Medicenna CEO Talks on Immuno-Oncology ‘Trojan Horse’ Drug Candidate Fighting Tumors

Medicenna Therapeutics (TSX:MDNA; OTCQX:MDNAF) is on a promising path. The Canadian immuno-oncology company is taking positive steps to solidify their novel treatment in a burgeoning biotech sector that could provide distant contenders with recognition in the market.
The immuno-oncology sector rose up thanks to the involvement of candidates from a number of industry leaders, namely AstraZeneca (NYSE:AZN), Bristol Bristol-Myers Squibb (NYSE:BMY), Merck & Co.(NYSE:MRK) and Pfizer (NYSE:PFE).
Despite the involvement of major role players in the life science sector, smaller companies have been able to fully compete against these industry leaders. The failure of other candidates and the general complexity of brain cancer has made the path to approval in the immuno-oncology field difficult for everyone.
Dr. Fahar Merchant, CEO, president and chairman of Medicenna, told the Investing News Network (INN) the current approach to targeting this type of cancer has made it incredibly difficult for long-term cures to be successful. Instead, he argued the most important thing to target is a system in place that hides tumors from the human body’s own immune system.

Fast track designation with the FDA could lead Medicenna to market sooner

A fast track designation from the US Food and Drug Administration (FDA) indicates the data for a candidate is so strong and its medical population is in such need, that a product being evaluated after a phase 2 stage could skip a phase 3 review process entirely and enter the market. Medicenna is working to capitalize on this possibility with MDNA55 as a treatment of recurrent glioblastoma (GBM).
Merchant explained their novel candidate isn’t administered through regular methods. Instead, MDNA55 gets injected in a procedure that Merchant said neurosurgeons perform very routinely.
“With MDNA55 what we actually do is we inject the drug directly in the tumor,” Merchant added as he explained the concept of a blood-brain barrier, which he says prevents the majority of orally or intravenous (IV) injection drugs from reaching the tumor completely.
When inspecting for tumors, neurosurgeons will take biopsies samples from patients, this requires a “bur hole” to be drilled and then a needle will take the sample.
“It’s the same technique but instead of putting a biopsy needle we put a catheter and then we inject and infuse the drug to the catheter… what happens is, unlike drugs that are taken in pill form or by IV injection, our drug will be able to bypass the blood-brain barrier completely,” Merchant said.
Since it upgraded to the Toronto Stock Exchange (TSX) in August, Medicenna has experienced a 35.88 percent increase in its share price. In October, Kumaraguru Raja, a biotech analyst with Brookline Capital Markets, initiated coverage of Medicenna with a “Buy” recommendation and a target price of $6.
“In our view, MDNA55 can deliver potent cell-killing agents to cancer cells without harming healthy cells leveraging the IL4 receptor which is over-expressed in multiple cancers,” Raja wrote in his note to investors.
On that note, below is a transcript of our interview with Dr. Merchant which has been edited for clarity and brevity. Read on to find out more of what Dr. Merchant had to say.

INN: Medicenna Therapeutics graduated to the TSX earlier this year. Can you tell me what has been the biggest impact that you have seen from that move? 
FM: It opens up a wider range of investors. Unlike being on the venture exchange (TSXV), we are able to interact with and also able to approach investors in the US. We are also listed on the OTCQX, so that gives us access to investors in the US and Canada. As you can see from our credit volume in recent weeks, [it has] dramatically increased [in relation] to where we were when the company was only listed on the TSX.
We seem to be getting more meetings with institutions than we could when we were just a venture company. We end up attracting biotech and pharmaceutical savvy investors as well, so that helps.
“We have a pretty substantial opportunity to make gains from a valuations perspective”
INN: You mention this new increase since joining the TSX, what does the company plan to do to maintain this increase and keep it going? 
FM: As we make progress with our project, and we continue to have success, it will translate to our volume and–we hope– we expect the price to trend upwards.
Being a Canadian company, although we are a phase 2 oncology company, you see that relative to other companies in the US–similarly placed–valuation is quite substantially discounted. Therefore I would say that we have a pretty substantial opportunity to make gains from a valuations perspective–as we talk to more investors in the US and as we make good progress on our clinical trials.
If you look at peer companies that are in the US [and] listed on the NASDAQ in similar space–the market cap is at five to eight times greater than Medicenna. [There is] obviously lots of room for growth.
INN: The immuno-oncology sector has been booming in the US. In Canada we’ve also had some companies working on novel therapies in the area as well, so what excites you the most about your candidate MDNA55? What differentiates it from the rest of the pack?
 
FM: I think from a ‘how do we differentiate from others’ oncology companies is simply that, first of all, we are targeting a biomarker… when nobody else is targeting that particular biomarker so we are [a] unique, completely separate novel approach. Second is that our drug also targets the tumor microenvironment (TME).
TME is, essentially, cells that are not cancerous cells but protect the tumor and hide the tumor from our own immune system. What’s quite unique is our drug targets the interleukin 4 interceptor which we now know is the biomarker that is also expressed on the tumor microenvironment as well.
Essentially what our drug is able to do is not only target and kill cancer cells but also target and kill the cells that make up the tumor microenvironment. What happens is we expose the tumor, with the immune system as well. It’s a simple two-prompt approach, which nobody else is [using].

“We’ve created what we call a trojan horse, or better still we call it a molecular cell trojan horse.”

INN: Does your agent accomplish this all by itself or in combination with another drug?
FM: No, the agent does it by itself. The way the drug has been designed and amplified is that it’s got two parts to it called two protein. One protein is called interleukin 4 and it looks and finds tumors that have interleukin 4 receptor. It’s very much like a GPS system and sticks to the tumor cells because generally tumor cells express the IL-4 receptor, not healthy cells. Interleukin 4 is quite unique [because it] is food for tumor cells to grow faster. It’s a nutrient and what we’ve done is attached the nutrient to a very powerful poison or a toxin and that’s what MDNA55 has.
We’ve created what we call a trojan horse, or better still we call it a molecular cell trojan horse. The cancer cell thinks it’s getting food but inadvertently we deliver a very powerful poison that actually kills the cell.
INN: So you are currently in phase 2 with MDNA55. What is the path forward-looking right now for the drug and when does the company expect to enter phase 3?


FM: Compared to other biotech companies that have to follow the long pathway where it can take 10-12 years to get a drug to the marketplace, Medicenna is relatively fortunate that we have a drug that has shown very exceptional efficacy on trials. If we want to get accelerated approval, the potential for market launch, for partnering or marketing the drug into the patient’s population would be in a relatively short time frame like two to three years.
Our plan immediately, of course, is to complete the medical trial early next year, we have results from that clinical trial mid next year. Then in the second half of 2019, the plan is to then get a breakthrough therapy designation, get the FDA to accelerate the approval pathway. If they agree obviously we would submit all the data… and hopefully potentially have a product approved under accelerated pathway by 2020.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in this article. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.