While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished. However, for Pfizer, BioNTech, and Moderna, their experience in this vaccine technology led to the rapid availability of mRNA vaccines for Covid-19, and now interest in mRNA cancer vaccines has been decidedly revived.
Akin to the Covid-19 mRNA vaccines, which work by containing an mRNA sequence corresponding to the presented spike proteins on the surface of SARS-CoV-2, mRNA cancer vaccines introduce a sequence of mRNA corresponding to an antigen expressed by a tumour cell, thereby stimulating an immune response to recognise and destroy cancerous cells expressing those antigens.
Cancer vaccines are classed as either universal, where they are given to all patients of a particular population with a tumour type, or personalised, where the patient’s tumour is profiled to find the best antigen match. According to over half of high-prescribing key opinion leaders who responded to a GlobalData survey in 2023, personalised mRNA vaccines are the most promising cancer vaccine type.
Merck & Co and Moderna’s personalised lipid nanoparticle mRNA cancer vaccine, mRNA-4157, is leading the field so far. The companies jointly announced that their vaccine candidate showed positive results in Phase II clinical trials in December 2022 when used in combination with Merck & Co’s checkpoint inhibitor, Keytruda (pembrolizumab), in patients with metastatic melanomas.
Using mRNA-4157 in combination with Keytruda was found to reduce the risk of recurrence or death by 44% in patients who had undergone surgery to remove metastatic melanomas 13 weeks prior to dosage in Phase II clinical trials.
Following these results, the Food and Drug Administration awarded the combination Breakthrough Therapy designation, which will expedite the development and review of the drug, with Moderna and Merck & Co initiating Phase III trials in July 2023.
The drug developers also plan on expanding the treatment to other forms of cancer and are continuing Phase I trials in patients with solid tumours in other cancer indications.
Genentech and BioNTech are not far behind with their jointly developed personalised mRNA cancer vaccine autogene cevumeran (BNT122 or RO71¬98457). With a strategic partnership announced in 2016, their lead candidate autogene cevumeran was created with Genentech’s individualised neoantigen-specific immunotherapy platform and BioNTech’s mRNA cancer vaccine platform.
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Their Phase II clinical trial is also evaluating autogene cevumeran in combination with Keytruda in metastatic melanoma. Initiated in 2019, Genentech and BioNTech’s trial is not estimated to finish until April 2024.
Notably, there are differences between the two vaccines and approaches, which could lead Genentech and BioNTech to require a higher efficacy bar. In the ongoing Phase II trial of autogene cevumeran, patients are untreated, which could make the cancer more difficult to treat, whereas in the trial of mRNA-4157, patients’ metastatic tumours were removed by surgery at least 13 weeks prior to dosage and no loco-regional relapse was seen.
Additionally, unlike mRNA-4157, autogene cevumeran contains unmodified mRNA. While this could lead to improved efficacy in the immune response, this approach is not as documented and there is a chance it may lead to tolerability issues for patients as a result of greater inflammation.
While Moderna and Merck & Co’s personalised mRNA cancer vaccine is further ahead in the pipeline in terms of development stage, Genentech and BioNTech’s candidate is tracked to launch commercially in the US by 2024, according to GlobalData estimates, and is advancing further with many other cancers.
In fact, 2023 will be a decisive year for the future of autogene cevumeran, as four clinical trials assessing the vaccine are due to reach primary completion or study end in 2023.
Phase I clinical trials for pancreatic cancer and breast cancer are due to end in November and December 2023, respectively, and a large Phase I clinical study testing the efficacy of the vaccine against multiple cancers, such as bladder cancer, colorectal cancer, and head and neck cancer, is due to end in September 2023.
Additionally, a Phase II clinical trial comparing the efficacy of the vaccine versus watchful waiting in patients with stage II/III colorectal cancer is due to reach primary completion by September 2023, with full completion in July 2027.
Finally, following initial positive results from the Phase I trial targeting pancreatic cancer, Genentech and BioNTech are also planning another Phase II clinical trial for adjuvant pancreatic cancer to start in 2023.
With only nine personalised mRNA cancer vaccines in product pipelines, the successful commercialisation of candidates from Moderna and Merck & Co or Genentech and BioNTech will provide a reassuring boost to the industry and a win for the field of precision and personalised medicine.
Other pioneers in personalised mRNA cancer vaccines include NeoCura Bio-Medical Technology, GreenLight Biosciences, and Stermina Therapeutics, all of which have candidates in the pipeline.