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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.
The global outbreak of dengue fever in 2023 includes countries in the Pacific Region, such as Taiwan.
Taiwan's National Infectious Disease Statistics System today reported the local dengue outbreak has begun to recede.
As of October 18, 2023, Taiwan confirmed 17,588 dengue cases and 32 related deaths this year. Tainan City has confirmed 14,017 of these dengue cases.
Separately, the Taipei Times reported the second instance of vertical transmission of dengue fever in 2023.
Taiwan's Centers for Disease Control physician, Lin Yung-ching, stated that a case of mother-to-infant dengue transmission was confirmed, affecting a five-day-old boy, the second such case in 2023, and the third ever in Taiwan.
The mother was diagnosed with dengue one day after giving birth. Dr. Lin said the infant developed a fever five days later and tested positive for dengue.
As the baby had been in hospital since birth and had a short incubation period, the disease was most likely transmitted vertically, he said.
The U.S. CDC says a pregnant woman infected with dengue can pass the virus to her fetus during pregnancy or around birth. And there has been one documented report of dengue spread through breast milk.
Because of the benefits of breastfeeding, mothers are encouraged to breastfeed even in areas with a risk of dengue, says the CDC.
Dengue is a vaccine-preventable disease, with two approved dengue vaccines in 2023.
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.
The U.S. Embassy in Kingston recently confirmed an outbreak of the dengue virus was announced on September 23, 2023, due to increased cases throughout the Caribbean island country of about 2.8 million people.
As of October 11, 2023, Jamaica's Ministry of Health has reported 1,060 confirmed dengue infections in Jamaica this year. There are no Dengue-related deaths classified at this time.
However, six deaths are being investigated.
All parishes have recorded dengue cases, with Kingston and St. Andrew, St. Thomas, St. Catherine, Portland, and St. James recording the most confirmed cases.
The dominant dengue strain is Type 2, which last predominated in Jamaica in 2010.
Dengue is an increasing health risk to international travelers throughout the Region of the Americas.
Jamaica's dengue outbreak in 2023 joins well-known vacation areas such as Southeast Florida, Costa Rica, and Puerto Rico.
Dengue is a vaccine-preventable, mosquito-transferred disease with two approved vaccines available in certain countries.
In the U.S., Dengvaxia® vaccine is approved by the U.S. FDA with specific testing requirements. On June 30, 2023, the FDA issued a Supplemental Approval letter.
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.
Diakonos Oncology Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's dendritic cell vaccine, DOC1021.
The pivotal FDA designation can help propel Diakonos closer to delivering DOC1021 to glioblastoma multiforme (GBM) patients, of which only 7% survive more than five years.
GBM is the most common malignant brain tumor, with an annual incidence of 3.19 per 100,000 persons in the U.S.
About 61% of patients have the unmethylated subtype, demonstrating a median survival of 15 months compared to 21.7 months for methylated GBM patients when treated with the standard of care.
Developed at the Texas Medical Center in Houston, Texas, DOC1021 represents a novel immunotherapy approach to fighting cancer that harnesses the body's natural anti-viral immune response.
By mimicking a viral infection with the patient's cancer markers, DOC1021 leverages the body's innate ability to detect and eliminate infected cells.
"The FDA's decision acknowledges the potential of this new treatment approach for a very challenging disease," said Mike Wicks, Chief Executive Officer of Diakonos, in a press release on October 17, 2023.
At the core of DOC1021 is Diakonos' proprietary "double-loading" technique, which stimulates a previously undiscovered viral recognition and response pathway.
Using a patient's dendritic cells, a type of white blood cell that detects threats, the unique cancer markers are loaded both internally and externally into the immune cells, which would simultaneously occur in a viral infection.
Once the patient's individualized treatment is prepared, it is administered through three precise injections targeting the deep cervical lymph node chains.
This approach results in immune responses that directly target the central nervous system.
This revolutionary approach has shown remarkable outcomes, as the earliest patients exceeded survival expectations. DOC1021 also maintains an impressive safety profile.
As the treatment enters the final stages of the clinical trial, no serious adverse events have been linked to it. In addition, without genetic modification or artificial stimulation, DOC1021 further stands apart from other cancer immunotherapies.
The DOC1021 clinical trial is underway at the MD Anderson Cancer Center at Cooper University Health Care in New Jersey and the University of Texas Health Science Center in Texas. This clinical trial is expected to be completed in 2023.
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.
