Vaccine News

Dynavax Technologies Corporation today announced that HEPLISAV-B® vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024.

HEPLISAV-B is the first and only adult hepatitis B vaccine approved in the U.S., the European Union, and Great Britain to enable series completion with only two doses in one month.

In 2024, HEPLISAV-B's total estimated market share in the U.S. increased to approximately 41%, and its estimated market share in the retail pharmacy segment increased to approximately 55%.

"The U.S. adult hepatitis B vaccine opportunity remains significant with over 130 million patients eligible, one of the largest addressable patient populations in the U.S., and the vast majority remaining unvaccinated," said Ryan Spencer, Chief Executive Officer of Dynavax in a press release on May 8, 2024.

Hepatitis B is a viral infection that affects the liver and can cause acute or chronic disease.

Driven by the U.S. CDC's Advisory Committee of Immunization Practices' universal recommendation for adult hepatitis B vaccination, the hepatitis B vaccine market continues to expand in the U.S. Dynavax believes the U.S. market has the potential to grow to over $800 million by 2027, with HEPLISAV-B well-positioned to achieve a majority market share.

A supplemental Biologic License Application for HEPLISAV-B vaccination of adults on hemodialysis is currently under review by the U.S. FDA, with a Prescription Drug User Fee Act action date planned for May 13, 2024.

A recent study aimed to compare the positive benefits between two U.S. FDA-approved influenza antiviral medications.

Published in the journal Influenza and Other Respiratory Viruses on May 6, 2024, this study concluded that Xofluza (baloxavir marboxil, BMX) appears to be more effective than Tamiflu (oseltamivir, OTV) in lowering the secondary attack rate.

The Poisson regression modeling showed that in those cases treated with BXM and OTV, the benefits were 10.8% and 18.5%, respectively; the adjusted relative reduction was 41.8% (95% confidence interval: 1.0%–65.7%, p = 0.0456) greater with BXM than OTV. 

These researchers wrote that one reason for this result may have been the difference in administration: a single dose of BXM versus twice daily for five days for OTV. Thus, BXM is expected to have higher compliance than OTV in children.

In summary, this post hoc analysis found that the secondary influenza illness attack rate was lower in household contacts exposed to BXM-treated than OTV-treated index cases.

ImmunityBio, Inc. announced today that the drug substance had been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA®.

ANKTIVA (nogapendekin alfa inbakicept-pmln) is the first U.S. FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells and memory T cells for a long-duration response.

Coupled with the recent announcement of a partnership with the Serum Institute of India for enhanced BCG vaccine availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company’s drug substance and fill-finish manufacturing plants in California and New York.

In 2024, Anktiva will be priced at $35,800 per dose. The cost of the BCG vaccine is additional.

Since the Company’s merger with NantKwest in 2021, ImmunityBio has made significant capital investments in personnel, plants, and equipment to ensure the global capacity of the ANKTIVA drug product for both the commercial launch and clinical trials in bladder cancer and other tumor types in its pipeline.

Both drug substance and drug product facilities are nearing completion to ensure sufficient capacity and multiple GMP manufacturing sites for ANKTIVA in its approved indication and for clinical trials and future indications.

“Our belief in the importance of this molecule and its potential to evolve immunotherapy to the next level guided our strategic plan to invest for the future with anticipation of ANKTIVA’s approval,” said Rich Adcock, CEO & President ImmunityBio, in a press release on May 7, 2024.

“I’m grateful for our employees and our investors who have supported and believed in our commitment to invest for our long-term vision and future.”

The Company is applying its science and platforms to treating cancers, including developing potential cancer vaccines, immunotherapies, and cell therapies that we believe will sharply reduce or eliminate the need for standard high-dose chemotherapy.

TCompany says these platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Valneva SE today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.

On May 7, 2024, the Company announced IXCHIQ®, the world's first and only licensed chikungunya vaccine, recorded initial sales of €0.2 million in the first quarter in the U.S.

In a press release, Peter Bühler, Valneva's Chief Financial Officer, commented, "The first quarter performance has been in line with our expectations. We are aiming to further capitalize on the travel industry recovery during the rest of the year (2024), including ramping up sales for IXCHIQ® to support our commercial sales growth while executing on our key R&D milestones."

IXCHIQ® is also under regulatory review in Canada, Brazil, and Europe, where it was granted accelerated assessment by the European Medicine Agency's Committee for Medicinal Products for Human Use. Decisions on these submissions are expected in 2024.

The U.S. Centers for Disease Control and Prevention (CDC) recently adopted the U.S. Advisory Committee on Immunization Practices recommendations, which include the chikungunya vaccine for persons aged ≥18 traveling to a country or territory with a chikungunya outbreak. 

In addition, the CDC says the chikungunya vaccine may be considered for those traveling to a country or territory without an outbreak but with evidence of chikungunya virus transmission among humans within the last five years. 

Persons aged >65 years, particularly those with underlying medical conditions, are likely to have at least moderate exposure* to mosquitoes OR Persons staying for a cumulative period of 6 months or more. Moderate exposure could include travelers with at least two weeks (cumulative) of exposure to mosquitoes in indoor or outdoor settings.

Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes infected with the chikungunya virus.

As of May 2024, the World Health Organization says chikungunya was identified in nearly 115 countries, primarily in the Region of the Americas.

According to the European Centre for Disease Prevention and Control, approximately 70,000 chikungunya cases and 15 deaths have been reported worldwide in 2024.

BioNTech SE today reported financial results for the first three months of 2024, and provided an update on its corporate progress.

Total revenues reported were €187.6 million for the three months in 2024, compared to €1,277 million for the comparative period in 2023.

The Germany-based company stated the year-over-year change was mainly due to lower commercial revenues from the sales of BioNTech’s COVID-19 vaccine worldwide, resulting from endemic-level demand for COVID-19 vaccines.

“In the past weeks, we have reported positive preliminary data for our individualized and off-the-shelf mRNA-based candidates, which further underline the potential of our iNeST and FixVac platforms. We look forward to providing more updates this year across our oncology portfolio, including our bispecific antibody and ADC programs,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, in a press release on May 6, 2024.

“In the remainder of the year, we plan to develop and commercialize a variant-adapted COVID-19 vaccine and accelerate our clinical development activities towards realizing the full potential of our oncology pipeline with a view to becoming a commercial company with marketed medicines for cancer and infectious diseases.”

BioNTech and Pfizer developed, manufactured, and delivered their Omicron XBB.1.5-adapted monovalent Comirnaty COVID-19 vaccine, which has received multiple regulatory approvals, including full approvals, authorizations for emergency or temporary use, or marketing authorizations, in more than 40 countries and regions.

BioNTech says it is now focused on preparing for variant strain vaccine adaptation to be ready for commercial launch ahead of the upcoming 2024/2025 vaccination season, pending approvals.

It has been about three decades since the U.S. Food and Drug Administration approved the first monoclonal antibody. Since then, antibody engineering has dramatically evolved. 

The recent pandemic was the first time monoclonal antibody-based therapies were produced in significant quantities to combat a new infectious disease. Globally, clinics administered hundreds of thousands of antibody injections over the first two years of the pandemic.

Antibody therapy worked... until it didn't.

The U.S. CDC says the infectious virus's rapid evolution outpaced the benefits derived from antibodies.

According to Michael Dumiak's article published by IAVI on April 25, 2024, this experience and other issues have researchers assessing the future of antibody therapies for treating or preventing infectious diseases, including some of the most complicated pathogens, such as HIV and antibiotic-resistant bacteria.

A potential application is blocking mother-to-child transmission of HIV during birth and through the breastfeeding period.

"We are in the position that if you want more antibodies for infectious disease, you need to be very cautious," says Rino Rappuoli, scientific director of the Biotecnopolo di Siena Foundation in Italy.

The unedited, complete IAVI article is posted at this link.

Note: As of May 5, 2024, the U.S. FDA has not approved an HIV vaccine candidate.