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As the multi-year Zika vaccine development process continues in late 2023, the mosquito-spreading disease is impacting more people in the Region of the Americas.
As of December 2, 2023, the Pan American Health Organization's data dashboard indicates there have been 31,780 Zika cases across the Americas, with the highest proportion of Zika cases reported in Brazil, Bolivia, Belize, Columbia, Paraguay, and Venezuela.
Brazil has reported the most Zika cases in 2023, with over 30,000 confirmed cases, primarily in high precipitation areas and low sewage network coverage.
Previous studies conducted in the states of Rio de Janeiro and São Paulo also indicated that temperature influenced the distribution patterns of Zika virus carrying Ae. aegypti and Ae. albopictus mosquitoes, consequently affecting the incidence of diseases they transmit.
While there have not been any Zika cases confirmed in the continental United States in 2023, two frequently visited destinations have reported locally acquired cases.
In the U.S. territory of Puerto Rico, week #44 shows 43 probable Zika cases as of 2023 and 20 cases during 2022.
And in Central America, Costa Rica's Ministry of Health recently confirmed there have been 27 Zika cases confirmed this year. In 2022, there were 45 Zika cases reported in Costa Rica.
According to the U.S. Centers for Disease Control and Prevention, about 25% of infected people may develop Zika symptoms, and the illness is usually mild, lasting between two and seven days,
However, Congenital Zika-associated syndrome is seen in infants born to mothers with a history of gestational Zika fever. These children may also develop microcephaly.
As of December 2023, various Zika vaccine candidates are conducting clinical trials without any indication of pending U.S. FDA approval. These trials include DNA, modified vaccinia Ankara vector platform, and purified inactivated virus vaccine technologies.
The Pan-American Health Organization (PAHO) recently issued an Epidemiological Alert following an increased number of invasive group A streptococcal (iGAS) infection cases, especially in children.
As of November 28, 2023, Argentina had reported 93 fatal cases.
About half of the 643 cases and over 38% of the deaths involved children younger than 16 years.
Previous reports of the National Epidemiological Bulletin of Argentina had alerted about the presence of the M1UK clone and the finding of a hypervirulent M1 sublineage that is being characterized.
Based on these findings, the National Reference Laboratory, the Epidemiology Directorate, and its municipalities are implementing an intensified surveillance protocol for non-invasive Streptococcus pyogenes disease.
PAHO noted that Argentina's developments follow an increase in GAS and scarlet fever cases in Europe and Uruguay in 2022.
Streptococcus pyogenes, or GAS, are gram-positive bacteria that cause a broad spectrum of infections. GASs can lead to life-threatening complications and immune-mediated diseases with chronic sequelae.
According to the PAHO, GASs are responsible for more than 500,000 deaths per year worldwide.
According to the U.S. CDC, most people exposed to someone with a group A strep infection should not receive prophylaxis. However, in some situations, healthcare professionals may recommend prophylaxis for someone exposed to an invasive group A strep infection.
As of November 30, 2023, there is currently no vaccine to prevent group A strep infections, although several vaccines are in development, says the CDC.
Merck today announced results from STRIDE-3, a Phase 3 clinical trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults.
The trial evaluated the immunogenicity, tolerability, and safety of V116 compared to a pneumococcal 20-valent conjugate vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine.
Results from the study’s primary objectives are posted at this PVax link.
“These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on November 28, 2023.
“We are excited by the potential of V116 to impact public health through primary prevention through the use of a population-specific strategy that targets the serotypes responsible for the majority of invasive pneumococcal disease in adults.”
According to U.S. CDC data from 2018-2021, the serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 and older.
Based on the same CDC data, V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, responsible for about 30% of invasive pneumococcal disease in individuals 65 and older.
V116 would be the first pneumococcal conjugate vaccine designed for adults if approved, says Merck.
As of November 29, 2023, various pneumococcal vaccines are U.S. FDA-approved and available at clinics and pharmacies in the U.S.
Emergent BioSolutions Inc. today announced that the U.S. Biomedical Advanced Research and Development Authority awarded a $75 million option to Emergent's existing contract to acquire the newly licensed anthrax vaccine CYFENDUS™.
The deliveries are expected to begin in 2023 and be complete in the late first quarter of 2024.
Previously known as AV7909, the CYFENDUS vaccine was approved by the U.S. Food & Drug Administration in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 and older.
"CYFENDUS™ vaccine is a critical component of Emergent's anthrax medical countermeasures franchise and supports the U.S. government's anthrax preparedness strategy," said Paul Williams, senior vice president, products head at Emergent, in a press release on November 28, 2023.
Anthrax is considered a high-priority national security threat and has the potential for significant public health impact, says Emergent.
Anthrax is a serious infectious disease caused by gram-positive, rod-shaped bacteria known as Bacillus anthracis, one of the most likely agents to be used in a biological attack.
Anthrax occurs naturally in soil worldwide and can cause severe illness in humans and animals, says the U.S. CDC. If you think you may have been exposed to anthrax, you need to go to a doctor.
However, anthrax is not contagious, which means you can't catch it from another person, like influenza.
SK bioscience today announced it is partnering with Hilleman Laboratories Singapore to develop a low-cost, improved manufacturing process, second-generation Ebola-Zaire vaccine.
Currently, Ebola vaccines have been authorized and used in Africa since 2019.
On November 22, 2023, SK bioscience confirmed it will acquire unique expertise and know-how for the use of recombinant Vesicular Stomatitis Virus Vector (rVSV) technology platform in close collaboration with Hilleman Laboratories to potentially jointly develop other vaccines against a variety of viral infectious diseases.
Jaeyong Ahn, CEO of SK bioscience, commented in a press release, "Developing a vaccine to prevent viruses causing diseases with a high fatality rate, such as Ebola-Zaire, is essential for us to protect humanity."
"By cooperating with Hilleman Laboratories for a successful development of the second-generation Zaire Ebolavirus vaccine, we will contribute to overcoming the Ebola Zaire disease burden and expand our cooperation with global companies and institutions."
In 2014, the World Health Organization declared an international public health emergency during the Ebola outbreak and encouraged the development of the vaccine when the virus was spreading rapidly in West Africa.
Ebola Virus Disease is a rapidly progressive, severe, and transmissible hemorrhagic illness caused by infection with one of the Ebola Virus (EBOV) species. While there are six identified EBOV species, the Zaire Ebola virus strain has been the leading cause of outbreaks over the last 20 years.
Ever since the Ebola virus was first discovered in 1976, there have been multiple outbreaks resulting in significant loss of lives (50% mortality rate) and economic impact.
Alzamend Neuro, Inc. today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for the treatment of patients with major depressive disorder ("MDD"), also known simply as depression.
While a wide variety of medications have been used historically for augmentation of an antidepressant in MDD, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials.
AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.
Alzamend's goal is to revive the utility of lithium treatment by significantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.
Stephan Jackman, Chief Executive Officer of Alzamend, commented in a press release on November 20, 2023, “If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD."
"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”
Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug's constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application pathway for FDA approval, which is available to new formulations of an approved drug.
As of November 21, 2023, the FDA has not approved a vaccine candidate targeting depression of Alzheimer's disease.
One of the world’s most formidable public health challenges, human immunodeficiency virus (HIV), is impacting more than 38 million people worldwide.
While there are no U.S. Food and Drug Administration (FDA) approved HIV vaccines in 2023, a novel arenaviral therapeutic vaccine candidate is being evaluated as a potential curative regimen for HIV.
HOOKIPA Pharma Inc. today announced that it has received clearance from the FDA for its Investigational New Drug (IND) application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.
HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV.
One vector is based on the lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.
Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial.
And Gilead Sciences, Inc. has the exclusive right to assume further program development afterward.
Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on November 20, 2023, “The ability to generate a potent and broad T cell response that can clear infected cells is critical for HIV control. Our novel arenaviral therapeutic vaccine (candidate) offers promise in helping to address the unmet need for a functional HIV cure.”
In November 2023, Nature Partner Journals Vaccines published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission.
The data show that arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality, and durable immune responses (antigen-specific T cells and antibodies) in non-human primates.
Additionally, arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo.
HIV, a sexually transmitted disease, is one of the world’s most formidable public health challenges.
The virus infects and kills immune cells and, without effective ongoing treatment, leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS in 2023.
Longhorn Vaccines and Diagnostics today presented new data from an animal study of LHNVD-301, the company's lead tuberculosis (TB) vaccine candidate.
The data presented at The Union World Conference on Lung Health 2023 on November 15, 2023, showed that a mycobacterium tuberculosis (MTB) vaccine could generate broader protection against pathogens susceptible to antimicrobial resistance (AMR).
LHNVD-301 is an unconjugated, peptide-based vaccine that combines a MTB heat shock protein epitope and a peptidoglycan (PGN) epitope.
PGN is a cell wall component of bacteria that plays a vital role in infections.
The combination of heat shock protein and PGN generates broad reactive antibodies.
It represents a novel approach that combats AMR while targeting tuberculosis by combining multiple epitopes specific to MTB and common to gram-positive bacteria into a peptide vaccine.
Longhorn CEO Gerald W. Fischer, MD, commented in a press release, "We are developing LHNVD-301 to address MTB as a global threat and combat AMR."
"Unconjugated peptides targeting epitopes of multiple pathogens enable a cost-effective, easily scalable approach for vaccine development, which is crucial for covering those most at risk for TB."
While TB is an ancient disease, outbreaks caused an estimated 10.6 million infections and 1.3 million deaths in 192 countries and areas in 2022.
As of November 2023, 16 TB vaccines are available globally, and various BCG vaccine candidates are under development.
Nouscom recently announced the completion of its Series C equity financing, raising $72 million that will be used to continue advancing and expanding Nouscom's wholly-owned clinical pipeline to achieve multiple clinical value catalysts.
As of November 13, 2023, the funding proceeds will support the following initiatives:
Readout from Nouscom's ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf vaccine targeting 209 shared neoantigens, in combination with pembrolizumab for the treatment of Mismatch Repair/Microsatellite Instable Metastatic Colorectal Cancer.
Final readout from the ongoing Phase 1b study and advancement of NOUS-209 monotherapy in Lynch Syndrome carriers investigating the potential to intercept, prevent, or delay cancer before it occurs. LS carriers have a genetic predisposition to and, consequently, a higher risk of developing certain cancers. Promising initial results from this study were reported on October 31, 2023.
Completion of a Phase 1b study evaluating NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs.
Nouscom has also exclusively out-licensed VAC-85135, an off-the-shelf immunotherapy developed under a multi-project agreement, which is currently under evaluation in a Phase 1 clinical trial for the treatment of Myeloproliferative Neoplasms sponsored by Janssen Research & Development and Bristol Myers Squibb.
Dr. Marina Udier, Chief Executive Officer of Nouscom, commented in a press release, ".... This financing will allow us to further accelerate development across our wholly-owned clinical portfolio reporting multiple clinical trial readouts, including from our ongoing randomized Phase 2 clinical trial with NOUS-209."
"These Phase 2 data, if positive, have the potential to position Nouscom's neoantigen-based cancer vaccines amongst the most thrilling developments in the field."
According to a Review Article published by the journal Frontiers in Immunology in February 2023, Neoantigen vaccines are based on epitopes of antigenic parts of mutant proteins expressed in cancer cells. These highly immunogenic antigens may trigger the immune system to combat cancer cells.
