Cancer Vaccine Breaking News

Moderna, Inc., today announced program and financial updates at its annual R&D Day event, demonstrating progress and strategic prioritization of its mRNA pipeline.

Stéphane Bancel, CEO of Moderna, commented in a press release, "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these ten products to patients, slow down the pace of new R&D investment, and build our commercial business."

Moderna's updates on September 12, 2024, include but are not limited to, several seasonal influenza vaccine candidates in clinical development.

The Company's investigational seasonal flu vaccine, mRNA-1010, has demonstrated consistently acceptable safety and tolerability across three Phase 3 trials.

In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a licensed standard-dose flu vaccine (Fluarix®).

In an older adult extension study of P303, mRNA-1010 met all primary immunogenicity, including superiority for all compared to a licensed enhanced flu vaccine (Fluzone HD®), and showed an acceptable reactogenicity profile.

The Company plans to start a confirmatory vaccine efficacy study for mRNA-1010 in 2024, funded by previously announced project financing through Blackstone Life Sciences.

Moderna also confirmed it is no longer pursuing an accelerated approval pathway for the regulatory submission of its standalone flu vaccine, mRNA-1010, to focus its resources on submitting a potentially more impactful flu/COVID combination vaccine, mRNA-1083, in 2024.

With the 2024-2025 flu season beginning in the United States, most health clinics and pharmacies offer flu shot vaccination services.

About 158 million flu vaccines had been distributed during the 2023-2024 season. 

According to an American Academy of Pediatrics study, the effectiveness of a single dose of the rotavirus vaccine against emergency department visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than five years and 53% in older children.

On September 10, 2024, these researchers wrote rotavirus vaccines remain highly effective in preventing disease in children.

The U.S. Centers for Disease Control and Prevention says two types of rotavirus vaccine are available for infants, and both are safe and effective. Two or more doses of the rotavirus vaccine are recommended as the best way to protect against it.

The Vaccines for Children (VFC) Program allows children to access no-cost vaccines such as rotavirus. The VFC program helps families of eligible children who may not be able to afford or have access to vaccines.

Merck today announced positive top-line results from its pivotal Phase 3 clinical trial evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL ® 9 vaccine, in Japanese males ages 16 to 26.

This trial (V503-064) met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo.

“A decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on September 11, 2024.

“These data build on the clinical efficacy of GARDASIL 9 for the prevention of persistent infection in males and can potentially make a significant impact in addressing the global burden of certain HPV-related cancers and diseases.”

This HPV vaccine is generally available at clinics and pharmacies in the U.S. However, Merck says the GARDASIL 9 vaccination may not protect all vaccine recipients.

According to a new modeling study published by the Canadian Medical Association Journal, targeting respiratory syncytial virus (RSV) vaccinations to older adults (70+) with underlying health conditions is the most cost-effective way to reduce disease.

Published on September 9, 2024, this study found RSV vaccinations based on age plus risk for RSV-related complications were projected to avert a median of 20% to 31% of outpatient cases, 38% to 42% of hospital cases, and 39% to 42% of related fatalities.

“Strategies focused on adults with underlying medical conditions that place them at increased risk of RSV disease are more likely to be cost-effective than general age-based strategies,” wrote Dr. Ashleigh Tuite, the Centre for Immunization Programs at the Public Health Agency of Canada and the Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, with coauthors.

“We found that vaccination of older adults may be less costly and more effective than no vaccination and that vaccinating people aged 70 years and older with chronic medical conditions is likely to be cost-effective based on commonly used cost-effectiveness thresholds.”

Three approved RSV vaccines are available in the United States for the 2024-2025 season. These vaccines are generally available at clinics and pharmacies in the United States.

OSE Immunotherapeutics SA today announced the launch of its international Phase 3 clinical trial (Artemia) of Tedopi®, the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, in second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC).

Tedopi® (immunotherapy activating tumor-specific T-cells, off-the-shelf, neoepitope-based) is the most advanced therapeutic cancer vaccine in development.

This pivotal study, accepted in 14 countries by international health agencies (Canada, Europe, U.K., U.S.), supports the registration of the product Tedopi® in parallel with the companion diagnostic for HLA-A2 positive patients.

Nicolas Poirier, CEO of OSE Immunotherapeutics, said in a press release on September 10, 2024, “This international registration trial is now on track, and we look forward to confirming the therapeutic benefit of Tedopi® for metastatic cancer patients."

"Tedopi® is the most advanced therapeutic cancer vaccine in clinical development and the first treatment option to address the high unmet medical need and largely untapped market in advanced and metastatic second-line NSCLC. “

NSCLC accounts for 85% of all lung cancers, and the HLA-A2 phenotype represents about 45% of the population.

Each year, more people die of lung cancer in the U.S. than of colon, breast, and prostate cancers combined. Lung cancer accounts for about 20% of all cancer deaths.

The American Cancer Society (ACS) estimates for lung cancer cases for 2024 are:

• About 234,580 new cases of lung cancer (116,310 in men and 118,270 in women),
• About 125,070 deaths from lung cancer (65,790 in men and 59,280 in women).

On a positive note, the ACS says the number of deaths from lung cancer continues to decrease due to fewer people smoking and advances in early detection and treatment.

The American Medical Association (AMA), in partnership with the U.S. Centers for Disease Control and Prevention (CDC), today announced it has developed a new toolkit to help clinicians offer better care for patients with prolonged, non-specific symptoms and concerns about Lyme disease. 

The CDC has scheduled a COCA Call for September 19, 2024, when presenters will share a brief overview of Lyme disease, provide a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and review new clinical tools and resources to help support these patients. 

If you cannot attend the live COCA Call, the recording will be available on the webpage. The slide set will be available on the day of the call under Call Materials on the COCA Call webpage.

According to recent data, Lyme disease has continued spreading in the United States from the northeast into the upper midwest. And in various Euopean countries.

About 329,000 persons annually are diagnosed with Lyme disease in the U.S.

While most patients recover fully after treatment, but about 5 to 10% can have prolonged symptoms such as fatigue, pain, and difficulty thinking.

As of September 9, 2024, there are no Lyme disease approved vaccines.

However, Valneva SE's VLA15 vaccine candidate has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.

The Africa Centres for Disease Control and Prevention (Africa CDC) and United Nations Children’s Fund (UNICEF) recently announced the arrival of the first shipment of 99,100 doses of the JYNNEOS® (MVA-BN®) mpox - smallpox vaccine.

On September 5, 2024, the Bavarian Nordic A/S produced vaccines were officially received by the Minister of Health of the Democratic Republic of Congo (DRC), Samuel Roger Kamba, alongside others.

Additional shipments to the DRC are planned for a total of more than 250,000 vaccines.

Since the start of 2024, DRC has reported over 4,901 confirmed mpox clade 1 cases, with more than 629 associated deaths, representing a sharp escalation in both infections and fatalities compared to previous years.

According to the Africa CDC, introducing the two-dose JYNNEOS vaccine is a decisive action to mitigate further spread and protect the most at-risk populations.

The U.S. government has confirmed that two doses provide robust protection against disease, and booster doses (3rd) are not endorsed. As of September 2024, JYNNEOS is commercially available in the U.S.; however, routine immunization against mpox is not recommended for the general public.