Episode 50: Steven Reed - Co-Founder & CEO at HDT Bio

What does it take to revolutionize the world of vaccines and touch lives across the globe? Join us on a riveting journey with Steven Reed, CEO and co-founder of HDT-Bio, as we explore the creation of the first refined tuberculosis vaccine and dive into the remarkable strides in RNA technology. This episode lifts the veil on the science that could redefine global health.

First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder. Episodes launch weekly on Tuesdays. To view the full transcript of this episode, click here.

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Transcript

Speaker 1: 0:07

You are listening to First In Human, where we interview industry leaders and investors to learn about their journey to inhuman clinical trials Presented by Vile, a tech-enabled COO hosted by Simon Burns, CEO and co-founder, featuring special guest host Rich McCormick, EVP of Clinical Strategy and Head of Oncology. In this episode, we sit down with Stephen Reed, co-founder and CEO at HDT-Bio, to explore the groundbreaking journey of vaccine development and the evolution of RNA technology.

Speaker 2: 0:46

Hi, I'm Rich McCormick, executive Vice President of Clinical Strategy, here at Vile. Today I have the pleasure of welcoming co-founder and CEO HDT-Bio, steve Reed to our First In Human podcast. Hi, steve, thanks for joining us. Thanks, rich, it's a pleasure to be here. Awesome, let's jump right in. Your contributions to vaccine research have been wide-ranging. Could you share some insights of your work, particularly interested in hearing about the development of the first-defying tuberculosis vaccine.

Speaker 3: 1:19

Sure, that was a wonderful project that we started with the NIH support back in the 90s. The idea was BCG, widely used as a vaccine around the world to prevent what is still the single largest killer of infectious diseases in the world TB. It was not really doing much. We needed to apply modern technology. Therefore, we set about finding the proteins in tuberculosis that could be used for vaccines. We partnered with SmithKline Beecham now called GSK to support this project. Along the way we helped them with adjuvant development as well as protein development. The result was after 10 years or more, I was always an M72 vaccine. That is currently moving forward. That's phase two. The phase two data were very good, showed that you could prevent TB. It was a good beginning. No one at the time knew that defined proteins could actually be protective. We thought we'd have to use whole bacteria, for example, like the old viral and bacterial diseases. That was a big breakthrough in infectious disease vaccines. It's still going with Gates Foundation support.

Speaker 2: 2:27

That's awesome. After 25 years of biopharmaceutical research. What inspired you in 2019, to establish HDT Bio?

Speaker 3: 2:37

Oh Rich. The experience with vaccine development, especially with global health, led me to the conclusion that technology was critical, but technology itself had to be chosen based not only on can it do the job, but can it be made locally, can it be made in a cost-effective way? Otherwise, the vaccines would not be available for the people that need it. We'd worked on adjuvants and proteins for decades. We decided to take that knowledge and apply it to RNA. But let's see, seven or eight years ago by 2019, we had a good idea of how to make RNA better than what was currently ongoing.

Speaker 3: 3:21

What's the unmet need is T cells and stability things that you need for these next generation vaccines, including those for cancer. Without abandoning our experience with protein vaccines, we just segued upstream to RNA, which actually coats for the proteins, in an attempt to improve the technologies for unmet needs and vaccines that we don't have yet today. We saw the potential RNA long before COVID came. Even though companies were largely failing with the RNA technology, we knew we could make it better. Covid came alone and showed that there is at least one way that RNA vaccines can actually save a lot of lives, so that was a good boost for our platform.

Speaker 2: 4:02

Steve, would you mind telling us about HDT bios COVID-19 vaccine, which is known as HGC019? Sure.

Speaker 3: 4:10

Actually, it's the first self-amplifying RNA vaccine to get approval and really the approval so far has only been in India. Recently, our tourists. Another self-amplifying RNA platform received approval in Japan. So so far this relatively new type of RNA, which we call self-amplifying RNA or REP RNA, has had limited uptake. But it's getting there and that's what distinguishes us from the current vaccines from Moderna or Pfizer, for example. The self-amplifying RNA has some advantages around the ability to induce a different kind of immune response, as well as being able to be used at very low doses. And what we're already focusing on, rich, is a very safe RNA platform. We don't want any side effects, especially those that are currently associated with RNA vaccines.

Speaker 2: 5:02

Great thank you for that. Hdt's Amplify is the exclusive vaccine platform used by the Prevent Cancer Program at the NCI. Could you elaborate, steve, on how it has the potential to revolutionize vaccine development? Sure?

Speaker 3: 5:17

Rich. As I said, we've developed this platform over the several years to try to fill the gaps that current RNA platforms aren't necessarily provided, in terms of both clinical applications and practical considerations. What we've seen in head-to-head comparisons with the so-called current RNA vaccines from Pfizer and Moderna is that we have the ability to induce stronger T-cell responses. T-cells are the branch of the immune system necessary for fighting cancer and for preventing cancer. With the Prevent Program, it's a visionary effort with the National Cancer Institute and the White House has supported this.

Speaker 3: 5:58

The visionary aspects are identifying early-stage markers that can be used to prevent cancer in the first place. So, obviously, if you're going into healthy people that might just have a marker and a risk, you don't want any side effects. You don't want any vaccine platform that can create health hazards because they're not patients at this point. They're healthy individuals you're trying to prevent from becoming patients. So the safety aspects of our platform is the most important of all and secondly, the ability to induce anti-cancer T-cells is the reason that I think NCI has been excited to become excited about our platform.

Speaker 2: 6:40

Interesting. You mentioned being cost effective a time or two so far. Maybe could you outline how HGTBio approaches this topic on the global scale, and sure it is much more challenging than it may seem.

Speaker 3: 6:56

Sure, there are several aspects to it Rich. One is that you want a platform technology that can be implemented on site in different countries. I lived and worked in Brazil for five years and, just like anywhere else, they are very interested in building up their own industry and not importing everything that they have to use for medicines. Transferability on site look production is one aspect. Secondly, stability it can be chipped around to different sites without having to use ultra low temperatures is another important aspect. Thirdly, using a very low dose enables you to have a cost effective approach, because you're using less of the vaccine, so it doesn't cost as much to make it.

Speaker 3: 7:38

I like to use a phrase that I borrowed from White Coat Rebels, a documentary not too long ago about insurance reimbursements and cost of medicines in this country. We think that no one should be sick because they're poor, but also no one should be poor because they're sick. Obviously, it's a huge problem in this country. Cancer therapies can cost hundreds of thousands of dollars. We think there are better ways to approach certain cancers that will be implemented in a way that doesn't cause someone to lose their home just because they have cancer.

Speaker 2: 8:15

Sure. Your company's approach, as you mentioned, involves regional partnerships for manufacturing and also for clinical development. Could you provide maybe some examples of those successful partnerships that have allowed your immunotherapy is to reach patients around the world?

Speaker 3: 8:32

Yeah, sure, early on we partnered with a longstanding collaborator in India, junova. That was able to take our recipes and move very quickly forward to launch a clinical program in India with self-amplifying RNA vaccines and led eventually to approval. We've had great experience working in Brazil and with their local regulatory agency, which is Mvisa. Like the FDA, we transferred technology to a group there that already had the ability to make vaccines. They quickly were able to take this process and implement it locally. Same thing happened in Korea with a company called Coradus, which is really unique. It's the first company in the world founded primarily on its ability to make a TB vaccine that they license from us tuberculosis Not a huge problem in South Korea, but it is a great problem in North Korea. There's still hope and talk of reunification someday. The company Coradus has also already made our RNA vaccine locally Interesting.

Speaker 2: 9:36

Last question for me, two parts. One is what excites you about the future of HGTBio a broad question. Second part of that is what message or advice would you like to give to the broader community of professionals and entrepreneurs that might be listening, that are involved in clinical research and biotech?

Speaker 3: 9:55

Well, the first part of the question. What excites me, rich, is look, I've been working in cancer target identification for almost three decades. What excites me is All the work that we did back in the 90s and 2000s with Big Pharma to identify tumor markers. But we could not produce those markers as protein. We could not produce those tumor vaccine candidates as proteins. Rna changes, all that RNA makes it possible to create vaccines that could never be made before. As I already mentioned, they can be made in a cost effective way safe and cost effective. That excites me tremendously because we're almost reinventing the whole cancer vaccine industry. It was very exciting back in the 90s dropped off because of technical issues, but never dropped off from proof of concept issues. Now we've got checkpoint inhibitors, for example, that are blockbuster drugs. They help stimulate the immune system. So if you combine that with a new vaccine platform, wow, then you've got a real combination. That's what excites me.

Speaker 3: 10:54

Immunotherapy for cancer. We have a whole society for immunotherapy of cancer. It's booming, and my advice is I don't do something you're passionate about, not just commercially interesting, but you're passionate about, because your team is going to perform much better if they know they have a very important reason to be doing the work they're doing and, you know, try to be patient. Our model is a little different than most biotech companies. I've created two other biotech companies in the past with venture capital money. That's interesting, but it also means you lose control and your company just gets sold when the time is right. Well, we've taken in a lot of grants and contract money so that we can work at our own pace and keep control of the company, and I think that's the model I prefer, after exploring other ones as well.

Speaker 2: 11:42

That's a great take and great advice. So, Steve, it's been a pleasure meeting with you today and thank you for being a guest on Bios First in Human podcast. Our team here wishes you and your team at HGT Bio Nothing but future success.

Speaker 3: 11:56

Appreciate it. Thanks very much, and have a great holiday and happy New Year.