Cancer Vaccine Breaking News

BioSpace reported today Vivek Shinde, vice president of clinical development and lead for older adult influenza & RSV vaccines at Novavax Inc., delivered an update on the Company's COVID-influenza combination (CIC) candidate at the World Vaccine Congress 2023.

The Company presented CIC data and poster presentations on its COVID-19 prototype vaccine during this conference in Washington, DC.

Shinde confirmed that CIC formulations were immunogenic and induced strong functional antibody and CD4+ T cell responses against SARS-CoV-2 and multiple influenza strains on April 5, 2023.

"I think a combination vaccine is only going to hopefully boost compliance in those who intend to get both vaccines," he informed Heather McKenzie at BioSpace on April 7, 2023.

Novavax intends to use these data to inform an ongoing Phase II dose confirmation study. Results from this study are expected later in 2023.

Novavax's COVID-19 vaccine (Nuvaxovid™, CovoVax™, NVX-CoV2373) protein-based vaccine has received various  authorizations from more than 43 countries.

The Wyoming State Veterinary Laboratory (WSVL) recently diagnosed the highly pathogenic avian influenza (HPAI) virus in a barn cat near Thermopolis, WY. This is the first report of HPAI in a domestic cat in Wyoming, and it likely became infected from ingesting meat from wild waterfowl.

'We know that wild birds, particularly waterfowl, have been affected in large numbers by HPAI, but in recent months we have detected the virus in wild carnivorous mammals, including mountain lions and a red fox,' wrote WSVL in April 2023.

As the HPAI outbreak continues, please ensure you use gloves and masks when handling sick or dead mammals and birds. And report any sick wildlife through the Wyoming Game and Fish Department's Wildlife Health Laboratory online reporting tool at this link.

Additionally, various mammals infected with bird flu have been reported in Canada, Mexico, and South America in 2023. 

And about eleven humans have recently been infected with this version of bird flu.

As of April 7, 2023, there are U.S. Food and Drug Administration-approved avian influenza vaccines, with several vaccine candidates conducting studies. Furthermore, annual flu shots are not effective against bird flu viruses.

ADvantage Therapeutics, Inc. today announced that the U.K.'s Medicines and Healthcare Products Regulatory Agency granted the Company's lead compound AD04™ an Innovation Passport for treating Alzheimer's disease (AD) under the Innovative Licensing and Access Pathway (ILAP).

ILAP was established in 2021 to reduce the time to market innovative medicines in the U.K.

A Phase 2b trial for AD04™ in the ILAP application will be a randomized, placebo-controlled, double-blind study to confirm proof of concept and establish the safety and efficacy of AD04™ in mild AD patients.

A 2mg dose of AD04™ served as a control in a prior study of another compound, where it demonstrated a statistically significantly slower decline in outcomes (cognition, function, and quality of life) than other arms of that trial.

In addition, the AD04™ control group showed a slower decline in MRI-measured hippocampal volume as a biomarker of AD progression.

To date, preclinical studies have shown that AD04™ decreased the number of inflammatory microglial cells in the hippocampus of mouse models. Inflammation and hyperproliferation of microglial cells are pathological immunological events in the brain of Alzheimer's patients.

Dr. Rudolph Tanzi, who serves as Chair of the Scientific Advisory Board at ADvantage, stated in a press release on April 5, 2023, "The democratization of AD treatments that are safe, effective, and affordable for all are of utmost importance."

"We hope this AD04 trial with ILAP designation will bring us one step closer," he concluded.

ADvantage is located in Miami, Florida, and is developing potentially paradigm-changing therapies to treat AD in its labs at the Vienna BioCenter.

Additional AD vaccine and treatment news are posted at Precision Vaccinations.

Updated on April 11, 2023, with related links.

The Canadian Food Inspection Agency (CFIA) recently confirmed a dog in Ontario had contracted avian influenza (bird flu) and died.

The CFIA reported on April 1, 2023; the dog was infected with bird flu after chewing on a wild goose.

“Based on the current evidence in Canada, the risk to the general public remains low, and current scientific evidence suggests that the risk of a human contracting avian influenza from a domestic pet is minor,” the CFIA stated.

Canada has previously reported bird flu infections have led to the demise of bears, foxes, and skunks.

Other bird flu news is posted at PrecisionVaccinations.com/BirdFlu.

InflaRx N.V. today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

The FDA granted EUA based on Phase 3 clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically IMV COVID-19 patients.

As of January 26, 2023, the FDA had withdrawn its EUA(s) for monoclonal antibodies (mAbs) for COVID-19.

“COVID-19 treatments remain a priority for CDER, as the disease continues to impact the lives of Americans,” said Center Director Patrizia Cavazzoni, M.D. “Today's authorization offers another potentially lifesaving treatment option for the sickest COVID-19 patients.”

The Annals of Internal Medicine recently published results from a study that concluded early mAb treatment among outpatients with COVID-19 was associated with a lower risk of hospitalization or death.

Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented in a press release on April 4, 2023, "We are thrilled and very proud that the FDA has issued a EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug."

"Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation."

"As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S., as reported by the U.S. Centers for Disease Control and Prevention."

"Today's announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible."

InflaRx stated it plans to apply for full approval to treat critically ill COVID-19 patients in Europe.

Additional mAbs news is posted at CoronavirusToday.com.

The Annals of Internal Medicine today published the results from a University of Pittsburgh Medical Center hypothetical randomized study that estimated administering monoclonal antibodies (mAbs) within two days of a COVID-19 diagnosis lowered the risk of hospitalization or death by about 39%.

The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively.

In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period.

Relative risk estimates for individual mAb products all suggested a lower risk for hospitalization or death. The RR was 0.45 (CI, 0.28 to 0.71) among immunocompromised patients.

mABS are human-made antibodies designed to prevent a pathogen, such as the coronavirus that causes COVID-19, from entering human cells, replicating, and causing serious illness. 

The U.S. Food and Drug Administration granted emergency use authorization to five different COVID-19 mAbs treatments between 2020 and 2022.

As of April 4, 2023, one mAbs (Gohibic) is authorized for use in the U.S.

The U.S. Federal Retail Pharmacy Program for COVID-19 Vaccination is part of the government’s strategy to ensure access to COVID-19 vaccines during the pandemic.

As of March 9, 2023, more than 301 million COVID-19 vaccines have been administered in the U.S. since 2020.

One aspect of this success story is that about 90% of Americans live within 5 miles of a community pharmacy.

To offer these vaccines, the U.S. government spent over $30 billion on COVID-19 vaccines, including the new bivalent boosters, reported Kaiser Family Foundation News.

As of April 4, 2023, the COVID-19 vaccines continue to be provided free of charge to the U.S. population.

Over twenty-five authorized COVID-19 vaccines and therapies are listed in the Precision Vaccinations library.