Research indicates that intranasal administration is effective at stimulating the mucosal immunity response

Preclinical study shows positive serum and mucosal immune response

TAPEI, Taiwan & ANN ARBOR, Mich.--(BUSINESS WIRE)--Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines through its patented NanoVax� adjuvant, today announced a partnership to develop S-2P-NE-01, a nasal vaccine for SARS-CoV-2, the virus that causes COVID-19.

While the majority of COVID-19 vaccines in development today are delivered via intramuscular injection, research has demonstrated that nasal delivery � often the initial site of the infection - can prevent the virus from taking hold in the body. Preclinical research demonstrated that BlueWillow�s nasal vaccine adjuvant combined with Medigen�s S-2P spike protein resulted in an extremely high neutralizing antibody response, as well as a superior immunoglobulin A (IgA) response in both serum and lung secretions (BAL) samples in mice compared to intramuscular injection of S-2P adjuvanted with alum. Mucosal immune response is critical in reducing viral nasal colonization and preventing the spread of SARS-CoV-2.

�Our partnership with MVC is a tremendous milestone in our plan to develop a nasal vaccine for SARS-CoV-2 and we are buoyed by the preclinical results showing that intranasal vaccination with S-2P-NE-01 holds great promise for both mucosal and serologic immunity to SARS-CoV-2,� said Chad Costley, MD, CEO of BlueWillow Biologics. �Our plan is to rapidly advance S-2P-NE-01 into human clinical trials as we move forward to battle this global pandemic.�

�As the COVID-19 pandemic continues to spread around the world, there is an urgent need to develop a vaccine to fight this global crisis and we are proud to partner with BlueWillow to create an intranasal vaccination that has the potential to save human lives,� said Charles Chen, CEO of MVC. �While there has been a lot of movement in the development of vaccines, research continues to show the vast benefits of an intranasal vaccination and we look forward to the ongoing clinical development of our product candidate.�

BlueWillow NanoVax Adjuvant Technology

BlueWillow�s vaccine technology utilizes a novel oil-in-water nanoemulsion (NE) adjuvant to enable intranasal vaccines for challenging diseases and intranasal immunotherapy (INIT) for food allergies. The adjuvant includes soybean oil, water and a cationic surfactant cetylpirdinium chloride (CPC) and is currently in use in the company�s clinical-stage anthrax and pandemic flu programs and National Institutes of Health (NIH)-funded preclinical stage RSV, HSV and peanut immunotherapy programs. When used with intranasal vaccination, the NE adjuvant elicits both mucosal and systemic immunity.

MVC S-2P Spike Protein

MVC�s subunit vaccine is based on the stable prefusion form of the SARS-CoV-2 recombinant spike protein with global technology license from the U.S. Vaccine Research Center at the National Institutes of Health (NIH).

About Medigen Vaccine Biologics (MVC) Corporation

MVC is a biopharmaceutical company using cell-based technologies for the development of vaccines and biosimilars. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC's pipeline includes enterovirus EV71 vaccine, dengue vaccine, and influenza quadrivalent vaccine, which have all entered late clinical stage. MVC's large-scale production facility is state of the art and adherent to international PIC/s and GMP requirements. For more information, visit www.medigenvac.com.

About BlueWillow Biologics

BlueWillow Biologics^� is a clinical-stage, privately held biopharmaceutical company focused on developing and commercializing topical antiseptic and anti-infective products and intranasal vaccines using its patented nanotechnology platform. The platform employs novel oil-in-water nano-droplets for products administered to the skin and nose. In addition to NanoBio^� Protect, BlueWillow is currently developing intranasal vaccines that elicit both systemic and mucosal immunity for several respiratory and sexually transmitted infections, including SARS-CoV-2 (COVID-19), RSV, HSV2, pandemic influenza and anthrax, as well as intranasal immunotherapy for peanut allergy and other allergic conditions. Visit www.BlueWillow.com for details on the company�s pipeline and studies completed to date.

Contacts

Medigen Contact:

Paul Torkehagen

Director, Overseas Business Development

[email protected]

BlueWillow Contact:

Lauren Arnold

Vice President

[email protected]