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#154 Kenneth Kovan & David Berd on Haptenized Vaccines

by Kira Dineen
August 20th 2021

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Now, click the link in the show notes for this episode. For more information or go to DNA podcast dot com, surrounded by such complexity. Such elegance. The genes of you and me jeans are you know, are all made of DNA were all made of the same DNA. Were all made to be in a Hello, you're listening to DNA today, a genetics podcast and radio show. I'm your host, Katie Janine. I'm also a certified genetic counselor practicing in the prenatal space on the show. We explore genetics impact on our health through conversations with leaders in the field. These are experts such as genetic counselors, researchers, doctors and patient advocates. My guest today are from Byob access a leader in the vaccine industry, Kenneth colvin is a founder and its president. Ceo. Oh and dr David Bird is also a founder and chief medical officer. So thank you both so much for coming on the show to dive into very timely topics.

Thank you. Thank you. Shut it. So a little background information on bio of Axis. It's um you are developing a vaccine platform for viral infections and cancers and also developing a really unique diagnostic in support to fight against for COVID-19. And what really brings all of this together with these three technologies is a focus on T cells which is what we're gonna be exploring in today's episode. So, Dr Bird, I'd love to start out by having you explain how the immune system typically fights cancer so that we understand this basic so that we can add more information on and dive into the details during the interview. Sure. Well the problem is that most of the time the immune system does not fight the cancer which is why people have cancer. The cancer grows and in the absence of effective treatment and it makes them sick and take their life when the immune system fights cancer. It's because cancer cells are are are slightly different from normal cells.

It's surprising how similar they are but there are slight chemical differences and they have they have proteins or what we call antigens on their surface which the immune system can recognize and uh that usually doesn't work. But when it does work, the response is mediated by a special kind of white cell called a T lymphocyte. So um T lymphocytes recognize the cancer antigens um and can fight the cancer in two ways. One, they can directly kill cancer cells or they can produce chemicals called cytokines, which kind of bring in a whole host of other kinds of immune cells which which is slow or or or prevent the tumor growth. So the trick and immunotherapy is to make some changes so that you shift the balance so that the immune system actually fights the cancer rather than tolerating it, which unfortunately is what happens most of the time. And so then how does these happen? Ized vaccines play a role in terms of taking advantage of how we know the immune system works.

And what is that process? So, happy optimization is an immunological trick that was discovered many years ago, probably almost 100 years old. So happen is a chemical and there are many different happens. We there are two that we were working with but there are thousands to choose from their small chemicals. And when they hook up with with with the protein, um they change them change the protein subtly so that the immune system can recognize the protein more strongly or in extreme cases can recognize the protein, which otherwise is ignored, totally ignored by the immune system. So this is a perfect situation for cancer because as I've already said, the cancer proteins are cancer added and usually aren't recognized when you have optimized them. Um you can get the immune system to recognize them. The immune system then makes a response. As I said, a T cell response against the cancer antigens which have the Captain.

Um and then there's a secondary response against the non optimized native tumor antigens which of course are the ones that you that you that you want to target. The optimization process can be applied to uh to to a cell um or can be applied to a purified protein in the case of cancer we just used to sell and um Captain eyes many of the cancer of the cancer antigens on the cell. In the case of covid where we know what the proteins are, we can directly happiness the protein and use that as the immunogen. The optimization process itself is very simple. You just take the cells with the protein and mix it with your captain of choice. And uh for variable periods of time, sometimes a half an hour, sometimes several hours, washout, washout the excess happen. And and you're done. So it's extremely simple process. Um and so we're using this approach for both.

Uh immunizing against cancer, which is I've already pointed out is extremely difficult and immunizing against a covid protein which is a lot easier. Obviously we have vaccines but which still is challenging to get a very strong immune response, particularly t cell response without having side effects. And so knowing all of this information, it really helps to be able to design these vaccines to target these cells and have the body understand how to fight this. What are the vaccines in development that are based on this process? Can I'd love to hear from you in terms of what you have in the pipeline right now? Sure, thank you. Uh Currently bio vaccines has two technology platforms that are based on the uh you know the optimization of uh cell proteins or antigens from tumors or or viruses. B. V. X 0918 A. Is our vaccine candidate for uh for treating ovarian cancer.

Uh And that is based on the optimization of ovarian tumor emergence. Bbx 03 to zero is a parallel program. Uh Also based on our optimization platform that is targeting uh SARS two virus um other optimized programs that we also have in development. They're not nearly far along as far along as uh on ovarian cancer and our source to program. But others that we're looking at or for HPV other corona viruses for that matter. Um And other you know, tumor types such as cervical cancer, renal cell carcinoma and melanoma. The beauty of the platform is that we're not just limited to treating one particular tumor type or one particular virus we've got the ability to throw the nest, so to speak very widely. Biology. How about a knowledge of next gen sequencing applications? You want to use those skills to influence change in the genomics market live in the west coast like to travel.

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That's gino bank dot io. Again, that's gino bank dot io for secure digitized vaccine record. And a lot of people have been learning more about vaccines with the covid 19 pandemic and learning about how those vaccines work. In terms of the M. RNA approach of vaccines like Pfizer Moderna, how is this different? Are there parallels to it for those that maybe understand the M. RNA process? How is it similar? Different. The they're quite different. But the similarities are that whether you're making an RNA vaccine or whether we are making a half organized vaccine. Everybody who's working on this so far is targeting one engine or one particular protein on on the on the SARS COv two which is a virus It causes to COVID 1919. And the name of the protein is the spike protein or s protein. So, uh everybody probably has seen if you look under a very powerful microscope and you look at this virus which is of course very tiny.

It has spikes coming spikes coming out of it looks like a crown, which is why they call them coronavirus. And the spikes in addition to being interesting are absolutely critical in the virus doing us harm because those spikes are the ones that attach onto the cells in the body, particularly for example, the lung, the lung cells. And once, once the virus is attached through those spikes, the virus can then enter the cell and then cause all kinds of trouble, including making people very sick, causing pneumonia and even in extreme cases causing causing people to die. So what we have in common with the RNA vaccine, it's the only thing that we have in common is that we're both using the spike protein. Um rather rather than uh injecting RNA and then having the the R. N. A. Get into body tissues and then have the body tissues make the spike spike spike protein. Um, we start with the purified spike protein, which of course we have to produce in a biological laboratory and then we have to analyze it and and and inject it.

So underlying it's the same. But technically it's it's quite a bit different. And there's been a lot of conversations regarding the safety concerns around vaccines. What are your thoughts and expectations for the safety profile of these happen? Ized vaccines. Yeah. Okay, so starting out with the cancer vaccines, we have a current version of the capitalized cancer vaccine that we're testing. But there was a previous version um that I tested and it was also tested by by a previous company which is no longer in existence. So, uh more than 500 patients have been uh injected with with the first generation have tonight's vaccine, Mainly people with melanoma, ovarian cancer and in 500 patients there have been no no serious side effects. In fact, the side effects are relatively trivial, just soreness and itchiness at the injection site. There have been no no no significant or serious adverse events.

So we believe that the new captain is cancer vaccine that by of access is developing which is a little little bit more complicated, little bit more sophisticated. Uh is going to have an excellent safety profile because we already have a lot of patient information. The R. R. Covid BbX uh B B X 03 to our Covid vaccine. Of course we haven't put into patients yet. So we don't know what the toxicity profile is going to be. However, we have done an animal study in in in mice where we got excellent immunological responses, anybody responses, t cell responses. So, despite protein by injecting our vaccine and there were there was zero toxicity in the mice the way you measure toxicity in mice. So that gives us a great hope and expectation that our our Covid vaccine is going to have an excellent safety profile in humans. Of course there's proof is in the pudding and we'll know as soon as we do the clinical trials.

But we're expecting this not to be a big problem. Excellent data to begin with. And just everything that you have with it. In terms of, you know, you've talked about developing this in the process for it. Is there any of a genetic aspect to this of looking at genetic sequences in terms of, you know, with the cancer side how cancer cells can have different genetics as opposed to normal human cells. Is that a part of it? Or is that completely separate and you're not focused on that because you're looking at the proteins? Well, I mean we're not focused on it technically, but genetics is behind everything. So if there is, if there's if there's an anti gene or protein on a cancer cell that elicits an immune response, obviously there is a genetics in that cancer cell that is making the self produced that protein. But practically our company doesn't need to be involved in the genetic, so we're not a genetics company. So we're starting with the proteins themselves. Um we're very interested in the genetics but we don't need to get into it. We don't need to understand it.

And because of because we were not involved with genetics, it makes our process simpler and and probably cheaper. Yeah, that's a good point because genetic can be so complex. So if you're kind of starting at that protein level, you don't need all of that background information on what's happening with the genetics and learn more about clinical genetics, molecular genetics and laboratory science, then you should check out the genetic assistant online training program at johNS Hopkins University School of Medicine by taking part in the program. You will be joining both national and international learners with the same passion for genetics interact directly with your johNS Hopkins instructors and fellow students throughout the program. Applications are now being reviewed for the fall 2021 Cohort and a limited number of spots are still available for more information. Use the link in our show notes. If you're listening to a podcast app, you can also access the link at DNA Podcast.com. We've all been out of restaurant where QR code is on the table to access the menu. It's the new normal for more than just restaurants though. QR codes are now rolling out for vaccine records.

California is starting the trend and more and more states are expected to follow instead of having your vaccine record card physically on hand, it's much easier to have a QR code saved on your phone. However, having this information in a central state database in California does raise privacy concerns. That's where gino bank dot io's Q R code design is innovative. That Gino bank dot Io solution offers more privacy and does not require storing records in a centralized hackable database. Instead, it uses Blockchain technology to protect your data and added bonuses. The QR code generated Is scannable by over six billion devices and it's accepted by the U. S. Department of Homeland Security and border agents across the globe to learn more about this protective QR code at Gino bank dot io. Again, that's Gino bank dot iO to secure your digitized vaccine record. We've been talking about just how things are in terms of the process and development side. Um, can can you share what are the currently available happen?

Ized vaccines and like what that looks like. Is this, are there any available at this point? Care? That's probably, I mean there's probably two parts to that, you know, question. Um the first being that, you know, there are currently a number of oncology programs uh with other companies that are based on the use of autologous cells. Which is what we're using in terms of creating our our our vaccines or cancer vaccines? Uh probably heard of it. Car T therapy, Heimerich androgen receptor. Uh that's derived from autologous T cells and uh you know, there are some currently approved products using autologous cells. So that's uh that is becoming much more uh well known in the field as of late. However, the concept and the practice of patronizing uh the tumor antigens or viral antigens were not aware of anyone that is doing this except for ourselves in this field. So we're it's a space that we believe that that we own.

We have filed a number of patents and have a fair amount of intellectual property that locks up the space for us and which is so exciting because this is a new way to develop a vaccine and we see just how important vaccines are, especially with this pandemic. We've all been impacted by vaccines. Um, you know, looking at The other side of it. Um usually we're getting a vaccine for prevention purposes to prevent us from having symptoms from COVID-19 for instance. But I was really intrigued to see that you're also developing a vaccine designed for people who have been diagnosed with ovarian cancer. Where are you at in terms of the stage of this vaccine, ken, did you want to chime in and just provide a little bit of information on the current status of that vaccine? D. V. X 0918 A. Which is our ovarian cancer vaccine. We're currently preparing that for a clinical study in the european union. We're working with our partner uh contract Development and Manufacturing Organization which is uh an outfit called bio Elpida and they're based in leon France.

Um we're working together now to build out the GMP bio production facility and to validate the production capability. We expect that to be completed by the by the end of this year. And in parallel with that, we should be ready to submit what's called the C. T. A. That's the european equivalent of the I. N. D. In the U. S. Uh late this year. Our plans for the clinical trial itself or for that beginning early next year in europe. And we're doing that together with the uh spanish pharmaceutical partner Pro Care Health of Barcelona. We're going to be a collaborating together on the clinical program development program and procreate will be marketing the vaccine in the european union once it is approved and very exciting because the treatment right now for ovarian cancer is not where we would want to see it, it's it's really debilitating.

And at this point there is not a lot of treatment options. So this is really to me groundbreaking because if we have more treatment options for people that have ovarian cancer, this could really change the course of, I imagine probably the symptoms, they may be experiencing longevity after being diagnosed. Um, and I haven't heard of anything like this before. Um, why why target ovarian cancer? From your perspective, I mean, there's a lot of different cancers out there. Was there a certain reason why ovarian cancer was higher on the list having been a clinician gave can probably address the, you know, the clinical aspects of that question better, you know, better than I. But in terms of the rationale for us uh selecting ovarian cancer as our initial target. You're right. I mean, it's ovarian cancer is a significant disease worldwide. Over 250,000 women are diagnosed with it annually. It's the leading cause of death from in fact, from Gynecologic malignancies in the us.

So, in terms of the the numbers of untreated patients and the severity of it, it made a lot of sense for us to target it. The other factor involved here is that the drugs that are currently used, the chemotherapeutic, they're marginally effective. And so there is an opportunity here for new therapeutic modalities are technology, whether it's whether it's happiness viruses or have two nice cancer cells, our platform technology. So although we're choosing certain diseases to start with there theoretically applicable to other diseases. So we could target other viruses and we can target virtually virtually any kind of cancer. Most of the work in the past, as I as I mentioned, um there's a lot of work that we did when when I was in in thomas, jefferson University and also a company that started from there. There's a lot of clinical work clinical trials with with the prior Captain Eyes vaccine. Most most of the work was in melanoma and ovarian cancer and the results were very promising that they were not controlled randomized controlled trials that were single arm trials.

But the results were promising and highly suggestive of improvements in survival in both melanoma patients and ovarian cancer that that received the vaccine. So, um, we we we've chosen ovarian cancer because we have some experience suggesting that it's going to work in that cancer. And secondly, because it's a terrible disease as are most cancers. And thirdly, although chemotherapy can produce very good results in maybe 20% 25% of patients, The other 75% do not respond and die of the disease. So there's a lot of room for improvement. So, um that's that's our reason for for choosing that if we're successful in the future. Our intention is to go after other cancer. We have kind of in our mind the list but certainly were still interested in melanoma, colon cancer or as an excellent target kidney cancer. But we could do virtually we could do virtually any cancer.

Just a matter of the resources of having the time to do the work. And the potential there is just it's hard to even imagine because if you're able to use this, as you said, this platform for varying cancer and then can move on to other cancers for treatment prevention. You know, so many different aspects there that we've touched on. Um that can really be life changing and could be a whole really new branch of medicine when we're looking at it that way. Um, in our last couple minutes I did want to touch space with COVID-19. And you know, we talked about that a little bit at the beginning. But what is the COVID-19 vaccine that you've been developing? Um how is that different from what we have right now? The code of ethics is as I described before, despite protein current virus, which is called SARS COv two, we make that protein or we haven't made for my contract manufacturing, it's gotta be made under special conditions so that it's absolutely clean and passes FDA specs, etcetera. But that protein is made for us, we put a happen on call Dinozzo fennel through a process that I described, which is very simple, that happiness protein is mixed with something called an immunological add event, which is a drug that increases immune responses that many other vaccines also used and just inject into the patient's muscle.

That's essentially the process. And we would probably uh anticipate um two injections similar to what you're seeing with the vaccines that are already being used. And with this type of vaccine would newer variants of COVID-19 that have been emerging. Would that vaccine be protective against those like the delta variant? I know a couple episodes ago we explored that on the show the different variants of COVID. Yeah, well, the two aspects that Number one for fortunately the vaccines that are currently available Um that you that use the spike protein used the original spike protein from the original virus that was first isolated in January of 2020. And um those vaccines so far have been have been have been pretty effective against all of the variants that have come up so far. So we think that our vaccine also would be however, it is very easy for us if there is a variant that arises um that that that that is resistant to the immune effects induced by the old call it spike protein.

We can pretty easily without any without much investigational work. Um take the new the variance by protein and make a new vaccine out of it and that can be done um at a fairly low cost in a fairly short amount of time. So we have just just as we have the opportunity to use many different kinds of cancers uh, to target with our happiness cancer vaccine, we have the capacity to target virtually any virus protein even even if it happens to be a coronavirus protein from, from a variant. Well, thank you so much both of you for coming on the show and just sharing all of this insight, there's so much buzz about vaccines right now and knowing that there are different types that are emerging like this is really encouraging to see and just everywhere that we're going with medicine. So if people want to learn more, they can go to bio vaccines dot com. That's B I O V A X Y S dot com.

And also there on twitter for company updates. If you're interested in learning more about the show, you can go to DNA podcast dot com. We have all episodes on there. So over 150 you can interact with us on social media by searching DNA today. Any questions for myself, can dr bird, you can email in, email is info at DNA podcast dot com and if you have a moment we would really appreciate you to rate and review on apple because that's how new listeners will find us and can learn more about genetics through the show. So thank you again, both for coming on the show. We really appreciate diving into these topics and really getting into the details of them. and really what's on the horizon and what we're looking at being new emerging technology and medicine. So thank you both for coming on the show. Thank you for having us. Do you want to influence change in the genomics market? Lucky for you. A new position just opened at Agilent where you can have an impact as a genomic software field application scientists in this west Coast remote based role. You will provide technical consultation training and education to enable customers to perform data analysis and clinical laboratory environments.

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#154 Kenneth Kovan & David Berd on Haptenized Vaccines
#154 Kenneth Kovan & David Berd on Haptenized Vaccines
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