Momentous BioNTech Lung Cancer Vaccine Trial Underway

Doctors have begun trialling the world’s first mRNA lung cancer vaccine in patients, with experts hailing its “groundbreaking” potential to save thousands of lives.

Lung cancer is the world’s leading cause of cancer death, accounting for about 1.8m deaths every year. Those with advanced forms of the disease have an extremely poor prognosis.

But clinicians across Europe are now testing a new jab that instructs the body to hunt down and kill cancer cells, and then stops them returning. Known as BNT116 and made by BioNTech, the vaccine treats non-small cell lung cancer, which is the most common form of the disease.

The vaccine works by virtue of Messenger RNA (mRNA) technology. This is the creation of vaccines that use a molecule containing instructions for cells to make a protein using its natural machinery. 

In 2020, BioNTech’s work in this area culminated in the development of the COVID-19 vaccine, in partnership with Pfizer.

The phase 1 clinical trial – the first human study of BNT116 – is now underway in 34 research sites in the UK, US, Germany, Hungary, Poland, Spain and Turkey.

A total of 130 lung cancer patients are set to have the jab, alongside immunotherapy treatment. 

Unlike chemotherapy, which is non-selective in the cells it targets, this treatment is designed strengthen the immune response to cancer while leaving healthy cells untouched. 

“We are now entering this very exciting new era of mRNA-based immunotherapy clinical trials to investigate the treatment of lung cancer,” said Prof Siow Ming Lee, a consultant medical oncologist at University College London hospitals NHS foundation trust (UCLH), which is leading the trial in the UK.

“It’s simple to deliver, and you can select specific antigens in the cancer cell, and then you target them. This technology is the next big phase of cancer treatment.”

In light of this trial, here is an overview of BioNTech, the company behind what promises to be a momentous breakthrough in lung cancer treatments.

Who is BioNTech?

BioNTech is a German biotechnology company that was founded in 2008. The Mainz-based firm specialises in developing immunotherapies for cancer and infectious diseases, utilising genetic instructions to direct cells to produce specific proteins.

In its early years, BioNTech concentrated on cancer immunotherapies, a move driven by its founders' expertise in oncology and immunology. 

But in the early 2010s, it began to focus on messenger RNA (mRNA) technology. This is the creation of vaccines that use a molecule containing instructions for cells to make a protein using its natural machinery. In 2020, its work in this area culminated in the development of the COVID-19 vaccine, in partnership with Pfizer.

BioNTech's approach to immunotherapies centres on harnessing the body's immune system to combat diseases. This involves developing treatments that stimulate or modify immune responses to target specific ailments. 

What are BioNTech’s therapeutic areas? 

Its research spans multiple therapeutic areas, including oncology, infectious diseases, and rare diseases.

The drug classes in portfolio include mRNA therapeutics, cell therapies, and small molecules. mRNA therapeutics form the core of the its pipeline, with applications ranging from cancer vaccines to infectious disease prevention. 

It is also developing cell therapies, including CAR-T cell treatments, for various cancer types. CAR-T stands for ‘chimeric antigen receptor T-cell’. It is a therapy tailored to individual patients, and involves reprogramming the patient's immune system cells, which are then used to target their cancer.

BioNTech's product candidates are aimed at treating various types of cancer, including melanoma, head and neck cancer and colorectal cancer. 

In the realm of infectious diseases, the company is developing treatments for influenza, HIV, and tuberculosis, in addition to its COVID-19 vaccine. 

The pipeline also includes projects that address rare diseases, though these are in earlier stages of development.

BioNTech is also working on several vaccine delivery platforms to enhance the efficacy and accessibility of its products. 

Lipid nanoparticles, used in the COVID-19 vaccine, remain a key technology for delivering mRNA vaccines. It is also exploring novel formulations for more-stable vaccine storage and transport, which could expand the reach of mRNA vaccines in regions with limited cold chain infrastructure. 

The firm is also investigating so-called ‘self-amplifying RNA technology’, which could potentially reduce the dose required for effective vaccination.

What trials is BioNTech running?

As of 2024, BioNTech has numerous clinical trials underway across different phases. These cover a range of indications, from solid tumours to infectious diseases. Its COVID-19 vaccine continues to be studied for efficacy against new variants and in different age groups. 

Oncology trials include studies on personalised cancer vaccines and combination therapies using mRNA-based treatments alongside existing cancer drugs.

What is BioNTech’s manufacturing capability?

 BioNTech has invested significantly in expanding its manufacturing capabilities to support its growing pipeline and global vaccine production needs. 

The company operates several facilities in Germany, including its headquarters in Mainz and a production site in Marburg. In 2021, It acquired a manufacturing site in Singapore to enhance its global production network. 

These facilities are equipped to produce mRNA-based therapeutics and vaccines at scale, with the capacity to manufacture hundreds of millions of doses annually.