As mosquito season kicks into high gear and the threat of Zika transmission in the United States grows, the global health community is grappling with how to address not only the potential for large-scale outbreaks in the near-term but the possibility that Zika will linger as an on-going threat, similar to West Nile virus, for years to come.
More than 15 companies and public-health organizations have publically stated that they are working on Zika vaccine candidates with some shooting to advance into Phase 1 studies by early next year. We recently connected with Nima Farzan, CEO of California-based PaxVax to talk about the company’s Zika vaccine candidate and some of the challenges of addressing fast-moving and unpredictable threats.
Founded in 2007, privately held PaxVax is emerging as a global player in the specialty vaccine industry with a current focus on the travelers market. The company closed out 2015 with $105 million in new funding and is awaiting word from the FDA on its cholera vaccine, Vaxchora, which was granted a priority review action date of June 15th this year. If approved, Vaxchora will be the only vaccine against cholera available in the United States.
PaxVax currently markets the typhoid vaccine Vivotif which it acquired, along with a Swiss manufacturing site, from Johnson & Johnson’s Crucell business in 2014. In addition to Zika, typhoid and cholera, the company has vaccines at various stages of research and clinical development for anthrax, HIV, adenovirus and hepatitis A.
Q: Earlier this year, PaxVax joined a number of other companies in the race to develop a Zika vaccine. How’s it going?
That’s right. In February we announced the initiation of our Zika program which is based in our San Diego R&D site and being led by PaxVax CSO, Dr. Jonathan Smith. We are really pleased with the progress to date and are currently in the preclinical phase and gearing up for animal studies. Assuming all goes well, we could be kicking off Phase 1 studies by early 2017.
Q: What made you decide to tackle Zika?
We have invested in research looking at other Flaviviruses and felt strongly that we could build on this work to quickly develop a viable candidate for Zika. It’s not a huge pivot for us and fits squarely into our sweet spot.
PaxVax was founded in 2006 to address concerns of pandemic preparedness spurred by the H5N1 influenza outbreak. At that time, and it’s still true today, there was a real gap in global immunization readiness. Tackling threats like Zika is why PaxVax was started.
Q: What technology platform are you using?
Our vaccine is being built on a VLP (Virus-Like Particle) platform which we think will offer a robust and safe option with rapid immunogenicity. VLP platforms have seen solid success and safety in other indications so we wanted to build on that. VLP-based vaccines also allow for faster development because you don’t have to deal with live virus and all the complications that come with attenuation. This is not a trivial issue when you consider one of the primary target populations for the vaccine is women who are considering pregnancy. We believe that a VLP approach will allow us to develop a safer, more effective vaccine faster.
Q: What are the biggest hurdles that vaccine developers face with a real-time threat like Zika?
When you’re chasing new threats like Zika you are inevitably behind where you want to be and that’s frustrating, especially when you know you have the capacity to develop a solution and there are people who will be affected while the vaccines are being developed and tested. But you can’t rush development, especially the clinical trials which are vital to demonstrating safety and efficacy in vaccines.
The bigger challenge, however, is that we keep finding ourselves in a position where we are starting from scratch. We need to be much more proactive in our approach to preparedness so that the cupboards are not bare every time we are threatened by a new pandemic.
Central to this are better incentive programs that allow companies to develop vaccines for which there is currently no market. Imagine if I went around asking for money to develop a vaccine for Zika five, or even two years ago? I’d be hard pressed to find anyone willing to give me a dime. Pandemic preparedness is one example of where market dynamics do not serve the public good.
The tropical disease Priority Review Voucher program, NIH and/or BARDA grants, and NGO funding are a start but are currently being co-opted for use in pandemic preparedness, none were designed specifically for this use. We can do more.
Industry has a role to play here too, but we need NGOs, global health organizations and government agencies to work together to create the policies and incentives that support development before there is a market. With incentives created to support this kind of preparedness we could fund more early-stage, even phase-one and –two development across more pathogens so when they do blow-up, we aren’t starting from the very beginning.
I am hoping that this is a wake-up call that allows us to bring all the stakeholders to the table and have real conversations about what’s not working and where we need to be in terms of establishing programs focused on preparedness. And, not just emergency response and research, but in how we can support the biotechnology industry that bears almost all of the risk in developing the diagnostics, vaccines and medicines that are required for sustainable management and protection against pandemic pathogens.
Q: Is this a call to action?
Yes, absolutely. And this is something many in industry are calling for.
Q: What’s next for PaxVax?
There is no shortage of nasty pathogens in the world so you can be sure that we’ll be keeping busy developing new vaccines to help protect people wherever they are and wherever they go.