“The six injections are spaced 20 minutes to half an hour apart, and then they are observed for about four hours to check that there are no immediate side effects.”
It might not seem like the best plan in the world to spend an entire morning getting shots and hoping they don’t cause a weird reaction, but these syringes are among the most promising cancer treatments in recent memory.
And as pointed out Marta DomenechOncologist at the Catalan Institute of Oncology and author of the quote, cancer patients are used to injections and spending hours with a drip connected to a line.
“They took it well, in the end it was a puncture and it didn’t last that long. Patients are very used to injectionswhether it’s for a blood test, a scan with contrast… In short, it’s like getting vaccinated normally.”
Because what the ICO and seven other centers in Spain (in Madrid, Barcelona, Valencia, Seville and Pontevedra) are testing is a vaccine, yes, but one of the most avant-garde. It is similar to the messenger RNA that became popular during the Covid pandemic, but the enemy is not a virus but lung cancer.
BioNTech, the German laboratory that partnered with Pfizer to develop and produce the world’s most widely used anti-Covid vaccine, had one goal before the pandemic: to produce the first truly effective cancer vaccines.
These are therapeutic vaccines and not preventive ones like those for Covid, but the mechanism is similar: introducing messenger RNA chains into the body with instructions to manufacture an antigen recognized by the immune system and acting against it, whether in a virus or in a cancer cell.
BNT116, which is the name of the lung cancer vaccine it developed, It’s actually six vaccines: each carries information for the production of a different antigen but shared in non-small cell lung cancers, the most common subtype of this tumor (it represents 85% of all diagnoses).
“In our center, we started the trial about six months ago,” explains Marta Doménech. “Two patients collaborated: one has already finished and the other continues to participate.”
This is the first human trial of this vaccine. In this phase of research, the objective is to observe whether the treatment is safe and whether it generates an antitumor response. That is why each center (hospitals from 34 countries participate) includes few patients and they have very different characteristics.
“For the first six weeks, we administer the treatment once a week. Then, every three weeks.”
So some people get the vaccine before surgery. Others, however, when the cancer is already advanced. Some get it as monotherapy and others in combination with chemotherapy or immunotherapy.
This is why one of Doménech’s patients has already completed his participation and the other will continue until the disease progresses or he can no longer tolerate the treatment.
If the data are good enough, trials will be conducted with more patients (thousands) and more specific interventions.
Preliminary data
What is known so far is positive. “Preliminary data demonstrate a favorable safety profile, durable immune responses against tumor antigens, and clinical responses that give these treatments promising clinical activity,” he says. Fabio Francooncologist at MD Anderson Cancer Center in Madrid and head of the Phase I Clinical Trials Unit of the MD Anderson Cancer Center Spain Foundation.
In their center, they have been testing the vaccine for more than a year and three patients have been recruited. “This type of treatment has great stability and has the capacity to generate a significant lymphocyte response (CD8+ and CD4+ T cells), which allows immunological control of the disease to be achieved.”
Also in Madrid is the Clara Campal Comprehensive Oncology Center of the HM Hospitals, which has been testing the vaccine on “several patients since 2023,” he comments. Mary of MiguelDeputy Director of the Center’s Phase I Clinical Trials Unit.
“Immunotherapies, or treatments that stimulate the immune system to attack the tumor, have already been shown to be effective in a wide range of tumors, including lung tumors, and vaccines represent a developing subgroup with great potential.”
The idea of a therapeutic vaccine against cancer is not new, but research has always ended in disappointment. With the development of vaccine platforms based on messenger RNA, the illusion was rediscovered: it was possible to manufacture a vaccine against one or more antigens in a very short time.
Several of these vaccines are currently under study and the results are promising for melanoma, prostate cancer, triple negative breast cancer, ovarian and lung cancer.
In fact, BNT116 is not the only mRNA vaccine being studied against this latest tumor. Moderna, the laboratory that developed the Covid vaccines in parallel with BioNTech, has its own candidate currently being tested.
The approach is quite different, however. While BioNTech’s approach relies on six “universal” antigens, Moderna’s seeks to sequence each tumor to find up to thirty unique, non-transferable neoantigens. A personalized vaccine.
“Both perspectives are very interesting and may play an important role in these patients, although this remains to be determined,” says María de Miguel.
Fabio Franco of the MD Anderson Cancer Center in Madrid agrees that the first thing is to confirm that these therapies are effective and safe through larger clinical trials.
He stresses, however, that “the development of personalized therapies and the development of patient-by-patient vaccines seem complex and difficult to implement in the clinic, because they require a an important technology that not all centers have“.
Marta Doménech, from ICO Badalona, thinks something similar. “At the response level, obviously, making a specific vaccine for the antigens that the patient already has seems to be a better option. At the commercial, manufacturing and pragmatic level, these strategies are difficult, even though they are already used with CAR-T cells.”
Everything will depend, says the doctor, on the results provided by each vaccine, which will take a few more years to clarify. For BNT116, it is expected that in 2026 there will be solid data on its viability. “It is probably much easier to implement, but at the physiological level it makes more sense to have a specific response in each patient… If you manage to activate the immune system.”
