our IP for the On-/Off-Switch to well-financed larger pharmaceutical companies working on a B Cell therapy to improve safety and efficacy or by co-development of a b cell therapy with an emerging start-up/research lab and share the earnings.

Customer Job

Regardless of the revenue stream, our customers need to fully ensure the safety of their B-cell therapy, especially since B-cell therapy is basically an improved antibody therapy, which can have heavy side effects. Thus, B-cells that still produce the respective antibody once activated aren’t favorable. However, when targeting endogenous structures, B cells still need to be activated because of the lack of activating T-cells. Our customers need a safe and swift way to turn B cells individually on and off.

Pains

The development of a B-cell therapy does cost a vast amount of money and since there aren’t any established and approved B-cell therapies yet, there is a lack of foundational data to back up the risks taken by a company developing B-cells.

Gains

A successful safety measure is worth developing since it can be applied to different B-cell therapies against several diseases because it wouldn’t depend on the antibody/protein itself.

Value Proposition

Product and Services

We are offering the license for our IP regarding a universal On-/Off-Switch. It can be (exclusively) licensed by any larger company developing B-cell therapies to control the chronological progress of the antibody/protein titer.

Alternatively, we offer the co-development of a B-cell therapy with an emerging start-up/research lab that has successfully identified and engineered a target and eventually share the revenue. This way, we would join forces to accelerate B-cell therapy.

Pain Reliever

We relieve our customers’ pain by ensuring a swift and safe way to control the b cells antibody/protein production. Once the license is bought, the technology can be transferred to other B-cell therapies and therefore save vast amounts of R&D costs. Additionally, our technology provides them with a clear advantage over their competitors, due to reduced severe side effects.

Gain Creactors

Since there isn’t an established On-/Off-Switch for B-cells yet, we can provide first-in-class and best-in-class technology for our customers or partners, which saves them time and money and they can focus on their expertise.

Customer Segment

As we have two services, out-licensing, and co-development, we also have two segments of our customers. One key segment that stands out is biopharmaceutical companies, particularly those that are well-funded and have shown a strong interest in B-cell therapy. The size and revenue of these companies play a significant role in our out-licensing deals.

For emerging biopharmaceutical entities, particularly those in the early stages of B-cell therapy development, an outright licensing model might not always be feasible due to financial constraints. This is where our flexibility shines. We can offer co-development opportunities, empowering these smaller entities to leverage our technology without the immediate financial burden of a traditional licensing agreement. It’s a win-win, providing them access to cutting-edge solutions while we can tap into their potential breakthroughs in therapy targets.

Revenue Streams

Our revenue streams result from our product’s two main services: licensing and co-development.

Licensing forms the foundation of our revenue generation, targeting entities with strong financial capabilities, such as prominent pharmaceutical companies and well-funded biotech startups. Our licensing model is versatile, incorporating various pricing strategies tailored to meet our clients’ needs and the market they intend to enter. We ensure a minimum guaranteed revenue and mitigate the risk of not receiving royalties by implementing an upfront payment. Additionally, milestone payments are linked to specific developmental or regulatory achievements, aligning our financial interests with the progress of the licensed technology. As the biopharmaceutical product reaches the market, royalty payments on net trade sales contribute to a continuous revenue stream, reflecting the real-world success of our innovations. The specific terms, including variable pricing based on market dynamics or fixed list prices, are determined through negotiations, considering the exclusivity of the license and the perceived value of our technology in the projected market landscape of 2025.

Co-development, on the other hand, represents a strategic and collaborative approach to revenue generation. We partner with research labs or individual scientists, venturing into the realm of joint innovation. Instead of a traditional transactional model, co-development often leads to forming a new subsidiary focused solely on clinical trials of the co-developed drug. In such scenarios, we typically retain 50% equity in this subsidiary. The financial implications are profound: if the co-developed drug gains regulatory approval and commercial success, we share the revenue generated, reflecting our shared efforts and investments. This model diversifies our revenue streams, as it resembles a traditional pharmaceutical company’s typical long-term financial return.

Excecution Plan

Roadmap

Our business begins with the initial focus on Research and Development (R&D), where we will focus on developing the B-cell Regulatory System and finalizing the data needed for Intellectual Property (IP) filing. This phase, spanning an estimated 12-21 months, commences with an intensive literature review and background research during the initial couple of months. The subsequent months are dedicated to the creative conceptualization and design of the system, followed by prototyping and initial lab testing. The majority of this phase is then devoted to iterative testing and refinement, leading to the final preparations for IP filing. ¹⁸

During this Intellectual Property phase. Here, within a span of 2-3 months, our focus is on preparing the necessary documentation and filing for a patent. While the application process is short, the approval timeframe may extend to 2-3 years or more. Simultaneously, we initiate the process of generating preclinical data. A significant amount of time, approximately 13-25 months, is dedicated to conducting in vitro studies, developing animal models, performing in vivo studies, and ultimately conducting thorough data analysis and generating comprehensive reports. With this data, it will be convincing for us to license our technology to prominent pharmaceutical companies. The next phase, estimated at 5-11 months, involves packaging our data, IP insights, and potential applications, followed by meticulous market research to identify ideal licensees. During this period, we will finalize the type of licensing, royalty, and market exclusions that our out-licensing model will be.

Our exit strategy is to publicly list the company through an Initial Public Offering (IPO) on the Hong Kong Stock Exchange (HKEX) under the Chapter 18A Listing Rule, which is detailed in Section 6.4 IPO on HKEX. Our comprehensive execution plan of the company, from ideation to public listing, spans an estimated 41-76 months or approximately 3.4 to 6.3 years.

Co-development for B Cell Therapy Products

The evolving landscape of biomedicine offers exciting opportunities for collaborative efforts. We recognize the immense potential of research labs with promising antibody¹⁹ sequences that target crucial diseases such as various cancer types, Alzheimer’s, and other neurological or rare diseases. To support these labs, which have made groundbreaking discoveries, we have developed a comprehensive execution plan for co-development.²⁰ Funding constraints often pose challenges for these labs, making the traditional model of out-licensing less feasible due to the costs associated with our advanced B-cell safety switch technology. Therefore, a co-development approach acts as a mutually beneficial solution that allows the financial rewards and risks to be evenly distributed between our company and the research labs.

We will initially focus on identifying potential collaborators that have identified antibody sequences for a promising target of a disease. By reaching out to these entities, articulating the distinct advantages of our B-cell safety switch technology, and highlighting how this collaboration could revolutionize therapeutic outcomes, we aim to establish a robust Partnership Framework with a complete due diligence process. Transparency is important in this kind of partnership. We would clearly set out financial terms, and carve out a joint intellectual property strategy, forming the pillars of this partnership.

In the development phase, we will harness the synergy between our safety switch technology and the partner’s antibody sequence. We will initiate comprehensive preclinical studies on non-human primates (NHP), such as bagel dogs and monkeys, to show the pharmacokinetics and toxicology in these animal models. These data are important for clinical trial submission.

Clinical Trials and IND Submissions to the FDA

An Investigational New Drug (IND) application²¹ to the U.S. Food and Drug Administration (FDA) forms the core of any biotech startup aiming to bring innovative new drugs to patients, conduct tests, and achieve the remarkable feat of establishing a revolutionary cure that has yet to be achieved. A new drug can enter a phase I clinical trial in less than five years, contrary to the common notion. If the patient’s condition is life-threatening and there is no comparable therapy available, an Investigational New Drug submission for treatment can be submitted.

There is also an option for individual patient IND application²², highlighting that the beginning of a clinical trial for immunotherapy or a new drug involves a small number of patients and is conducted on a small scale.

According to industry experts, an IND submission with convincing and compliant data typically receives FDA approval in approximately one month. Subsequently, the drug can be manufactured and delivered to patients. Patient monitoring, on-site visits, and other events in the clinical trial then follow.

To submit an IND filing, a long list of documents is needed.²³

Documents worth highlighting are:

1. Pre-clinical animal data such as pharmacovigilance
2. investigator’s brochure
3. GMP-graded manufacturing documents of the therapy product,
4. Clinical trial management plan such as patient informed consent form, enrollment criteria, site management plan
5. Members of the Institutional Review Board (IRB)

Dose Limiting Toxicity (DLT) The early phase I clinical trial of an IND aims to assess Dose Limiting Toxicity (DLT) in humans.

Typically, there is a predefined enrollment schedule and criteria for the clinical trial plan. This phase of the clinical trial is designed to be a small-scale study that focuses on evaluating the toxicity of the therapy product.

Looking at the bigger picture, once the DLT is determined, subsequent clinical trials will evaluate efficacy and potential side effects. These clinical trials typically involve not only in-vitro data, but also the effects of the drug on animal models such as bagel dogs and certain primate models like monkeys.

21 CFR part 11 compliant

This data management requirement applies to all documents involved in the IND submission, including preclinical data, site management plan, clinical trial management plan, project plan, list of vendors, agreements, meeting records, etc.

IPO on HKEX

For biotech companies, going public through an Initial Public Offering (IPO) can be a compelling exit strategy. Interestingly, this option is often perceived as more accessible compared to the alternative route of mergers and acquisitions (M&A).

Specifically, a company in the biotech industry can pursue an IPO on the Hong Kong Stock Exchange’s Biotech Section under the listing rule of Chapter 18A. Herein lies an intriguing aspect: unlike traditional listings that require profitability or market-ready products with established price points, companies seeking listing on this platform only need to present complete accounting records for two financial years.

This unique feature has piqued interest within the biotech industry because it allows early-stage companies to go public even while their product is still in development and they are operating at a loss. The principal buyers of shares understand these dynamics and believe in the future and potentials of the therapy products and the company.

On one hand, through buying shares in the company, investors support the development of the company as a long-term investment. On the other hand, biotech startups that go public will have access to more capital that are important for them to further develop their products and expand the markets.

Advisors

Alessio Nahmad | Co-Founder Tabby Therapeutics

Alessio Nahmad is a co-founder of Tabby Therapeutics, a seed stage biotech focused on B cell engineering, where he leads research harnessing the platform he co-invented and developed during his PhD. Alessio has a proven track-record in novel gene and cell therapy characterization and applications as highlighted by two first-author Nature Biotechnology publications and by his multiple awards including the ASGCT Excellence in Research Award and ESGCT Early Career Investigator Award.

We met with Alessio Nahmad to discuss the feasibility of our CDMO business idea and the B-cell engineering landscape. He inspired us and generously sharing his experience from founding an early stage biotech start up.

Matthew Scholz | Founder of Immusoft, Board Member

Matthew Scholz is Immusoft’s founder and served as the company’s Chief Executive Officer from 2009 through 2017. After Immusoft, Matthew co-founded Oisín Biotechnologies. He serves as Oisín’s Chief Executive Officer and its oncology-focused spin-out OncoSenX, two biotech firms commercializing a breakthrough platform technology for killing unwanted cells based on their genetics. Matthew Scholz speaks and presents regularly to scientific association and academic audiences. He served for several years as a mentor to recipients of the Thiel Fellowship, a program that awarded grants to some of the world’s brightest scientific minds under age 20.

We met with Matthew Scholz in the early stages of our project to evaluate early stage business models and discuss opportunities in B-cell engineering. It was an honor to meet Matthew and learn from him about biotech and entrepreneurship. He inspired us to solve current drawbacks of b-cell therapy.

Jérôme Lutz | Founder, CEO & Visionary Lead of Smart Lab Architects

Jérôme Lutz is a former iGEM Team member and entrepreneur. He recently founded his newest venture: Smart Lab Architects. We are grateful for his general advice on the iGEM competition and entrepreneurship in the biotech field.

Dr. Christoph Klöckner | Patent Attorney, European Patent Attorney and Representative at the Unified Patent Court (UPC) at df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB

Dr. Christoph Klöckner is admitted as a German and European patent attorney and is mainly active in the patenting of inventions in the fields of biotech, pharma, and life science. His work includes the patent attorney representation of major international companies in Germany and Europe, as well as obtaining worldwide patents for inventions from universities and research institutes in Germany and Europe, such as the EMBL Heidelberg, the Charité Berlin, the Technical University of Munich, and many more. As part of his work for technology transfer departments, he also continues to regularly handle international patent portfolios on behalf of startup and spinoff companies emerging from academic research in Germany and Europe. In addition, he regularly advises scientists at research institutes, European startup companies, and a network of investors interested in such early-stage projects on specialized patenting strategies for startups, spinoffs, and divestments to large pharmaceutical companies.

With the help of our sponsors BioM we had the opportunity to meet with Dr. Christoph Klöcker. With his extensive expertise in the fields of biotech, Pharma und Life Science , he gave us valuable advice on our current project and its potential for IP. After consultation with him, it was clear further development of our current technologies was needed to file a patent in the future.

Dr. Bastian July | CEO of GoodIP

Dr. Bastian July is the CEO of GoodIP, which helps startups protect their innovations. Before Bastian founded GoodIP, he successfully negotiated various multi-million patent license agreements for the lighting company Osram and ran Osram’s patent litigation globally. Bastian is admitted to practice law in Germany and New York.

We met Dr. Bastian July at a networking event of Nucleate Germany. He gave us valuable advice about Intellectual Property in the iGEM Competition as well as funding opportunities for patent filing in Germany.

Full version of business plan

Footnotes

1. “Alzheimer’s drug donanemab helps most when taken at earliest …” 17 Juli. 2023, https://www.nature.com/articles/d41586-023-02321-1. Aufgerufen am 12 Okt.. 2023. ↩

2. “Clinical characteristics and prognosis of Glioblastoma patients with …” 7 Jan.. 2023, https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-022-03047-9. Aufgerufen am 12 Okt.. 2023. ↩

3. “Cancer Recurrence Statistics.” 30 Nov.. 2018, https://www.cancertherapyadvisor.com/home/tools/fact-sheets/cancer-recurrence-statistics/. Aufgerufen am 12 Okt.. 2023.Cancer Recurrence Statistics ↩

4. “V(D)J recombination, somatic hypermutation and class switch …” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7341547/. Aufgerufen am 12 Okt.. 2023. ↩

5. “CAR-T cell therapy: current limitations and potential strategies - Nature.” 6 Apr.. 2021, https://www.nature.com/articles/s41408-021-00459-7. Aufgerufen am 12 Okt.. 2023. ↩

6. “Reversible ON- and OFF-switch chimeric antigen receptors … - NCBI.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8045771/. Aufgerufen am 12 Okt.. 2023. ↩

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