Cancer Vaccine Breaking News

Anixa Biosciences, Inc. today announced that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company's breast cancer vaccine candidate with Keytruda®.

This treatment arm aims to determine if the vaccine/Keytruda combination increases immune response.

Anixa's breast cancer vaccine is designed to generate T cells that target triple-negative breast cancer ("TNBC"). This vaccine takes advantage of endogenously produced proteins that function at certain times in life but then become "retired" and disappear from the body.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated in a press release on August 7, 2023, "Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response–including, we believe, production of T cells that can target TNBC–so we believe that the addition of Keytruda could have a synergistic effect."

"If a vaccine induces the creation of T cells targeting TNBC, and Keytruda generally maintains T cell activity, the combination could be very potent."

Keytruda, a type of immunotherapy known as a checkpoint inhibitor marketed by Merck, is approved for use with chemotherapy before surgery and then alone after surgery to treat high-risk early-stage and advanced TNBC. 

The Phase 1a study evaluates the vaccine's safety, identifies the Maximum Tolerated Dose, and monitors the immune response in vaccinated women.

According to the Company, one in eight women in the U.S. will be diagnosed with invasive breast cancer at some point in their lives.

The U.S. CDC published a Morbidity and Mortality Weekly Report (MMWR) that concluded post-authorization safety data after receipt of a primary Novavax COVID-19 vaccine dose is limited by the low number of doses administered (0.01% of total COVID-19 vaccines administered), available data are consistent with those from preauthorization clinical trials.

And no new safety concerns were identified, wrote the CDC on August 4, 2023.

This MMWR stated from July 13, 2022–March 13, 2023, a total of 69,227 Novavax doses were administered to persons in the U.S., and 230 reports of adverse events after vaccination were received by the Vaccine Adverse Event Reporting System (VAERS).

Among the 230 reports received, 19 (8.3%) were classified as serious, and no deaths were reported after vaccination.

Serious reports included one case of thrombosis, two of pericarditis, one of Guillain-Barré syndrome, and two of seizure.

The remaining serious reports described chest pain, arrhythmia, sickness, hospitalization, adverse event not otherwise specified, balance disorder, peripheral neuropathy aggravated, and vaccine failure. 

Limitations of this analysis include reporting biases and inconsistency in the quality and completeness of reports to VAERS.

Furthermore, VAERS data generally cannot be used to determine whether a vaccine caused an adverse event.

In addition, approximately one-half of the reports representing adverse events of special interest lacked medical records for CDC review.

Novavax COVID-19 Vaccine Adjuvanted (Nuvaxovid™, CovoVax™, NVX-CoV2373) was the first protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus.

Every year, rare human infections with zoonotic influenza viruses usually spread in birds and pigs. The U.S. Centers for Disease Control and Prevention (CDC) recently reported the first two human infections with swine flu viruses in 2023.

These infections were caused by two different types of flu viruses that generally spread among pigs, and they occurred in two people who attended various agricultural fairs in Michigan and had exposure to pigs.

These influenza A(H1N2)v virus infections were thoroughly investigated to ensure that such viruses are not spreading in people and to limit further exposure of people to infected animals if infected animals are identified.

As of August 4, 2023, the CDC recommends people take precautions to prevent the spread of swine influenza viruses to people and has guidance for people exhibiting pigs at fairs, people attending fairs, and fair organizers.

Since 2005, over 500 swine influenza infections have been identified in the U.S.

Unlike, avian influenza (Bird Flu), which has recently spread among birds, mammals, and humans, there are no approved swine flu vaccines.

Furthermore, the CDC says the annual 'flu shot' does not prevent swine influenza infections in people.

Each summer, influenza viruses are detected in both the northern and southern hemispheres. What happens in one hemisphere does not necessarily predict what will happen in the other because influenza viruses evolve and impact populations differently.

While the exact timing and duration of any flu season varies by country, the World Health Organization (WHO) recently reported most detections in late July 2023 are moderate.

The WHO recently published Influenza Update N° 450, indicating some countries in the southern hemisphere reported changes in influenza detections in recent weeks, while others seemed to have already peaked.

And Australia's Department of Health and Aged Care published report No. 8, which stated insufficient information to assess the 2023 influenza season's potential severity comprehensively. 

The WHO and the U.S. CDC suggest international travelers speak with a healthcare provider about flu shot options before visiting countries reporting influenza outbreaks in August 2023.

As of August 5, 2023, most health clinics and community pharmacies in the U.S. offer various flu shots targeting 2023-2024 influenza viruses.

The World Health Organization's (WHO) latest multi-country cholera outbreak situation (#5) says that Based on the large number of outbreaks and their geographic expansion, WHO continues to assess the risk at the global level as very high. 

As of August 4, 2023, twenty-five countries have reported cholera outbreaks since the beginning of 2023.

India became the 25th country on May 15, 2023.

The WHO African Region remains the most affected region, with 14 countries reporting cholera cases this year.

In the Region of the Americas, Haiti reported 54.826 cholera cases last year. 

The overall capacity to respond to multiple and simultaneous outbreaks continues to be strained due to the global lack of resources, including shortages of the Oral Cholera Vaccine (OCV).

Since the start of 2023 and as of July 24, 2023, a total of 49.9 million OCV doses have been requested, of which 19.3 million (39%) have been approved for 11 countries. The available (not yet allocated) global OCV stockpile was 2.7 million doses.

In the current outbreak context, only one-dose courses have been validated and implemented in these reactive campaigns. Doses for preventive campaigns cannot be supplied due to the low global stockpile, says the WHO.

In the U.S., the CDC recommends that adults traveling to areas with active cholera transmission get vaccinated with a newly licensed cholera vaccine, Bavarian Nordic's Vaxchora®. 

This OCV is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults.

According to Vaxchora's manufacturers, the vaccine has limited availability in 2023.

Another vaccine. Valneva SE's Dukoral® is administered with a buffer solution that, for adults, requires 150 ml of clean water. Dukoral can be given to all individuals over the age of 2 years. 

The Access to Advanced Health Institute (AAHI) today announced that it has received an $18 million award from the National Institutes of Health (NIH) to develop a temperature stable, single-dose, RNA chikungunya vaccine candidate.

The NIH award disclosed on August 3, 2023, supports the development, preclinical testing, and human clinical evaluation of a vaccine that meets an increasingly urgent need for a reliable, abundant supply.

Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes infected with the chikungunya virus (CHIKV), says the U.S. CDC.

Chikungunya outbreaks are significant causes of morbidity and mortality in Asia, Africa, and Latin America, for which no vaccine is currently approved.

From 2006–2021, 4,590 chikungunya cases in travelers were reported in the U.S. 

Several vaccine candidates are conducting late-stage clinical trials, such as Valneva SE's VLA1553, a monovalent, single-dose, live-attenuated vaccine candidate.

AAHI's approach to an RNA vaccine against chikungunya differs from the RNA vaccines the U.S. FDA currently approves to prevent other diseases.

“This project will demonstrate the use of RNA vaccine technology to avoid some of the classic manufacturing challenges in the large-scale manufacture of live-attenuated vaccines,” said Emily Voigt, Ph.D., Principal Scientist, AAHI RNA Platform Lead, and Co-Principal Investigator for the award, in a press release.

Unlike other RNA vaccines, this candidate will generate a live "attenuated" virus that could induce strong and long-lasting immune protection against this mosquito-borne disease.

The new 5-year project builds upon work supported by the NIH (R43AI127053) for AAHI's proof-of-concept ground-laying work, which demonstrated that a liquid presentation of this live-attenuated chikungunya RNA vaccine candidate elicited strong immune responses in animals after a single dose, protecting them from mortality and joint swelling after being challenged with the virus (Voigt et al. 2021). 

AAHI is a nonprofit biotech research institute located in Seattle, Washington, that combines the high-quality science of an academic research organization with the product development capabilities of a biotech company to help combat some of the world's deadliest diseases, including infectious diseases