Critically important in the fight against COVID-19, mRNA vaccines are now emerging as a promising innovation in cancer treatment. As clinical trials progress, Ben Hargreaves discovers this technology is poised to revolutionize oncology treatment by delivering personalized targeted therapy for different types of cancer. I did.
For the pharmaceutical industry, the pandemic can now be considered a temporary boost in terms of revenue, reputation, and cooperation. However, one innovation that emerged from the industry during this period moved from a potential treatment option to a proven and durable approach. That is mRNA technology. mRNA vaccines quickly became the core of vaccine strategies, and the technology has proven promising in infectious diseases.
The significant revenue generated by COVID-19 vaccines is accelerating the development of the remaining mRNA vaccine pipeline. As a result, the potential global market for this technology is estimated to grow to be worth $68 billion by 2030. These huge revenue projections are supported by the therapeutic areas that companies developing mRNA vaccines are currently focused on, with cancer being the next big target. .
vaccines against cancer
There are various types of vaccines against cancer. For example, there are human papillomavirus (HPV) vaccines that reduce cancer risk by protecting against the HPV types that cause cervical cancer. There are many different ways mRNA vaccines can be used against cancer, including cancer vaccines as well as adoptive T-cell therapy, therapeutic antibodies, and immunomodulatory proteins.
The latter is particularly promising for cancer immunotherapy, as it can stimulate and enhance existing immune responses against tumor antigens, increasing recognition and elimination of tumor cells. This could potentially allow mRNA vaccines to be used as monotherapy or in combination with other anticancer drugs.
mRNA vaccines also have the advantage that they can be tailored to each patient by identifying mutations that are unique to each patient and thereby creating a personalized cancer vaccine that targets them. This may help patients by preventing cancer recurrence after surgery by stimulating the patient’s immune system to recognize and destroy remaining cancer cells.
The trial begins
Research is underway to build on the lung cancer vaccine that the first patient received in the UK in August. The mRNA vaccine, known as BNT116, is being developed by BioNTech and is targeted for the treatment of non-small cell lung cancer (NSCLC). The Phase 2 trial will recruit 130 participants across seven countries, with six sites in the UK. Patients enrolled in this study are at various stages of NSCLC lung cancer, from early stages before surgery or radiation therapy to stage 4 or recurrent lung cancer.
The purpose of this trial is to determine the safety and tolerability of the mRNA vaccine. The trial will test the vaccine as a monotherapy, but some patients will also receive established chemotherapy or immunotherapy in combination with the vaccine. According to BioNTech, the immunotherapy is Sanofi and Regeneron’s PD-L1 checkpoint inhibitor Libtayo (cemiplimab).
Sarah Benafif, oncology consultant and study leader at University College London Hospital, said: “The strength of our approach is that the treatment aims to highly target cancer cells. ” he said. In this way, we hope that in time we will be able to prove that this treatment is effective against lung cancer without affecting other tissues. ”
Recent studies have pointed to several advantages that mRNA cancer vaccines have during the development process, with the development of such treatments being relatively quick and inexpensive compared to traditional vaccines. Other benefits outlined include that it is not generated by pathogen particles, reducing the risk of an unwanted immune response, and that clinical trials to date have shown that it has generated reliable immune responses, high efficacy, and is well tolerated. This includes having good gender.
Expanding the pipeline
Targeting lung cancer is particularly important given that it is the most commonly diagnosed type of cancer and causes the most deaths worldwide. However, this type of therapy may be applicable to many different types of cancer and is already being tested in this area. In July, BioNTech announced that another mRNA vaccine candidate, BNT111, ranked statistically alongside Sanofi and Regeneron’s PD-L1 checkpoint inhibitor Libtayo (cemiplimab) in overall response rates for this combination therapy. We have published Phase 2 results showing that we have achieved significant improvements. Treatment of advanced melanoma.
Moderna, another company that won approval for an mRNA COVID-19 vaccine, also has a pipeline of cancer vaccine candidates moving forward. The majority of targets within cancer utilize the mRNA-4157 vaccine candidate to target various types of therapy in combination with PD-1 therapy, with oncology indications such as melanoma, NSCLC, and cutaneous squamous cell carcinoma. Target cancer. Each of these potential combination therapies has progressed to Phase 2 and beyond.
Since PD-1/L1 therapy is an effective treatment for a wide range of cancers, it is hoped that an mRNA vaccine that will further increase its effectiveness will help cancer patients remain cancer-free. Although there are financial implications for successful combination therapy, if it can be proven to be more effective than checkpoint inhibitors alone, it may become the standard of care in certain areas. Given that PD-1/L1 is some of the most lucrative therapies across the industry, this could be a major coup for mRNA developers who have successfully co-developed such therapies.
the last hurdle
Moderna and Merck’s mRNA-4157/Keytruda (pembrolizumab) combination has three years of data that could support an accelerated application for melanoma, and the approach should soon be submitted to the FDA. Earlier this year, FierceBiotech reported that Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the FDA is prepared to consider mRNA vaccines on the same basis as CAR-T treatments.
The need to make clear that authorities are willing to review potential products highlights the complexities faced by regulators with respect to these products. As outlined in a recent paper, challenges exist regarding the commercialization of this new class of treatments. The authors note that the regulatory framework for pharmaceutical modalities with diverse uses is unclear. He added that mRNA vaccines are sometimes referred to as gene therapy, while gene silencing and gene delivery through RNA molecules are sometimes referred to as RNA therapeutics, and definitions need to be harmonized across regulatory agencies. Some mRNA approaches use AI to personalize each vaccine for patients, which also raises questions about how to regulate products that may be different each time they are delivered.
As such, this new approach will require significant flexibility on the part of global institutions and may require regulatory adaptation if it proves effective enough to be approved. Such hurdles will likely be lowered in the short term, as many mRNA therapeutics target indications in oncology. In the long term, mRNA vaccines could change the way cancer is treated.
