Zika Breaking News

ImmunityBio, Inc. today announced Dr. Karim Chamie, Associate Professor of Urology at UCLA, will be presenting “Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15R⍺Fc superagonist N-803 plus BCG” at the ASCO Genitourinary Cancers Symposium conference on February 16-18, 2023.

N-803 (Anktiva™), ImmunityBio’s lead cytokine fusion protein, is a novel IL-15 superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS NMIBC.

N-803 is currently under review by the FDA for this indication with a Prescription Drug User Fee Act target date of May 23, 2023.

Previously, on November 10, 2022, the peer-review journal NEJM Evidence published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease.

The published results demonstrate that in patients with BCG-unresponsive NMIBC CIS and papillary disease, BCG plus N-803 (referred to as NAI) CRs were achieved with the persistence of effect with a 90% probability of avoiding cystectomies in responders, a life-changing procedure of removing the bladder, and 100% bladder cancer-specific survival at 24 months.

“The peer review and publication of data in NEJM Evidence highlights the significance of the positive results of the QUILT 3.032 trial in patients with BCG-unresponsive NMIBC,” commented  Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on November 10, 222.

“These data further our understanding of N-803’s unique role in potentially boosting the proliferation of natural killer and T cells while synergistically enhancing BCG efficacy.”

ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. 

The Public Health Agency of Canada (PHAC) today issued a statement offering an update on the ongoing response to the Mpox outbreak.

On February 9, 2023, the World Health Organization (WHO) Director-General declared that Mpox remained a Public Health Emergency of International Concern.

This initial declaration was issued on July 23, 2022.

On February 14, 2023, the WHO noted a sustained decline in Mpox cases globally, with the majority of cases being reported from the Regions of the Americas, with 200-250 cases per week,

And about 4% of Mpox cases occurred in women.

Since the beginning of the Mpox outbreak, the Government of Canada has taken action to protect the health and safety of Canadians.

The ongoing management of Mpox relies on continued vigilance, re-emergence of cases, various public health measures, and vaccination.

Mpox vaccines will continue to be available in Canadian provinces and territories for those at higher risk, including second doses of Imvamune®.

Bavarian Nordic's MVA-BN vaccine is approved by the U.S. Food and Drug Administration for smallpox and Mpox under the JYNNEOS® brand.

Since May 2022, the Government of Canada has deployed over 145,000 doses of vaccine.

Mpox information can be found on the Government of Canada's Mpox: For health professionals website. Other outbreak news is posted at Mpox Today.

The Nigeria Center for Disease Control and Prevention (NCDC) confirmed 216 diphtheria cases with 40 related fatalities deaths since December 2022.

About 184 diphtheria cases were reported as children, confirmed a news report on February 14, 2023.

The NCDC confirmed a previous diphtheria outbreak in Borno, north-eastern Nigeria, in 2011, with 98 cases and 21 deaths (the case-fatality ratio was 21.4%). 

Diphtheria spreads quickly between people by direct contact or through the air through respiratory droplets from coughing or sneezing. It may also be spread by contaminated clothing and objects.

In Nigeria, Diphtheria infection is treated by administering a diphtheria antitoxin intravenously or through an intramuscular injection.

Antibiotics can also be given to eliminating the bacteria to prevent transmission and toxin production to others.

Children are fully vaccinated against diphtheria after three doses of the pentavalent vaccine, as the Nigerian immunization schedule recommends. 

The latest U.K. travel advisory says serious tropical illnesses like malaria, typhoid, Lassa fever, and yellow fever occur in Nigeria. 

And as of February 16, 2023, the U.S. CDC has issued various health alerts for Nigeria.

VBI Vaccines Inc. today announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179), VBI's HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an HBV-targeting siRNA candidate, in chronically infected HBV patients.

The data, which will be featured in an oral presentation on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses when compared to BRII-835 alone.

Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or the lower limit of quantification (LLOQ) were achieved by Week 40, which were associated with robust HBV-specific antibody and T-cell responses.

Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI's Chief Medical Officer, commented in a press release on February 15, 2023, "Numerous studies have assessed the potential of siRNA candidates in hundreds of chronically infected HBV patients, but this is the first time we've seen data from the combination of an HBV siRNA with an HBV-specific immunomodulatory."

"Consistent with the known mechanism of action of VBI-2601 and its inclusion of the pre-S1 and pre-S2 antigens in addition to the S antigen, these interim data indicate that VBI-2601 may be able to break tolerance to the S antigen, achieving immune restoration."

"Additionally, the reduction of S antigen to at or below the LLOQ, as seen in the two patients, is a noteworthy achievement in this population."

"We are very encouraged by these interim data, which suggest that the combination of VBI-2601 and an HBV siRNA has the potential to be a meaningful part of a functional cure regimen."

"We look forward to additional data from this study, as well as data from the ongoing Phase 2 study of VBI-2601 as an 'add-on' to existing pegylated interferon and nucleos(t)ide reverse transcriptase inhibitor therapy in non-cirrhotic chronic HBV patients, both of which are expected later this year."

An abstract summarizing the interim data is available at this link.

Vaxart, Inc. today announced that it had dosed the first subject in a Phase 2 dose-ranging clinical trial of its oral tablet bivalent vaccine candidate.

Vaxart expects to report topline data from the Phase 2 study in mid-2023.

"Initiating the Phase 2 clinical trial of this candidate is an important achievement toward our goal of developing an oral tablet vaccine that may reduce the significant global health threat that norovirus poses to children and seniors," said Dr. James F. Cummings, MD, Chief Medical Officer at Vaxart, in a press release on February 14, 2023.

"Results from the Phase 1b clinical trial in healthy adults demonstrate that this candidate stimulates robust IgA antibody-secreting cells against the prevalent strains of two norovirus genotypes that cause most norovirus disease."

"Data from the Phase 2 trial will inform our further clinical development strategy for this promising vaccine candidate."

As previously reported, Vaxart's bivalent vaccine candidate demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain, with no interference observed.

Three Phase 1 studies of Vaxart's norovirus pill vaccine indicated it is well tolerated and generated systemic and local immune responses that are both robust and persistent. 

In the U.S., norovirus causes 21 million illnesses each year, infecting 15% of all children under the age of five years and resulting in illness — which frequently requires hospitalization — in 7.5% of people over 65 years.

Other norovirus vaccine candidate news is posted at PrecisionVaccinations.

Valneva SE today announced that it completed enrollment and vaccination for a Phase 3 clinical trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553.

This live-attenuated, investigational vaccine candidate targets the chikungunya virus and was designed by deleting a part of the chikungunya virus genome.

The initial results of this trial are expected in mid-2023, which are intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S.).

This adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the FDA in the U.S.

Furthermore, the adolescent trial is expected to supvaccine'svaccine's licensure in Europe and Brazil, which would be the first potential approval for use in these chikungunya endemic regions.

Previously, Valneva completed the rolling submission of the Biologics License Application (BLA) to the FDA for approval of VLA1553 in persons aged 18 years and above (adults) in December 2022. 

If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S.

The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination.

Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this pediatric study, commented in a press release on February 14, 2023, "Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur."

"The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licensed for use."

"Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate.

To make VLA1553 more accessible to Low- and Middle-Income Countries, Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing, and marketing of the chikungunya vaccine.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes.

A CHIKV infection leads to symptomatic disease in up to 97% of humans after three to seven days following the mosquito bite.

While mortality with CHIKV is low, morbidity is high.

Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia.

Additional chikungunya outbreak news at Vax-Before-Travel.