On August 8, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported it has begun working on vaccine candidate constructs that directly target new omicron variants of concern and is preparing to release top-line data in the third quarter of 2022 from its Phase II COVID-19 testing of a Wuhan strain vaccine construct (Press release, Vaxart, AUG 8, 2022, View Source [SID1234617780]).
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"We continue to be very excited about the cross-reactivity of our current vaccine candidates, as seen in preclinical and early clinical studies," said Andrei Floroiu, Chief Executive Officer. "The characteristics and prevalence of newer SARS-CoV-2 strains, along with our plans for a human omicron challenge study, led us to begin working on clinical vaccine candidates that directly target omicron variants of concern, which also conforms to recent Food and Drug Administration (FDA) guidance that boosters should target omicron BA.4/5.
"We plan to evaluate these new constructs both as omicron-only monovalent vaccine candidates and bivalent candidates in combination with our Wuhan constructs, and to compare the clinical results of our S-only and S+N constructs to determine the best path forward in developing a vaccine that can hinder viral infection and transmission for current and emerging variants. Our expectation is that the omicron vaccine candidates will be available to evaluate preclinically in the fourth quarter, and clinically in the first half of 2023. In addition, top-line Phase II results from our Wuhan S-only construct are expected in the third quarter of 2022.
"During the second quarter, we also continued to make progress on our norovirus program," Floroiu said. "The data from our trial in elderly adults is very encouraging, as it suggests similar activity to that in younger adults, which is often not the case with injectable vaccines. This adds to the already compelling clinical data on this program and increases our confidence as we continue our development."
Recent Business Highlights
COVID-19 Vaccine Developments
Reported multiple data sets supporting the potential of Vaxart’s COVID-19 vaccine candidates to tackle the challenge of an evolving virus that evades immune protection provided by approved vaccines or natural infection.
In May 2022, announced data from a preclinical hamster study conducted by researchers at Duke University and published in Science Translational Medicine, which demonstrated that Vaxart’s S-only COVID-19 candidate reduced disease and airborne transmission.
In June 2022, announced preclinical data demonstrating that two COVID-19 vaccine candidates targeting either the SARS-CoV-2 spike (S) protein for Wuhan or S protein for omicron protected hamsters when challenged with the omicron BA.1 variant.
In July 2022, updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate induced long-lasting mucosal IgA antibodies in saliva and nasal samples against SARS-CoV-2 and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2.
Earlier this year, Vaxart released non-human primate data that demonstrated that administration of Vaxart’s S-only or S+N COVID-19 vaccine candidates to the nasal mucosa of non-human primates produced significant increases in serum IgG and IgA and up to 1,000-fold increases in nasal IgA.
All vaccinated animals challenged with SARS-CoV-2 B.1.351 (beta variant) had a significant reduction in viral titers in the nasal passages compared to unvaccinated controls.
In June 2022, established an agreement with hVIVO Services Limited, a subsidiary of Open Orphan, a research company specializing in human challenge clinical trials for infectious and respiratory disease products, under which hVIVO will conduct a characterization study and, if successful, develop a human challenge model based on the omicron variant of SARS-CoV-2, with the intent to conduct a subsequent Phase II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19 vaccine candidate.
Norovirus Vaccine Developments
In June 2022, Vaxart reported positive top-line data about its norovirus vaccine candidate. No vaccine exists in the United States to treat norovirus, a virus that causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States. The June data, from Vaxart’s Phase Ib trial in subjects aged 55-80, demonstrated that Vaxart’s oral norovirus vaccine candidate stimulated a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells.
Results were consistent with previous studies conducted in younger populations, which is typically not the case, as the immune system often weakens with age, and older people tend to have less robust responses to vaccination than younger people.
Vaxart also reported in June 2022 on top-line data from a Phase I trial evaluating different boosting regimens with Vaxart’s oral norovirus vaccine candidate. The data showed that the candidate was able to successfully boost antibody responses, with antibody responses trending better with administration spread out over three months versus a shorter interval.
This data and previous results support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations, including elderly adults, and add to the growing body of evidence supporting its clinical utility.
Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines
Selection of COVID-19 vaccine constructs expected in Q4 2022 with clinical trials to start in 1H 2023of COVID-19 vaccine constructs expected in Q4 2022 with clinical trials to start in 1H 2023.
After determining which COVID-19 vaccine candidate to advance, Vaxart anticipates updating its plans for its India trials.
Planned start of Phase II trial of Vaxart’s bivalent norovirus vaccine candidate in Q4 2022.
Preliminary data from ongoing Phase II norovirus challenge study expected at the end of Q1 2023 or early Q2 2023.
Omicron Human Challenge Study in the UK starting in the 2H 2023 using selected vaccine construct.
Financial Results for the Three Months Ended June 30, 2022
Vaxart ended the second quarter with cash, cash equivalents and available-for-sale debt securities of $131.5 million, compared to $157.0 million as of March 31, 2022. The decrease was primarily due to $25.9 million of cash used in operations. The Company’s existing funds are expected to be sufficient to fund its operations into the second half of 2023.
The Company reported a net loss of $29.4 million for the second quarter of 2022, compared to $16.1 million for the second quarter of 2021. Net loss per share for the second quarter of 2022 was $0.23, compared to a net loss of $0.13 per share in the second quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development expenses.
Research and development expenses were $19.9 million for the second quarter of 2022, compared to $10.7 million for the second quarter of 2021. The increase was mainly due to increases in headcount and related costs, and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
General and administrative expenses were $9.3 million for the second quarter of 2022, compared to $5.2 million the second quarter of 2021. The increase was mainly due to the cost of settling shareholder litigation and increases in legal and professional costs and in headcount and related costs.
Conference Call
The Vaxart senior management team will host a conference call to discuss the business update and financial results for the second quarter of 2022 today, beginning at 4:30 p.m. ET.
The conference call can be accessed using the following information:
A replay of the webcast will be available on the Company’s website at www.vaxart.com following the conclusion of the event.