Dr. Amit Kumar is an experienced research scientist, executive and investor, who has founded, built, run, and invested in a number of biotechnology enterprises. Over the last 25 years, Dr. Kumar has either performed or managed research programs in both cancer diagnostics and therapeutics. Over the last 20 years, he has helped his private and publicly listed companies raise over $500 Million dollars.
In addition to his commercial activities, Dr. Kumar sits on the National Board of the American Cancer Society.
Currently, Dr. Kumar is the Chairman, President and CEO of Anixa Biosciences (NASDAQ:ANIX), a cancer therapeutic company. Previously, Dr. Kumar was CEO of GFF, a privately held biotech company. Before that, Dr. Kumar was President and CEO of CombiMatrix Corporation (CBMX:NASDAQ), a position he held from 2001 to 2010. CBMX was a cancer and genetic diagnostic company that Dr. Kumar took public.
At CBMX Dr. Kumar led efforts to utilize genetic testing to address a number of diseases including cancer. In addition, with millions in funding from the US DOD, Dr. Kumar led efforts to identify and study a number of infectious agents that could potentially be used as biological weapons as well as natural infectious agents suh as the SARS virus that arose in 2003. CBMX was recently acquired by Invitae (NASDAQ:NVTA).
Dr. Kumar is currently Chairman of another public company, and Chairman and founder of two private companies. Dr. Kumar has also held positions at Venture Capital Firms (Oak Investment Partners, Acacia Research Corp.) and Biotech firms IDEXX Laboratories (IDXX:NASDAQ), Signature BioSciences (sold), Tacere Therapeutics (sold), Idetek Corporation (sold), and others.
He has also been an advisor or consultant to Fortune 500 companies, venture capital firms, private equity funds, and private early stage healthcare companies. He has 40 peer-reviewed technical publications and holds seventeen patents with others pending.
Dr. Kumar also has extensive experience working with the US government. He has presented to individual members and committees of the US House of Representatives and Senate as well as White House Staff. He has also worked with various defense agencies as well as the US FDA.
1) What has been your most challenging moment as an entrepreneur and how did you overcome it?
All my entrepreneurial endeavors have required R&D, especially in the healthcare arena. To conduct such R&D, capital is necessary. The hardest aspect of such entrepreneurial activities is to convince an investor to part with his or her money to buy into your vision. Raising capital is harder than product development, sales and marketing, and all other aspects of the business. Therefore, one has to have a compelling vision that is easy to articulate and easy to grasp for the investor.
2) I read that your company’s vaccine for breast cancer has been approved for clinical trials. Can you tell us about how the vaccine works?
This is a prophylactic vaccine whose goal is to prevent breast cancer. There is a protein that exists only in the breast and only during lactation, because this protein aids in the production of milk for an infant. Our collaborators at the Cleveland Clinic discovered that this protein appears again once breast cancer develops. Our goal is to vaccinate women after they have passed the age of childbirth (40 or 45 years of age). We are training the individual’s immune system to destroy cells that are making this protein. When a cell in the breast becomes cancerous, it makes the protein and the immune system destroys it before it can replicate and eventually become a tumor. We have proven that this approach works in animals, and now the FDA has cleared us to begin testing in humans. The initial clinical trials will be conducted at the Cleveland Clinic, one of the best hospitals in the world. Additionally, the US government is partnering with us to provide the funding for the initial trials. More information is available at our website, www.anixa.com.
3) What can you tell us about the process of getting a vaccine approved by the FDA for clinical trials?
Vaccines go through a three-phase development and approval process. In phase 1 and 2, we are trying to set dosage and evaluate safety as well as see indications of efficacy. The key indicators of efficacy that we will monitor is whether we can induce a woman’s immune system to create antibodies and t-cells (a type of white blood cell) that will attack the noted protein and cells producing the protein. Phase 3 is the critical study where a large number of women will be vaccinated and an equal number of women will be given a placebo. We will than watch these women to see the incidence of cancer in the vaccinated group and also in the placebo group. The ratio of cancer incidence in the two groups will indicate the efficacy of the vaccine. The hope is that most if not all the incidences of cancer occur in the placebo group because the vaccinated women are protected.
4) If the clinical trials go well. What is the next step and how soon could we see the vaccine be available for the public?
If the initial clinical trial is successful we will proceed to phase 2 and then to phase three. We expect this process may take a few years to complete. While some of the Covid-19 vaccines were developed in a year or so, traditional vaccine development takes a few years, especially for something like this which is not an infectious disease. if the initial trials are successful, we also expect to partner with a larger pharmaceutical company to help complete the larger trials and eventually to commercialize the product, in a similar fashion to the partnership between BionNTech and Pfizer for the Covid-19 vaccine.
5) Anixa is also developing other vaccines. What can you tell us about those?
We are also working on developing, along with the Cleveland Clinic, a vaccine for ovarian cancer. This vaccine utilizes the same principal as the breast cancer vaccine, but it’s focused on a different protein. This protein disappears when a woman reaches menopause, and it appears again in ovarian cancer. Therefore, we would vaccinate women after menopause in a manner that will destroy ovarian cancer cells as they arise.
6) Can you leave us with 3 tips for aspiring entrepreneurs reading this who may want to enter into the health tech space?
- Make sure you are designing a product or service that is addressing an unmet need for all the constituents (patients, clinicians and payors).
- Have an easily understandable and defensible financing plan.
- If the product needs regulatory approval, have a plan for that and know as many of the answers when defending the plan. Regulators can kill a company and investors are always wary about uncertainties in this arena.