Vaccine News

 Anixa Biosciences, Inc. today announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine.

The data were presented by G. Thomas Budd, M.D., a staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study, in a poster entitled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC."

Patients who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFNγ and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect.

Data from the 16 patients treated to date showed that:

Most patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.

12 (75%) of the women had antigen-specific IFNγ and/or IL-17 ELISpot responses at all dose levels, while ELISA antibody responses at Dose Level 2 and higher.

A statistically significant (P = 0.03) increase in IFNγ over baseline (Day 0) was observed by Day 56, while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.

Among the doses studied, Dose Level 1 (10 mcg α-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose and the maximum tolerated dose (MTD).

No significant side effects were observed at the MTD besides irritation at the injection sites. No myalgias, flu-like symptoms, or aberrant laboratory values were noted.

Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine's safety and immunologic effects in two additional patient cohorts.

The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.

The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation-positive and are planning prophylactic risk-reducing mastectomies.

"The data from our Phase 1 trial has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, in a press release on December 7, 2023.

"We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine."

"Our goal is to initially evaluate the vaccine's ability to prevent recurrence of cancer in survivors and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC."

Anixa is the exclusive worldwide licensee of the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase 1 trial. The U.S. Department of Defense grant was made directly to the Cleveland Clinic.

The approval of yet another RNA-based vaccine might not seem momentous, wrote Elie Dolgin in an article published by the journal Nature.

But the endorsement last week by Japanese authorities of a jab against the SARS-CoV-2 coronavirus constructed using a form of RNA that can make copies of itself inside cells — the first 'self-amplifying' RNA granted full regulatory approval anywhere in the world — marks a pivotal advance.

The December 6, 2023, article is posted at this link.

In late November 2023, CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor, and Welfare approved ARCT-154, a self-amplifying Messenger RNA COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. 

The U.S. CDC's Weekly COVID-19 Vaccination Dashboard estimates vaccinations and intent for vaccination using various data sources, including surveys, healthcare claims, electronic medical records, and immunization information systems data.

As of December 6, 2023, category highlights include the following data:

As of November 25, 2023, 6.9% (95% Confidence Interval: 6.0%-7.9%) of children were reported to be up-to-date with the 2023-24 COVID-19 vaccine.

About 17.3% of children had a parent who reported they planned to get their child vaccinated. Additional COVID-19 vaccination data for children by demographic characteristics at the national level and overall estimates by jurisdiction are available at this CDC link.

For pregnant women, 8.9% had received the updated 2023-24 COVID-19 vaccine.

Vaccination coverage was highest among non-Hispanic Asian (15.2%) women and lowest among non-Hispanic Black (2.7%) pregnant women.

And for adults, about 16% reported having received an updated 2023-24 COVID-19 vaccine since September 14, 2023. Vaccination coverage increased by age and was highest among adults 65 and older [33.3%, (31.2%-35.3%)].

From a geography perspective, the District of Columbia reported the most significant number of vaccinated adults, with about 30.7%.

COVID-19 vaccination coverage estimates among all adults are based on CDC's National Immunization Survey–Adult COVID Module data.

Novavax, Inc. today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals aged 12 and older.

The Public Health Agency of Canada's National Advisory Committee on Immunization recommended XBB COVID-19 vaccines that target more recent, immune-evasive virus variants.

The expanded authorization was based on non-clinical data showing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16, and XBB.2.3 variants.

Additional non-clinical data demonstrated that Novavax's vaccine-induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

These data indicate that Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.

In Canada, recombinant XBB sub-lineages remain dominant, representing 93% of sequences in the past month. HV.1, HK.3, and BA.2.86 (including JN.1) are the major lineage groups demonstrating consistent growth in Canada.

Health Canada's latest COVID-19 numbers were updated at this link as of December 5, 2023, 8 am ET.

"Today's expanded authorization will support the Canadian government's strong commitment to provide its citizens with effective options, such as our protein-based non-mRNA vaccine, in the campaign against currently circulating COVID-19 variants," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on December 5, 2023.

Novavax's updated COVID-19 vaccine is also authorized in the U.S. and Europe by the World Health Organization and is under review in other markets.

Osivax today announced that it has received a grant of over $1.5 million from the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The grant will support preclinical studies evaluating the breadth of protection and immune response induced by OVX836 against pandemic influenza strains.

OVX836 is a first-in-class influenza vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response.

OVX836 will be evaluated against two pandemic influenza A-strains in preclinical models: the once pandemic but now seasonal, pH1N1, and the highly pathogenic variant with pandemic potential, H5N1.

Osivax’s oligoDOM® technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses.

OVX836 has been tested in 5 clinical trials with 1200 participants, showing promising safety, immunogenicity, and efficacy read-outs. 

“Receiving this grant from the NIAID will support our progress in developing OVX836 to provide broad-spectrum protection against influenza, which remains a perennial pandemic threat,” commented Alexandre Le Vert, Co-Founder and CEO of Osivax, in a December 5, 2023 press release.

“We believe that by generating these additional data against pandemic influenza strains, we will be able to bolster the positive results generated by OVX836 against seasonal strains, placing us on a strategic path toward future regulatory approval.”

Osivax also recently published the results of a Phase 2a dose-optimization study (OVX836-003) in The Lancet Infectious Diseases, showing efficacy in humans against seasonal strains.

Valneva SE today announced positive antibody persistence data twenty-four months after vaccination with a single dose of its chikungunya vaccine IXCHIQ®.

As reported on December 4, 2023, 97% of the 316 healthy adults still enrolled in a phase 3 study retained neutralizing antibody titers above the seroresponse threshold.

The persistence of antibodies in older adults aged 65 and above was as robust as in younger adults and even slightly higher in terms of geometric mean titers and seroconversion rates.

This outcome underscores the vaccine's potential to offer strong and lasting protection against chikungunya across different age groups.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said, "We are very pleased about these twenty-four-month data, which confirm IXCHIQ®'s ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination."

"Being the world's first approved vaccine against chikungunya, each positive outcome further strengthens the defense against this significant and expanding public health threat."

These results from VLA1553-303 follow the completion of the pivotal Phase 3 study published in the Lancet in which a seroresponse rate of 96% six months after a single vaccination1 was reported.

Valneva was granted U.S. FDA approval for IXCHIQ in November 2023, and two marketing applications are currently under review by Europe and Canada, with potential approvals in mid-2024.

The U.S. CDC intends to review the use of IXCHIQ in 2024.

The World Health Organization says the chikungunya virus was identified in over 100 countries, and 340 related deaths have been reported in the past year.

The New England Journal of Medicine recently published results from late-stage clinical trials that concluded among persons with early Alzheimer's disease (AD), the use of Gantenerumab led to a lower amyloid plaque burden than placebo at 116 weeks.

However, Gantenerumab, a monoclonal antibody (mAb), was not associated with slower clinical decline as of November 16, 2023.

According to these researchers, mAb target amyloid-beta (Aβ) has the potential to slow cognitive and functional decline in persons with early Alzheimer's disease.

Gantenerumab is a subcutaneously administered, fully human, anti-Aβ IgG1 mAb with the highest affinity for aggregated Aβ that has been tested for treating AD.

In 2021, Gantenerumab was granted the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in AD.

Genentech, F. Hoffmann–La Roche, produces Gantenerumab and continues exploring multiple approaches and molecules that may address key pathways of AD.

AD is a progressive, fatal disease of the brain characterized by a decline in memory, language, and other thinking skills, as well as changes in mood and behavior.

Biological changes in the brain are believed to start decades before clinical symptoms of AD become evident.

Alzheimer's is the most common form of dementia. Given the medical and societal complexities of AD, several tools and treatment options will likely be required to meet the multiple and diverse needs of people living with the disease, says Genentech.

Recently, LEQEMBI®, a humanized immunoglobulin gamma 1 mAb directed against aggregated soluble and insoluble forms of Aβ, was approved in Japan.

LEQEMBI reduces the rate of disease progression and slows cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates that contribute to neurotoxicity in AD.

Japan is the second country to approve LEQEMBI, following the FDA approval in July 2023.

As of December 2, 2023, the FDA has not approved an Alzheimer's preventive vaccine candidate.