PharmaJet Releases Positive Phase I Results for Hantavirus Vaccines

PharmaJet, headquartered in Golden, Colorado, released positive interim results from the U.S. Army’s Phase I clinical trial of two hantavirus vaccines to prevent hemorrhagic fever with renal syndrome (HFRS).

The trial was conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). PharmaJet’s Stratis needle-free injection system was used.

PharmaJet focuses on marketing its needle-free devices for vaccine delivery. The PharmaJet Stratis received U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines intramuscularly or subcutaneously. In August 2014, it was approved for influenza vaccine delivery. And the PharmaJet Tropis device for intradermal injections received the CE Mark authorization in May 2016.

Hanatavirus infection can progress to Hantavirus Pulmonary Syndrome (HPS), which can be fatal. Individuals who are infected typically do so by contact with rodents or their urine and droppings that have been infected with hantavirus. There are New World hantaviruses, such as the Sin Nombre hantavirus, first recognized in 1993, that circulate in the U.S. Old World hantaviruses, including Seoul virus, are seen around the world and can cause HFRS.

Hemorrhagic fever with renal syndrome is a cluster of illnesses with clinical similarities that are caused by hantaviruses from the family Bunyaviridae. It includes Korean hemorrhagic fever, epidemic hemorrhagic fever, and nephorpathia epidemica. The known viruses that cause HFRS include Hantaan, Dobrava, Saaremaa, Seoul, and Puumala. They are widely observed in eastern Asia, especially in China, Russia, and Korea, although the Puumala virus is found in Scandinavia, western Europe, and western Russia, and the Dobrava virus is mostly seen in the Balkans.

The most severe form of HFRS has a 5 to 15 percent fatality rate and affects tens of thousands of patients annually. No vaccine is currently available.

"The interim immunogenicity results in the Phase I trial look promising, and the PharmaJet needle-free device has an excellent safety profile in humans," said Jay Hooper, chief, Molecular Virology Branch, Virology Division, USAMRIID, in a statement. "An added benefit of the needle-free injector is that it eliminates needles completely from the process of administering vaccines, as well as the costs and dangers associated with sharp-needle waste."

Most recently, on February 20, PharmaJet announced a global license agreement with Genexine Co. Ltd., based in South Korea, to develop and commercialize DNA vaccines using the PharmaJet injection systems. Under the deal, Genexine will use the PharmaJet Stratis and Tropis in their Phase I and IIa clinical trials. There is also a provision for Phase III studies and commercialization as well.

Genexine’s product pipeline includes a vaccine for human papilloma virus (HPV) type 16 and 18 associated with cervical intraepithelial neoplasia (CIN), which can cause cervical cancer.

The company also announced on February 6 that it is expanding the Phase IIa clinical trial of an HPV vaccine with Norway’s Vaccibody using the PharmaJet Stratis.

The company’s technology is being in used in numerous vaccine clinical trials, including for cancer, Zika Virus, poliovirus, rabies and influenza.

"We are pleased with the interim results from the Phase I clinical trial for a hantavirus vaccine that has the potential to save lives," said Ron Lowy, PharmaJet’s chairman and chief executive officer, in a statement. "Our needle-free devices are continuing to help novel DNA technologies move successfully from preclinical studies into early and late stage clinical trials."

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