Vaxart’s COVID-19 Oral Vaccine Candidate Gets Boost from Operation Warp Speed

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An Asian Or Chinese Doctor In A Dressing Gown And Medical Mask, Holding A Pill In His Hand . Concept Of Prevention And Treatment Of Viruses And Flu, Outbreaks Of Pneumonia And Coronavirus Epidemics.

Vaxart’s oral COVID-19 vaccine candidate has joined the handful of experimental vaccines being studied as part of President Donald Trump’s commitment to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021—while the company gears up to manufacture as many as one billion doses a year.

The South San Francisco, CA, vaccine developer said Friday that its room temperature stable tablet vaccine had been selected for a non-human primate (NHP) challenge study organized and funded by Operation Warp Speed.

The study is designed to demonstrate the efficacy of Vaxart’s COVID-19 vaccine candidate, which is based on the company’s Vector-Adjuvant-Antigen Standardized Technology (VAAST) Platform.

According to the company’s most recent investor presentation, Vaxart plans an IND submission for its COVID-19 vaccine “soon,” with a Phase I open-label, dose-ranging study set to enroll its first patient later this summer.

VAAST uses enteric-coated tablets designed to release in the small bowel the contents of the vaccine, which combines an adenovirus 5 (Ad5) vector, vaccine antigen, and a TLR3 adjuvant. VAAST vaccines are designed to activate the immune system of the gut, generating broad systemic and local responses—and are designed for a wide range of recombinant antigens.

For COVID-19, Vaxart said, it created multiple vaccine candidates encoding for various configurations and combinations of the spike protein and one or more targeted internal proteins for evaluation in a preclinical model. On April 30, Vaxart disclosed that it obtained positive preclinical results for its COVID-19 vaccine candidates, with “several” of the candidates generating immune responses in all tested animals after a single dose. A final vaccine candidate was selected for cGMP manufacturing by Emergent BioSolutions and KindredBio

“We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated,” Vaxart CEO Andrei Floroiu said in a statement.

Vaxart’s vaccine candidate has been upgraded to the second highest category, “Definitely Maybe,” in GEN’s updated “COVID-19 Drug & Vaccine Candidate Tracker,” which lists approximately 250 therapeutics under study.

Newly appointed CEO

Floroiu was appointed CEO effective June 14, in part to accelerate development of the COVID-19 vaccine candidate; he retains the seat on Vaxart’s board he has held since April. The board is chaired by Floroiu’s predecessor as CEO, Wouter Latour, MD.

Floroiu noted in the statement that SARS-CoV-2 is primarily transmitted by viral particles that enter through the nose, mouth, or eyes, “strongly suggesting that mucosal immunity could serve as the first line of defense.

“In addition, our vaccine is a room temperature stable tablet, an enormous logistical advantage in large vaccination campaigns,” Floroiu added.

Investors appeared to share Vaxart’s enthusiasm, as the company’s stock price on Friday surged, rocketing 128% to a 52-week high of $14.30 before falling to $8.04 at the close of trading on NASDAQ.

That closing price was still 28% above the previous day’s close of $6.26, and came on a day when the NASDAQ Composite plunged by 259.78 or 2.59% due to spikes in COVID-19 cases in some U.S. states. Shares of Vaxart have risen more than 20-fold this year, from a close of 36 cents a share on January 2.

Vaxart shares have zoomed from a closing price of 34 cents a share on January 2.

“Warp” drive vs. COVID-19

Among the Trump administration’s responses to COVID-19 has been Operation Warp Speed, which commits the federal government to funding and coordinating development of vaccines, drugs, and diagnostics across agencies of the Departments of Defense (DoD) and Health and Human Services (HHS)—the latter agency including the FDA, the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA).

Fourteen of the 100+ vaccine candidates in development against COVID-19 were under study by Operation Warp Speed when it was announced on May 15, with former GlaxoSmithKline (GSK) vaccines chairman Moncef Slaoui, MD, as chief advisor and General Gustave F. Perna as chief operating officer.

Earlier this month The New York Times reported that the program had concluded that developers of five vaccine candidates were most likely to produce a vaccine for the virus, citing unnamed “government officials,” and that a formal announcement would come in weeks. The five candidates were Ad26.COV2-S by Johnson & Johnson (Janssen Pharmaceutical); AZD1222 by AstraZeneca, University of Oxford, and Vaccitech; BNT-162 by Pfizer and BioNTech; mRNA-1273 by Moderna; and an unnamed vaccine being developed by Merck & Co. and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges.

Four of the five candidates have won varying amounts of funding from BARDA totaling more than $2 billion. The largest award was the $1.2 billion given to AstraZeneca by BARDA. The agency also committed to Moderna up to $483 million in April and another $53 million in May toward expanding the company’s domestic manufacturing capacity for mRNA-1273. Also, BARDA committed $456.2 million from development to licensure for Janssen and just over $38 million for Merck and IAVI. Pfizer and BioNTech have declined to accept Operation Warp Speed funding.

The BARDA funding covers R&D, clinical trials, and manufacturing.

Manufacturing agreement

Vaxart announced its inclusion in Operation Warp speed a day after disclosing plans to ramp up manufacturing of its COVID-19 vaccine to one billion or more doses a year, through a Memorandum of Understanding the company signed with Attwill Medical Solutions Sterilflow (AMS).

The agreement—whose value was not disclosed— affirmed the companies’ intent to establish AMS as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine, Vaxart said.

AMS agreed to assign dedicated resources and equipment for scale-up and commercial production of the vaccine, based on finalizing a formal agreement.

“We believe AMS’ experience coupled with its ability to manufacture a billion or more doses per year would be a beneficial addition to our group of CDMO partners and enable the large scale manufacturing and ultimate supply of our COVID-19 vaccine for the United States, Europe, and other countries in need,” Floroiu stated.

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