Early last month, it was announced that our fair city of Cambridge, MA, had attracted yet another up-and-coming biotech company, Vaxxas Inc. (MassHighTech article). Vaxxas is a spin-out from the University of Queensland, Brisbane, Australia, that is developing the Nanopatch™, a one-centimeter square micro-patterned silicon chip that, with a spring-loaded applicator, delivers a vaccine dose into the skin (nice pictures at Vaxxas). The advantages of the technology are that it may allow the use of less vaccine per dose (may be 100x), require less training to administer, and not need refrigeration before use, all good for mass immunization campaigns in under-resourced areas. Those familiar with vaccine practicalities will recognize the Nanopatch as the latest in the evolution of technologies to deliver vaccines and injectable drugs in general that avoid syringes which are fragile, wasteful, dangerous (to the administrator), and scary (to some recipients). The most numerous of these alternatives are various liquid injectors that a use stream of gas to propel the med into or through the skin, e.g., products made by Bioject Medical Technologies, D’Antonio Consultants, AcuShot, Injex, and PharmaJet. Another approach and the only one used with a commercially-available vaccine (Sanofi’s influenza vaccine) is a microneedle made by Becton Dickinson (Soluvia). Other technologies in development are microneedle arrays by Zosano Pharma (Zosano) and by a team at Georgia Tech (GEN article) and a miniature solid dose injector by Glide Pharma (Glide). One projection puts the market for these alternatives at $4.4 billion by 2022 (Visiongain Research Report 2012).
Various groups in the international public health community has been promoting the development of liquid injection technologies for global health use since the mid-2000s with PATH and the WHO being the most active (PATH Projects). For example in the past two years, PharmaJet had received funding to develop its technology for global health use from several sources: a Gates Grand Challenges award, a Centers of Disease Control SBIR II, a US Army CRADA, and a $15.5-million, five-year grant jointly awarded to Inviragen by the NIAID (PharmaJet PR). However, other than being tested in many pilot studies, the alternative technologies have not been adopted for routine use. A recent WHO bulletin cited 90 clinical trials of intradermal delivery against 11 diseases and provided a number of possible reasons limiting wider use (Hickling et al. 2011):
- uncertainty on the equivalence of protection between the intradermal and subcutaneous and intramuscular routes of injection;
- uncertainty on which vaccine is appropriate;
- lack of clear cost benefits;
- need for manufacturers to reformulate vaccines and redesign packaging lines; and
- regulatory approval.
In fact, Pharmajet’s launch of its FDA-approved injector was tripped up by a regulatory problem. When its partners, several retail pharmacies, started touting “needleless shots” for the 2011 ‘flu season, the FDA pointed out that, while the device was approved, the use of the device with a particular vaccine requires separate evaluation and approval (Govtech article and FDA Questions).
So Vaxxas faces challenges in commercializing its Nanopatch. On the technical side, the company will need to jump from demonstrating induction of an immune response in rodents (which have pretty tough skin) to humans (according to Vaxxas, their applicator design “addresses variations in the skin by exploiting our knowledge of the skin’s mechanical properties to achieve uniform penetration and delivery across the natural variation in a patient population,” Vaxxas Technology). On partnering with vaccine makers, its move to the Boston area helps both by being closer to a major investor (it occupies a suite in the HealthCare Ventures offices) and in gaining visibility with potential partners, like Novartis’s vaccine division, which is down the street. And its new CEO, David Hoey, a local biotech guy, has lots of deal-making experience.
A bigger challenge, and one that I may be the only one thinking about, is how the company will license its technology so it may improve the health of the greatest number of people, especially those in the low- and middle-income countries. As I wrote in a previous blog (“Starting Uphill”), I think small companies with innovative enabling technology (that is, not a product but technology that enables the development or use of products, like a drug delivery or manufacturing platform) should sell product-specific licenses and not licenses for broad use, e.g., for vaccination against a certain disease. Of course for Vaxxas, this non-exclusive type of licensing will not be as lucrative as exclusive licensing, but it would allow a much wider use of the patch technology including by companies that specialize in low-cost, global health vaccines like the Serum Institute of India. Alas, it appears that Vaxxas is not on this track. At the same time the company announced its move to Cambridge, it also announced its first corporate deal with Merck in which it will receive an upfront payment and research support and milestones and royalties on a Merck vaccine for an undisclosed disease and will grant options to Merck for use of the patch with two other diseases to be negotiated (In Vivo Blog). But it is not too late for Vaxxas to modify it partnering strategy since there are lots of existing vaccines and some in development for global health where the patch technology may have significant benefit. Vaxxas could easily set up a low-fee piloting program to allow vaccine manufacturers to do proof-of-concept tests with the Nanopatch and their vaccines with an option to license at predetermined terms. Looking at the Vaxxas board, all of whom have lots of experience in first-world biotech mega-dealing, I’m not hopeful they will see the good in this approach. I did note, however, that the Mark Kendall, the company’s scientific founder, may have an interest in increasing vaccine access. He is the principal author on a paper titled “Improving the reach of vaccines to low-resource regions, with a needle-free vaccine delivery device and long-term thermostabilization” (Chen et al. 2011).