Like most academic scientists, Mark Slifka wears many hats – principal investigator, grant writer, manuscript editor, manager, and administrator, to name a few. Perhaps less common is his entrepreneurial “hat.” Dr. Slifka is the president and Chief Scientific Officer (CSO) of Najít Technologies, Inc., a clinical stage startup company based on a platform vaccine technology that he developed at OHSU’s West Campus.
Najít’s platform uses a novel, patented approach to inactivate viruses while still maintaining their key immunogenic structures. This technology is unique in comparison to other vaccine technologies because the inactivation method employed uses oxidation instead of alkylation or cross-linking by formaldehyde. The oxidation method is simple, safe, and more immunogenic than other more outdated vaccine approaches.
- Simplicity in process means that the platform will be easier to get through the appropriate regulatory processes.
- This technology is safer for clinical development, since it uses inactivated viruses instead of live viruses.
- The vaccines produced are more immunogenic, meaning that the vaccine is better recognized by the immune system, which triggers an improved immune response.
Najít’s pipeline currently includes vaccines for Yellow Fever, West Nile, and Dengue viruses, which have SBIR, U01, and R01 funding to perform clinical-grade manufacturing in addition to an NIH contract to perform a Phase I clinical trial of their current West Nile virus vaccine. Part of Najit’s success is due to how the company chooses its pipeline. Some factors considered are:
- Unmet clinical need/market size (e.g. neglected diseases, populations in developing countries, international travelers)
- Feasibility (e.g. Is a vaccine seed available, and can it be manufactured on a large scale?)
- Cost effectiveness (e.g. Can the end user afford the treatment?)
- Funding options (e.g. Do any grant-giving institutions prioritize this type of research?)
This is exemplified in the newest addition to the Najít pipeline, the chikungunya virus (a.k.a. “CHIK-V”). CHIK-V has spread rapidly in the western hemisphere since late 2013, starting in the Caribbean and moving to South America, Central America, and even to Florida. Slifka is collaborating with several talented virologists including Dr. Michael Diamond at Washington University-St.Louis, and Drs. Dan Streblow and Vic DeFilippis at the Vaccine & Gene Therapy Institute. CHIK-V largely affects underserved populations and developing countries and has been identified by the National Institute of Allergy and Infectious Disease as an emerging global health concern. Furthermore, an attenuated vaccine seed exists and the virus grows well in tissue culture. Thus, CHIK-V is a good candidate for Najit’s future vaccine pipeline.
Najít Technologies’ funding situation is rare among startup companies. They have raised more than $19 million to date from non-dilutive sources, mainly through grant money and service contracts. This is advantageous for Najít because they plan to de-risk their vaccines through Phase I and Phase II trials, which will make them more valuable to large Pharma companies who can carry the vaccine candidates through Phase III trials and commercial production. Successfully completing mid-stage trials through non-dilutive sources is impressive in itself, but, more importantly, completing this stage of development will greatly increase the value of the vaccines making them more attractive to investors or collaboration partners. As a result, Najít could have a broader array of exit options, including sub-licensing their technologies to other companies, acquisition by a larger company, or continuing to grow Najít under Dr. Slifka’s current management team.
Mark Slifka joined OHSU in 2001. Prior to that, he trained at both UCLA and the Scripps Research Institute in La Jolla. Dr. Slifka spent the first year of his graduate training at UCLA doing research and taking core courses in addition to working part-time performing literature searchers for a local biotech company, which sparked his initial interest in entrepreneurial activities. However, Dr. Slifka credits his graduate mentor, Dr. Rafi Ahmed, director of the Emory Vaccine Center, for teaching him the mindset that, instead of starting every experiment from scratch, use simple tools to solve more than one complex problem at a time. This approach has ultimately led to his company’s success as they utilize their peroxide-based platform technology to make multiple vaccines against multiple infectious diseases of global importance.
When asked if he would engage in other commercialization or entrepreneurial activities based on his experience with Najit, Dr. Slifka jokingly replied that it has been, “Painful. And exhausting, and a whole lot of fun,” and he would definitely do it again, if the right opportunity presented itself. On that note, Dr. Slifka also offered some advice to fledgling entrepreneurs:
- Hire only the best
- Apply for grant money to advance your technology in its early stages
- Talk to people who are knowledgeable in your target area – gathering good advice is key
- Do your homework on potential market size and filling unmet needs
Najít Technologies, Inc., currently holds two patents on their HydroVaxTM vaccine technology. They received their second patent on May 6, 2014, which was, very fittingly, the exact 10-year anniversary of Najít’s incorporation.