Anixa Biosciences Inc (ANIX)

[Paullee]

Anixa’s Breast Cancer Vaccine; A Conversation With Dr. Vince Tuohy
By
Daniel Carlson, Tailwinds research
-
September 22, 2020
This week I had the opportunity to speak with Dr. Vincent Tuohy of the Cleveland Clinic. Dr. Tuohy is the inventor and research leader of the breast cancer vaccine program that has been partnered with Anixa. The program has had very successful animal trials and is in the final stages of prepping for an IND filing. It’s often rare for Key Opinion Leaders (KOLs) to talk to non-scientists, but Dr. Amit Kumar of Anixa helped enable this conversation in anticipation of the IND filing, and the upcoming month of October, which is Breast Cancer awareness month.
I left the conversation very excited about the product, its prospects with the FDA and the implications for Anixa. Here is my summary of the key portions of the conversation (I have bolded what I believe are the highlights), followed by my thoughts on the program.
Tailwinds Research – how does this technology work and why do you think it will be successful?
Dr. Tuohy – In the area of vaccination against infectious disease, scientists have been very successful in battling many diseases like small pox, polio and others. The cancer vaccine story is rife with many failures, and there are many reasons for this. We designed a program that takes lots of lessons from the success of childhood vaccines, the failures of cancer vaccines, and an understanding of autoimmunity. Our program identified an antigen, or target for the immune system, that is no longer around in adult women who are not lactating, but shows up in the breast when cancer develops. We also use a very powerful adjuvant, which helps the immune system mount a strong response to the antigen. Based on my background and understanding of how the immune system can sometimes destroy organs, I identified an approach for the immune system to destroy not the organ but the cancer in that organ. The studies in animals showed a powerful effect, and now this is the most powerful immune response that I could think of creating.
And we’re on the verge now of being able to test it in humans. We’ve generated the vaccine, the adjuvant. We’re submitting the application to the FDA shortly within the current month. And we think that we should be able to start phase one trials for dosage and safety by the beginning of this coming year
Tailwinds Research – What gives you comfort that the FDA will accept an IND for your cancer vaccine?
Dr. Tuohy – We’ve already had two pre-IND meetings with the FDA and we’ve discussed our plans with them extensively, really, I mean, in great detail. And they have indicated very clearly what they wanted from us. And we spent the last, oh, I would say over a year now, dealing with everything that they told us to do. They always have the right to ask for more, but we are hopeful that we have addressed everything they want.
Tailwinds Research – what kind of data do you expect to get out of a Phase one trial? And what specific end points are you using in this trial?
Dr. Tuohy – Well, phase one is a classic phase one. It’s a dosage and safety trial. So, we will increase the dosage until we reach toxicity and then pull back until we have a dose that gives us an effective immune response. We do not expect much toxicity because the protein target is not there in women who are not lactating or who don’t have cancer.
And so far in our toxicology studies and our immunogenicity studies, we haven’t seen anything that is out of the ordinary in terms of the common side effects that you get from any cancer vaccine.
Besides safety we will be monitoring the patients to see if our vaccine has induced antibodies that target our protein and the T-cells that target the protein. These antibodies and T-cells will be measured before vaccination , so if they are there after vaccination, we know our vaccine induced their creation and the vaccine is doing what we want.
We hope we can finish the first trial within 2021, then we will follow up with the second trial.
Tailwinds Research – you did mention that Phase I studies are funded by the government. Do you think there’s any possible possibility, based on success there, that the government will fund phase II studies?
Dr. Tuohy – I think it’s definitely possible if we can show that we have a very active immune response, which I’m very confident about. This is not a weak vaccine. This is the most powerful vaccine I could think of making. And I have no doubts that we’re going to get there.
This is not a critique, but a lot of people are down on cancer vaccines because they haven’t worked and they haven’t worked, in my opinion, because, A, they have been using cryptic antigens that have no high affinity T cell clones in the repertoire available to react to them. And B, they’re not using aggressive Type 1 and Type 17 adjuvants to induce a very, very powerful immune response.
So, I’m confident that we can get a very good immune response. I think if we show the results that I anticipate, there is likely to be a lot of interest in funding to continue the development of the vaccine. The US spends over $40 BB dollars annually for breast cancer. So, yes, I do think the government would be interested when they look at just the finances.
At Tailwinds, as investors, we remain very optimistic about Anixa’s breast cancer vaccine program. There are several key points to keep in mind here when one looks at what Anixa is doing.
• The Cleveland Clinic is a world-class research organization. They are at the top of the pyramid along with others like the Mayo Clinic and Sloan Kettering. It’s easy to dismiss Anixa as a micro-cap company with few employees and a small budget, but their strategy of working with the best possible partners gives them a depth and breadth of research that extends far beyond the normal reach for a company their size.
• The market for vaccines is massive. If this product works, you’re looking at a multi-billion-dollar opportunity. (For a case in point, just look at what happened to Moderna stock recently) We will know if there is a positive response sometime in 2021. So, in less than one year, we’ll know if this $60M market cap company could have a billion-dollar program on their hands.
• For further proof of the market size here in Triple Negative Breast Cancer, look at Gilead’s purchase of Immunomedics. They paid $21 billion for a drug that has only increased survival from 1 ½ months to 5 ½ months. Once again, IF the vaccine works, this is a big opportunity.
The management of Anixa has continually bought shares in the open market, which demonstrates not only their belief in the product pipeline, but the deeply discounted valuation. The risk/reward here seems incredible to me.
By the end of next year, Anixa will have two potential blockbuster programs returning human data. Due to the unique nature of their business model, these programs aren’t costing an arm and a leg. Tremendous upside from a small investment…it’s a great business model.
Anixa is on the cusp of going from pre-clinical to having two simultaneous in-human trials. The first step is an accepted IND submission. We are only a handful of days away from the first IND being submitted and less than two months from learning if it is accepted. Exciting times ahead.
Tailwinds' Disclaimers & Disclosures: Tailwinds may have been compensated for writing this article. For a full list of disclaimers and disclosures, please visit http://tailwindsresearch.com/disclaimer/.
https://tailwindsresearch.com/2020/09/anixas-breast-cancer-vaccine-a-conversation-with-dr-vince-tuohy/