Vaccine News

The global search for innovative urinary tract infection (UTI) treatments recently received a $10 million boost.

Recce Pharmaceuticals Limited, a leading Australian developer of a new class of Synthetic Anti-Infectives, announced it had received binding commitments to raise about $10 million in new funds.

On July 2, 2024, Recce confirmed that the funds raised from the Placement will be used to advance clinical trials for intravenous use of R327 and topical applications of R327G, including Registrational Phase III clinical activities in Indonesia, Investigational New Drug (IND) enabling activities, working capital, and offer costs.

In a press release, Chief Executive Officer James Graham commented on the capital raising: "We are" delighted with the support of our capital raising from our existing shareholders and welcome new institutional shareholders to our register. We thank NorthStar Impact Fund for taking the time to understand Recce and the positive impact we aim to achieve."

Recce stated the Company will be fully funded through to FY2026 to fund significant IND-enabling clinical trials in Australia, covering intravenous and topical treatments for UTI/Urosepsis and ABSSSI, including Diabetic Foot Infections, as well as U.S. Department of Defence Burn Wound Program, Continued development of a pre-clinical portfolio, manufacturing expansion and provides the necessary capital to see Indonesian clinical trials for topical treatments through to commercialization.

On July 1, 2024, Recce clarified the Phase I/II clinical trial is an Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE® 327 (R327) Intravenous Dose and Infusion Rates.

The primary trial outcomes were to evaluate the safety and tolerability of R327 administered at various infusion rates ranging from 15 to 45 minutes in healthy male and female participants, and to assess the plasma pharmacokinetics of R327 using the same infusion rates.

The secondary trial outcomes focused on evaluating the concentration of R327 in urine at various doses and infusion rates and examining the ex vivo pharmacodynamics, specifically the minimum inhibitory concentration, of urine and blood samples from participants. Trial outcomes were successfully achieved.

An independent data review has been conducted, and the positive safety and efficacy conclusions stated in the announcement released on June 28, 2024. A comprehensive data review will be conducted, with results to be made available to the Company, which are expected to align with findings to date.

In the United States, And in the United States, Pivya™ (pivmecillinam) recently gained the Food and Drug Administration (FDA) approval for treating adult women with uncomplicated UTIs. Pivya's availability in the U.S. is forecasted for 2025.

Despite the World Health Organization declaring an end to the recent pandemic about a year ago, COVID-19 remains a significant health risk for immunocompromised patients.

To address this unmet need, AstraZeneca today announced its Marketing Authorisation Application for sipavibart (AZD3152), an investigational long-acting monoclonal antibody, has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA) for preventing COVID-19 in immunocompromised patients. 

This passive immunization is essential for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

Prof. Paul Loubet, M.D., Ph.D., MPH, Professor of infectious diseases, University of Montpellier, head of the Infectious and Tropical Diseases Department, Nîmes University Hospital, France, and SUPERNOVA clinical trial investigator, said in a press release on July 1, 2024, “The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination."

"With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk, and it has demonstrated COVID-19 protection in a mixed variant environment.”  

In addition to the EMA, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.

West Nile fever cases have been reported in Israel for many years and generally occur between June and November each year. That annual trend changed in 2024, with fatal cases reported earlier than usual.

The Israeli Ministry of Health (MOH) recently reported that 81 people have been diagnosed with West Nile fever in 2024. Sixty-four people have been hospitalized.

As of July 1, 2024, a total of 7 people who were diagnosed with the virus died.

All of these West Nile cases have been reported in the center of Israel.

The MOH says the risk of significant morbidity is among older adults and people with immunosuppression.

To reduce exposure to mosquitoes, the MOH recommends using mosquito repellents and appropriate measures to keep mosquitoes away in living rooms, as well as turning on fans in the place of residence.

The U.S. CDC says there are no licensed vaccines or medicines to prevent or treat West Nile virus in humans. However, several vaccine candidates have shown safety and immunogenicity in clinical trials.

 Valneva SE announced today that the European Commission (EC) has granted marketing authorization in Europe for the IXCHIQ® vaccine, which is used to prevent diseases caused by the chikungunya virus in adults.

IXCHIQ® is the world’s only licensed chikungunya vaccine.

The EC decision marks the third approval the Company has received for IXCHIQ® following approval from the U.S. FDA in late 2023 and Health Canada last month.

On July 1, 2024, Valneva stated it expects to deliver the first vaccine doses in Europe in the fourth quarter of 2024.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, “The EC approval marks a crucial milestone toward making this vaccine available to as many European citizens as possible .... It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa.

Valneva has also submitted a Marketing Authorization Application to the UK Medicines and Healthcare products Regulatory Agency and the Brazilian Health Regulatory Agency, with potential approval in 2024.

Since the start of 2024, the Democratic Republic of Congo (DRC) has reported over 20,000 mpox cases, with more than 1,000 deaths, primarily affecting children.

In June 2024, the U.S. CDC issued a Level 2 Alert reporting a mpox outbreak in 25 out of 26 DTC provinces, including urban areas.

According to media sources, authorities in the DRC have responded to this outbreak by approving the use of two new vaccines.

AfricaNews.com reported on June 28, 2024, that emergency use authorization had been issued for the Jynneos® vaccine, developed by Bavarian Nordic, and LC16, produced by KM Biologics.

LC16 is a 3rd generation, live attenuated vaccine containing live vaccinia virus (LC16m8 strain) used to prevent smallpox and mpox.

The DRC decision follows rigorous evaluation by relevant authorities and stakeholders involved in the authorization process.

JYNNEOS (MVA-BN®, IMVAMUNE®) is a two-dose vaccine based on a live, attenuated vaccinia virus, Modified Vaccinia Ankara, and has been offered in the United States since May 2022.

 PharmaJet® today announced that their Tropis® Intradermal (ID) Needle-free System will be used in a house-to-house polio immunization campaign.

Over a quarter million PharmaJet’s needle-free intradermal syringes have been provided to support this initiative.

The campaign will be conducted in two rounds to reduce the immunity gap significantly against type-2 poliovirus. Young children will receive the needle-free polio vaccine and novel oral polio vaccine (nOPV2) to achieve 95% coverage in each round.

The polio campaign, a collaboration of the African Field Epidemiology Network, WHO, UNICEF, BMGF, GAVI, and U.S. CDC, targets over 170,000 children in Somalia.

The most recent evidence for human circulating vaccine-derived polio virus-2 was in March 2024.

Through the Somalia Emergency Action Plan, the country will continue to work with humanitarian partners to reach about 1.5 million zero-dose children, most of whom live in the country’s highly populated central and southern areas.

Paul LaBarre, Vice President of Global Business Development at PharmaJet, commented in a press release on June 27, 2024, “In Somalia, we are eager to build on previous house-to-house campaign experience that demonstrates how needle-free enables vaccination teams to move quickly and achieve high coverage without the burden of sharps waste management and with reduced vaccine volume and cold chain logistics.”

The U.S. CDC reissued a Global Polio Alert on May 23, 2024, regarding polio outbreaks and poliovirus detections in 34 countries. The CDC recommends that visitors to these countries be fully vaccinated against polio.

Dynavax Technologies Corporation today announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles (herpes zoster).

The Phase 1/2 randomized, active-controlled, dose escalation, multicenter trial is expected to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia and will evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to the Shingrix® vaccine.

Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will also support the validation of a Patient-Reported Outcome measurement tool to differentiate Z-1018 on tolerability and support potential label claims.

"We believe there is an opportunity to develop an improved shingles vaccine with a significantly better tolerability profile than the market-leading shingles vaccine. One of the unique advantages of our vaccine candidate is CpG 1018 adjuvant's established safety and tolerability profile, combined with its ability to induce strong CD4+ T-cell responses, which are thought to be critical in preventing the reactivation of the herpes zoster virus," said Rob Janssen, M.D., Chief Medical Officer of Dynavax, in a press release on June 27, 2024.

Dynavax anticipates reporting top-line immunogenicity and safety data in the second half of 2025, including comparing CD4+ T-cells one month after the second of two vaccine doses.

According to the U.S. CDC, shingles risk increases with age and in people with weakened immune systems. About 33% of people in the United States develop shingles at least once, and fewer than 100 people die of shingles each year.

As of June 2024, there are four approved shingles vaccines and several vaccine candidates conducting clinical research.