The latest breakthrough in personalized cancer vaccines
15 Oct, 20263+ minutes
Following a cascade of news headlines about a promising cancer vaccine last month, we're zooming in on this breakthrough and what it means for cancer patients, healthcare professionals and the future of personalized medicine.
On August 19th, biopharma companies Merck and Moderna released positive results off the back of a phase 3 trial for intismeran autogene, an mRNA cancer vaccine. The vaccine was given in conjunction with another cancer therapy called Keytruda to patients with high-grade melanoma, who had previously had their tumors surgically removed.
The results signify a breakthrough which has been in the making for decades. Building personalized vaccines that teach the body’s immune system to detect and destroy their own unique cancer cells is a remarkable concept – and this positive data is the closest we’ve come to making it a real possibility for patients.
A phase 3 trial win, while significant, is far from approval. It also poses a challenging question about the product: how do you make a unique vaccine for thousands of individuals quickly, reliably and affordably?
Let's explore the science and significance of this milestone in cancer therapies while examining the challenges that stand between this successful trial and a treatment that actually reaches melanoma patients.
Merck and Moderna’s cancer vaccine
Merck and Moderna have been working together since 2016 to produce a series of mRNA vaccines. A decade of co-development has resulted in the making of intismeran autogene, a personalized vaccine that treats late-stage melanoma (a very common kind of skin cancer).
Unlike standard vaccines, intismeran must be customized to each individual patient’s tumor. To achieve this, the companies use AI to analyze each patient’s tumor before inputting specific mRNA instructions. Once administered, these instructions are essentially picked up by the body’s immune system, which helps it recognize and attack specific tumorous cells.
It’s also been designed as a treatment for cancer rather than being preventative, as is usually the case for vaccinations.
Moderna’s CEO Stéphane Bancel has said: “For many years, the idea of creating an mRNA treatment designed specifically for an individual patient's cancer was aspirational. We are now helping turn that vision into a reality.”
This advancement follows Moderna’s recent approval for the first-ever mRNA flu vaccine, mFLUSIVA, which was approved for people aged 50-64 on the 5th of August this year.
The Phase 3 trial
The large Phase 3 clinical trial enrolled 1,137 high-risk melanoma patients who had recently had their tumors surgically removed. These patients were then administered with intismeran and Keytruda (another approved cancer therapy), or Keytruda alone.
The positive data showed that the group who received the first option remained cancer-free for a significantly longer time compared to the latter. It was also announced that no new safety concerns were found.
As well as providing encouraging news for people battling melanoma, the trial has created more opportunity and hope for other biopharma companies to explore the avenue of mRNA for personalized cancer treatments.
Hurdles in producing personalized vaccines
While this is an exciting milestone in personalized medicine, the positive data remains investigational. The cancer vaccine also poses a novel set of challenges if it were to gain approval and become mass manufactured for patients.
Because each patient requires their own unique analysis and version of the vaccine, the biopharma companies would need to carefully consider how they can address the time, infrastructure, access and cost involved with producing them at scale.
Unlike conventional vaccines which are made in batches, intismeran would need to go through the following steps for every single person:
Select patient tumour → sequencing → identify mutations → design vaccine → manufacture individual vaccine → quality control → match it back to the patient → administer
As well as increasing cost exponentially, there’s also the issue of access for patients in remote geographical areas as health centers would need to get tumor samples before the vaccine could be developed.
It will be interesting to keep eyes on this advancement as it undergoes more testing and to see if there’s any new progress in personalized vaccines among other cancer types.
