BlueWillow Biologics and Medigen Vaccine Biologics Announce Positive Results for Intranasal COVID-19 Booster Candidate in Pre-clinical Studies

BW-1019 elicits mucosal immunity, stopping spread at the entry of the virus

Intranasal booster following primary intramuscular vaccine series shown to be a successful follow-on solution

ANN ARBOR, Mich. & TAIPEI, Taiwan–(BUSINESS WIRE)–BlueWillow Biologics, Inc., a pioneer in intranasal vaccine development, and Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, today announced that its intranasal COVID-19 booster (BW-1019) provided protection and boosted immune response when administered following an intramuscular vaccine series in preclinical studies.

The study examined the responses in hamsters receiving various regimens of intramuscular-only, intramuscular primary and intranasal booster vaccine, and negative control group receiving no vaccination. The results, which have been published on the preprint server bioRxiv, showed that the groups receiving the intranasal booster had significant induction of virus neutralizing antibodies and showed protection against COVID-19 disease. In addition, all animals boosted intranasally with BW-1019, except that of the dose sparing group, had no detectable virus in their lungs and nasal passages.

�COVID-19 has proven the importance of eliciting mucosal immunity through intranasal vaccination in order to stop the cycle of upper respiratory viral carriage and spread,” said Vira Bitko, PhD, Vice President of Vaccine R&D at BlueWillow Biologics. “We are excited to demonstrate that our intranasal vaccine candidate not only provides mucosal protection but also boosts the systemic immunity elicited from intramuscular vaccination against COVID-19. We have previously shown similar results in other diseases.”

The intranasal COVID-19 booster combines BlueWillow’s proprietary nanoemulsion technology, which acts as both an efficient antigen delivery and adjuvant, with Medigen’s U.S. National Institutes of Health-licensed SARS-CoV-2 spike protein. BlueWillow’s technology platform enables its robust pipeline of vaccine candidates, which includes programs directed at HSV-2, RSV, influenza, Anthrax and food immunotherapy. The company recently announced positive interim data from a Phase 1 clinical trial in Anthrax. The platform is unique among intranasal solutions in that it does not rely on an adenovirus vector but rather utilizes the adjuvant that is proven to be safe in humans.

Charles Chen, Chief Executive Officer of Medigen, commented, “We are pleased that the jointly developed intranasal vaccine has shown strong results in this preclinical study. We are very excited to see the promising boosting effect, which may be an ideal COVID-19 vaccine candidate and complimentary to intramuscular vaccinations. We hope that it will significantly assist in preventing viral transmission of COVID-19.”

“We look forward to rapidly advancing this intranasal COVID-19 booster into clinical trials,” added Chad Costley, MD, Chief Executive Officer of BlueWillow. “The current intramuscular vaccines have saved millions of lives, but the limited durability of immune response and lack of sufficient mucosal immunity from these vaccines is now evident. In addition, to properly scale worldwide vaccination, boosters need to be less expensive and more easily administered. BlueWillow’s nanoemulsion adjuvant and Medigen’s spike protein have both already been proven safe in humans, which enables our COVID-19 vaccine candidate to rapidly advance into clinical trials.”

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 COVID-19 vaccine (MVC-COV1901), enterovirus EV71 vaccine, dengue vaccine, and influenza quadrivalent vaccine, which have all entered late clinical stage. MVC-COV1901 vaccine’s clinical study data has shown robust safety and promising immunogenicity responses and has as a result obtained Taiwan’s EUA approval on July 19th, 2021, and Paraguay’s EUA approval on February 14th, 2022. MVC COVID-19 vaccine is indicated for adults over 20 years old and is administered in two doses 28 days apart for prevention of COVID-19. MVC will continue to collaborate with international partners to develop promising COVID-19 vaccines and assist the global community in its fight against the ongoing pandemic. 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 developing a new generation of safe and effective nasal vaccines to help protect humankind from respiratory infections, sexually transmitted diseases and food allergies. Our novel intranasal antigen delivery technology platform activates mucosal immunity, the body’s first line of defense, while also inducing systemic immunity. We are a clinical-stage company advancing a pipeline of proprietary programs including COVID-19, pandemic flu, RSV, HSV, anthrax and peanut allergy (www.bluewillow.com).

MVC’s Forward Looking Statements

This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 6547.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC’s COVID 19 vaccine candidates, MVC-COV1901 and jointly developed BW-1019, and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, such could be affected by, among other things, uncertainties involved in the development and manufacture of MVC’s COVID19 vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, changes in global financial markets and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC and is providing the information in this press release as the date hereof, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts

Medigen Contact:
Paul Torkehagen

Director, International Business Development

paul@medigenvac.com

BlueWillow Contact
Lauren Arnold

MacDougall Advisors

LArnold@macdougall.bio