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The U.S. Centers for Disease Control and Prevention (CDC) today announced an Emergency Preparedness and Response COCA Call on July 20, 2023, where participants will learn how to prevent, diagnose, and treat malaria.
And how the biology of the pathogen contributes to the clinical management of the disease,
And how CDC and state and local health departments respond to the locally acquired mosquito-borne malaria cases in Florida and Texas.
Previously, the CDC issued a Health Alert Network Health Advisory on June 26, 2023, to share information on the recent identification of locally acquired, mosquito-transmitted malaria cases (P. vivax) in Florida and Texas.
Although these are the first documented instances of locally transmitted malaria in the U.S. since 2003, approximately 2,000 malaria cases are diagnosed and treated in the U.S. each year.
Malaria cases are primarily confirmed in individuals returning from travel to malaria-endemic countries such as Brazil and Cuba.
These malaria infections present a potential risk of subsequent transmission domestically since Anopheles mosquitoes, capable of transmitting malaria, are broadly distributed across the United States.
For example, locally-infected and travel-related malaria cases in Florida were confirmed in July 2023.
During this COCA call on July 20, 2023, at 2:00 PM – 3:00 PM ET, at Webinar Link: https://www.zoomgov.com/j/1618112526, will learn CDC and state and local health departments are responding to the locally acquired mosquito-borne malaria cases in the U.S.
Unfortunately, the U.S. government has not approved a malaria-prevention vaccine as of July 18, 2023.
Florida Health's latest Mosquito-Borne Disease Surveillance report indicates the recent malaria outbreak in the Sarasota area has continued into the summer of 2023.
As of July 15, 2023, Florida Health'w week #28 reported confirmed the seventh locally-acquired malaria case in the Sarasota area since May 2023. The Plasmodium species reported were Plasmodium vivax.
And state-wide, there have been 26 travel-related malaria cases reported in Broward (5), Duval, Hillsborough (4), Lee, Leon (2), Miami-Dade (5), Orange (2), Osceola, Pinellas (3), Sarasota, and Volusia counties this year.
The majority of travel-associated malaria cases in Florida were in people who had recently visited Africa.
Malaria still threatens international travelers, military personnel, and U.S. citizens living and working abroad, says the Centers for Disease Control and Prevention (CDC).
According to the World Health Organization World Malaria Report, the global number of malaria outbreaks reached about 240 million cases, with over 600,000 related fatalities in 2021.
As of July 18, 2023, the U.S. CDC says the bite of an infective female Anopheles mosquito spreads malaria.
The disease can cause fever, chills, and flu-like illness. If it is not treated, it can cause severe complications and death.
The CDC has issued malaria alerts for malaria-endemic countries, including Costa Rica, but not Florida.
Various antimalarial treatments are approved by the CDC in 2023, but not no malaria vaccines.
As of July 5, 2023, twelve African countries are set to receive 18 million doses of GSK's Mosquirix recombinant vaccine over the next two years.
Pfizer Inc. and Flagship Pioneering, Inc. today announced a partnership to create a new pipeline of innovative medicines. The focus will be addressing unmet needs within Pfizer's core strategic areas of interest, including in broad patient populations and diseases with high potential to benefit from diverse technology platforms and modalities.
Pfizer will fund and have options to acquire development programs.
Under the terms of the novel agreement, Flagship and Pfizer will each invest $50M upfront to explore opportunities to develop ten single-asset programs by leveraging Flagship's ecosystem of more than 40 human health companies and multiple biotechnology platforms.
To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.
Per the new agreement, Flagship and its bioplatform companies can receive up to $700M in milestones and royalties for each successfully commercialized program.
"At Pfizer, we are expanding our efforts to pursue potential breakthrough science with unique approaches and funding mechanisms designed to leverage the dynamic scientific ecosystem," said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer, in a press release on July 18, 2023.
"This collaboration is an exciting opportunity for Pfizer to bring deep scientific expertise and apply our development and regulatory strength to Flagship's diverse portfolio of technology platforms, translating early-stage innovation to potential medicines."
Vaxxinity, Inc. today announced new data from an early-stage clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson's disease, UB-312, slows the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients as demonstrated using multiple target engagement assays.
These data signify that UB-312 has established clear target engagement in Parkinson's disease (PD) patient CSF.
Jean-Cosme Dodart, Ph.D., SVP of Research at Vaxxinity, commented in an email, “The more data we see from our UB-312 program, the more excited I get for the future of this vaccine and its potential positive impacts for patients with PD or other a-synucleopathies."
"Demonstrating target engagement in PD patients immunized with UB-312 is an exciting milestone which encourages us to push this program further into clinical development.”
UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies.
"Our candidate has shown target engagement of the toxic species of alpha-synuclein in patients, demonstrating not only proof of our technology platform but also proof of the mechanism of our vaccine-derived antibodies specifically engaging with the toxic target in vivo," said Mei Mei Hu, CEO of Vaxxinity, in a press release on July 17, 2023.
"Showing target engagement has always been a key challenge to overcome in neurodegeneration and is of critical importance when demonstrated – a milestone worth celebrating."
"It is beyond our expectation to see this in our Phase 1 clinical trial."
"We are endlessly grateful to the patients who participated and to The Michael J. Fox Foundation and our collaborators for their work on these cutting-edge assays that supported this breakthrough."
Last month, Vaxxinity announced clinical data from Part B of its Phase 1 clinical trial of UB-312 demonstrating that UB-312 was well-tolerated and induced anti-aSyn antibody responses in participants with early PD and that antibodies were detectable in the CSF.
As part of this trial, The Michael J. Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients and to conduct exploratory research to characterize the anti-aSyn antibodies produced after UB-312 administration and assess target engagement.
Mark Frasier, Ph.D., Chief Scientific Officer of MJFF, commented, "Integration of critical biomarker insight into therapeutic development programs is essential for building confidence in the treatment approach and designing informative trials. We're pleased to support efforts of this kind that can have a major impact for people with Parkinson's disease."
AstraZeneca and Sanofi's today announced Beyfortus™ (nirsevimab-alip) has been approved in the United States for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.
And for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Beyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term or preterm or with specific health conditions that make them vulnerable to severe RSV disease.
Furthermore, the single dose can be flexibly administered at the beginning of the RSV season or at birth for those born during the RSV season.
The companies confirmed on July 17, 2023, Beyfortus will be available for the 2023-2024 RSV season in the U.S.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said in a press release, "Beyfortus represents an opportunity for a paradigm shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S."
"The science that Beyfortus is built on demonstrates AstraZeneca's continued leadership in addressing the needs of the most vulnerable populations and reducing the burden on healthcare systems."
The Food and Drug Administration (FDA) approval followed the unanimous vote by the Antimicrobial Drugs Advisory Committee on the favorable benefit-risk profile of Beyfortus. It was based on the extensive clinical development program for Beyfortus, spanning three pivotal late-stage clinical trials.
Beyfortus was generally well tolerated, with a favorable safety profile consistent across all clinical trials.
Beyfortus has already been approved in the European Union and the United Kingdom.
According to the U.S. Centers for Disease Control and Prevention, RSV is a very contagious virus that can lead to serious respiratory illness in infants. Two out of three infants are infected with RSV during their first year of life, and almost all infants are infected by their second birthday.
The JAMA Network's Original Investigation in 2022 reported 6,549 respiratory fatalities were associated with RSV each year, including 96 (95% CI, 92-99) among children younger than one year.
RSV mAbs (Synagis) have been approved in the U.S. since 1998. Additionally, RSV vaccines have recently been approved by the FDA.
Invivyd, Inc. today announced additional positive initial data from its ongoing Phase 1 healthy volunteer clinical trial of its lead investigational monoclonal antibody (mAb) candidate, VYD222.
The results announced today add to the positive initial Phase 1 data reported by Invivyd in June 2023.
VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.
"We are pleased to see a favorable safety and tolerability profile as well as robust serum neutralizing titers against Omicron XBB.1.5 for all the VYD222 dose levels tested in our ongoing Phase 1 clinical trial," said Dave Hering, chief executive officer of Invivyd, in a press release on July 17, 2023.
"We believe these high neutralizing titer values and fold increases at this early timepoint are extremely encouraging as they indicate the potential for VYD222 to protect longer between doses and to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves."
The Phase 1 clinical trial of VYD222 enrolled 30 healthy volunteers across three dosing cohorts. In each cohort, participants were randomized 8:2 to VYD222 or placebo.
The initial Phase 1 data showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested, with no serious adverse events (SAEs) reported to date. At the middle VYD222 dose tested (2500 mg), geometric mean serum neutralizing titers were 9647.0 (95% CI: 6115.4, 15218.0) against Omicron XBB.1.5 at Day 7, with a geometric mean 92.82-fold rise (95% CI: 21.2, 406.6) from baseline to Day 7.
At the highest VYD222 dose tested (4500 mg), geometric mean serum neutralizing titers were 16864.7 (95% CI: 12825.5, 22176.1) against Omicron XBB.1.5 at Day 7, with a geometric mean 120.97-fold rise (95% CI: 31.4, 466.2) from baseline to Day 7.
The higher VYD222 dose levels tested in the Phase 1 clinical trial are designed to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves.
Analysis of the serum-neutralizing activity from samples collected at different time points across all dose cohorts in Phase 1 clinical trial is ongoing, as is detailed pharmacokinetic analysis and modeling.
Invivyd intends to use these analyses, combined with published clinical outcome data from prior clinical trials of vaccines and mAbs for the prevention of symptomatic COVID-19, including data from its Phase 2/3 clinical trial of adintrevimab for the prevention of COVID-19 (EVADE), to inform its VYD222 dosing strategy further.
Mr. Hering continued, "As a point of reference, we find it encouraging to observe that even our lowest VYD222 dose tested in our Phase 1 clinical trial resulted in higher titers against Omicron XBB.1.5 than the maximum titers against XBB.1.5 from investigational XBB-containing mRNA vaccines tested in humans that were shared at the FDA's recent vaccines advisory committee meeting."
"Higher VYD222 doses tested in our Phase 1 clinical trial have resulted, as expected, in higher titer levels that were well above those reported mRNA COVID-19 vaccine titer levels."
"We believe these initial Phase 1 clinical trial results support the potential for VYD222 to provide safe, meaningful, durable protection for vulnerable populations, such as immunocompromised people who may not generate adequate protection from COVID-19 vaccines, and we look forward to advancing VYD222 as fast as possible in collaboration with global regulators, starting with the FDA."
As of July 2023, mAbs targeting COVID-19 are in use globally.
While five World Health Organization (WHO) regions recently reported decreases in both cases and deaths, the African Region has reported an increase in fatalities, albeit from a relatively low baseline.
As of July 13, 2023, the WHO's Weekly epidemiological update Edition #151 revealed that during these 28 days, 57% (133 of 234) of countries and territories reported at least one COVID-19 case, which has been declining since mid-2022.
At the country level, the highest numbers of new 28-day cases were reported from the Republic of Korea (372 557 new cases; -22%), Australia (62 748 new cases; -59%), Brazil (56 744 new cases; -50%), New Zealand (38 949 new cases; +12%), and Singapore (28 333 new cases; -59%).
Furthermore, the WHO has recently Listed its twelfth COVID-19 vaccine.
In the U.S., COVID-19 trends by geographic area are posted by the CDC Data Tracker.
