mRNA COVID-19 vaccine approvals likely to increase development and approvals in oncology: GlobalData

The rapid advancement of mRNA vaccine development in recent months – in an attempt to halt the COVID-19 pandemic – is expected to continue to break barriers in the pharma industry, with the oncology market being the most likely to benefit, says GlobalData.

Miguel Ferreira, Oncology and Hematology Analyst at GlobalData, comments, “mRNA vaccines were among many novel drug classes of interest for future drug development in oncology indications. However, historical clinical and regulatory barriers prevented this particular drug class from advancing much further until the pandemic paved the way for mRNA vaccines into the pharma industry.”

Currently, there are 44 ongoing clinical trials exploring mRNA vaccines, of which 48 per cent are for oncology indications, where subsequently the highest stage of development is Phase II, comprising 33 per cent of these oncology clinical trials. Therefore, mRNA vaccines are still in early development for oncology, but a significant increase in development is expected in the near future – particularly from companies already set to benefit from the COVID-19 mRNA vaccines.

Ferreira continues, “BioNTech and Moderna are both set to profit from their investment into the COVID-19 market and interestingly, both companies were already co-developing cancer-related mRNA vaccines with the pharma giants Roche and Merck Co, respectively, and are likely to pioneer a new competitive landscape in the oncology market with their mRNA vaccines.”

BioNTech is in a particularly strong position; with six ongoing trials, and a further three planned, the company is currently involved in almost a third of all ongoing mRNA-based cancer vaccine trials. It is also pioneering two distinct approaches: an off-the-shelf vaccine that targets several antigens, as well as a personalised vaccine targeting a unique set of antigens specific to each patient.

Jessica McCormack, Oncology and Hematology Analyst at GlobalData, comments, “Both BioNTech and Moderna have valuable experience in this area, including in trial design and patient recruitment, and currently appear to be most likely to gain the first approval for an mRNA-based cancer vaccine. Both companies’ expertise with both personalised and universal vaccines, which they are testing in a range of cancers, meaning that they will be well placed to focus on whichever area appears most promising.”

It will be important to understand if a personalised approach will be necessary, as this will significantly impact both development and approval timelines. So far, the personalised vaccines appear to be more effective though.

McCormack continues, “While the approval process would be more complicated for a personalised vaccine, we have seen approvals of personalised therapies in the past. Historically, there has been some scepticism around the use of cancer vaccines, but should the clinical data be positive, mRNA-based vaccines could significantly increase vaccine use in the oncology sector.”