The AFCM iGEM team worked closely with patients, doctors, and industry experts to understand the real gaps in severe asthma care. This has helped PRESS to be a practical, scalable solution that addresses those needs. Moving forward with clear milestones, risk assessments, and financial models, we will ensure that we have a plan to mitigate strong partnerships to guide our therapeutic approach.
In order to prove feasibility, we have already built a bench-scale MVP that shows PRESS can work beyond theory. We also mapped out a pipeline sector that demonstrates a biological asthmatic therapy that is close to our approach. Alongside this, we defined exit strategies such as acquisition, licensing, or creating a biotech spin-off. Thus, giving PRESS a realistic path from lab to market.
Finally, we assessed both the positive and potential negative impacts PRESS could have on patients. Our team has illustrated a PEST model to identify how we may further impact broader sectors. This ensures we develop responsibly by delivering long-term value while setting the stage for sustainable growth.
Asthma is the most common chronic respiratory disease, affecting more than 300 million people worldwide (1). It impacts both children and adults, limiting development,and quality of life. Despite being manageable, asthma is still one of the top causes of preventable deaths, with the WHO estimating 455,000 asthma-related deaths annually (2).
Our patient surveys highlighted this daily struggle: 96% of 120 respondents reported tight, mucus-filled airways leading to wheezing and coughing. Moreover, physicians noted that poor adherence to treatment is one the main challenges to control, with about 70% identifying it as a major complaint. See Integrated Human Practices page for full analysis.
This figure deomonstrates the commonest symptoms amnog patients in our survey.
This figue demonstrates Doctors's views on the major gaps in asthma managment.
Asthma forces lifestyle adjustments—avoiding exercise, losing sleep, and frequent ER visits for severe cases. Over time, these struggles often contribute to depression, anxiety, and fear of sudden attacks (3). In Egypt, 5–10% of children are diagnosed with asthma, though many young adults remain undiagnosed (4). This gap in awareness leaves a significant portion of the population at risk of severe attacks and hospitalization.
Economically, asthma medications represent a major burden. In the U.S. alone, the annual cost exceeds $80 billion (5), while global costs were estimated at $130.3 billion in high income countries (6). On another note, developing countries similar to ours ,where delayed diagnosis and under-treatment are evident, usually drive patients towards emergency care. This alternative is far more expensive and puts a load on already limited healthcare resources. Addressing this gap presents an opportunity to reduce both patient suffering and expended costs.
Different statics that reflect asthma crisis globally
Due to the vigorous increased demand for asthma treatments worldwide. In 2024, the market size for asthma drugs accounted for USD 25.17 billion, and it is expected to exceed around USD 41.04 billion by 2034, growing at a CAGR of 5.01% from 2025 to 2034 (7). This enormous expansion is due to rising incidence of asthma, poor patient adherence to medications, and increased need for personalized treatment. In addition, some types of asthma are often uncontrolled with the current medication options.
This illustration demonstrates the growth of asthma market over the years.
The mean cost per patient with the severe asthmatic is $18,500. We identified 19.8 million severe asthma patients globally, representing a total addressable market (TAM) of $366.3 billion (8).
Moreover, the team focused the market research on the 1.7 million severe asthmatic patients in the USA and on the 14 million patients in Europe due to their regulated data and statistics. This data represented a serviceable addressable market (SAM) of $31.45 billion in the USA and $259 billion in Europe (9,10).
The estimated price for PRESS is $5,000. Given its superior benefits, our product is expected to achieve a market share of 5% within the next 5 years. This reflects the serviceable obtainable market (SOM) of $1.57 billion in the USA and $12.95 billion in Europe.
This illustration summarizes (TAM), (SAM), (SOM) for USA and The UK regarding asthma.
We arranged several visits and meetings to figure out the gap of the unmet needs for both patients and the doctors. For more details, you can take a look at our Integrated Human Practices page.
This figure highlights the major gaps of unmet needs for both patients and the doctors
First of all, asthma treatment doses differ according to the grade and severity, but generally, an asthmatic patient requires an average of 2-4 puffs of SABA daily for acute attacks and an average of two puffs of inhaled corticosteroids daily for persistent asthma (11). This puts patients under great pressure to be adherent to these frequent medications, which creates the greatest gap in controlling asthma.
Moreover, all subtypes of asthma are controlled with current medications except neutrophilic asthma. As it involves different inflammatory pathways, which make it resistant to the inhaled corticosteroids (12). It is known that neutrophilic asthma is one of the main subtypes associated with asthma-related death.
Current asthma management leaves the patients with a number of side effects including tachycardia, tremor, hypokalemia, anxiety ,oral thrush, voice hoarseness, infections, and weight gain. Additionally, the inability of current medications to prevent exacerbations in some asthma subtypes, especially severe and uncontrolled asthma, remains a major issue. This is reflected by the high rate of asthma exacerbation and hospitalization. (13)
Consequently, this leads us to the next point, which is the poor control of severe asthma. Severe asthma remains poorly controlled in a subset of patients, particularly those with eosinophilic asthma, neutrophilic asthma, and non-allergic asthma. (14)
Finally, We've noticed the lack of personalized medication in the market. Asthma is a heterogenous disease with various causes and is affected by genetic and environmental factors. This creates different personal patients' responses to the current medications. Although biologic therapies have shown promise, their use is often restricted to specific asthma phenotypes and has immune-related side effects, leaving others untreated or undertreated. (15)
To better understand the magnitude of asthma and uncover the unmet needs in its management, we conducted two targeted surveys, one for patients and another for doctors. These surveys provided valuable insights into patients’ daily struggles and physicians’ perspectives on current treatment limitations. In addition, these surveys helped guiding the development of PRESS.
Developing PRESS required us to carefully map out all the stakeholders who could influence its journey from idea to market. At the center are patients with asthma, whose struggles and feedback guided our design and focus on safety and usability. We also worked closely with healthcare providers including pulmonologists and allergists. They shaped how PRESS could fit into real treatment protocols.
On the market side, we engaged with pharmaceutical and biotech companies for their expertise, technology, and potential role in co-development and manufacturing. Insurance providers were another key focus, since coverage will determine how accessible PRESS can be given its cost as a synthetic biology-based therapy.
We also explored regulatory pathways, learning from experts about the steps and barriers PRESS must overcome through for approval and long-term evaluation. Lastly was our own team ,the driving force that carryied PRESS from proof-of-concept through preclinical planning toward eventual clinical use.
This table distribute our relevant stake holders based on their power and impact over our approach.
Our journey to identify our targeted customers started with customer discovery evidence throughout our visits and meetings. This is shown on the Integrated Human Practices page.
Our team targeted major drug manufacturing companies since they have the resources needed to bring PRESS from lab to market. These companies have a wide distribution network that will enhance our product availability and accessibility. Additionally, they have a fully experienced team that will guide us throughout our developmental stages. Moreover, they will help regulate heavy authority applications, especially with the FDA and EMA, which are considered as one of the main milestones in our development plan.
Hence, to ensure a successful journey, we chose to collaborate with the following companies.
Leading pharmaceutical innovation
AstraZeneca's groundbreaking work with Tezepelumab (Tezspire) has validated the TSLP pathway as a critical target for severe asthma. For this reason, we have chosen to partner with a respected global brand like AstraZeneca, which will ensure significant credibility for PRESS, allowing easier acceptance from healthcare providers and patients. (16).
Strategic collaboration for TSLP-targeted therapy development and market validation.
Hard capsule drug delivery technology
Lefancaps is a pharmaceutical provider of Hard Capsule drug delivery technology. They provide high-quality and specialized capsules for our platform.
Specialized capsules that store dried bacteria and ensure long-term storage stability.
We chose these companies due to their ability to fund our approach and their possession of the necessary knowledge needed to bring PRESS from lab to market. They also have a wide distribution network that will enhance our product availability and accessibility. Additionally, these companies have profound experts that will provide us with experience, guiding our timeline plan and milestones throught our development process.
Health insurance companies like AXA are increasingly moving beyond their traditional role as a simple payer of medical bills. They are becoming active "health partners" that aim to improve patient outcomes, reduce overall costs, and manage chronic conditions more effectively. A partnership with a major insurance provider like AXAcould ensure reduced hospitalizations and ER costs for our product users. (20)
We have used Top Certifier's senior consultants to guide us through our regulations. Additionally, they could help in filing FDA applications in our later stages. (21)
We have designed PRESS to meet the asthmatic patients’ demands. As it relieves the issue of asthma exacerbations, improves lung functions, and eliminates the undesired side effects of other drugs. In the following we highlighted the asthmatic patient journey, starting from their chief complaint to the post-traumatic consequences.
This figure demonstrates an asthmatic's patients journey, reflecting their suffering in every stage.
The chief complaint for the severe asthmatic patient varies according to different parameters (type of asthma, onset, severity, and patient's age).
Mild and moderate asthmatic patients experience many symptoms, such as cough, wheeze, shortness of breath, chest tightness, and insomnia, which limit their activities of daily life. Whilst there are more severe cases that experience continious shortness of breath, cyanosis and tachycardia. (22)
They usually start by asking their relatives or consulting a family doctor about what their symptoms signify.
Afterwards, heading to a primary physician, then to a pulmonologist, passing through all procedures, history taking, physical examinations and diagnostic tests, allergy tests, and chest x-rays. This phase is one of the most exhausting phases during the patient journey.
Asthma management protocols are divided into two main categories: lifestyle modification and medical treatment.
It’s better for the asthmatic patient to start with lifestyle modifications through avoidance of triggers, maintaining a healthy weight, stress management, a healthy diet, and breathing exercises.
Medical treatment depends on the severity of the case. Asthmatic patients’ severity relies heavily on the frequency of attacks. Starting with the intermittent cases: SABA “albuterol” 90 mg/puff (2-4 puffs).
Moving to the persistent cases, there are three grades: mild, moderate, and severe. For the MILD cases, the patients require low-dose inhaled corticosteroids or a leukotriene receptor antagonist (10 mg adult, 5 mg child).
On the other hand, MODERATE cases need low-dose inhaled corticosteroids + formoterol inhalers (LABA).
Finally, with the SEVERE cases, they require inhaled corticosteroids + LABA + LAMA.
Generally, asthmatic patients show improvement on 2-4 weeks of ICS (inhaled corticosteroids), according to the severity of the case. (23)
Asthma not only affects a patient's physical health, but it also affects his mental, social, and psychological well-being. As for the physical consequences ICS may cause oral thrush , poor physical activity, potentiality of remission, proneness to infection, and osteoporosis. Moving on to the psychological effects, asthma drastically reduce patient self-esteem and causes anxiety, depression, and fear of social engagement.
PRESS uses a genetically modified Lactobacillus plantarum strain that produces a specific siRNA (small interfering RNA) that is carried by CO-BERA, the RNA scaffold
The CO-BERA scaffold is designed to carry two siRNA molecules that target an upstream inflammatory cytokine. This siRNA specifically suppresses thymic stromal lymphopoietin (TSLP), a key inflammatory cytokine in the lungs that mediates asthma exacerbation.
This modified bacteria will be loaded inside specific capsules to be used within our therapeutic approach, serving as an optimal therapeutic option for severe asthmatic patients. Further details are mentioned on the Project Description page.
This figure illustrates the overall idea of our therapeutic approach
PRESS is a novel therapeutic approach designed specifically to tackle asthma inflammation pathways.The scientific base of PRESS rests on four main pillars: Lactobacillus plantarum bacteria, Thymic Stromal Lymphopoietin (TSLP) as a therapeutic target, a CO-BERA (Co-Bioengineered RNA Agent) loaded with siRNA, and a H₂O₂-Responsive Gene Regulation System. These pillars are discussed below.
This figure represents our projects four main pillars
: Lactobacillus species have proved to have an immunomodulatory role in various respiratory diseases. Several studies on both animal models and clinical trials have explored the efficacy of administering specific Lactobacillus strains in relieving symptoms of different respiratory diseases such as lung cancer, asthma, respiratory tract infection, and cystic fibrosis. Its therapeutic and immunomodulatory role efficacy is affected by many factors, including time of administration, bacterial dosage, and the host's background (24).
TSLP is a key regulatory cytokine in the asthma inflammation pathway. TSLP is produced mainly by epithelial cells in response to multiple stimuli, including allergens, viral infection, and pollutants or other signals of tissue damage. It activates dendritic cells, which subsequently guide T helper cells to differentiate into Th2 cells. These Th2 cells then produce various cytokines that are central to asthma-related inflammation. Additionally, TSLP exerts direct or indirect influence on other immune cells involved in the asthma inflammation cascade, such as innate lymphoid cells (ILCs), mast cells, basophils, and eosinophils. Furthermore, chronic TSLP activity contributes to airway remodeling, characterized by thickening of the airway wall and increased smooth muscle mass. (25)
Hydrogen peroxide (H₂O₂) is acknowledged as a key biomarker for oxidative stress in asthma [1]. During an asthma exacerbation, pro-inflammatory signals, including reactive oxygen species (ROS), trigger the activation of the pKatA promoter, which is sensitive to H₂O₂ [2]. This promoter, in turn, is tightly regulated by the LacR repressor, expressed under the control of the p170-CP25 hybrid promoter in acidic conditions (pH 5.5–6.5) [3]. In our system, elevated H₂O₂ levels (10–100 µM) in inflamed, acidic microenvironments, such as those found in asthmatic airways [4], activate a genetic circuit designed to selectively induce the expression of co-BERA. (26 , 27 , 28)
CO-BERA is an engineered version of BERA (Bioengineered RNA Agent) that functions as a vehicle that carries two antisense sequences. In other words, it is an advanced RNA construct designed to deliver two distinct siRNAs (small interfering RNAs) to knock down the expression of the TSLP sequence. Studies have demonstrated that CO-BERA can increase the percentage of released siRNA from a baseline of approximately 5% to as high as 30%.(29 , 30)
Tezepelumab (Tezspire) is a new biologic drug that is expected to inhibit thymic stromal lymphopoietin (TSLP) in severe asthma patients. It is a monoclonal antibody that will bind to TSLP, preventing its interaction with various immune cells. This subsequently reduces asthma inflammation cytokines secreted in the asthma inflammation cascade. This inhibition provides relief from airway inflammation, hyperresponsiveness, reduces asthma exacerbations,and ultimately improving lung function. (31)
This product is co-developed by Amgen and AstraZeneca; tezepelumab has been commercially available under the brand name Tezspire. It has been shown in several studies to symbolize its clinical advantage and substantial contribution toward reducing the rate of asthma exacerbation.Additionally, It has proven to enhance the control of asthma and improve lung function. However, the initial FDA approval did not distinctly include an oral corticosteroid (OCS)-sparing label. This implied theoretically the continuation of long-term oral corticosteroid side effects in patients. (32,33)
On the other hand, Tezspire has several drawbacks. Firstly, as with any biological drug, its price is very exorbitant which adds a barrier to its access. Secondly, its administration route is subcutaneous injection every four weeks. This can be a barrier for most patients who prefer oral medication. Thirdly, there is a possibility of patients developing anti-drug antibodies.
Tezspire is also in the post-marketing phase at the moment, with marketing approval having been obtained in the USA and European regions in 2021 and 2022, respectively. During this time, our therapeutic approach will be evaluated on its long-term safety, effectiveness, and real-world effectiveness. The monitoring also aims to identify unusual side effects and, potentially, identifying new uses or patient populations. (33 , 34 , 35)
PRESS is envisioned to follow the standard regulatory pathway for new drug development. Thus, we met with Dr. Wagida, one of our college's ethical committee. She provided valuable guidance in identifying the requisite regulatory steps and understanding their associated challenges. In addition, Dr. Wagida assisted us in structuring our approach and developing a comprehensive regulatory plan projected for the next 12 years. (For further details regarding this meeting, For more details, you can refer to the Integrated Human Practices page.
This illustrates or stepwise apprach to develop
We aimed to design PRESS to be able to control all asthma subtypes, especially severe asthma. This will be done through effective knocking down of TSLP genes, depending on a novel technology approach. Further details are discussed on the Project Description page.
First and foremost, our team expects that PRESS will provide long-term remission for its patient with merely 1 to 2 puffs per year. Thereby, saving patients from the adherence issues that are considered as one of the main challenges in asthma management. Secondly, PRESS will be able to relieve patients from competitors' severe side effects. Lastly, our therapy targets controlling neutrophilic asthma and other subtypes of asthma that are known to be resistant to current medications. These prepositions reflect the superiority of PRESS over the current competitors.
In order to protect our ideas and our novelty, we have reached out to Mr. Rejeesh, who has helped us plan four key stages that should secure a patent for our innovation. Maintaining these rights will ensure our exclusivity and protection of our therapeutic approach.
Further details are discussed in the Integrated Human Practices page.
This figure outlines our plans for obtaining IP Protection.
It is a critical first step to prevent public disclosure of our invention before filing a patent application. As we regularly organize meetings with medical doctors and specialists, such a novel idea is at risk for potential leaks. Any party that was even slightly involved in our project was asked to sign NDAs (Non-Disclosure Agreements) in order to protect the confidentiality of our project and ensure that sensitive information remains exclusive to our team.
In order to correctly patent this project, our team had to conduct a deep search of the existing patents to prove the novelty and uniqueness of our product. For PRESS, we started by identifying our invention clearly. This identification process included knowing the specific strain of Lactobacillus used, its modification method, and the specific delivery method.
Next, we researched patent databases. After extensive research, we particularly chose WIPO’s PATENTSCOPE as it was tailored exactly for our requirements. In addition, it has a high global reach with at least 60 patent collections. (36)
Following the search, we had to apply for our patent through the World Intellectual Property Organization(WIPO). We chose to do a a provisional patent application to establish an early date that safeguards our intellectual property and fosters a safe atmosphere with our external advisors. Following that, we prepared a detailed invention disclosure where we described PRESS as “a novel therapeutic approach for curing asthma through inhalation of Lactobacillus targeting TSLP in the human lungs.”
Finally, after the filing, we will receive a filing receipt with an application number and date, which will help us track our application and respond to any requirements.
The following document demonstrates our provisional filing for patent application.
After our team is officially granted, we would be eligible to apply for PCT (Patent Cooperation Treaty), which is a formal international application that would later streamline our process of applying at an international level. Fortunately, our WIPO PCT application will cover over 157 countries that we may proceed with. Besides, the application will provide us with about thirty one months before we enter the “National Phase”.
In this way, our team is granted market access and competition with complete security and confidentiality. This approach will help us enter the market by facilitating further licensing, strategic investment, and funding.
PRESS is a new step forward in medicine; its uses go far beyond asthma. It could help with other lung problems, whether it's inflammatory or infectious. One clear example is COPD (Chronic Obstructive Pulmonary Disease). PRESS may slow the disease or even fix some of the damage by sending siRNAs directly into the lungs. It might also support patients with cystic fibrosis by breaking down mucus or targeting the factors that trigger it (37).
Our idea is not exclusive to the lungs. PRESS could be tuned for gut diseases like IBD (Inflammatory Bowel Disease). By adjusting probiotics, it may deliver protective agents such as anti-TNF nanobodies or IL-10 inside the intestine, thus curing inflammation. Our therapy could also guide the release of useful metabolites and prebiotics through microbiome control (38). Another option is cancer therapy, where modified Lactobacillus can act like a smart carrier. The modified bacteria can travel through the body and deliver tumor-suppressing proteins directly to cancer cells, which may improve tumor cell targeting and reduce side effects compared to traditional treatments (39).
PRESS could even work as an inhaled vaccine. Opposed to an injection, antigens could be loaded into Lactobacilli and inhaled to boost immunity against infections such as COVID-19 and other respiratory illnesses (40).
All these ideas convey PRESS's potential flexibility & scalability. Using the right development methods, PRESS could become a tool used not just for treatment, but even for prevention.
Fig(12):
This illustration explains the provisional applications for our approach
PRESS will go through several key stages, including proof of concept, preclinical testing, clinical trials (I, IIa, IIb, and III),market approach, and commercialization. This will help us ensure our product viability with respect to the criteria we have in mind. This is clearly shown in the following diagram.
This figure outlines our manufacturing stages to scale PRESS
Through Pulmoevent, our team gained deeper insights into the scale of the asthma crisis and discussed ideas with chest disease and allergy specialists. At Abbasya Chest Hospital, we engaged directly with patients. This allowed us to explore unmet needs, understand treatment protocols, and address common misconceptions. These discussions, which are more detailed on the Integrated Human Practices page, guided our human-centered design. .
In order to proceed our wet lab research forward, we are working with the Egypt Center for Research and Regenerative Medicine (ECCRM). Their support gives us access to BSL-2 laboratories and clinical research expertise, both of which are essential for safely handling our Lactobacillus plantarum strain (41). We have also partnered with Eva Pharma, who would provide us an artificial lung model that enables us to test efficacy and fine-tune the dosing of PRESS.
As for our in-vivo trials, we will be using mice, as they reflect key features of asthma: high serum immunoglobulin E (IgE) and airway inflammation. These trials will help us confirm our core hypotheses while assessing delivery, stability, and distribution of the engineered bacteria when delivered by a Dry Powder Inhaler (DPI).
In early phases, we will collaborate with Lefancaps research labs for the development of specialized capsules compatible with our platform. In addition, AFCM iGEM’s advanced laboratories and expertise will support us in conducting early-stage clinical studies. Their facilities, combined with our academic partnerships, will ensure a smooth transition from lab to clinic.
For later stages, AstraZeneca will serve as a strategic partner. Their facilities comply with GMO regulations and are fully licensed for advanced clinical trials. More importantly, AstraZeneca will provide respiratory disease experts to lead site trials, collect outcome data, and validate efficacy as well as safety. Their production infrastructure, financial resources, and established experience in drug development make them an ideal collaborator for scaling PRESS into a market-ready product
At the bench scale, our MVP shows that PRESS is more than a concept. We engineered Lactobacillus plantarum with the conditioned expression of siRNA targeting TSLP in response to a specific inflammatory biomarker. Then, we evaluated its activity in in-vitro trials through co-culturing of the engineered Lactobacillus plantarum with human cell lines. The results confirmed that our strain can survive the formulation process,express the intended therapeutic elements, and remain compatible with capsule delivery systems.
To ensure PRESS can move from concept to real-world application, we designed a step-by-step production plan. Starting with small-scale validation, moving through pilot-scale development, and ultimately reaching full-scale manufacturing, each stage is tailored to secure efficiency, safety, and scalability of our therapeutic capsules.
Our production upscaling plan starts with a small-scale setup that helps validate critical processes. This plan includes Lactobacillus plantarum strain selection and preparation, optimization of bacterial growth conditions through formulation conditions in 1-5 L bioreactors, and initial testing of application techniques like dry freezing our modified bacteria before inserting it inside the capsule.
The pilot-scale phase will further extend the process scalability and protocol development using 10-50 L bioreactors. Thus, we chose our skilled biotech partners who have experience with regulatory issues, Lefancaps, to conduct a larger scale of production.
Full production will be transferred to large-sized bioreactors (>200 L).This requires adjusting the process parameters for optimal performance, which includes feed rates, oxygen levels, and nutrient media. Subsequently, we planned to utilize AstraZeneca's full-scale production.This would help us by transitioning from prototyping to pilot manufacturing so we can eventually detect our capsule reliability.
As PRESS gets closer to showing real clinical benefit, our plan for growth is becoming more concrete. We don’t will to cease asthma prevelance alone. PRESS can be adjusted to help with other lung and inflammatory diseases, giving it a wider medical role. At the same time, scaling PRESS will need partnerships abroad.That is why working with international health systems and pharmaceutical companies is a key step. By broadening the medical use and reaching new markets, PRESS moves from being just one therapeutic idea to becoming the start of a long-term pipeline.
To discover how the public may perceive our therapeutic approach, we conducted two surveys: one for patients and one for doctors. Through these surveys, we explored how patients feel about using a biological inhaler and how doctors perceive prescribing it. Their feedback gave us a clearer picture of both the hopes and concerns surrounding innovative therapies like PRESS, helping us shape a solution that truly responds to real needs.
With Ali Salah’s extensive laboratory experience, he outlined the wet lab plan and the ideal protocol for each step. Ali also participated in numerous team meetings to discuss PRESS development.
Ahmed actively explored strategic collaboration opportunities to support team growth and impact. Also contributing to the Human Practices Team by organizing community engagement events and initiatives aligned with the project's mission.
Mostafa is an expert in mathematical modeling and plays a key role in the dry lab. He applies advanced computational tools to simulate laboratory experiments and support the project’s design and validation.”
Ahmed has played a significant role in the development of the PRESS initiative by leading the design and validation of the genetic circuits and advance our therapeutic platform
Mostafa is also highly skilled in media production and graphic design. He contributed to creating and applying the visual illustrations featured throughout our wiki.”
Youssef excels in engaging with diverse stakeholders to gather insights and feedback, ensuring our project aligns with societal needs and ethical considerations.
Amr Strengthened the team with his programming expertise by building reliable, clean solutions and jumping in to debug complex issues fast. He has also set up and maintained our team wiki, organizing docs and guides so everyone can find what they need quickly
With his knowledge in molecular dynamics and mathematical modeling, Saher has provided critical computational validation for the team's research initiatives, ensuring PRESS's ideas are scientifically robust and methodologically sound.
By combining mathematical insight with computational tools, Galal contributed to the simulation and validation of key synthetic biological structures.
With his communication skills he has helped the team with meeting up with relevant stakeholders. Karim has put in his efforts for the development of key points regarding entrepreneurial spirit of PRESS
Mohanad's exceptional communication and presentation skills helped us excel throught our develeopment and social outreach. His good coordination among team members has made a suitable environment for productivity.
Mohamed Ehab excels in educational development skills, bringing innovative presentation methods and creative tools to our journey. His contributions added unique value to the way we shaped and presented our project
Mohammad is skilled in media and graphic design, bringing a creative and distinctive style to his work. His innovative approach has enriched the project visuals with fresh and original perspectives
Ahmed conducts a comprehensive literature review and data collection. I specialize in searching databases and scientific papers to identify the most effective biological components and validate our design choices through existing experimental evidence.
Mohamed contributed to handling wet lab protocol, such as plasmid design and bacterial transformations, to support the development of our project
Mazen excelled in dry lab modeling, optimizing press therapy dosing through mathematical and statistical analyses while developing scalable manufacturing models. Mazen also led impactful outreach through his educational sessions at factories and agricultural institutions, promoting asthma awareness and sustainable green land initiatives.
Omar is responsible for preparing the laboratory protocols that guide our experimental work. He is deeply engaged with lab techniques and always keeps up with the latest updates in laboratory practices
Mahmoud effectively managed safety protocols and security procedures throughout the project. He contributed to developing a novel inhaler design and created the first edition of a breakthrough SynBio analysis tool. His work in scientific analysis and safety management significantly improved PRESS development and implementation.
Hazem is responsible for the marketing and entrepreneurship aspects of the project, driving its outreach and business vision. He is known for his exceptional skills and versatility, which adds great value to the team
Shazly has a strong passion for mathematical modeling and enjoys exploring its applications within our project. He is always eager to expand his knowledge and push the boundaries of what modeling can achieve.
Our approach will have to go through several phases in development. For starters we had to validate our ideas by making a proof of concept for our design. Then, we carried out in vitro studies by collaborating with experts to guide us through our protocols. Following that, we will gather all the data needed, and proceed to an in vivo study, which involves testing the product on an animal model to evaluate its safety and efficacy. Subsequently, we will conduct clinical trials that require FDA and IND approval, while carefully recruiting participants. In addition, our team must adhere to regulatory guidelines. Finally, our product will be released into the market. This would require us to evaluate its real-world performance after its distribution and market expansion. This timeline represents our optimistic estimates, however, actual biotech development may take longer depending on regulatory and funding burdens.
(All financial cost projections, and budgetary considerations are outlined separately in the Financial Analysis section.)
This illustration demonstrates the timeline with our projected milestones in the following years.
Milestone 1: Proof of Concept
At the start of our project, we identified asthma patients’ unmet needs through medical training and our visit to Abbasya Chest Hospital. As we aimed to demonstrate the viability of our hypothesis before going through our full development. .
In our initial stages, we anticipated challenges such as limited patient feedback due to low disease awareness and potential bias in healthcare providers’ opinions. These risks could narrow the integrity of the validation we receive.
Hence, we participated in the Pulmo Event (mentioned in our Integrated HP page), which expanded our stakeholder network and provided access to clinical and scientific expertise. During PulmoEvent, we met Dr. Ahmed Beshir, who played a key role in validating our initial concept. He introduced us to TSLP inflammatory markers as potential targets for our therapeutic approach, refining and strengthening our therapeutic approach. (43)
Milestone 2: Early In Vitro Studies
In this phase, we tested our hypothesis and observed the efficacy of our modified bacteria. With the help of ECRRM specialized labs, our team conducted an initial evaluation of the effects of our modified Lactobacillus on bronchial epithelial cells. This evaluation was conducted by collaborating with experts who will later guide us throughout our wet lab work. In order to effectively complete the in vitro stage, our team secured access to well-equipped labs and tools required for specialized protocols. Lastly, we needed specialized microbial media such as MRS agar for handling our modified bacteria.
Of course there is a chance of having data instability of the therapeutic strain due to the inherent limitations of simplified in vitro models, resulting in lack of prediction of clinical efficacy. Therefore, we will work under biosafety level 2 (BSL-2) conditions, which are required for our modified Lactobacillus plantarum. Additionally, we worked with lab experts like Dr. Atef, Dr. Raghda, and Dr. Hazman. These experts gave us their expertise by collaborating with us on conducting our wet lab trials to accurately interpret our data. Their contribution are also found on theIntegrated HP page .
Milestone 3: In-Vivo Studies
At this stage, it is crucial to translate findings into real-world applications. We will start selecting the appropriate animal in an animal care facility that is compliant with ethical guidelines.
However, there are multiple possible gaps that are involved in this stage. These gaps are mainly health and safety risks, data interpretation inaccuracies, and ethical concerns linked with animal testing.
To acheive such milestone we prepared a meeting with Dr. Wagidaa Anwar, the head of the IRB committee at our own college. Dr. Wagida will be able to give us her insights about the ethical framework and the essential practices for using animals in clinical trials. Moreover, she will guide us to obtain approval from the Institutional Animal Care and Use Committee (IACUC), an ethical review board specializing in animal research.
Milestone 4: IND/CTA Submission
Prior to our clinical trial phase, we firstly had to submit a Clinical Trial Application (CTA). During this step, we had to prove preclinical data, which includes the blueprint for our protocol, in order to conduct the trial using information on study design, safety, dosing, and interventions.
Secondly, we had to conduct CMC (chemistry, manufacturing, and controls) initial evaluation data. This data is crucial for the development of PRESS, as it will ensure a GMP (good manufacturing practice). Lastly, the toxicity potential is used in order to compile the results demonstrating the safety margin of our therapeutic approach.
Therefore, we had to seek the opinion of Mr. Rajeesh, a consultant who specializes on FDA Policies. Mr. Rejeesh gave us his opinion and advice on laboratory regularities and guidelines that we have to go through. His meeting is thoroughly explained inthe Integrated HP page.
Milestone 5: Clinical Trials
AFCM iGEM plans to conduct regular safety assessments and make adjustments to protocols for monitoring safety. The team will also establish a data safety monitoring board to oversee patient safety and ensure the integrity of the trial. Additionally, we will implement a variety of recruitment strategies to engage severe asthmatic patients and healthcare experts.
This stage involves numerous risks. For starters, there is the difficulty in recruiting a sufficient number of eligible patients for our trials. Then, there is the potential for unexpected adverse reactions or complications arising from the trials. Lastly, delays in approval or the addition of regulatory requirements can result in further setbacks in our progress.
To counteract these setbacks, we will partner with powerful pharmaceutical companies as Lefancaps and AstraZeneca.These companies would provide us with researchers who will aid in conducting clinical surveys and interpret the effects of.These trained personnel ensure strict adherence to protocols.
Fortunately, we have had a chance to meet with Mr. Abdelsabour from EIPICO Pharmaceuticals, who highlighted the best way to utilize our dry powder bacteria inside a specialized capsule.In order mitigate our approach, we will outline strong participant recruitment strategies ,in addition to our partnership with local hospitals. These hospitals would act as our backup if we fail to maintain our initial partnerships. (44)
Finally, our team set up a meeting with a representative from the Egyptian Drug Authority. Mr. Yahia Badawy ,who is also an Egyptian legal counsel, helped us outline regulatory guidelines to obtain drug licenses that include the development of our drug’s timeline and implementation plan.
Milestone 6: FDA/NDA Submission
For this phase, we will have to compile all of our preclinical data and clinical trial results to file for our FDA application. In order to correctly complete the application processes, we've reached out to consultants who have extensive expertise in FDA and NDA regulations. Additionally, we will have to set out a budget to cover the application costs and additional expenses that the FDA may request.
However, this phase carries certain risks. We have to make sure that the data on safety and efficacy is sufficient. The AFCM iGEM team plans to conduct a detailed review of all clinical data to ensure full alignment with FDA standards. We will also maintain open communication with FDA representatives throughout the submission process in order to make sure we are on the right track. Lastly, we will implement a quality assurance strategy to evaluate all of our data and documentation to meet the FDA’s rigorous requirements. .
Milestone 7: Commercialization and Market Expansion
A successful market approach and guarantee our product quality requires that we hire a trained staff to collect and report adverse events that could be caused by PRESS. Our team will have to evaluate long-term safety and efficacy, which will help us build rapport and trust. Additionally, we have to foresee funding and collaboration resources to support our lab infrastructure, general team costs, manufacturing scalability.
Our team may also have issues with delayed identification of safety risks and hazardous events that could occur through the manufacturing process. This is due to the result of limited resources for conducting post-market studies and difficulty in determining whether the adverse events are truly caused by PRESS or other factors. Incomplete or inaccurate data collection may hinder the integrity of our product.
Therefore, the team aims to maintain an open channel with healthcare providers and patients to encourage reporting of side effects. Also, the team aims to provide an easy-to-use reporting mechanism and data analysis experts to assess different case controls and observation of external and internal factors that could potentially harm PRESS.
Moreover, we planned to collaborate with the FinTech Innovation Fund to be our main partner. This company possesses the financial resources and necessary knowledge to produce and distribute PRESS to the market. (45)
Finally, we had a meeting with Mr. Yehia Houry, CEO of Flat6Labs. This meeting resulted in another partnership that would later result in applying our marketing plan professionally. This ensures extensive expansion for our novel therapeutic approach and reaching our potential customers. (46)
This financial analysis provides a comprehensive forecast of the development costs, scaled production expenses, revenue potential, and profitability of PRESS. The product is designed for annual dosing (1–2 capsules per patient per year), allowing competitive pricing for patients that are managed poorly with standard severe asthma therapies. The analysis covers estimated costs for preclinical studies, clinical trials, manufacturing, marketing, and commercialization, alongside sensitivity tests for pricing and adoption. The goal of this financial model is to demonstrate the economic feasibility, profitability, and long-term sustainability of PRESS for stakeholders and potential investors. (50,51,52)
After we set our aims on this year's project idea, it was crucial to analyze the stakeholders with relevancy to our approach. They may have a direct impact on us by guiding the project's direction and ensuring its success.
Stakeholders can serve us at different areas of PRESS. Moreover, every stakeholder is mutually impacted differently by our project. For these reasons, we had to classify them into different groups at each step we took to reach our goal.
At Abbasya Chest Hospital, we sat down with Dr. Sameh Ahmed, consultant of pulmonology and allergies. We shared our idea for PRESS, and he raised honest concerns about its use, safety, and long-term value. That conversation helped us see where the current treatments fall short and what patients might still be missing. His feedback gave us a clear path to focus on as we progressed to the next stage.
Dr. Mohamed Anany is the Chief of the Chest Department at Zagazig Hospital, a highly experienced chest and respiratory disease specialist. Due to his vast experience, Dr. Mohamed pointed out our strengths and weaknesses. He also helped us in exploring asthmatic patients' major concerns.
Chronic asthma patients are the end-users for PRESS. They have direct influence on our project; similarly, their feedback and concerns are the essential tools that shape our therapeutic approach. In every single step we took further into our project, patient's safety and well-being were always our absolute priority.
At the Abbassia Hospital, we got the opportunity to have a talk with asthma patients and know their life struggles with the disease; along with that, we got to address some of their misconceptions regarding their inhaler use.
During our meeting with Dr. Mohamed El-Hussainy—Associate Professor, City of Hope, CA, USA / Professor, Zagazig University, Egypt—he gave us information on outlining experiments required to generate the necessary data to validate our therapeutic approach. His valuable additions helped us discover the conflict between ASO needs and our initial formulation that we had in mind. With his advice, we were compelled to search for other alternatives to target TSLP.
In order to optimize our powder and ensure its maximum efficacy during our preclinical trials. We turned to Dr. Ahmed Atef, CEO of the Egyptian Genetic Engineering Society. He provided us with valuable practical support in plasmid purification, transformation, and DNA assembly methods. Therefore, enhancing our wet lab work accuracy and efficiency.
Throughout our work with research institutions for laboratory space, we got the chance to collaborate with the Egypt Centre for Research and Regenerative Medicine (ECRRM) to conduct a larger scale of production in our preclinical stages. Additionally, they explained the protocols for utilizing Lactobacillus plantarum in the laboratory and clarified the ethical commitments and standards.
Dr. Mohamed Hazman is a brilliant mind at Nile University. Dr. Hazman brings his expertise as he is an associate professor at the Genetic Engineering Research Institute (AGERI). He was a great addition as he helped us settle on L. plantarum as a suitable bacteria for delivery within our platform.
Dr. Raghda is an expert in molecular biology and bioinformatics. She is well known for her expertise in both wet lab experimentation and dry lab validation. Hence, she provided us with enough additional information to initiate our dry lab validation process and tips on minimizing the risk of off-target effects related to PRESS.
In order to ensure our project aligns perfectly with the ethical and legal standards, we've contacted Dr. Wagida Anwar. This step was crucial, not only to reduce the potential risks but also to help build trust with customers. Dr. Wagida has emphasized regulatory compliance, a key target for any business to build its rapport.
The authority sector plays a key role in how our project can move forward. In order to better understand the legal side, we met with Yahia Badawy, a legal counsel at AXA Health Insurance. He walked us through the Egyptian laws and regulations that apply to drug development and how they affect our work.
Mr. Yahia also guided us on how to make sure our product meets safety and quality standards for public health. Together, we discussed whether our project could be patented and whether it fits the criteria for EDA drug approval. For more details about this meeting, you can check our Integrated HP page.
FDA certification is an important step in protecting public health in Egypt. To learn more, we spoke with Mr. Rejeesh, a senior consultant at TopCertifier, a company that assists with FDA approvals in Egypt. He explained why this accreditation matters and reminded us that our company must fully follow federal standards. He also broke down the expected costs and the key conditions we need to meet before receiving the "Safe and Effective" approval. At the end of our conversation, he suggested a long-term plan, while showing us what biotech startups should prepare for as they grow.
During our visit to the World Asthma Day Event, mentioned in our Integrated HP page, we had a chance to meet up with other inhaler company representatives like Mr. Tarek Selim from Eva-Pharma, who provided valuable insights regarding modern ways to test the efficiency of PRESS. During our discussion, Mr. Tarek showed us how his company manufactured a successful fixed-dose inhaler in the market, which was inspirational for us to lead our thinking into implementing ideas like this in our approach. (47)
Lefancaps offers a wide range of high-quality customized capsules specifically designed for pharmaceutical applications, including gelatin, pullulan, and HPMC capsules. After having a discussion with Mr. James Cao, Lefancaps representative, who stated they will be able to provide us with high-quality and specialized capsules to be used in our therapeutic approach. Therefore, AFCM iGEM recognizes Lefancaps as one of the primary customers for PRESS.
We reached out to Mr. Mohamed Mahrous, who specializes in respiratory and immunology at AstraZeneca. At this meeting we made sure that we know the specific criteria needed to establish a potential collaboration for our future manufacturing stages.
INETWOK Middle East has aided us significantly in improving our marketing strategies. Their creativity, medical communications, and market access have been a great addition in our market approach. This is essential for entering the market and growing our business with a focus on clinical accuracy. (48)
Flat6Labs collaborates with national, regional, and global partners to build programs that help startups scale and expand. With over a decade of expertise and a powerful network, Mr. Yehia Houry, Chief Executive Officer of Flat6Labs, gave us invaluable information on different market strategies. Additionally, the company will boost our market expansion and upscaling once PRESS is on the market.
FinTech Fund supports startups in their early and growth stages by providing the tools they need to move forward. They have already supported companies to build tech solutions for banks and financial institutions in Egypt during the COVID-19 crisis. Seeing this, we decided to get in touch and ask about their funding.
During our talk with Mr. Omar Saleh, co-founder and CEO of FinTech, he shared the key points our project would need to cover in order to qualify for their support. We were highly encouraged to meet his qualification requirements as his company is a strong fit for our future plans. Those plans do not just entail launching in Egypt alone, but expanding worldwide.
During our visit to the World Asthma Day Event, mentioned in our Integrated HP page, we had a chance to meet up with other inhaler company representatives like Mr. Tarek Selim from Eva-Pharma, who provided valuable insights regarding modern ways to test the efficiency of PRESS. During our discussion, Mr. Tarek showed us how his company manufactured a successful fixed-dose inhaler in the market, which was inspirational for us to lead our thinking into implementing ideas like this in our approach. (47)
Lefancaps offers a wide range of high-quality customized capsules specifically designed for pharmaceutical applications, including gelatin, pullulan, and HPMC capsules. After having a discussion with Mr. James Cao, Lefancaps representative, who stated they will be able to provide us with high-quality and specialized capsules to be used in our therapeutic approach. Therefore, AFCM iGEM recognizes Lefancaps as one of the primary customers for PRESS.
We reached out to Mr. Mohamed Mahrous, who specializes in respiratory and immunology at AstraZeneca. At this meeting we made sure that we know the specific criteria needed to establish a potential collaboration for our future manufacturing stages.
INETWOK Middle East has aided us significantly in improving our marketing strategies. Their creativity, medical communications, and market access have been a great addition in our market approach. This is essential for entering the market and growing our business with a focus on clinical accuracy. (48)
Flat6Labs collaborates with national, regional, and global partners to build programs that help startups scale and expand. With over a decade of expertise and a powerful network, Mr. Yehia Houry, Chief Executive Officer of Flat6Labs, gave us invaluable information on different market strategies. Additionally, the company will boost our market expansion and upscaling once PRESS is on the market.
FinTech Fund supports startups in their early and growth stages by providing the tools they need to move forward. They have already supported companies to build tech solutions for banks and financial institutions in Egypt during the COVID-19 crisis. Seeing this, we decided to get in touch and ask about their funding.
During our talk with Mr. Omar Saleh, co-founder and CEO of FinTech, he shared the key points our project would need to cover in order to qualify for their support. We were highly encouraged to meet his qualification requirements as his company is a strong fit for our future plans. Those plans do not just entail launching in Egypt alone, but expanding worldwide.
We’ve created a business model for PRESS to simplify visualization of our main building blocks & comprehension of how this business functions.
This chart highlights our main acquisitions over the following year.
Delivering “PRESS” as a new product into the asthma market is an essential milestone in asthma management protocols. As a new product, PRESS needs several studies and data to assess its long-term impact. In this stage, we are trying to explore the long-term positive and negative impacts of PRESS on patients’ lives, the healthcare system, the environment, and the local area.
This figure shows our long-term postive and negative impact.
PRESS will have the ability to improve health outcomes by reducing exacerbation and improving lung functions; as well asreducing the doses needed for asthma control. This means better patient adherence to medications, which is one of the main barriers in asthma management protocols. Additionally, the patient will have the chance to freely perform his everyday activities without the fear and anxiety of developing acute exacerbations. Overall, PRESS will offer patients a xbetter quality of life. Moreover, we would see an overall normalization of the idea that “asthma is an easily controlled disease.” Finally, we would gladly witness generations arising that do not have a fear of developing asthma even if “it runs in the family.” Individuals would have a great sense of security from such a previously fatal atopic disease.
As PRESS will have the ability to reduce asthma exacerbations and the needed medications, it subsequently will reduce asthmatic patients’ emergency visits and hospitalizations. This will significantly reduce the expended health care costs on asthmatic patients and allow optimal usage for hospital resources.
As PRESS is expected to improve asthmatic patients’ quality of life, they'll get back to work without limitations. In addition, PRESS will decrease missed workdays due to asthma exacerbations. This will lead to an overall increase in productivity and economic growth. Overall, a national reduction in asthma exacerbations will lead to an overall healthier population.
As a response to the decrease in daily medications needed for asthmatic patients, less pharmacological waste would be generated. This will have a long-term positive impact on the environment.
Long-term use of genetically modified organisms could pose unforeseen health risks.This could lead to unexpected side effects that subsequently affect patients' trust in the product.
The introduction of PRESS into the pharmaceutical market will require ongoing monitoring for long-term effects. This will require additional costs on health care resources. Also, as a synthetic biology approach containing modified organisms, PRESS will face strict regulatory and ethical considerations through the development and diversification process. All this may impose barriers against its availability for patients.
Public opinion about genetically modified organisms could easily generate social controversies, which would influence public policy and public opinion on healthcare and biotechnology. Depending on whether PRESS becomes restricted by cost or availability, disparities in the management of asthma may become more extreme, negatively affecting vulnerable groups.
Putting a genetically modified organism into a medical device calls into question its effect on local ecosystems, in this case, biodiversity.
In order to better understand our project’s position, we carried out a SWOT analysis. This helped us map out our strengths and opportunities, while staying aware of the challenges and risks that could affect PRESS.
In general, asthma management protocols differ according to the grade of the severity and frequency of the attacks. Regarding mild and moderate forms, those patients depend mainly on SABA and LABA with a combination of ICS.
On the other hand, severe asthma depends mainly on corticosteroids, whether inhaled or systemic, and advanced biologics for its control. Even with these medications, there is still neutrophilic asthma, which is resistant to corticosteroids and proved to be associated with asthma-related death.
In the following we are going to discuss these medications from different aspects to represent their efficacy, annual cost, and side effects.
| Therapy | Efficacy | Annual Cost | Side Effects | Features |
|---|---|---|---|---|
| Inhaled Corticosteroids | Moderate - insufficient alone | Low $120-$600/yr | Local (oral thrush, dysphonia); systemic only at very high doses |
First-line controller; easy access; steroid-responsive phenotypes benefit most
|
| Systemic Corticosteroids | High - Short term control | Drug cost low (<$100/yr) but complication costs very high | Major long-term toxicities: weight gain, diabetes, HTN, osteoporosis, adrenal suppression |
Effective but undesirable long-term; major driver of morbidity/cost
|
| Advanced Biologics | High | High — ~$30k-$60k+/yr | Injection reactions; immune effects |
Targeted, often steroid-sparing; best for eosinophilic/allergic phenotypes; access depends on biomarkers & payer rules
|
| Macrolide Antibiotics | Modest with neutrophilic asthma | Low — generic: <$100-$1,000/yr | GI upset, QT prolongation risk, hearing loss (rare), risk of antimicrobial resistance |
Only non-biologic option with evidence in neutrophilic asthma; public health/AMR concerns limit uptake
|
| PRESS | Expected high | High (per model): $8k-$15k per capsule | Unknown long-term risks for engineered live microbe & expressed siRNA. Long-run use of bacteria may cause pleural effusion |
Novel modality: infrequent dosing, local delivery, H₂O₂-responsive control; could compete with biologics if safety & efficacy
|
Adapted from Global Initiative for Asthma (GINA, 2023), National Heart, Lung, and Blood Institute (2022), and additional modeling for PRESS. (49)
Inhaled corticosteroids are the most important controller medications for asthma. A few examples are fluticasone and budesonide, which help reduce airway inflammation. When used consistently, they prevent symptoms of asthma and exacerbations. For persistent asthmatic patients, ICS are highly effective and considered the cornerstone for management. Side effects usually include oral thrush, hoarseness, and cough.Additionally, high doses may lead to systemic effects like bone density reduction or adrenal suppression. These inhalers are readily available and not costly, with an average price of $120–$600 per year.
Systemic corticosteroids like prednisone and methylprednisolone are strong anti-inflammatory drugs. They are used with acute attacks and asthma exacerbations. In addition, they are the drug of choice in case of failure of other medications and due to its relatively low cost under $100 per year. However, systemic CS is not suitable for long-term daily management since its long therapeutic courses can lead to serious complications such as weight gain, diabetes, osteoporosis, hypertension, and vulnerability to infections.
Biologic therapies like omalizumab and tezepelumab are novel injectable drugs that are reserved for severe allergic or eosinophilic asthma. They target specific immune pathways such as IgE, IL-5, or TSLP that cause airway inflammation. Biologics may reduce corticosteroid need and control exacerbations. Nevertheless, their greatest drawback is that they are extremely costly, typically $30,000 to $60,000 per year, and necessitate regular injections every 2 to 8 weeks. Besides, their side effects include typical injection site reactions, mild immune reactions, and some drug-specific issues like conjunctivitis with Dupixent.
For patients with neutrophilic asthma, long-term use of low-dose macrolide antibiotics such as azithromycin has shown some benefit. As this subtype has also been shown to be corticosteroid and biologic resistant. These medications can potentially reduce airway neutrophilia and reduce the number of exacerbations. Their use is not without challenge, as the risk of antibiotic resistance, gastrointestinal intolerance, cardiac rhythm disturbances, and hearing loss are worries. Despite these worries, they are one of the few treatment options for this subgroup. It is comparatively low cost, usually ranging from $100 to $1,000 per year.
Alternative controller medications, montelukast (Singulair) and zafirlukast (Accolate), block inflammatory cytokines, bronchoconstriction, and mucus production within the airways. LTRAs are particularly helpful as an add-on therapy to ICS for better control, particularly in children or those with seasonal allergies and exercise induced asthma.Their cost is relatively low, with their price being $30–$50 per month. However, these antagonists have a number of side effects, including headache, gastrointestinal disturbance, and possible mood changes, e.g., irritability, aggression, and sleep disturbance (especially in children). .
These are a combination of a corticosteroid (to reduce inflammation) and a long-acting beta agonist (to relax the muscles and block bronchoconstriction). They are very effective for moderate to severe asthma. These are typically given one or two times daily, depending on the combination and the severity of symptoms. Side effects are equal to ICS and LABA (thrush, headache, tachycardia, etc.). Asthma complications are also a risk if not used properly. Lastly, they cost $200 to $300 per inhaler.
Bringing PRESS from the lab to market doesn't require only clinical and technical milestones; it also requires a realistic plan for long-term sustainability. Our team has outlined three possible exit pathways depending on market adoption, regulatory progress, and strategic partnerships:
PRESS takes a fresh microbial approach to asthma treatment. Therefore, we expect to peek the interest of powerful pharmaceutical companies that already have their eye on asthma. Some examples include AstraZeneca, Sanofi, and EvaphaRma. Their acquisition of PRESS would open the door for a faster global rollout and accessibility into large-scale clinical trials.
Another pathway is out-licensing PRESS to pharmaceutical or inhaler manufacturing companies after achieving clinical proof-of-concept. This lowers our team’s direct commercialization burden while ensuring wide-scale deployment. Licensing revenues would also support ongoing R&D into next-generation formulations.
If PRESS proves especially disruptive in clinical trials, we may establish a dedicated biotech spin-off to manage commercialization. This route grants us greater control over product vision and pipeline expansion by targeting other inflammatory diseases.As for funding, it could be secured through FinTech funds. In addition, we will seek partnerships with the government which will give us a legitimate impression, faster market reach and additional funding.
Our financial analysis demonstrates that proof-of-concept by Phase II trials ($30M milestone investment) is the critical inflection point where exit opportunities become most attractive to partners. This gives PRESS a clear exit strategy heads up through every phase of our development.
This timeline highlights our exit strategy through every phase of development.
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