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Blue Water Vaccines (BWV) is a preclinical stage developer of vaccines for the prevention of infectious diseases. They have exclusive licenses to intellectual property developed at the University of Oxford, St Jude’s Hospital and Cincinnati Children’s hospital. The company is a recent IPO, and the stock hasn’t done too well since they launched. I sat down virtually with Blue Water management, including CEO Joseph Hernandez, to discuss his company and what they have been doing.

At the forefront of their efforts is a universal flu vaccine. There are a number of flu vaccines in use today, but these have to be administered every year because the virus keeps changing. There is one universal flu vaccine in clinical trials today, but it is being run and sponsored by the US National Institutes of Health, and hence is currently uninvestable. 

Blue Water’s plan is to identify regions on the virus which do not vary from year to year. These are called epitopes of limited variability, or ELV, and if vaccines can target these, they may potentially enable protection against all strains of influenza. While the vaccine they are developing will require two doses “to focus the immune response on the regions of limited variability,” they will potentially provide life-long protection against yearly changes in viral strains. Some of the technology they are using has been licensed from Oxford, which is a major positive for the company.

Developing a vaccine takes millions of dollars and years of effort. While the company seems to possess exciting science, they are in quite an early stage, and they will need a lot more cash than they have right now before they can get an approval.

So there’s potential, but there are issues. Recently, I sat down virtually with Blue Water CEO Joseph Hernandez to discuss his company and what they have been doing. I asked him about the science, why they are focusing on BWV-102, a flu vaccine with somewhat limited applicability, and how they plan to fund their program. Here is our discussion:
 

ACP: Blue Water has inlicensed technology pertaining to influenza epitopes of limited variability, or ELV, from the lab of Dr. Sunetra Gupta of Oxford. Can you briefly discuss the science - what is an epitope? What is limited variability and how does it help develop broad spectrum vaccines? And anecdotally, how did you - an emerging biotech - acquire the license to this technology?

BWV: Our lead influenza (flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins of antigens, with cross-reactive properties, that enable the potential development of a universal flu vaccine.

Our exclusive license agreements include patented influenza epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered by Dr. Sunetra Gupta and her team at the University of Oxford.  Joseph Hernandez, is a serial entrepreneur and through much due diligence recognized this technology to have the capability to develop a potential transformational universal flu vaccine with long term immunity.

(More Technical) In 2007, Sunetra Gupta led a group of researchers at the University of Oxford who published a proprietary mathematical model proposing that the single strain dominance, typically seen worldwide annually, could be explained by hypothesizing that epitopes of ‘limited variability’ exist (Antigenic Drift Hypothesis). The model hypothesizes that while there is a significant amount of mutation of influenza strains, this variability occurs in a specific portion of the virus, while certain epitopes are required to remain relatively constant and are more limited in their variability in order for the virus to infect individuals, thus clarifying how influenza is not as variable as commonly thought. 

ACP: You have a second asset, the Norovirus shell and protrusion (S&P) nanoparticle vaccine platform, which you licensed from Cincinnati Children’s Hospital Medical Center, or CHMC. Again, please briefly describe the science. How does this tie up with the ELV platform?

BWV: The S&P platform combines two or more immunogenic components, a norovirus antigen plus at least one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity.  There is a S and P domain that allows us to attach other antigen(s) such as ELV flu to create potential vaccines.  We are currently researching the broad capability in other indications as well such as malaria.

ACP: How does your third asset, the S. pneumoniae vaccine candidate you licensed from St Jude’s, find synergy with the rest of your program?

BWV: BWV-201 is a live attenuated serotype-independent intranasal vaccine candidate for S. pneumoniae induced AOM. This means there should be broad coverage of multiple strains and enhance immunity.   AOM is infection in the middle ear, typically of young children, and can cause long term damage.  This asset was also recognized by Mr. Hernandez as having potential to access large market in a high unmet need space.

ACP: Please discuss your clinical trial plans. When do you plan to bring your first program to the clinic? 

BWV: Currently we are a preclinical pipeline company.  We are constantly learning more and optimizing to make sure our assets are the best possible.  We plan to enter at least one program into Phase 1 in 2023.

 

ACP: How does your BWV-101 program differ from BWV-102? What prompted you to use BWV-102 - which is limited in scope - as proof of concept for BWV-101? Why not run with BWV-101 instead?

BWV: BWV-102 is exploring the H1 ELV for a potential stand-alone flu vaccine.  This is what most common flu strains derive.  BWV-101 would like to include ELV from all flu strains such as H1, H3, Flu B for broader immunity. 

ACP: Please discuss your cash position. A typical clinical process will take 5-6 years and millions of dollars. How do you intend to fund your operations - through debt, dilution, or partnerships?

BWV: BWV is opportunistic in seeking funding and business development initiatives to position the company with a secure balance sheet and the ability to continue development of our vaccine programs.   We are committed to executing and building value for all stakeholders.

ACP: Lastly, can you discuss the total addressable markets for your various candidates and key differentiating factors? 

BWV: When pursuing assets, we considers multiple factors including addressable markets with differentiated products that are sizable and justifiable to invest in the long-term development.  For instance, our flu program, BWV-101 and BWV-102, leverage the proprietary ELV that are cross-reactive and should provide better longer immunity than the current flu shots that are available.  Our S&P norovirus platform is versatile.  It has the ability to carry either a large antigen or multiple antigens to target up to 3 potential different viruses.  And BWV-201, is live attenuated and stereotype independent, therefore it may potentially be able to present a broad immune response to multiple virus strains.  

Blue Water is doubtless doing interesting science. Unlike a lot of emerging biopharma, they have managed to secure license to technology with convincing pedigree. They have some preclinical proof of concept data, and they have enough cash to last them for a few quarters. The flu vaccine market is a large market, and it has an unmet need which can actually make it much larger. While we do not invest in newly launched companies with preclinical stage assets, I will be sure to keep checking BWV for developments.

Blue Water Vaccines competes with Moderna (MRNA), Pfizer (PFE), Johnson & Johnson (JNJ), Novavax (NVAX), AstraZeneca (AZN) and other vaccines producers.

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