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Projects

We are currently developing four products targeting influenza, norovirus and rotavirus.

CompletedOngoingUnder Preparation
UMN-0502
Seasonal Influenza Vaccine
Details

UMN-0502 is a seasonal influenza vaccine manufactured using a baculovirus expression vector system to grow three types of hemagglutinins in insect cells using recombinant DNA technology. A cell-based influenza vaccine offers key advantages over influenza vaccines manufactured using older traditional production methods such as speed, safety and cost effectiveness.
Phase III clinical trials were conducted by Astellas Pharma Inc. in Japan with favorable immunogenicity and safety data confirmed in March 2013 and January 2014. Now, UMN Pharma and Astellas Pharma are preparing for the application for marketing approval of UMN-0502 in Japan.
Protein Sciences Corporation is developing Flublok ® in the United States, a seasonal influenza vaccine, which is identical to UMN-0502. Flublok has successfully completed Phase III clinical trials and obtained formal marketing approval, in January 2013, from the U.S. Food and Drug Administration.
In South Korea, clinical trials are under preparation with ILDONG Pharmaceutical Co., Ltd.
UMN holds exclusive rights from Protein Sciences Corporation to commercialize influenza vaccines in Asian countries such as Japan, China, South Korea, Taiwan, Hong Kong and Singapore. UMN is actively negotiating with several local pharmaceutical and vaccine companies in these countries.

UMN-0501
Pandemic Influenza Vaccine
Details

UMN-0501 is a pandemic influenza vaccine manufactured using a baculovirus to grow the H5N1 hemagglutinin in insect cells using recombinant DNA technology. A cell-based influenza vaccine offers key advantages over influenza vaccines manufactured using older traditional production methods such as speed, safety and cost effectiveness.
Phase I/II clinical trials have been successfully completed with both immunogenicity and safety data confirmed. Results were presented in February of2008 at the World Health Organization's 5th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials. UMN-0501 was granted orphan drug status in Japan in June of 2008. UMN's influenza program was licensed from Protein Sciences Corporation in the United States. Astellas Pharma Inc. conducted Phase II clinical trial under their own project code number ASP7373 in 2011, and immunogenicity and favorable tolerability data have been confirmed.
UMN has entered into negotiations with several local pharmaceutical and vaccine companies in China, Taiwan, Hong Kong and Singapore.
In South Korea, clinical trials are under preparation with ILDONG Pharmaceutical Co., Ltd.

UMN-0901
Pandemic Influenza Vaccine
Details

UMN-0901 is a pandemic influenza vaccine manufactured using a baculovirus to grow the H9N2 hemagglutinin in insect cells, with a combination of recombinant DNA technology. H9N2 influenza virus is endemic in many Asian countries and is regarded as a candidate for the next human pandemic. We are currently executing nonclinical studies and planning phase I/II clinical trials in Japan.



CompletedOngoing
UMN-2003
Norovirus/Rotavirus Vaccine
Details

UMN-2003 is a norovirus VLP + rotavirus VP6 non-live injectable trivalent vaccine for the prevention of two major causative agents of acute gastroenteritis in one injection. The norovirus VLP + rotavirus VP6 combination vaccine is proven to be highly immunogenic in mice and the combination does not interfere, but rather potentiates the immune response of each component. We are currently executing nonclinical studies and are planning phase I/II clinical trials in Finland.

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