Coronavirus Breaking News

GSK plc today announced that the European Commission had authorized Arexvy™ for active immunization to prevent lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in adults 60 and older.

The first launches are planned for the 2023/2024 RSV season, which typically starts in the autumn.

Tony Wood, Chief Scientific Officer, GSK, commented in a press release on June 7, 2023, "This authorization for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK's long history of vaccine innovation."

Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the (RSV) vaccine as countries begin to launch."

RSV is a common, contagious respiratory virus that leads to over 270,000 hospitalizations and approximately 20,000 in-hospital deaths each year in adults aged 60 years and over in Europe.

Those with underlying medical conditions, such as diabetes and chronic heart and lung disease, drive the majority of RSV hospitalizations.

In the U.S., two RSV vaccines have been authorized for seniors, and one RSV monoclonal antibody (Beyfortus®) is seeking authorization for infants/children.

The Florida Department of Health published an updated Respiratory Syncytial Virus (RSV) weekly report that indicates an increased positivity rate but no outbreaks as of June 3, 2023.

This is positive news since Florida’s RSV season is traditionally more extended than the rest of the U.S. 

During the summer of 2021, Florida reported an unseasonably high number of RSV outbreaks, but activity during the 2021-22 season returned to a more typical trend.

From a global perspective, the World Health Organization Influenza Update N° 446, published on May 29, 2023, disclosed RSV activity was generally low except in Australia and a few countries in the Region of the Americas. 

And RSV has increased in several countries in tropical and temperate South America.

Furthermore, the U.S. is better prepared for the 2023-2024 RSV season than ever.

As of June 6, 2023, there are two approved RSV vaccines and several candidates conducting late-stage studies.

The journal Vaccine published results from a peer-reviewed study that concluded a fourth dose of Novavax Inc.'s NVX-CoV2373 protein-based COVID-19 vaccine enhanced immunogenicity for ancestral and variant SARS-CoV-2 strains without increasing reactogenicity, indicating that updates to the vaccine composition may not be currently warranted.

Furthermore, correlates of protection imply post-boost efficacy of ≥ 82% for Omicron variants.

Published on June 2, 2023, this study reported a fourth dose of NVX-CoV2373 (5 µg SARS-CoV-2 recombinant spike protein + 50 µg Matrix-M™ adjuvant) did not increase local/systemic reactogenicity, enhanced immune response to SARS-CoV-2 variants, and NVX-CoV2373 fourth dose induced robust immunogenicity in those aged 18–84 years.

In conclusion, despite the call for variant-specific vaccines, an increase in the number of vaccine booster doses with NVX-CoV2373 enhances immunogenicity for the ancestral SARS-CoV-2 strain and its variants without a notable increase in reactogenicity. Therefore, these data suggest that further boosting with the ancestral sequence used in NVX-CoV2373 should retain meaningful utility in preventing variant virus-associated illness, wrote these researchers.

This work was supported by Novavax, Inc. and initially by the Coalition for Epidemic Preparedness Innovations.

As of June 5, 2023, Novavax COVID-19 Vaccine (Nuvaxovid, CovoVax, NVX-CoV2373) was authorized in forty markets.

Queensland Health recently reported the number of potential rabies exposures in returned travelers has increased in 2023, impacting 116 Queenslanders in 2023.

Chief Health Officer Dr. John Gerrard said in a government press release on June 1, 2023, "It is important to seek advice from your doctor or a travel health clinic about the best way to protect yourself before heading overseas, especially if you are traveling to a country where rabies is present."

"For humans, rabies can be deadly - once symptoms develop, it's almost always fatal," Dr Gerrard added. 

Unfortunately, almost 60,000 people worldwide die from rabies annually.

"The risk of rabies infection varies depending on the country you visit and what activities are planned while abroad."

"While the preexposure rabies vaccine can effectively prevent infection, an additional course of post-exposure rabies vaccines may be required in these circumstances."

Rabies is a virus that can be transmitted to humans through the bite or scratch of an infected animal or by being exposed to infected animals' saliva through the eyes, nose, mouth, or broken skin.

In the U.S., bat bites generate more rabies infections than dogs.

The U.S. Centers for Disease Control and Prevention recently updated its recommendations for rabies preexposure prophylaxis for humans, replacing the three-dose vaccination schedule with a two-dose program.

Several rabies vaccines are available worldwide in 2023.

Note: Article updated with corrected phase on June 12, 2023.

Moderna, Inc. and Merck today announced distant metastasis-free survival (DMFS) results from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV).

In the overall intention-to-treat (ITT) population, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DMFS, a key secondary endpoint of the study, compared with KEYTRUDA alone and reduced the risk of developing distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063).

The secondary endpoint of DMFS, defined as the time from the first dose of KEYTRUDA until the date of first distant recurrence or death from any cause, was pre-specified for statistical testing following the positive primary endpoint of recurrence-free survival.

"We are excited to share these results with the oncology community and thrilled to see such an exceptional result in distant melanoma recurrence or death. Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus, these results showing a reduction in the risk of distant recurrence underscore the potential of neoantigen therapy," said Kyle Holen, M.D. Moderna's Senior Vice President and Head of Development, Therapeutics, and Oncology, in a press release on June 5, 2023.

Companies plan to initiate a Phase 3 study in the adjuvant setting in patients with high-risk melanoma in 2023 and rapidly expand to additional tumor types, including non-small cell lung cancer.

Based on data from KEYNOTE-942/mRNA-4157-P201, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma following complete resection.

Transgene today announced that new data confirm the ability of this novel investigational therapeutic cancer vaccine to induce immune responses against human papillomavirus (HPV) 16 antigens that are associated with antitumor response.

TG4001 is an investigational viral vector-based therapeutic cancer vaccine.

It is being evaluated in a randomized controlled Phase II clinical study comparing TG4001 with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors. 

The data presented on June 5, 2023, were generated from 46 patients in both trial arms.

• TG4001 induced the priming of adaptive immunity
• 58% of patients receiving TG4001 + avelumab showed an increase of immune responses against HPV antigens versus 9% in the avelumab arm. At baseline, immune responses against HPV antigens were limited to 4/46 patients.
• An immune response was detected at day 43 and tended to increase intensity at day 85.
• These data demonstrate that Transgene's TG4001 could induce a specific immune response against the antigens vectorized within this vaccine.
• 11 of the 13 patients with an immune response had either stable disease, partial or complete tumor response according to RECIST criteria.
• Remarkably, two case studies are presented, with patients exhibiting a strong E6 and E7 immune response while showing a complete clinical response.
• Transgene anticipates that the last patient will be randomized in the current Phase II clinical study in the first half of 2024. The final results will be communicated in 2024.

Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, commented in a press release, "These data further confirm that our therapeutic vaccine TG4001 can induce clinically meaningful immune responses that are associated with antitumor response."

The abstract and poster can be accessed on the ASCO and Transgene websites.

TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector, which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2).

TG4001 was designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). 

HPV is a group of more than 200 related viruses, some of which are spread through sex. Researchers previously confirmed that infection with HPV16 precedes the development of some head and neck cancers. 

Other HPV cancer vaccine news is posted by Precision Vaccinations.

When it comes to immunotherapy, a tumor’s classification as hot or cold is essential. Hot refers to tumors showing signs of inflammation, meaning the immune cells have recognized and responded to the malignant cells, wrote Kim Polacek, APR, CPRC, on June 4, 2023.

These tumors respond well to immunotherapy because the immune system is already activated.

Cold tumors, on the other hand, contain immune suppressive cells and are more challenging to treat.

Breast cancer was once regarded as a cold tumor disease and therefore difficult to treat with immunotherapy, but that is changing thanks to research happening at Moffitt Cancer Center.

A new clinical trial led by Dr. Heather Han is evaluating a combination therapy utilizing two immunotherapies (dendritic cell vaccine and pepinemab), along with trastuzumab, followed by adoptive T cell therapy, for patients with metastatic HER2 positive breast cancer.

“The goal of this therapy is to activate the immune system and create a hot tumor environment so we can collect those immune cells to create a specific cellular immunotherapy to better target their cancer,” said Dr. Han, clinical research director in the Department of Breast Oncology at Moffitt.

Information about this phase 1 clinical trial is being presented at the American Society of Clinical Oncology Annual Meeting. The clinical trial is ongoing. Han says this combination therapy could provide a new option for HER2-positive breast cancer patients with metastatic disease.