Cancer Vaccine Breaking News

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.

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.

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.

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.

The World Health Organization (WHO) today reported a steady increase in the proportion of SARS-CoV-2 coronavirus variant EG.5 reported, and based on its characteristics, EG.5 may spread globally & cause a surge in COVID-19 cases.

However, as of August 9, 2023, while EG.5 has shown increased prevalence, growth advantage, and immune escape properties, there have been no reported changes in COVID-19 severity to date.

Based on the available evidence, the public health risk posed by EG.5 is evaluated as low globally, aligning with the risk associated with XBB.1.16 and the other currently circulating variants of interest.

During epidemiological week #29 (17 to July 23, 2023), the global prevalence of EG.5 was 17.4%.

This is a notable rise from the data reported four weeks prior (week 25, 19 to June 25, 2023), when the global prevalence was 7.6%, wrote the WHO.

Novavax, Inc. today announced its operational highlights for the second quarter ended June 30, 2023. 

"During the first half of 2023, Novavax has been focused on execution, making significant progress on all three of our key priorities. We have initiated the filing for authorization of our updated XBB COVID vaccine in the U.S., with submissions in the European Union and Canada to follow. We are manufacturing at commercial scale in support of our plan to deliver our vaccine on time for the fall season," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on August 8, 2023.

"We continue to work towards deriving additional value from our pipeline and technology and will be advancing our COVID-Influenza Combination vaccine candidate through the next stage gates and towards late-stage development."

Novavax also received first Full Marketing Authorization in Europe for Nuvaxovid™ as a primary series in individuals aged 12 and older and as a booster in adults aged 18 and older.

Since authorization, Nuvaxovid™, a protein-based vaccine, has been distributed in about 40 markets.

On July 11, 2022, Novavax announced an agreement with the U.S. HHS to secure 3.2 million doses of Novavax's COVID-19 vaccine.

And the company initiated the rolling submission of a U.S. Biologics License Application for full approval of the Novavax COVID-19 Vaccine, Adjuvanted for adults and adolescents aged 12 through 18.