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Global interest in developing vaccines against Neisseria gonorrhoeae (NG) has been sparked by the increasing threat of gonococcal antimicrobial resistance and the number of new infections.
And according to the U.S. Centers for Disease Control and Prevention (CDC), over 600,000 cases of gonorrhea were reported in 2020, making it the second most common sexually transmitted infection in the United States.
And the disease is known to be contracted repeatedly without apparently developing protective immunity.
To address this extensive health need, Intravacc today announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed in partnership with Therapyx inc.
The results of the candidate, a proprietary outer membrane vesicle (OMV) platform-based gonorrhea vaccine combined with encapsulated IL-12, showed protection against subsequent infection with NG.
In this study, mice were vaccinated via the intranasal route, and the results of this intranasal study were similar to the intravaginal vaccination route. Intranasal immunization resulted in high serum IgG, salivary IgA, and vaginal IgG and IgA anti-gonococcal antibodies when OMVs were administered with IL-12 ms.
The serum IgG and salivary IgA antibodies induced in male mice were similar to the response induced in female mice.
Gamma interferon (IFN-g) production by CD4 T cells from iliac lymph nodes was elevated after vaccination intranasally or intravaginally.
Female mice immunized with OMVs plus IL-12 ms by either route resisted challenge with NG to an equal extent, and resistance generated by intranasal immunization extended to heterologous strains of NG.
These results were published in the peer-reviewed journal MSphere of the American Society of Microbiology.
Dr. Jan Groen, Intravacc's CEO, commented in a press release on January 16, 2023, "Together with our partner Therapyx, we are very pleased with the preclinical data of the intranasal candidate vaccine Avacc 11®."
"This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments."
In October 2022, Intravacc was awarded a $14.6 Million U.S. NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further.
For the development of vaccines, Intravacc has designed and developed a platform based on outer membrane vesicles, spherical particles with intrinsic immune-stimulating properties.
The OMVs can be designed with immunogenic peptides and/or proteins that stimulate effective adaptive immunity.
The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens.
Intravacc has also developed genetic tools to increase the yield of the OMVs, reduce toxicity and achieve the desired antigenic composition.
Intravacc's OMV platform is scalable and allows rapid and efficient modification of the antigen composition, either through genetic modification of the bacterial host or by associating antigens with stored OMVs.
As of January 2023, there is no effective gonorrhea vaccine available in the U.S.
As the new year began a few weeks ago, various scientists are focused on developing Human Immunodeficiency Virus (HIV) vaccines. And vaccine development has accelerated in 2023 with candidates utilizing innovative technologies such as mRNA.
Vaccines work by inducing the immune system to make antibodies that can neutralize a particular pathogen.
But doing so for HIV has been challenging because there are countless variants worldwide, wrote the U.S. National Institutes of Health (NIH) on December 13, 2022.
This challenge is why mRNA vaccines may become the solution.
Encouraging news was announced in 2022 when Moderna Inc., a global leader in mRNA vaccines, confirmed it was participating in the NIH's HVTN 302 study that examines the safety and immune responses of BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, and BG505 MD39.3 gp151 CD4KO vaccines.
Each of Moderna's vaccine candidates are designed to present the spike protein found on the surface of HIV that facilitates entry into human cells and encodes for different but highly related stabilized proteins.
While this early-stage, Phase 1 clinical trial was updated on October 3, 2022, it could be years from achieving U.S. Food and Drug Administration (FDA) approval.
As of January 15, 2023, the FDA had not approved any HIV prevention vaccine for use by people.
Unfortunately, the AIDS epidemic continues to impact people everywhere, specifically in Africa.
About 38 million people worldwide are living with HIV, and about 70% of them live in Africa.
However, over 28 million people were accessing antiretroviral therapy in 2022, a significant increase from 7.8 million in 2010.
And in 2023, these people have expanded treatment options.
Gilead Sciences, Inc. announced on December 22, 2022, that the FDA approved Sunlenca® for treating HIV-1 infections in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
And previously, the U.S. FDA-approved Apretude for use by at-risk adults and adolescents weighing at least 35 kilograms for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV on December 20, 2021.
Anthony S. Fauci, M.D., former director at the U.S. National Institute of Allergy and Infectious Diseases, recently commented about HIV vaccine development efforts in an Emerging and Reemerging Infectious Diseases Perspective: It Ain't Over Till It's Over…but It's Never Over.
An innovative dual-action cell therapy engineered to eliminate tumors, train the immune system to eradicate primary tumors, and prevent cancer recurrence is progressing.
Cancer vaccines are an active area of research for many labs, but this new approach is distinct.
Scientists in Boston are now harnessing a new way to turn cancer cells into potent, anti-cancer agents.
In the latest work led by Khalid Shah, MS, Ph.D. at Brigham and Women's Hospital, investigators have developed a new cell therapy approach to eliminate established tumors and induce long-term immunity, training the immune system to prevent cancer from recurring.
The team recently announced their dual-action, cancer-killing vaccine candidate in an advanced mouse model of the deadly brain cancer glioblastoma, with promising results.
"Our team has pursued a simple idea: to take cancer cells and transform them into cancer killers and vaccines," said the study's corresponding author Khalid Shah, MS, Ph.D., director of the Center for Stem Cell and Translational Immunotherapy (CSTI) and the vice chair of research in the Department of Neurosurgery at the Brigham and faculty at Harvard Medical School and Harvard Stem Cell Institute (HSCI), in a press release on January 4, 2023.
"Using gene engineering, we are repurposing cancer cells to develop a therapeutic that kills tumor cells and stimulates the immune system to destroy primary tumors and prevent cancer."
Instead of using inactivated tumor cells, the team repurposes living tumor cells, which possess an unusual feature.
Like homing pigeons returning to roost, living tumor cells will travel long distances across the brain to return to the site of their fellow tumor cells. Taking advantage of this unique property, Shah's team engineered living tumor cells using the gene-editing tool CRISPR-Cas9 and repurposed them to release tumor cell-killing agents.
In addition, the engineered tumor cells were designed to express factors that would make them easy for the immune system to spot, tag, and remember, priming the immune system for a long-term anti-tumor response.
The team tested their repurposed CRISPR-enhanced and reverse-engineered therapeutic tumor cells (ThTC) in different mice strains.
Shah's team also built a two-layered safety switch into the cancer cell, which, when activated, eradicates ThTCs if needed.
This dual-action cell therapy was found safe, applicable, and efficacious in these models, suggesting a roadmap toward therapy.
While further testing and development are needed, Shah's team specifically chose this model and used human cells to smooth the path of translating their findings for patient settings.
"Throughout all of the work that we do in the Center, even when it is highly technical, we never lose sight of the patient," added Shah.
"Our goal is to take an innovative but translatable approach to develop a therapeutic, cancer-killing vaccine that ultimately will have a lasting impact in medicine."
Shah and colleagues note that this therapeutic strategy applies to a broader range of solid tumors and that further investigations of its applications are warranted.
The study's findings are published in Science Translational Medicine on Jan. 4, 2023. Disclosures: Shah owns equity in and is a member of the Board of Directors of AMASA Therapeutics, a company developing stem cell-based therapies for cancer. This work was supported by the U.S. NIH (grant R01-NS121096).
There are several new scientific developments regarding COVID-19 that might be useful to you for navigating the pandemic, wrote Katelyn Jetelina, Ph.D., an epidemiologist trying to make sense of this pandemic world.
All stem from different COVID-19 "story threads" I've written before. So, a quick round-up was posted by Jetelina at this substack link.
Separately, the U.S. CDC's Data Tracker publishes various information that is perpetually updated.
And the WHO publishes weekly epidemiological updates (Jan. 4, 2023) on the ongoing COVID-19 pandemic.
Interesting Engineering (IE) reported today that while attending the Consumer's Electronic Show 2023 in Las Vegas, Nevada, it learned the kind of solutions being developed to provide humans food during space flight to Mars.
One solution that stood out was turning plastic into consumable food during the long trip.
NASA says if a spacecraft departs Earth at a speed of about 24,600 mph, the trip to Mars will take about seven months.
To feed inter-galaxy travelers, Columbus, OH-based Beehex is developing deep-space food solutions using various 3D-printed food technologies in microgravity.
"So if you want to create steak out of plastic, the entire mechanism on one side of this container will be able to produce steak out of plastic- or chicken breasts," wrote IE.
Typically, BeeHex's 3D decoration equipment allows bakeries to produce decorated cookies, cakes, cupcakes, and more with high speed and precision.
The full IE article is posted at this link.
As of January 8, 2023, the U.S. CDC has not posted vaccination recommendations for when people visit Mars.
When BioNTech SE announced that the first person was dosed in a first-in-human Phase 1 clinical trial with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1, there was much enthusiasm generated by millions of people.
BioNTech's placebo-controlled, observer-blinded, two-dose-escalation study was launched on December 8, 2022, and is expected to enroll around 108 healthy adult volunteers.
This first-in-human HSV vaccine study was last updated on January 5, 2023.
However, it is scheduled for a June 2025 completion date.
BNT163 is not the only herpes vaccine candidate conducting early-stage research.
Still, it is the only mRNA vaccine that encodes three HSV-2 glycoproteins to help to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs.
"My colleagues and I are proud to have contributed to the early development and preclinical testing of this exciting new mRNA vaccine candidate that may have the potential to prevent people from contracting the virus," commented Prof. Harvey M. Friedman, M.D., Professor of Infectious Diseases at the University of Pennsylvania's Perelman School of Medicine, in a press release.
Dr. Friedman conducted preclinical and discovery science work on HSV and is the University's principal investigator for the preclinical discovery and enabling studies.
The U.S. Centers for Disease Control and Prevention (CDC) recently estimated that there were 572,000 new genital herpes infections in a year.
Throughout the U.S., about 12% of persons aged 14 to 49 have an HSV-2 infection.
From a herpes treatment perspective, research recently indicated about 15 vendors were participating in the herpes treatment market, which is valued at over three billion dollars annually.
Acyclovir and Valtrex® have significant shares in the pharmacy segment.
And United BioPharma is developing UB-621 as a first-in-class anti-gD monoclonal antibody candidate with demonstrated viral suppression of transmission and recurrence of HSV-1 and HSV-2.
This HSV antibody candidate's phase 2 study was last updated on May 18, 2022.
Updated herpes vaccine candidates and treatment news are posted at PrecisionVaccinations.com/Herpes.
