Vaccine News

With approved Ebola vaccines and monoclonal antibody therapies available in Africa, a safe and effective treatment option is now the goal for researchers.

RedHill Biopharma Ltd. today announced that its two novel, oral host-directed investigational drugs, opaganib and RHB-107 (upamostat), demonstrated robust synergistic effect when combined individually with Veklury®, significantly improving viral inhibition while maintaining cell viability in a new U.S. Army-funded and conducted Ebola virus disease in vitro study.

Jeffrey Kugelman, Ph.D., Major(P), U.S. Army MSC, Branch Chief Synthetic Biology & Surveillance, Molecular Biology Division, U.S. Army Medical Research Institute of Infectious Diseases, who led the bioinformatics analysis of the study, commented in a press release on December 20, 2023, "The results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as Veklury, to improve treatment outcome, increasing efficacy while maintaining safety."

Opaganib (ABC294640) is a proprietary investigational host-directed and potentially broad-acting drug and is a first-in-class, orally administered sphingosine kinase-2 selective inhibitor with anticancer, anti-inflammatory, and antiviral activity, targeting multiple potential diseases.

"Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, and these results add to a recent U.S. Army Ebola virus study in which opaganib delivered a statistically significant increase in mice survival time in vivo," added Reza Fathi, Ph.D., RedHill's SVP R&D. 

RHB-107 (upamostat) is a proprietary, first-in-class, once-daily orally administered investigational antiviral that targets human serine proteases in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease.

There are two types of Ebola causing outbreaks in Africa.

The initial Zaire Ebolavirus disease outbreak was confirmed in 1976 in South Sudan and the Democratic Republic of Congo.

African countries have endured Zaire Ebolavirus outbreaks between 2014, 2016, 2018, and 2022. Over 29,000 people were infected, and more than 11,000 died.

Separately, there have been five Sudan Ebolavirus outbreaks. 

The World Health Organization issued new guidelines (August 2023) on Ebola infection prevention and control.

Uvax Bio, LLC today announced acknowledgment from the Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in Australia.

The two vaccines being tested are based on Uvax Bio's proprietary 1c-SApNP® technology, displaying 20 uncleaved, prefusion-optimized (UFO) HIV envelope (Env) trimers in wild-type and glycan-trimmed forms (UVAX-1197 and UVAX-1107, respectively).

Uvax Bio's HIV-1 vaccines are combined with Dynavax's CpG 1018® adjuvant and aluminum hydroxide.

Uvax Bio will work with their Australia-based clinical research partners Avance Clinical and the Nucleus Network study site to initiate this study in January 2024.

Previously, in a preclinical toxicology study, UVAX-1107 & 1197 combined with CpG 1018® and aluminum hydroxide were safe with no serious adverse events.

In a second preclinical immunogenicity study, immunization with Uvax Bio's HIV-1 vaccine candidates elicited robust neutralizing antibody responses against the vaccine-matched virus in 99% of the animals.

Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.

"The body of evidence from our preclinical studies and GMP manufacturing runs was instrumental in facilitating this authorization to begin preparation for our first Phase 1 trial," commented Ji Li, Ph.D., Uvax Bio CEO, in a press release on December 19, 2023.

"Our clinical team will begin preparing to initiate this trial in January 2024."

As of December 20, 2023, the U.S. Food and Drug Administration, Japan's National Institute of Infectious Diseases, the European Medicines Agency, and the United Kingdom had not approved an HIV prevention vaccine.

The Novo Nordisk Foundation today announced it is committing up to $260 million to establish a state-of-the-art research and vaccine development initiative.

The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis, influenza, and Group A Streptococcus.

This is the first vaccine initiative globally to focus solely on understanding how to generate immunity in the airway. This is a potentially revolutionary means to block infection and prevent airborne diseases from spreading between humans.  

The research arm – the Novo Nordisk Foundation Center for Vaccines and Immunity – is funded via an eight-year grant and anchored in the Department of Immunology and Microbiology at the University of Copenhagen, which has gained global recognition for its expertise in infectious disease, immunology, and technological innovation.  

“Basic research carries great importance when it comes to the health and well-being of the world’s population – both present and future,” says Dean Bente M. Stallknecht from the Faculty of Health and Medical Sciences, University of Copenhagen, in a press release on December 18, 2023.

“Vaccines and knowledge of immunology is a key part of that. Boosting excellent basic research within this field of research will pave the way for discoveries and hold the potential to make a huge difference to so many people globally.”  

A key partner in the initiative will be Denmark’s Statens Serum Institut.

GeoVax Labs, Inc. today announced that it has amended a previously executed Patent and Biological Materials License Agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in support of GeoVax's development of a vaccine against the SARS-CoV-2 betacoronavirus that causes COVID-19.

The NIAID amendment expands GeoVax's commercial license to include the mpox and smallpox orthopoxviruses as additional indications.

The License Agreement, as amended, enables the creation of preventive Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccines that prime and/or boost the immune system against COVID-19, as well as mpox and/or smallpox.

David Dodd, GeoVax President and CEO, commented in a press release on December 19, 2023, "...The addition of the Mpox and smallpox indications to our NIAID License Agreement complements GeoVax's license agreement with City of Hope National Medical Center for GEO-CM04S1."

Mr. Dodd continued, "We anticipate that adding the Mpox/Smallpox indication to an MVA-vectored COVID-19 vaccine is a viable regulatory pathway and may be an important product differentiator from other competitors."

"For those regions/populations where Mpox and/or smallpox may be of a concern, we believe our COVID-19 vaccine will be a better choice."

Modified Vaccinia Ankara (MVA) is the vaccine currently used and stockpiled in the U.S. Strategic National Stockpile for immunization against the Mpox (JYNNEOS) and smallpox (ACAM2000) viruses. 

GeoVax Labs, Inc. is a clinical-stage biotechnology company. The unedited press release is available at this link.

Invivyd, Inc. today announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody (mAb) candidate for the prevention of symptomatic COVID-19.

Results showed that the safety and tolerability profile of VYD222 remains favorable, with no study drug-related serious adverse events reported to date.

The company also reported on December 14, 2023, that in vitro pseudovirus testing shows VYD222 has potency against various SARS-CoV-2 coronavirus variants currently circulating, such as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3.

Importantly, VYD222 continues to show neutralizing activity against variants with the F456L mutation found in most variants in the U.S.

Currently, no mAb is authorized or approved in the U.S. to prevent symptomatic COVID-19.

"We are pleased to share positive initial topline results from CANOPY, which bolster our belief that VYD222 holds the potential to provide vulnerable people, particularly the immunocompromised (IC), with meaningful protection from COVID-19," said Dave Hering, Chief Executive Officer of Invivyd, in a press release.

"VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort, essentially replicating the titer levels observed in our Phase 1 clinical trial of VYD222 in healthy volunteers."

"We are also encouraged by the potential early signal of strong clinical protection from symptomatic COVID-19 in the CANOPY clinical trial to date, which would be expected given the high VYD222 sVNA titer levels and dose selected."

"We look forward to continued engagement with the FDA on these promising results, and we intend to submit a request for Emergency Use Authorization as soon as practicable."

Globally, there are millions of immunocompromised people, with more than 9 million in the U.S. alone who may not adequately respond to COVID-19 vaccination.

The U.S. National Center for Health Statistics (NCHS) Mortality Surveillance mortality surveillance data indicates that 0.2% of deaths during the week ending December 9, 2023 (Week 49) were due to influenza.

This NCHS percentage remained stable compared to Week 48.

Unfortunately, the U.S. CDC reported two additional influenza-associated pediatric deaths last week.

As of December 14, 2023, a total of 14 influenza-associated pediatric deaths, vaccination status not reported, have occurred during the 2023-2024 flu season. 

The CDC reported seasonal influenza activity remains elevated in most parts of the country and recommends that most people over six months get an annual flu shot.

Furthermore, based on when you get a flu shot, your health condition, and where you live, a second vaccination may be appropriate based on a conversation with a doctor, nurse, or pharmacist.

During this flu season, over 152 million nasal, egg-based, and cell-based influenza vaccines were distributed in the U.S. These vaccines remain available at most pharmacies.

A recent study published by The New England Journal of Medicine confirmed the benefits of getting a quadrivalent recombinant influenza vaccine this flu season.

Although numerous clinical studies have shown that high-dose influenza vaccines (Flublok®) offer benefits over egg-based flu shots, “Data are needed on the relative effectiveness of recombinant vaccines as compared with standard-dose vaccines against influenza-related outcomes in adults under the age of 65 years,” wrote these researchers on December 14, 2023.

The Sanofi-funded study population included 1,630,328 vaccinees between 18 and 64 years old.

During this study period, 1,386 cases of PCR-confirmed influenza were diagnosed in the recombinant-vaccine group and 2,435 cases in the standard-dose group.

Among the participants who were 50 to 64 years of age, 2.00 cases per 1000 tested positive for influenza in the recombinant-vaccine group compared to 2.34 cases per 1000 in the standard-dose group.

This data indicates a relative vaccine effectiveness of 15.3%; 95% confidence interval [CI], 5.9 to 23.8; P=0.002).

However, the recombinant vaccine was not significantly more protective against influenza-related hospitalization than were the standard-dose vaccines.

In summary, the high-dose recombinant vaccine conferred more protection against PCR-confirmed influenza than an egg-based standard-dose vaccine among adults between 50 and 64 years old.

Flublok is made by Sanofi and is licensed by the U.S. Food and Drug Administration and the European Medicines Agency as Supemtek.