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For the first time, messenger RNA (mRNA) immunotherapy will be studied in a phase 1 clinical trial for lung cancer in the UK, where the University College London Hospitals (UCLH) Clinical Research Facility is the lead research site.

As of August 23, 2024, a lung cancer patient at UCLH became the first person to receive a novel cancer vaccine candidate designed to prime the immune system to recognize and fight cancer cells.

Made by BioNTech SE, the investigational mRNA cancer immunotherapy/vaccine for non-small cell lung cancer (NSCLC) known as BNT116 is designed to enhance immune responses against targets primarily expressed by cancer cells.

This process reduces the risk of toxicity to healthy, non-cancerous cells—unlike chemotherapy, which often affects both cancerous and healthy cells.

UCLH consultant medical oncologist Siow Ming Lee, who leads the national study, said in a press release, “Lung cancer remains the leading cause of cancer deaths worldwide, with an estimated 1.8 million deaths in 2020."

“We are now entering this exciting new era of mRNA-based immunotherapy clinical trials to investigate lung cancer treatment, thanks to the foundation laid by the Office for Life Sciences within the Department for Science, Innovation and Technology and the Department for Health and Social Care.

The trial will enroll patients at different stages of NSCLC, from early-stage NSCLC before surgery or radiotherapy (Stages 2 and 3) to late-stage disease (Stage 4) or recurrent cancer.

The trial aims to establish the safety profile and safe dose of BNT116 monotherapy combined with established NSCLC treatments to see if it has a synergistic anti-tumor effect when given with these established chemotherapy or immunotherapy treatments.

Approximately 130 participants will be enrolled in the study across 34 research sites in seven countries, with six UK sites selected. Patients interested in participating in the trial should be directed to their GP or oncologist in the first instance, and their doctor can refer them to the study's trial centers to assess suitability.

BNT116 is also being evaluated in a Phase 2 trial as a first-line treatment for patients with metastatic NSCLC in combination with cemiplimab, a PD-1 inhibitor, and cemiplimab alone. 

Bavarian Nordic A/S recently announced it received a new contract of 440,000 doses to supply its MVA-BN® smallpox and mpox vaccine from an undisclosed European country. 

The Company confirmed all vaccines under this contract will be delivered in 2024.

Immediate access to these vaccines is essential since the mpox clade 1b outbreak is spreading in Africa.

Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on August 21, 2024, “Bavarian Nordic can still supply up to 10 million doses of our smallpox and mpox vaccine by the end of next year, with 2 million doses of this capacity available during the remaining part of this year.”

The MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (JYNNEOS®, IMVANEX®, and IMVAMUNE®) is a non-replicating vaccine approved by several countries, including the United States.

Moderna, Inc. announced that the European Commission (EC) has granted marketing authorization for mRESVIA®, an mRNA respiratory syncytial virus (RSV) vaccine.

RSV is a highly contagious seasonal respiratory virus that causes an exceptionally high burden of disease in infants and older adults.

As of August 23, 2024, this EC authorization is indicated to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

The marketing authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

"The EC's approval of mRESVIA is an important milestone for public health and highlights Moderna's mRNA leadership," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

In the European Union, RSV is estimated to cause approximately 160,000 hospital admissions in adults each year, with 92% of these admissions occurring in adults aged 65 and over.

In the United States, the RSV season has already begun in Florida and is expected to spread throughout the U.S.

For the 2024-2025 RSV season in the U.S., three vaccines and one monoclonal antibody were approved by the U.S. FDA.

Novavax Inc. today announced, 'We are working productively with the U.S. Food and Drug Administration (FDA) as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization.'

'We expect to have authorization in time for peak vaccination season.'

Novavax filed for U.S. Emergency Use Authorization of our 2024-2025 formula protein-based COVID-19 vaccine (NVX-CoV2705) in June 2024.

In the United States, Novavax's products have been and will be available after FDA authorization in thousands of locations nationwide, including pharmacies.

For example, Walgreens recently confirmed their pharmacists are available to help patients navigate the latest vaccination guidance, including the timing of vaccinations, given the uneven geographical spreading of the coronavirus.

Additionally, numerous countries have authorized Novavax's COVID-19 vaccines over the past few years.

Novavax wrote on August 22, 2024, 'Our 2024-2025 formula COVID-19 vaccine targets JN.1, the "parent strain” of currently circulating variants and should provide acceptable coverage and cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1.'

'Upon authorization, Novavax’s vaccine will be the only protein-based option available in the U.S. for individuals aged 12 and older to prevent COVID-19.' 

On August 8, 2024, Novavax reported it achieved total revenue of $415 million in the second quarter of 2024 and ended the period with $1.1 billion in Cash.