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Blue Water Vaccines (VWV) Inc. recently announced the signing of a Sponsored Research Agreement with The University of Texas Health Science Center at San Antonio to fund a non-human primate ("NHP") study to evaluate the efficacy of BWV-401, a live attenuated, orally delivered Chlamydia vaccine candidate.

In this new effort, BWV will fund an NHP study to evaluate the efficacy of BWV-401 further and provide additional support for development towards human clinical trials.

In this upcoming study, NHPs will be vaccinated with BWV-401 and subsequently challenged against Chlamydia to validate the hypothesis that, along with being safe, this vaccine, when delivered orally, can elicit an effective immune response in the genital tract and can protect against Chlamydia infection.

BWV-401 utilizes a modified strain of Chlamydia to colonize in the gastrointestinal tract and has produced transmucosal protection against genital tract Chlamydia infection in mouse models without altering the gut microbiota.

"We are thrilled to initiate this study with our partners at UT Health Science Center San Antonio for BWV-401," said Joseph Hernandez, Chairman and Chief Executive Officer of BWV, in a press release on April 12, 2023.

"There remains a high unmet need for an efficacious Chlamydia vaccine to prevent the millions of infections worldwide each year."

According to the U.S. CDC, Chlamydia is the most frequently reported bacterial sexually transmitted infection in the U.S., with about 1.6 million new cases reported in 2020. 

As of April 30, 2023, no U.S. FDA-approved Chlamydia vaccines.

In the United States, there remains a considerable burden of disease attributed to serotypes not included in currently approved pneumococcal conjugate vaccines.

To address this need, Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved PREVNAR 20® for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children six weeks through 17 years of age.

And for preventing otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on April 27, 2023.

"This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness, highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life-threatening infections."

Pneumococcal vaccine news is posted by Precision Vaccinations.

ImmunityBio, Inc. today announced the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination and its IL-15 superagonist N-803 for people with a hereditary condition known as Lynch syndrome.

An estimated 1 in every 300 people may be carriers of a mutation in a gene associated with Lynch syndrome. 

This Phase 2b clinical trial, sponsored by the National Cancer Institute (NCI), will study whether Tri-Ad5, in combination with N-803, works to prevent colorectal and other cancers in study participants.

Tri-Ad5 vaccines target three tumor-associated antigens: brachyury, carcinoembryonic antigen, and mucin-1. 

The vaccine combination studies whether activating dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer advances.

N-803 is designed to enhance the effects of the vaccines by increasing the proliferation and activation of natural killer and T cells, thereby increasing the potential for cancer prevention in study participants.

"We are excited to partner with the NCI on this important cancer vaccine study to potentially prevent or delay the onset of cancer for people who carry the gene associated with Lynch syndrome," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on April 25, 2023.

"Lynch syndrome affects tens of thousands of people each year, and the average age of cancer diagnosis for them is just 44."

"People known to have the gene for Lynch syndrome can be followed closely by their doctors with regular examinations and scans to watch for cancer development, but, currently, there is no treatment that prevents cancer development in these patients."

Lynch syndrome is one of the most common hereditary cancer syndromes, says the U.S. CDC.

Not only can people with Lynch syndrome develop colorectal cancer some twenty years before the average age of diagnosis for this cancer, but they are also at an increased risk of developing multiple types of other cancers, including endometrial, stomach, ovarian, pancreas, ureter, and renal pelvis, biliary tract, brain, and small intestinal cancers.

Colorectal cancer is the second-deadliest cancer type in the U.S., and approximately 3% to 5% of the 153,000 cases of colorectal cancer annually are thought to be due to Lynch Syndrome.

As are 2% to 3% of all cases of endometrial cancer.

"The Tri-Ad5 vaccine trial will be the largest Lynch syndrome cancer prevention study done in the U.S.," commented Asad Umar, D.V.M., Ph.D., a senior advisor to the director for translational research in NCI's Division of Cancer Prevention and a scientific lead for the trial.

Note: ImmunityBio is also conducting a bladder cancer vaccine study.