March 5, 2018 (Rockville, MD) – ABL, Inc. (ABL) is working with Najít Technologies, Inc. (Najít) to advance the development of Najít’s novel HydroVax™ vaccine platform. ABL will utilize its GMP manufacturing expertise for the advanced development of virus-based vaccine candidates to protect against a number of emerging and re-emerging infectious diseases. The scalable GMP process will be based on Najít’s proprietary platform designed to optimize immunogenicity through use of inactivated viruses.
Under the agreement, ABL will produce multiple vaccine candidates using Najít’s HydroVax™ technology. Services include process development, production of well-characterized virus seeds, bulk drug substance and aseptic fill/finish. Currently, four vaccines are in development for protection against Chikungunya virus (CHIKV), Zika virus (ZIKV), Dengue virus (DENV) and yellow fever virus (YFV) infections. ABL previously worked on Najít’s platform technology for a YFV vaccine and will look to leverage the existing processes and protocols established at ABL to streamline development of an effective new YFV vaccine, as well as subsequent vaccine candidates.
The Najít platform is aimed at enabling more rapid vaccine development using a novel oxidation-based vaccine production system, HydroVax™. This exciting new platform uses hydrogen peroxide to inactivate viruses and other microbes, while maintaining neutralizing epitopes and inducing strong immune responses. Other advantages include vaccine formulations with improved stability at room temperature with the potential to eliminate cold chain requirements. This is especially important for vaccine storage and availability in endemic countries with little or no cold chain infrastructure, and these inactivated vaccines provide a safety profile that is suitable for immunizing vulnerable or immunocompromised populations.
This program has the potential to establish a platform process for Najít’s technology, which would promote more rapid development of vaccines when needed most. “As new emerging diseases surface every year, some are causing pandemics for which the traditional product development timeline of 5-10 years for an effective vaccine will be woefully late, as with the recent Zika and Ebola outbreaks,” ABL’s President and CEO Dr. Thomas VanCott reflected. “ABL has been working to prevent emerging and reemerging diseases for decades, and we offer our deep expertise in viral vaccine process development and GMP production to bolster Najít’s candidate development.”
According to the CDC, more than $3.6 billion was spent to fight the 2014 Ebola epidemic, yet over 11,000 people died. Only a few years later, the 2016 Zika outbreak resulted in more than 217,000 cases with a short-term economic impact in the Latin America and Caribbean region of $3.5 billion (Colon-Gonzales, et al. 2017 PLOS), highlighting the need for rapid vaccine development platforms.
The vaccine platform technology at Najít fits this unmet need, with the ability to generate new vaccines quickly.
“Our primary focus has been to rapidly develop vaccines against potentially dangerous viruses that impact many developing countries and are encountered by international travelers,” noted Dr. Mark Slifka, President and Chief Scientific Officer at Najít. “For example, CHIKV is known to cause painful arthritic disease, but you may not realize that in 2017 it also killed about 1 out of every 1,800 infected people. Zika, on the other hand, needs no introduction as many people have seen how devastating this virus can be, especially among pregnant women in terms of causing terrible birth defects including microcephaly.”
Slifka noted the importance of having the right partner. “We were very selective in identifying a qualified partner on these projects and we are fortunate to be working with such an experienced cGMP manufacturer as ABL. Developing safe and effective vaccines is a complex process and through our knowledge of vaccine development, coupled with ABL’s manufacturing expertise, we are looking forward to bringing several new vaccines to the clinic.” Slifka went on to say, “Based on the success that we have had with ABL, I believe that we are ready to tackle even bigger problems. Influenza for example, has been on our radar for some time, and our latest preliminary data indicates that we may be on the verge of solving the flu puzzle by developing a greatly improved seasonal flu vaccine in addition to designing a novel form of universal flu vaccine with the potential to prevent future pandemics.”
ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL has extensive experience working with diverse organizations including industry, government and academic entities. ABL maintains GMP facilities meeting U.S. and European regulatory standards, providing process and assay development, cGMP manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC bioanalytical testing. Our U.S. and European immunological and molecular laboratories support clients’ preclinical and GCLP clinical sample processing and testing needs. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.
Najít Technologies, Inc. is a clinical-stage vaccine development company founded in 2004. The company’s platform technology, termed HydroVax™, relies upon a proprietary approach of using oxidation-based inactivation of viruses to produce inactivated vaccines with improved structural integrity and enhanced immunological potency. The Mission of the company is to develop safe and effective vaccines against infectious diseases of global importance.
For more information visit http://www.najittech.com.