Joseph Hernandez, Blue Water Vaccines: Developing Transformative Vaccines to Address Major Health Challenges

DocWire News recently spoke with Joseph Hernandez, CEO of Blue Water Vaccines, a company developing transformational vaccines to address significant global health challenges. One of the company’s lead candidates, BWV-201, is a live-attenuated intranasal vaccine for S.pneumoniae-induced Acute Otitis Media (AOM), which is planned to enter the clinic this year.

Mr. Hernandez discussed the company’s intranasal vaccine candidate and other exciting new developments Blue Water has in the pipeline.

DocWire News: Can you tell us more about your background and why you decided to start Blue Water Vaccines?

Joseph Hernandez: I’ve been lucky. I was able to really work with some amazing companies. Really the genesis of my path was my education. I have graduate degrees in molecular genetics and microbiology, and a degree in finance, and started my career at Merck, the pharmaceutical giant. And there I really had the experience of working with a well-greased machine, marketing machine, that has really the highest level of ethical standards and that was really … I was lucky. That was my foundational education to my biotech and pharmaceutical career.

From there I really went out to Silicon Valley, which was the next sort of phase of my career, which taught me how to be an entrepreneur, and how to work hard, and how to change paradigms. And I had the pleasure of working with a company at the time called Affymetrix, which is a company that developed the microarray and there they put a young 20-something year old to run their marketing department, so I headed up their marketing and we launched 12 different products, and built the company close to a $3 billion company.

And then from there came back east, after a couple of years at Silicon Valley, worked with a pioneering company in the area of HPV developing the first test for HPV and sold that company for 1.6 billion. And then that capital that we garnered from that I was able to use for doing my own spinouts and financing my own entrepreneurial ventures. And since then I’ve been lucky to have done 10 different spinouts from different universities and the latest venture, which is Blue Water Vaccines, which has its genesis of the spinoff from Oxford University.

Can you tell us about the company’s intranasal vaccine candidate for S.pneumoniae-induced Acute Otitis Media/AOM (BWV-201)?

Yeah, we’re quite excited about that program. Actually, as I mentioned earlier, the genesis of our company was a program that we had licensed from Oxford and the UK, and that was a … Or that is a universal flu vaccine, so that’s a vaccine that you should get once in your life, or the theory is, or the thought is, or the hope is it will vaccinate you for once in your life and you have full coverage for the rest of your life on flu.

The second program we in-licensed was a program out of St. Jude’s Children’s Hospital, which we have also a great relationship with. They’re a very ethical and just a great entity. The work they do is really amazing. And so they have been working for a while on a intranasal live-attenuated vaccine for strep pneumonia, specifically for use in otitis media, which is commonly known as middle ear infection in pediatric cases. If you have a child I’m sure you’ve experienced this in a not so positive way. So we thought it was an interesting program. We thought it had some additional applications in invasive disease and in lung pneumonia, so we in-licensed that program and we’re moving it to the clinic, and we’re quite excited about the progress there. It’s effectively a bacteria that we genetically modified so that it doesn’t cause disease but it allows the immune system to recognize it and generate mucosal immunity, which is really important in respiratory infections and deliver it through the nose. You get broad coverage for otitis media and other indications, that’s the goal and we’ll find out how efficacious it is as we move into the human trials.

Regarding its route of administration, why did you choose an intranasal vaccine?

Well it’s a natural infectivity path of bacteria. It turns out a lot of respiratory viruses and bacteria their first entry point is your nasal cavity. You breathe it in from the environment, and the natural infection of strep pneumonia is actually no different than this particular vaccine, so it’s actually using the natural mechanism of infectivity and we use it as a mechanism to really, again, generate mucosal immunity, which is really what you need for protection in this particular disease.

Would this vaccine be designed to treat all ages and ethnic groups? Or is there a certain group you want to target first?

Well we want to focus … The initial indication is in pediatric use, but obviously the elderly benefits quite significantly from a vaccine that treats respiratory infections that are commonly encountered in hospitals. And, of course, the invasive disease is also incredibly important in both pediatric and the elderly population.

What are your future plans for this vaccine?

Well we hope to move to clinical trial in the not too distant future and, again, beyond that seek for additional indications, additional claim, around invasive disease and around lung pneumonia. We’re looking to potentially partner it up with a large pharmaceutical company for commercialization, but we’re really focused on moving the clinical programs forward.

Can you tell us more about some of your other vaccine programs?

Yeah, so we have another exciting program that we in-licensed from University of Texas and it’s a chlamydia vaccine and, as you know, there are no vaccines for chlamydia. Chlamydia is an important sexually transmitted disease, primarily impacting women. Women that have prolonged infections develop pelvic inflammatory disease, which yields to infertility in many cases, so having a vaccine that addresses that we think it’s an important healthcare technology; so we’re focusing on getting the data necessary to move that program to humans. We’re doing some animal studies to confirm that in fact this bacteria, which actually happens to be also a live-attenuated bacteria but in this particular case we actually … It’s an oral administration, so you swallow it and it creates mucosal immunity in your gut, in your GI, and that immunity is transferred to other mucosal layers, including the vaginal walls in this particular place. So we think it’s an exciting program, it’s transformative. It’s akin to the HPV vaccines and we’re looking forward to moving that program forward as well.