We are attempting to raise 1-2 million dollars (Canadian dollars), to design, develop and test immunotherapy based cancer therapeutics up to human clinical trials. We estimate that this will take 5 years, but the time frame can be expedited significantly by licensing existing technology, this will depend on investor wishes. The proposed budget is as follows:
Salaries: $500’000 (for 2 scientists, for 5 years)
Research budget: $500’000
Total Research Budget: $1 million
If the therapeutics show efficacy, then:
Patent and legal fees: $100’000- 1 million
Total budget:$1.1 – 2.0 million
If the therapeutics show efficacy in animal models, they will be patented and we will seek collaborators to conduct clinical trials. The cost of clinical trials is typically over 100 million dollars and it is therefore necessary to partner with a large company capable of funding this process. The nature of this arrangement, necessitates strong, proactive, international patent protection. We will require substantial financial backing in order to develop sound patents and ensure a financial return on our inventions. We will not proceed in this endeavor without the means to protect what we develop. We will be systematic and meticulous from the start in this regard.
WHAT WE PROVIDE
• We’re able to independently design, develop and test immunotherapies up to human clinical trials. Our greatest expertise lie in the following areas: cancer vaccines, oncolytic viruses and adoptive T-cell transfer techniques using CARs and TCRs. We will discuss options with our investor.
• We will apply for grants from the provincial and federal government, which, if obtained, would supplement the budget.
• We are forming a new company without complications that are sometimes present in other companies. We have no ongoing corporate expenses, no debt, no problematic intellectual property, no existing legal agreements, or obligation to anyone. We are free to form any manner of agreement that suits our investor/s.
1. Obtain Financial support: We require approximately $250’000 in the first year and up to $750’000 over the next 4 years. The time frame and costs may be reduced significantly by licensing existing technology. In addition, in the event that the therapeutics that we develop show efficacy in animal models, we’ll need substantial funding to patent the intellectual property that we develop. We are requesting access to up to 1 million dollars for legal fees relating to this process, like everything, these details are open to discussion.
2. Decide the basic strategy: The type of cancer to be worked on and the specific immunotherapy approach to be used, will be discussed with our investor/s.
3. Background Research:
“A coupla months in the laboratory can save a coupla hours in the library” chemistry Professor Frank Westheimer
We will perform a research phase in which we’ll investigate the possible approaches to achieving the desired goal. This phase will consist of reviewing the literature for the latest advances, patent searches, legal consultation and private discussion with experts and collaborators, as appropriate. Following this, we’ll develop a detailed research plan, including steps, protocols, expenses, and a timeline. If the plan involves using existing intellectual property, we’ll discuss specifics and arrange a legal agreement.
4. Lab set up: We will attempt to keep the purchase of new lab equipment to a minimum, but will require approximately $50’000 for basic equipment and to stock consumables. We will arrange to rent access to more expensive equipment as may be required for the project (flow cytometer, etc.) and we will identify outsourcing options where appropriate. Early on, we will begin to make arrangements for animal studies.
5. Select, find or verify targets: One of the most important steps will be to select the marker that distinguishes a cancer cell from a normal cell. We can select from known targets, verify putative ones, find new ones, or outsource this step.
6. Design and build: We will design and build the therapeutics, with some steps possibly being outsourced, depending on time and economic considerations.
7. Test phase: This stage will begin with molecular biology and cell culture, followed by testing in animals.
8. Decision to proceed and patent: If the results from animal testing do not show adequate efficacy, we may need further funding to revise our strategy and continue. If the results show efficacy, we’ll discuss options with our investor/s and file for patents.
9. Find a partner for clinical trails: Once our intellectual property is secured, we’ll seek collaboration with a large pharmaceutical company and / or raise venture capital, in order to proceed to phase I trials. Though difficult, raising the roughly $25 million required to conduct a phase I trial is sometimes possible. This is a substantial investment, however, a promising result at this stage will raise the value of the therapeutic considerably.
10. Phase II, III and IV trials: If the therapeutic performs well in the first clinical phase, it must then pass phases II and III, before entering the review process. Clinical trails are overseen by the FDA in the US and Health Canada in Canada. If the therapeutic is approved, it will then be available for use by the public, although it will continue to undergo post-market safety monitoring (known as phase IV). Very successful therapeutics may have sales in the billions and the intellectual property that underlies a therapeutic that has obtained FDA approval can be very valuable. Rogue Life Sciences and its investors would be entitled to only a fraction of this, as the investor/s that funded the clinical trials would require sizable compensation, however, in the realm of 10 digit valuations, even fractions can be extremely valuable.
11. Repeat: Immunotherapy for cancer is a rapidly emerging field. There are many opportunities and we like to think ahead and think big.