Virugene Biotechnologies Business Plan

Executive Summary

Virugene Biotechnologies is meant to be a Biotechnology-based start-up company based on providing cancer therapy products primarily using a combination of the oncolytic virus therapy and CAR-T cell therapy. The plan is to found the company as an LLC with headquarters at and and registered in San Francisco, CA; where the main focus would initially be on beginning the research toward the intended product.

Mission and Goals

The mission statement would be “To innovate the paradigm shift in Cancer therapy”. This implies to the various advances that are taking place in biotechnology that can be implemented not only in the field of origin within biotechnology but can be extended and put into use in other areas too. With our novel approaches of combing to already existing approaches to cancer therapy, we are trying to show that just because it works perfectly doesn’t mean it cannot be improved.

Employees and Organizational Structure

The above shown is the structure in which the organization and its employees shall be placed. Each department in under the chief officers will initially have 3 to 4 employees. If required and possible, the research and development team will hire college students for internships hence providing them with a platform to learn and to present novel ideas.

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Financial Strategy

Virugene Biotechnologies would follow a pre-profit business strategy considering that the work begins before the product is in the market, i.e., we can only get the product to the market after it has been developed. The company would however require funding in order to get the research and development up and running for at least the first two years. The aim is to get the product FDA approved within the first to second year and hence start generating some revenue.

Investments and Partnerships

Initially the income will depend on investments and partnerships with companies that can help work with different stages of the product. For example, a partnership with Gilead (Kite Pharma) would be beneficial in developing the CAR-T phase of our product. Apart from this, companies like LG electronics and GE (General Electric) could help with designing the necessary equipment that would be required for the product to be effective.

Initial Expenses

Break down of the start-up expenses:

• Insurance, Licensing and Registration $7000
• Equipment and Inventory $500,000
• Business Consultant $3000
• Furniture and Gadgets $10,000
• Phone and Utilities $10,000
• Rent of Office/Lab space for 24 months $200,000
• Operational Cost for first 6 months $200,000
• Travel and Marketing $50,000
• Miscellaneous $20,000
• Total $1,000,000

Lead Product – Benoncartogen

Product Description

As mentioned previously, the company is mainly focused on cancer therapy using a combination of oncolytic virus and CAR-T cell therapy. To explain individually, oncolytic virus is basically a virus (mostly herpes simplex virus) that selectively attacks cancer cells and CAR-T cell therapy is a method where the host’s T-cells are used to attack the cancer cells. Previous studies showed that oncolytic viruses have not been successful in the secondary aim, i.e., is to induce an immune response in the body.

Thus, with Benoncartogen, the idea that would be implemented is that along with the oncolytic virus, when T-cell therapy is combined, it would cause an additive effect of destroying the tumor as well as preventing new tumor cells from recurring. This treatment is exclusively for patients with benign cancers that are inoperable. Each cancer cell is different and hence would be studies and the CAR-T cell therapy would be customized for the specific cancer in the specific patient.

Treatment

1. Step 1: Leukapheresis – T-cells for the CAR-T therapy are extracted from the host.
2. Step 2: Oncolytic Virus is injected directly into the carcinogenic cells
3. Step 3: The T-cells are transformed into CAR-T cells. This process takes about 2-3 weeks meanwhile giving the oncolytic virus to act in the patient’s body.
4. Step 4: If positive results are observed from the oncolytic virus therapy, the CAR-T cells are injected into the patient.

Note:

• The company would be in partnership with medical organizations like hospitals and cancer clinics.
• The patients will be selected based on a set of criteria provided by the company to the medical organization. They will be enrolled into this treatment via the medical organization.
• There will be requirement of conditional radiation to prepare the body for the treatment

Projected Development Timeline

2019

1. Research and Development regarding Benoncartogen will take off.
2. Will begin phase 1 and 2 of clinical trials.
3. Will apply for FDA approval.

2020

• Phase 3 of Clinical trials would be complete.
• Drug will obtain FDA approval.
• Therapy will be made public by the end of the year.

Market and Business Analysis

The target market can be segmented as a. Hospitals and clinics within the state b. Hospitals and clinics out of the state. The services provided by our company is required to have its products developed in the company lab itself. Partnerships with transport companies like airline can improve the implementation of the treatment initially. On achieving breakeven, we plan to extend our company and open branches across the country at key locations.

Once the product is up and running and generating revenue with profits locally, a plan to market and publicize the product in other states will be put into place. This will act as the initial step to extend our services to neighboring states and eventually the rest of the country. We will also be having a website that would enable consumers to directly apply for the therapy rather than via a hospital; but they still would be required to submit to a full medical background check.

IP Strategy

The protection of the intellectual property rights is very important in today’s day and age. Than to go about it would be to: a. License the patents linked to CAR-T cell therapy and oncolytic virus. b. File patent for therapy with the combination of the both being used together. Filing and licensing of patents would be done before the research and development can completely begin. These procedures would be handled by our legal and accounts team.

Value Statements: Virugene Biotechnologies is dedicated to: a. Innovating the change in the methods of cancer therapy b. To provide cancer patients with a better form of therapy that does not affect the quality of life.