Small Business Innovation Research (SBIR) Small Business Technology Transfer (STTR)
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Steve Hoffman

"NIH SBIR funding provided Sanaria with critical early-stage dollars to get our lead vaccine off the ground. Without this funding, Sanaria would have never gotten started and our malaria vaccine would not exist. No other investor would have provided money for this type of high-risk research."

– Dr. Steve Hoffman, CEO of Sanaria

Founded in 2003 by Dr. Steve Hoffman, Sanariaexit disclaimer iconis a biotechnology company that is working to eradicate malaria through vaccination. Malaria is an infectious disease that kills 0.6-1 million people each year and sickens hundreds of millions more. This tremendous burden of morbidity and mortality is caused by a parasite transmitted by mosquitoes. The disease also levels a heavy economic toll on many developing countries, especially in Sub-Saharan Africa and South Asia.

The Beginnings of Sanaria

After leaving his position as Senior Vice President at Celera Genomics in August 2002, Hoffman received a Phase I Small Business Innovation Research (SBIR) grant that allowed Sanaria to move into a small lab space in Rockville, Maryland. Two more Phase I awards followed, and all three initial grants were successfully converted into Phase II SBIRs from the National Institute of Allergy and Infectious Diseases (NIAID), totaling approximately $10.75 million in funds. Work on developing a first-of-its-kind attenuated whole parasite malaria vaccine greatly accelerated as the company grew in personnel and capabilities. Sanaria’s research focuses on developing a live attenuated malaria vaccine consisting of sporozoites-the stage of the parasite that is normally transmitted by the bite of the mosquito. With NIH SBIR support, Sanaria has produced an aseptic, purified vaccine that protects individuals against malaria parasite infection, prevents disease, and has the potential to protect communities against the spread of infection.

Sanaria's Social and Medical Impact

The company's lead product is Sanaria® PfSPZ Vaccine which is currently undergoing clinical evaluations at five study sites in the United States, Mali and Tanzania. It will soon be further tested in Equatorial Guinea and Germany.

 

Sanaria mosquitos

Sanaria mosquitos (pictured above) and mosquito dissection (picture below)

mosquito dissection

These clinical trials are being done in collaboration with teams from NIAID, University of Maryland, University of Bamako, Ifakara Health Institute, Swiss Tropical and Public Health Institute, Naval Medical Research Center, Walter Reed Army Institute of Research, Equatorial Guinea Ministry of Health, Marathon Oil, and the University of Tübingen. Each team has acquired the funds for the clinical trials they are conducting.

Sanaria’s goal is to make a significant social impact with its vaccine by preventing malaria infection and disease among all individuals living in a severely affected area, thereby blocking malaria transmission and eliminating the disease. Other key beneficiaries of the vaccine will be travelers, military personnel, aid workers, and others who are exposed to malaria while in affected areas. It is anticipated that the vaccine will be made available and affordable for populations most in need through direct sales to international organizations like UNICEF, the Global Fund, and GAVI, that will oversee the distribution of the vaccine.

PfSPZ Vaccine is produced at Sanaria’s clinical manufacturing facility. All clinical trials are conducted under an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA).

Sanaria's manufacturing facility in Montgomery County, Maryland

Sanaria's manufacturing facility in Montgomery County, Maryland

The company next plans to build an expanded state-of-the-art manufacturing facility in Montgomery County, Maryland, with an annual production capacity of approximately 2 million vaccination regimens. Plans include submitting an application for a biological license application (BLA) to the FDA.

The Impact of NIH SBIR for Sanaria and Public Health

The initial $10.75 million in NIAID SBIR funds were instrumental in getting this venture off the ground. The funding supported efforts to secure lab and office space and hire personnel. Today the company employs nearly 50 staff. Sanaria soon leveraged NIAID’s seed investment to secure $4.1 million from a Congressional Special Appropriation, and has subsequently attracted capital from multiple other sources.

Sanaria’s Future Direction and Notable Achievements

Approximately $120 million has now been invested in Sanaria’s malaria vaccine development effort. The company is working to secure the additional funds required to scale up and optimize manufacturing in support of its multi-stage clinical development plan, receive licensure from the FDA and other regulatory authorities, launch the vaccine as a commercial product, and demonstrate that it can be used to eliminate Plasmodium falciparum malaria from defined areas.

Sanaria® PfSPZ Malaria Vaccine won the 2014 Vaccine Industry Excellence Award for “Best Prophylactic Vaccine,” among a lineup of top five industry giants. The company also received the Montgomery County Emerging Business of the year award in 2013.

 

Sanaria employees smiling

Sanaria wins 2014 Best Prophylactic Vaccine at the 2014 World Vaccine Congress, Vaccine Industry Excellence Awards.

Sanaria employees smiling

Sanaria wins the 2013 Verl Zanders Emerging Business of the Year Award from the Montgomery County Chamber of Commerce.

 

Location: Rockville, Maryland

Company Website: http://www.sanaria.com/exit disclaimer icon

Contact: http://www.sanaria.com/index.php?s=9exit disclaimer icon

 

Information for this success story was gathered through an interview that was conducted by Dr. Lenka Fedorkova, the NIH SBIR/STTR Program Manager and Betty Royster, the NIH SBIR/STTR Communications Coordinator.