Is There Room for Latecomers to the COVID-19 Party?

In this video from Motley Fool Live recorded on Nov. 12, Henry Ji, chairman, president, and CEO of Sorrento Therapeutics (SRNE.Q), talks with host Brian Orelli about how better-designed neutralizing antibodies can still make an impact in the crowded COVID-19 treatment and vaccine space. Mark Brunswick, senior vice president of regulatory affairs at Sorrento, also chimes in on the benefits of the company's antibody therapies. Sorrento is developing STI-1499 (COVI-Guard) as well as a second-generation antibody called STI-2020 (COVI-AMG).

Brian Orelli: So we have a vaccine from Pfizer (PFE -3.85%) and BioNTech (BNTX -1.57%), which is showing about more than 90 percent effectiveness, and Moderna's (MRNA -2.45%) on their heels with another vaccine, and we have quite a few other ones in phase 3 development. We have an antiviral from Gilead Sciences (GILD 0.28%) that's received emergency use authorization, and a therapeutic antibody from Eli Lilly (LLY -1.00%) that also has an authorization. Regeneron (REGN -1.75%) has an antibody cocktail that's under review by the FDA, and the data looks pretty promising. Then last time I checked, there was a 288 different COVID-19 tests that have been authorized by the FDA.

With that context, where do you see the pandemic going from here, and is there room for others like yourself in the market?

Henry Ji: Yes. Actually, maybe I'll answer first and Mark, you can chime in. We believe the antibody is the key. You need a neutralizing antibody. If you look at the neutralizing antibody, it's the one you wanted for the vaccine. If you do vaccination with different type of antigen, different type of vehicle, like a virus or messenger RNA or plasmid DNA, you all want to have the body to generate immune response to the viral antigen, which is neutralizing antibody. So you have Moderna and BioNTech and Pfizer, CureVac (CVAC -7.97%), they're all using messenger RNA to express the viral protein. We can always talk about the pro and con of that approach because that can be designed very quickly, you produce it. The other way is using plasmid DNA. Inovio (INO -0.34%) are using the plasmid to express the viral protein. Then you have the Johnson & Johnson (JNJ -1.15%), AstraZeneca (AZN 5.38%) using adenovirus to express the protein. The same strategy; getting the neutralizing antibody.

The other strategy you have is since it's an antibody, you can always get the antibody made outside of the body not using the vaccine approach. They made it outside the body and then produce it in large quantity. That's our approach, which you have Regeneron, and you have Eli Lilly, you have AstraZeneca, you have Sorrento.

Now, what are we differentiating from here? What we have done is, firstly, we engineered the antibody to a extremely high potency. That means if you have a high potency against the virus, you can use much less quantity. Secondly, the safety issue is very critical. In the pre-determined antibody you produced, you actually can engineer individual antibodies such that it can avoiding the side effect, for example, the antibody-dependent enhancement which is big issue. If you don't get rid of that one, then you may actually exacerbating the condition.

Giving example, the [antibody drug enhancement] (ADE), when you have antibody, the Fc region binds to the immune cells. They have two function; binds immune cell, meanwhile, binds the virus. The virus originally cannot infect the immune cell. Now, you binds to it was a bridge. They actually can infect the immune cells. Now, you make the matter even worse.

So what we did is engineer the Fc region so that they not bind the immune cells. This way, you're preventing the virus bind to immune cell and kill the immune cells. We did it, we took our time to engineer it, and I think the first batch of the people did not do it, like Regeneron, they did not do the engineering. So nobody knows what happens because they have some of the in-hospital type that may have the safety issue. Then you have Eli Lilly had the first compound, which is not engineered. And AstraZeneca right now recently announced they engineered the Fc region, so avoiding the ADE. I think that we are in a cutting-edge here. We are not only having one of the most potent antibody; secondly, we're testing these antibody every time we have a chance with a mutant. Remember, the first antibody come out mostly is isolated from the patient. These antibody may work on the wild type -- may not work on the mutant like the most dominant strains right now in North America and Europe. Some of them already have a published paper that some of the antibody have 100-fold of potency reduction, and the same things for the vaccine. The initial design is all against the wild type. Almost all of the vaccine right now is designed on the wild type. If you look at these, their potency could be dropped dramatically if a mutant strain kicks in. So with this, I'm stopping here. Mark, you want to adding more on our careful thinking? How we do it?

Mark Brunswick: We've got a great deal of expertise in antibodies. Using that expertise, we have very quickly from a small facility moved on to manufacture large quantities of an antibody that is anywhere from 10-100 times more potent than the antibody being used by Lilly and Regeneron. Because of that, if our antibody proves effective, it will be much easier to make and distribute than the antibodies being made by Lilly and Regeneron. Lilly, the [emergency use authorization] requires a one-hour infusion and then you have to wait around after the one-hour infusion for one hour to ensure there are no safety issues.

Our antibody is given intravenously, is given as an intravenous push. That means it takes about two minutes to give the antibody and we're not requiring patients to wait around because we're not anticipating any adverse events. Also, because of our extreme potency, we're able to formulate the antibody to be delivered intranasally, which means that someone can get a diagnosis from their physician that they have COVID. They could go to their local pharmacy, get some drops, put some drops in their nose, and then if they're clinical [...] support, that will show that they were being cured or eventually cured and they wouldn't be able to spread any more virus.

Henry Ji: Brian, we are the first company and filed the [investigational new drug application] for the intranasal application. We're actually so excited about this approach. Reason is we see in the animal data, we did both intravenous and the intranasal approach, we're seeing this as potentially synergistic. The intranasal upon post-infection, 12 hours later we apply the intranasal, the intranasal immediately works and you preventing the disease progression from right on, early on.

Brian Orelli: This is all on animal models though, right?

Henry Ji: Yes, that's a hamster. But so far, Brian, animal model, the hamster model translate very well to human. As all of the company, Eli Lilly, Regeneron, they all publish the paper on the hamster models, and we publish our animal model too. I would believe the intranasal works very early on and very quickly while the intravenous takes a little bit time and a little bit lacked time. But the combination of intranasal locally on the respiratory system and in the lung, and then you have the IV that covers all of the other organs, all of the other system, that could be a fantastic combination. Especially in the IV, you may have a longer half-life while in the respiratory areas was intranasal, we may have a little bit shorter but works so immediately. We thought of both form. If both form of our test there, we can do a combination both intranasal and IV, that will give you both systematic and local, and the short term and long term.