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Vaxxinity, Inc. today announced The Lancet's eBioMedicine published results of Phase 2a clinical trial stating that UB-311 "was safe and well-tolerated," with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer's disease (AD).
In this 78-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2a, Vaxxinity-funded study, UB-311 was reported to elicit a robust, rapid, and titrated antibody response to Aβ.
And UB-311 was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H.
"This publication supports the innovative work that we and our collaborators are conducting to advance UB-311 for the potential treatment, and even prevention, of Alzheimer's disease," said Mei Mei Hu, CEO of Vaxxinity, in a press release on August 10, 2023.
"Imagine expanding the addressable patient population of beta-amyloid immunotherapies by multiple orders of magnitude, potentially over 1,000x, and delivering life-changing medicine at a fraction of the cost. That is our vision for UB-311 and the potential power of active immunotherapies."
AD is the most common form of dementia, is a progressive neurodegenerative disorder that slowly destroys memory and cognitive skills and eventually the ability to carry out simple tasks.
UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aβ) oligomers and fibrils and oligomers.
Two passive immunotherapies – monoclonal antibodies targeting Aβ – have recently been authorized by the U.S. FDA, validating Aβ as a target for disease-modifying immunotherapies of AD.
However, these passive immunotherapies have been associated with amyloid-related imaging abnormalities (ARIA), which can present as vasogenic edema or sulcal effusion (ARIA-E) or as hemosiderin deposits such as micro hemorrhages and superficial siderosis (ARIA-H).
Although the trial was not powered to make conclusions about efficacy, secondary efficacy outcomes on cognitive, functional, behavioral, and global assessments such as ADAS-Cog, MMSE, ADCS-ADL, and CDR-SB were evaluated.
Trends of slowing disease progression were observed across key cognitive and functional measures for UB-311-treated versus placebo-treated participants over 78 weeks of observation, including a 48% slowing of decline on CDR-SB in the UB-311 quarterly boosting group.
Furthermore, the U.S. FDA-licensed mAbs require IV infusions every two weeks and are priced at $26,500 annually, not including the cost of administering them or monitoring for ARIA.
In contrast, UB-311 has the potential to offer multiple competitive advantages, including lower rates of ARIA-E, improved convenience through less frequent dosing and ease of administration through intramuscular injection, and overall improved accessibility and cost-effectiveness for patients and health systems.
As of August 10, 2023, the U.S. FDA had not approved an Alzheimer's vaccine candidate.
The U.S. Department of State today confirmed visiting the Republic of Fiji is safe, but people should exercise normal precautions.
The State Department disclosed on August 9, 2023, a higher level of caution is suggested when visiting Colo I Suva Forest Park. Be aware of your surroundings and be extra vigilant along the trails when displaying items like jewelry, bags, and cell phones in public.
In July 2023, a security alert notified U.S. citizen victims of sexual assault are encouraged to contact the U.S. Embassy for assistance at + (679) 331-4466.
Fiji is an island country in Melanesia, part of Oceania in the South Pacific Ocean, where over 200,000 people visit annually.
If you decide to travel to Fiji, the no-cost Smart Traveler Enrollment Program is available to receive security messages and make it easier to locate you in an emergency.
From a health perspective, the U.S. CDC suggests visitors to Fiji speak with a healthcare provider about routine and travel vaccines, including the annual flu shot.
The CDC recently (July 2023) reissued a Travel Health Advisory for the Pacific Islands regarding various dengue outbreaks.
Meissa Vaccines announced positive safety and immunogenicity data for MV-012-968, the company's intranasal live attenuated Respiratory syncytial virus (RSV) vaccine candidate.
Meissa is developing MV-012-968 as a needle-free, adjuvant-free vaccine to protect infants and toddlers from the respiratory syncytial virus (RSV).
The company says RSV is the leading cause of infant hospitalization in the United States and is considered a "missing" pediatric vaccine.
The clinical study in RSV-naïve (seronegative) participants between the ages of six and 36 months enrolled 79 participants at multiple sites in the U.S. to evaluate the safety and immunogenicity of MV-012-968 (NCT04909021).
At the highest dose tested, no serious adverse events related to vaccination were reported with no evidence of any lower respiratory tract symptoms, no Grade 2 or 3 fever observed, and low level, transient vaccine shedding detected.
All RSV-naïve infants and toddlers demonstrated a vaccine response to two doses of 107 PFU.
Serum-neutralizing antibody responses to MV-012-968 were robust and comparable to those seen with previous live attenuated RSV vaccine candidates demonstrating high efficacy against medically-attended RSV disease.
Moreover, MV-012-968 demonstrated significantly greater tolerability to date than these previous candidates.
"With this outstanding safety and robust serum antibody response, we believe Meissa's live attenuated vaccine has the potential to be a best-in-class solution to protect infants and toddlers from RSV, and we are now preparing to advance MV-012-968 into a Phase 2/3 clinical trial next year (2024)," said Martin Moore, Ph.D., co-founder and Chief Scientific Officer, Meissa Vaccines, in a press release on August 8, 2023.
"These data also demonstrate the power of our AttenBlock platform to generate live attenuated vaccines with outstanding safety and immunogenicity – something that we've not seen with other platforms."
As of August 10, 2023, the U.S. FDA has approved RSV vaccines for seniors and antibody therapies for infants.
The World Health Organization (WHO) published Influenza Update N° 451 that stated virus detections remained low, with activity in many countries in the southern hemisphere now decreasing after having peaked in recent weeks.
And no exceptional flu outbreaks were confirmed over the past two weeks.
On August 7, 2023, the WHO reported that influenza activity decreased in Oceania, Central America, and temperate South America, with influenza A viruses predominant.
Furthermore, in the temperate zones of the northern hemisphere, influenza activity was reported at low levels or below the seasonal threshold in most reporting countries.
And in the Caribbean countries, influenza activity remained low overall.
As of August 10, 2023, over 100 million flu shots are available at most health clinics and pharmacies in the U.S.
SK bioscience recently announced that it secured 6.5 million shares of common stock through a private placement investment in Novavax, a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant.
Concurrent with the equity investment announcement, SK bioscience and Novavax have extended their current license agreement, adding Novavax's updated COVID-19 vaccine ((Nuvaxovid, CovoVax, NVX-CoV2373)
The agreement serves as a strategic shift of partnership from the pandemic period to the endemic phase, in which SK bioscience will obtain exclusive rights to Novavax's COVID-19 variant vaccine in South Korea and non-exclusive rights in Thailand and Vietnam to supply and commercialize the vaccine.
Jaeyong Ahn, CEO of SK bioscience said in a press release on August 8, 2023, "We believe that the strategic equity investment and the continuous cooperation between SK bioscience and Novavax, which are among the few companies that focused on developing COVID-19 vaccines during the pandemic, will create a powerful synergy."
Through the enhanced partnership, SK bioscience will explore potential future collaborations with Novavax such as utilizing Novavax's adjuvant, Matrix-M. Novavax also develops COVID-Influenza combination, stand-alone influenza, and high-dose COVID-19 vaccine candidates.
Taiwan's Centers for Disease Control (TCDC) today reported seven new mpox cases. The patients develop symptoms like fever, swollen lymph nodes, and blistering rash between July 24 and August 1, 2023.
As of August 7, 2023, a total of 266 mpox cases (250 local cases and 16 imported cases) have been diagnosed.
The TCDC stated that according to the research, mpox vaccination (Jynneos) could effectively reduce the risk of infection.
In July, Taiwan expanded its mpox immunization drive at 125 medical institutions, especially those who have been "infected with sexually transmitted diseases.
According to statistics from the TCDC, as of August 7, 2023, a total of 77,809 Mpox vaccination services have been completed, including 447 post-exposure prophylaxis vaccinations and 77,362 pre-exposure prophylaxis vaccinations.
About 25,803 people have completed two vaccinations, and 19,510 people received only one dose.
As influenza and respiratory syncytial virus (RSV) seasons approach the U.S., health leaders focus on pregnant women's vaccination needs.
The Centers for Disease Control and Prevention (CDC) will conduct a Clinician Outreach and Communication Activity (COCA) webinar on August 10, 2023, to share updated clinical vaccination guidance for pregnant women.
The CDC and the American College of Obstetrics and Gynecology emphasize the importance of vaccinations for pregnant women and recommend vaccinations against pertussis, flu, and COVID-19 to protect themselves and their babies during the first few months of life.
The CDC says there have been recent declines in vaccination coverage for Tdap (tetanus, diphtheria, and pertussis) and flu shots and low uptake of COVID-19 vaccines among pregnant women.
During Thursday's COCA Call, presenters (Naima T. Joseph MD, MPH, Tara C. Jatlaoui, MD, MPH) will give a comprehensive overview of the timing and promotion of vaccines people should receive during pregnancy and provide an update on RSV vaccine candidates for pregnant women.
This one-hour webinar is scheduled for Thursday, August 10, 2023, 2:00 PM – 3:00 PM ET, at Webinar Link:
https://www.zoomgov.com/j/1604412918; ID: 160 441 2918; Passcode: 650748. Note: Zoom recently modified its privacy policies.
Updated August 10, 2023 - presentation slides.
Dallas County Health and Human Services (DCHHS) today reported the first West Nile Virus (WNV) death in Dallas County, Texas, for the 2023 season.
The patient was a female resident in the City of Irving diagnosed with West Nile Neuroinvasive Disease.
This is the second WNV human death reported in Texas this year.
For 2023, a total of one hundred and sixty-seven mosquito traps have tested positive for WNV.
Over the last five years, Texas has had 485 WNV cases and 65 related deaths.
“It’s very sad to report the first West Nile Virus death this season,” said Dr. Philip Huang, Director of DCHHS, in a press release on August 9, 2023.
“This again reminds us how important it is to protect against mosquito bites that can carry multiple diseases like WNV. Mosquito activity remains high in Dallas County.”
DCHHS says most people exposed to WNV don’t get sick, but about 20% develop symptoms like headache, fever, muscle and joint aches, nausea, and fatigue. In a small proportion, less than 1%, the virus affects the nervous system, leading to the more severe West Nile neuroinvasive disease that can cause neck stiffness, disorientation, tremors, convulsions, paralysis, and even death.
Aedes albopictus and Aedes aegypti mosquitoes, which transmit WNV, are currently circulating in Texas and remain active in much of Texas into November and December.
As of August 9, 2023, no U.S. FDA-approved WNV vaccines are available.
