Bringing ABBBA to the market

iGEM Stockholm and “ABBBA” against cancer. The Stockholm-based team is currently developing a novel in vitro diagnosis test to detect cancer in early stages. The test, based on a Affibody-Based Bacterial Biomarker Assay, also known as “ABBBA”, aims to enable physicians to diagnose early stages of cancer. In this report, we want to build the case that ABBBA has the potential improve cancer prognosis, which affects 14 million new patients every year. Here, we envision how we would bring ABBBA to market if we turned the project into a company.

About us

iGEM Stockholm is committed to enhance patients’ quality of life by providing a sensitive and cost-efficient in vitro diagnostic product, enable to detect cancer at it earliest stage. Our company is driven by the need of finding sustainable solutions to one the most pressing healthcare challenges of our world, cancer.

The need

Cancer is one of the leading causes of morbidity and mortality worldwide. In 2012 alone, 14 million new cases and 8.2 million cancer related deaths were registered. Moreover, it is estimated that in the next two decades, this number will increase by 70%, which will constitute an economical and social burden. Among cancer, lung cancer is the most common cause of death. Just in the United States, it accounts for 29% of all cancer deaths. In 2014, the global market for lung cancer was $21.9 billion. From 2014 to 2019, this market is forecasted to grow 8.7% Compound annual growth rate (CAGR), resulting in $31.8 billion in 2019. Furthermore, lung cancer contributed for 13% of the total number of new cases diagnosed in 2012, killing more people than prostate, breast, and colorectal cancer combined. The prognosis for patients diagnosed with lung cancer is strongly correlated with the stage of the disease at the time of diagnosis, in spite of this, the ability to detect lung cancer at an early stage is poor, primarily due to lack of effective detection methods. Given this, less than 15% of patients with lung cancer survives five years after diagnosis and over 60% are diagnosed at advanced stages when a cure is unlikely. For the aforementioned reasons, a low cost screening method able to detect cancer in early stages is required to promote better prognosis and quality of life of cancer patients.

Competition

There are methods available to detect lung cancer today, including imaging tests (chest x-ray and Computed Tomography (CT) scan), bronchoscopy, or sputum exam, however, they are usually not used to detect lung cancer but other diseases. Among theses tests, chest x-ray and CT scan are more commonly used. CT has shown to be more effective, nevertheless, is also has downsides, for instance, it also detects other abnormalities that need to be examined with more tests and 1 out of 4 cases turns to be not cancer, leading to additional tests such as other CT scans or more invasive tests. Moreover, CT scan exposes people to a small amount of radiation with each test, which may cause people to develop other types of cancer.

Current developing methods are focusing on biomarkers, however, discovering and validating these molecules in a clinical setting have represent a challenge still to be overcome. Within this field, various targets such as plasma DNA, circulating tumor DNA, autoantibodies and proteomics, have been proposed as potential solutions. Commercially, only one test is available at this moment, EarlyCDT-Lung test by Oncimmune. The test is comprised of 7 autoantibodies associated specifically with lung cancer.

Our solution

iGEM Stockholm has designed a transferrable microbiological system for the detection of low quantities of cancer biomarkers in a sensitive-specific way. This assay aims not only to be highly sensitive and specific but also to be user-friendly and more cost-efficient than existing techniques, making it a first choice for early detection of this condition. The development process considers a proof-of-concept test to detect human epidermal growth factor receptor 2 (HER2), an abundant biomarker for breast cancer which has been widely studied. We aim to sensitively and specifically detect HER2 in body fluid samples such as blood serum using an engineered receptor. The solution comprises a technology based on the fusion of an affibody molecule to the receptor EnvZ in E. coli strain. Detection of the biomarker triggers a signal amplification using intracellular OmpR regulated gene expression that activates the reed out strain trough a quorum sensing system. In a second stage, the team will use this principle to detect lung cancer biomarkers. Furthermore, this approach may be use in the detection of other biomarkers present in different diseases.

Having a diagnosis kit based on a bacterial system provides the advantage of low costs related to manufacturing process. Bacteria comprised in the kits are produced by fermentation of a working cell bank, which is placed into tanks together with nutrients which aid bacteria to grow. Afterwards, bacteria is harvested, purified and tested in order to determine the amount of bacteria needed for each kit. This process has the advantage that the bacteria duplicate themselves using their own “machinery”, reducing the production cost. Each batch of the product is then tested to ensure that is complies with the quality product profile.

Market strategy

The market for diagnosis and therapeutic products for cancer constitutes a promising business opportunity for iGEM Stockholm. This is driven by the increasing number of new cancer cases, high cost to diagnose and treat the condition, and increasing risk factors among the populations. Nevertheless, this is also a complex and competitive market, therefore, in order to excel in this arena, our team has developed a comprehensive marketing strategy to position the product and reach our customers and users.

The company will start by stating the proof of concept of the bacterial system using a well known biomarker, HER2, and then diversifying into lung cancer as it is the largest contributor to new cancer diagnoses and to cancer deaths. iGEM Stockholm’s go to market strategy considers gaining trust among healthcare professionals by providing a clinically proven and cost effective method. The company will approach key opinion leaders in the oncology field and cancer organizations to gain advocates. Furthermore, strong clinical data collected during the development process will provide the company with elements to get positive Health Technology Assessments. Later on, the company will work alongside with the government and insurance companies to implement screening programs to target potential cancer patients based on their medical history and lifestyle. This approach aims to promote utilization of the product in the general population. By implementing this strategy, the company will involve both users (physicians) and payers (governments, insurance companies), promoting a better understanding of the system and the benefits of adopting this new technology.

Product development

iGEM stockholm is currently working on the proof of concept of the product. Our goal at the end of this phase is to establish the functionality of our product in vitro. In order to cover expenses related to this phase, the team has been actively seeking both, financial and non-financial resources through public and private sponsors. Later on the product development process, a prototype of the diagnostic test will be designed and validated using samples from diagnosed patients and healthy people. This has the purpose of determining normal ranges of the biomarkers and the threshold, at which a positive or negative result can be provided. The information collected during this phases will then be used at the next step regulatory approval. As regulatory approval and scaling up are phases that requires resources, both in expertise and strong financial aid, our team will seek for partners and collaborations in order to continue the product development process.

Figure 1. ABBBA development process: Business model - Revenue model, Pricing, Average account size and/or lifetime value, Sales & distribution model, Customer/pipeline list

Preliminary introduction to the business model

Correspondingly to the business model, a business model canvas accordingly to Osterwalder have been created for the company. The business model for iGEM Stockholm describes how the company creates and provides value for the target customer segments and users. While users are defined as patients, laboratory technicians and physicians, customers is somewhat broader category. This group consists of the payers, meaning private and public hospitals and laboratories. Correspondingly to having various customers and users, the value provided by the ABBBA product will be appreciated differently. For patients, ABBBA will detect cancer at an earlier stage of the disease and thus, higher likelihood of survival rate and improved quality of life. For doctors this would mean that they increase their patient/survival rate, and that they can take on new patients as they discharge recovered ones.

For the customers segments, hospitals and laboratories, ABBBA provides a cost-efficient and highly specific method to detect early-stage cancer. Costs related to medication, treatment, long-term care and rehabilitation of late-stage cancer patients can be reduced in terms of cost/patient and number of patients diagnosed with late-stage cancer. In addition to cost-effective benefits, the technique provides sensitive and specific results through easy-to-use method and thus, clear benefits for healthcare- and laboratory personnel.

In order to reach iGEM Stockholm’s customers, several different channels will be utilized. By using social media and attending conferences of both broad and more specific focuses (e.g. cancer and biomarker detection), their target customers can be localized and key opinion leaders (KOLs) will be attracted. Government relations will also be maintained given the clear benefits of being reimbursed and having approval from governmental instances.

Through the different channels, the company can provide a personalized in-view to customers needs and desires. Channels and customer relationship will be clearly linked to iGEM Stockholm’s key activities and resources. Both the Royal Institute of Technology (KTH) and Karolinska Institutet (KI) brands as well as the team’s broad background in life science, will be essential for their activities of promoting synthetic biology and entrepreneurship to their collaborations and customers. In relation to this, KI and KTH are considered key partners together with Affibody AB and the iGEM Foundation. Affibody AB is a key collaboration given that the product ABBBA is based on use of affibodies. This is also true for iGEM Foundation, as without them several essential components of ABBBA would not be available and biobricks would not have been provided.

Revenue streams at the company are mainly consisting of asset sales and add-ons in terms of service and packages. Due to the transferability of the ABBBA system, it is possible to not only have breast cancer but other above mentioned cancer types in the future product portfolio. Cost of the company are link to research and development of the diagnosis kit for breast cancer and the diversification into other type of cancer such as lung, prostatic and colorectal. Additionally, cost are also driven by manufacturing, distribution and storing of kits. Finally, marketing activities including conferences, advertisement, workshops, training sessions also contribute to the cost structure of this company.