Zika Breaking News

The Sabin Vaccine Institute today announced it launched a Phase 2 clinical trial for its vaccine candidate against the Marburg virus disease (MVD).

As of October 20, 2023, there are currently no vaccines or antiviral treatments approved to treat Marburg, a filovirus in the same family as the virus that causes Ebola.

Marburg has a case fatality rate of up to 88%.

Based on the ChAd3 platform, Sabin’s single-dose investigational Marburg vaccine was found to be promising in a Phase 1 clinical trial.

Dr. Betty Mwesigwa, deputy executive director of the Makerere University Walter Reed Project, is the principal investigator for the Kampala portion of the Sabin-sponsored trial.

A few weeks later, participants will also be enrolled at a second site at the Kenya Medical Research Institute, with Dr. Videlis Nduba as principal investigator. 

In a press release, Amy Finan, Sabin’s Chief Executive Officer, commented, “Sabin’s Phase 2 clinical trial builds on a solid safety and immunogenicity foundation, and we hope it will generate the information needed to move the vaccine toward licensure.”

In addition to the Sabin vaccine candidates, other Marburg vaccines are conducting clinical trials.

According to Sabin, the number of MVD outbreaks in Africa has climbed steadily in recent years.

Two outbreaks of Marburg virus disease have occurred in 2023: Equatorial Guinea reported its first documented Marburg outbreak, which killed 12 people, followed by Tanzania, where six people succumbed to the virus.

Communities in Uganda and Kenya are familiar with Marburg, having been ravaged by outbreaks over multiple years in the last few decades.

MVD was first observed in 1967 during outbreaks in Germany. 

The U.S. Centers for Disease Control and Prevention published Health Alert Network CDCHAN-00489 on April 6, 2023, confirming no cases of MVD have been reported in the U.S.

Ultimovacs ASA today announced the results from a phase 2 clinical trial for second-line treatment in patients with malignant mesothelioma.

The data presented as a late-breaking abstract at the ESMO Congress shows that Ultimovacs' cancer vaccine UV1, in combination with ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement of overall survival versus ipilimumab and nivolumab alone, a key secondary endpoint.

The UV1 cancer vaccination combined with ipilimumab and nivolumab reduced the risk of death by 27%.

"For patients with malignant mesothelioma, few treatment options are available after first-line chemotherapy. The NIPU study showed that patients receiving UV1 vaccination as an add-on to nivolumab and ipilimumab experienced an increased objective response rate and a clinically meaningful prolonged survival."

"These encouraging results provide a foundation for advancing further clinical development with UV1 vaccination in mesothelioma patients," said Principal Investigator of the NIPU clinical trial, Professor Åslaug Helland, MD Ph.D., in a press release on October 18, 2023.

UV1 is a therapeutic cancer vaccine that generates an immune response against the human telomerase enzyme.

The enzyme is essential for the ability of cancer cells to proliferate. Telomerase is present in 85-90% of all cancers across the stages of the disease. The vaccine is manufactured as an off-the-shelf product with a long shelf life. UV1 is easy to use and does not require sophisticated hospital infrastructure.

The results showed that UV1 plus ipilimumab and nivolumab improved overall survival (OS), reducing the risk of death by 27% (HR=0.73 [80% CI, 0.53-1.00]). The median OS was 15.4 months (95% CI, 11.1-22.6) for UV1 plus ipilimumab and nivolumab (treatment arm) versus 11.1 months (95% CI, 8.8-18.1) for ipilimumab and nivolumab alone (control arm), with a median observation time of 17.3 months. This degree of improvement met the protocol's predefined threshold for statistical significance.

The data further demonstrated a benefit in terms of objective response rate, as determined by a blinded independent central review. In the UV1 arm, 31% of the patients experienced an objective response compared to 16% in the control arm (odds ratio 2.44 [80% CI, 1.35-4.49]).

The safety profile of the combination of UV1 plus ipilimumab and nivolumab observed in the trial was consistent with the safety profile of ipilimumab and nivolumab alone, confirming the good safety profile for UV1.

The patients will continue to be monitored for efficacy and safety endpoints over the next years.

Malignant mesothelioma is an aggressive, complex form of cancer with a high mortality rate and few therapeutic options. Patients affected have often been occupationally or environmentally exposed to asbestos. Several efforts have been made in the last decades to improve the survival outcomes of patients with mesothelioma.

There is currently no established standard of care in second-line treatment.

In October 2023, Ultimovacs announced that the U.S. FDA had granted Orphan Drug Designation for UV1 to treat mesothelioma (based on the NIPU data from June 2023).

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biologies and disease stages, combined with different checkpoint inhibitors. 

The title of the late-breaking ESMO abstract is "LBA99 First survival data from the NIPU trial; A randomized, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second-line treatment in patients with malignant mesothelioma."

Oslo University Hospital sponsors the NIPU study with support from Bristol-Myers Squibb and Ultimovacs.

Novavax, Inc. today announced that its prototype COVID-19 vaccine Nuvaxovid™, was granted full approval for active immunization to prevent COVID-19 in individuals aged 12 and older by Singapore's Health Sciences Authority (HSA) and the U.K. Healthcare products Regulatory Agency (MHRA).

In recent clinical trials, the protein-based Nuvaxovid (NVX-CoV2373) vaccine demonstrated the efficacy and safety of its prototype vaccine as a primary series in individuals aged 12 and older and the immunogenicity and safety of the vaccine as a booster in individuals aged 18 and older.

"Full marketing authorization of our prototype COVID-19 vaccine in the U.K. is a stepping stone to enable authorization of updated strains of our vaccine in the future," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on October 18, 2023.

"We are working with the MHRA to provide the information needed for the rapid review of our updated protein-based non-mRNA COVID-19 vaccine as an important step to ensuring access to vaccine options in the U.K. this coming vaccination season."

Novavax Inc.'s vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. 

While authorized in the U.S., the trade name Nuvaxovid™ has not been approved by the U.S. Food and Drug Administration (FDA).

On October 3, 2023, the FDA amended its authorization of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the 2023-2024 formula. 

Since December 2021, Novavax's COVID-19 vaccines have been distributed in about 40 countries.

While the U.S. government recommends most people get an annual flu shot, according to new data, a significant percentage of children and adolescents were unvaccinated last flu season.

The U.S. Centers for Disease Control and Prevention (CDC) confirmed on October 13, 2023, that the 2022–23 influenza season had high severity among children and adolescents.

Among children and adolescents hospitalized with influenza during the 2022–23 season in hospitals participating in the Influenza Hospitalization Surveillance Network, a lower proportion were vaccinated (18.3%) compared with previous seasons (35.8%–41.8%).

Early influenza circulation, before many children and adolescents had been vaccinated, might have contributed to the high hospitalization rates during the 2022–23 season.

Peak influenza-associated outpatient and hospitalization activity occurred in late November and early December 2022.

Nationally, the incidences of influenza-associated outpatient visits and hospitalization for the 2022–23 season were similar compared with previous seasons.

Last flu season, the CDC reported 178 influenza-associated pediatric fatalities.

The CDC's recent Morbidity and Mortality Weekly Report recommends that all persons aged ≥6 months without contraindications should receive the annual influenza vaccine, ideally by the end of October each year.

Similar to last year, nasal, egg-based, and various cell-based vaccines are available at health clinics and pharmacies.

As of October 10, 2023, the CDC reported that 128.35 million flu shots had been distributed in the U.S. for the 2023-2024 flu season. This data compares with 173 million influenza vaccines distributed last season.

Measles cases increased by about 80% worldwide during 2022 compared with 2021, and experts have recently warned of increasing measles outbreaks in 2023. 

India remains the leader globally, with 46,231 measles cases reported over the past year.

In the United States, the Centers for Disease Control and Prevention (CDC) confirmed that as of September 29, 2023, 29 cases have been reported in 16 jurisdictions this year.

This is positive news compared to 2022 when six jurisdictions reported 121 measles cases.

However, the Illinois Department of Public Health announced on October 13, 2023, that a measles infection had been confirmed in Cook County. The case is the state’s first since 2019. This person was unvaccinated and had been exposed during international travel. 

And in Wisconsin, the City of Milwaukee Health Department received a report of a confirmed case of measles in a City of Milwaukee resident employed in Waukesha County.

As of October 10, 2023, local health agencies were working to identify and notify individuals in Wisconsin who may have been exposed to the measles virus and are implementing control measures.

Measles is a very contagious but vaccine-preventable disease, says the CDC.

In the U.S., various measles vaccines are available at most health clinics and pharmacies in 2023.

An innovator of novel immunotherapies has partnered with one of the largest cancer research in evaluating a CAR T therapy for HIV in an early-stage clinical trial so that one day, more people with Human Immunodeficiency Virus might achieve long-term remission.

Helocyte, Inc. today announced that it executed an exclusive option agreement with the City of Hope for patent rights to use Triplex, a cytomegalovirus (CMV) vaccine, in combination with cytomegalovirus-specific, Anti-Human Immunodeficiency Virus ("HIV") Chimeric Antigen Receptor ("CAR") (collectively, CMV/HIV-CAR) T Cells for the treatment of adults living with HIV.

Additionally, the California Institute for Regenerative Medicine recently awarded a $11.3 million grant to the City of Hope to fund a Phase 1 clinical trial that is expected to enroll up to 12 healthy individuals living with HIV-1 on stable anti-retroviral therapy ("ART") who have maintained viral suppression for at least 48 weeks.

The study will include three dose-escalating cohorts, along with an expansion cohort. Other cohorts will include further vaccination of subjects with Triplex to drive the continued proliferation of the CAR.

Triplex is a universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara viral vector vaccine engineered to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins [UL83 (pp65), UL123 (IE1), UL122 (IE2)] linked to CMV complications in the post-transplant setting.

Triplex was initially developed by the City of Hope and exclusively licensed to Helocyte in 2015.

"City of Hope made a major advancement when our transplant team helped a patient achieve remission for both HIV and leukemia," commented John A. Zaia, M.D., the Aaron D. Miller and Edith Miller Chair for Gene Therapy at City of Hope, in a press release on October 16, 2023.

The clinical study will build upon preclinical data published in Molecular Therapy - Methods & Clinical Development in April 2022, demonstrating the potential efficacy of combining a CMV vaccine and CMV/HIV CAR T cell therapy to eradicate HIV.

The study illustrated the potential long-term durability of the combination therapy, which induced therapeutic immune cells to take hold in bone marrow.

This approach aims to target and eradicate latent viral T cell reservoirs in immune cells to achieve complete HIV clearance.

To date, the engineering of T cells to express HIV-specific CAR T cells has failed to demonstrate meaningful clinical benefits. This is believed to be partly due to the effectiveness of highly active ART, which reduces HIV viral load to a level that prevents the activation of CAR T cells.

The use of Triplex is believed to stimulate CMV/HIV-CAR T cells to proliferate within patients' bodies.

In the preclinical study, CAR T cells were engineered to target and kill cells tagged with a particular protein called gp120, expressed in all HIV viruses, frequently with mutations that cause the virus to evade natural immunity without affecting healthy cells.

Lindsay A. Rosenwald, M.D., Fortress' Chairman and Chief Executive Officer and Chairman of Helocyte, Inc., added, "We look forward to building upon the data that continue to be generated relating to the use of Triplex in the treatment of HIV, including an ongoing Phase 2 clinical trial evaluating the safety and efficacy of Triplex in eliciting a CMV-specific immune response and reducing CMV replication in adults co-infected with HIV and CMV."

Helocyte, Inc., a subsidiary company of Fortress Biotech, Inc. For additional information regarding the grant, please see https://www.cirm.ca.gov/our-progress/awards/evaluation-safety-and-feasib....

As of October 16, 2023, there are no approved HIV prevention vaccines in the U.S.