Lumicure represents part of the first wave of bacteriotherapy, novel clinical treatments that represent more affordable, effective and efficient replacements for modern procedures in many categories of healthcare. Instead of many conventional treatment methods, which are delivered in isolated but frequent instances, bacteriotherapies require far fewer clinical visits because of their prolonged effects on the body. This saves valuable time and resources for both the patient and the healthcare providers. Additionally, bacteriotherapies are target-tissue specific, which means that many negative side effects on other parts of the body can be averted.
Knowing that Lumicure itself has the potential to replace current forms of cancer therapy and usher in a new age of oncology, we want to discuss it’s market appeal as well as the process of how we think it can be implemented as a viable cancer treatment option in the future clinical market. We would like to first present our value proposition model for Lumicure, followed by a forecast of Lumicure’s progression throughout the stages of FDA patenting. Finally, we would like to conclude with a discussion on how we can work with other companies and governments to promote bacteriotherapy treatments for cancer and other illnesses.
In order to be approved for use in the current American market of cancer diagnostics and therapeutics, both the Trichoscan and Trichotherapy components of Lumicure and its genetically engineered E. coli have to undergo an extensive patenting process with the U.S. Food and Drug Administration (FDA). On average, this process takes 8-10 years, and consists of four testing and experimentation phases.
The purpose of this phase is to assess the biological activity of the treatment on in vitro cell cultures as well as in vivo animal subjects. An initial treatment synthesis/formation mechanism is explained, performed, and documented in front of various review committees. These committees then continue to observe the biological changes that the drugs cause in healthy model organisms and those with conditions mimicking that of the illness(es) the drug is supposed to treat for. If the institutional review boards conclude that the treatment is (a) safe for use in treatment quantities on animals, (b) relatively reasonable to manufacture and reproduce, and (c) effective in achieving its target biological effects, the drug will pass on to the next phase.
During this phase, many key aspects of Lumicure will be tested, including the efficacy of released Trichosanthin on stopping tumor growth, reliability of the holin/antiholin kill switch in preventing proliferation of bacteria outside cancer sites, and signaling ability of mCardinal in revealing tumor sites and sites of metastasis. If qualified through this stage, a Investigation New Drug (IND) application will be submitted and approved, so that Lumicure can move into phases 2-4 of testing.
A. Testing in Healthy Subjects (1-2 years): The safety of the product will be further tested, and the dosage/concentration adjusted based on trials involving 20-100 person volunteer groups. Side effects will be more clearly documented and defined by review committees.
Because bacteriotherapies generally have very little side effect on non-target tissues if confined to an area of treatment, we are confident that Lumicure will be able to pass this phase quickly.
B. Small Scale Testing in Disease Subjects (1-2 years): The product will be administered in set amounts for a small group of volunteer individuals (up to 300) with a disease. After a set treatment and response time, review committees will then assign a score to Lumicure based on its treatment efficacy for volunteer patients with breast cancer.
C. Large Scale Testing in Disease Subjects (1-3 years): The final stage before the New Drug Application (NDA) is approved. The product is administered to a large group of volunteer patients (up to 3000) and for longer amounts of time than before to gauge its long-term efficacy. Ideally, Lumicure treatment will be able to demonstrate the prolonged effect on suppressing cancer growth due to persisting Trichosanthin-releasing bacteria. If long-term viability and efficacy are both accepted, Lumicure will receive a patent and become a market breast cancer treatment supplement option.
Even before Lumicure becomes patented, a large priority for CU iGEM team is to promote the usage of and spread awareness about bacteriotherapy as an alternative and/or supplemental form of cancer treatment. To that end, the team has been considering partnering with various biotech and biochemical startups in the northeastern United States as a consultant for other projects involving engineered bacteria. Because of our unique experience, familiarity and recent knowledge of bacteriotherapy, CU iGEM hopes to encourage and empower other organizations to also consider pursuing a project and/or business endeavor that uses this new technology. Perhaps the components of Lumicure itself can be used as a template for future, superior bacteriotherapy designs.
The ultimate goal of Lumicure from both a scientific and entrepreneurial standpoint has never been to create a lucrative product, or anything that could be distribute for the purpose of profit. CU iGEM was inspired to create Lumicure because of a shared goal between some of our members to provide cancer patients with a new reliable, dynamic and proactive dimension of treatment using the principles of synbio. As such, it is a resolution of CU iGEM to make Lumicure and other bacteriotherapies affordable yet effective market treatment options for breast cancer and all related diseases. Part of realizing this goal is to advocate for reducing the price of bacteriotherapy treatment and encouraging physicians to recommend bacteriotherapy treatment as a supplement to primary breast cancer treatment in hospitals and doctor’s offices nationwide. CU iGEM also hopes that Lumicure and other patented treatments can receive government-subsidization so that the patients they help to treat will not be barred from better health due to price and accessibility.
[1] Yaghoubi, A., Khazaei, M., Hasanian, S. M., Avan, A., Cho, W. C., & Soleimanpour, S. (2019). Bacteriotherapy in Breast Cancer. International journal of molecular sciences, 20(23), 5880. https://doi.org/10.3390/ijms20235880
[2] Onofrey, Bruce E. (2013). From Molecule to Medicine Cabinet: A Drug’s Long Journey from Development to Approval, Review of Optometry, https://www.reviewofoptometry.com/article/from-molecule-to-medicine-cabinet-a-drugs-long-journey-from-development-to-approval
[3] Frequently Asked Questions on Patents and Exclusivity. (2020). U.S. Food and Drug Administration, https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity