Migraines affect an estimated 10% of people worldwide, causing severe headaches and other symptoms such as light sensitivity, nausea, and vomiting. The WHO reports that migraines are “more common in women, usually by a factor of about 2:1”. This is attributed to “hormonal influences”. However, labiotech.eu suggests that, like other diseases that “primarily affect women”, migraines have been “overlooked” for several reasons such as “gender biases in research and diagnoses”. Hoping to change the narrative is US-based biotech Vaxxinity. Using novel technology and the benefits of vaccine delivery, Vaxxinity is targeting chronic conditions like migraines with the intention of producing affordable solutions.
What do we currently have?
At present, treatment for migraines will generally involve anti-inflammatory painkillers, but these are often “discontinued” by 80% of patients after 12 months. Other therapeutic options include monoclonal antibodies (mAbs), which block calcitonin gene-related peptide (CGRP). This is an effective but inaccessible solution. Labiotech.eu suggests that mAbs are “dominating the drug development landscape”, particularly in the US.
“However, mAbs are difficult to manufacture and administer, and carry a hefty price tag that has made them globally inaccessible”.
Thus, the need for new and more financially sustainable options is pressing.
Speaking to PharmaVoice’s Woman of the Week podcast, Hu described Vaxxinity’s “North Star”.
“we want to bring the efficiency of vaccines to chronic diseases – basically a third biologic revolution…And these vaccines would be accessible to everyone.”
In order to make this a reality, Hu’s team is using a platform that uses synthetic peptides to provoke the immune system to develop antibodies. She suggests that the “concept is very similar to other vaccines”.
“The difference is that traditional vaccines will fight against foreign infections. Our vaccines are designed to harness the immune system.”
Implementing the mission
Vaxxinity’s platform “turns the body into its own antibody factory against self-antigens of chronic diseases”, Hu explained to labiotech.eu. Although the immune system is “very smart” and avoids self-destructive attacks, they have overcome this protective mechanism by “presenting the self-antigen as a threat”.
“If we imagine the sheep as the self-antigen, which the body does not respond to, we can dress it up in just enough wolf’s clothing that when the body first sees it, it sounds alarm bells”.
In Hu’s metaphor the wolf’s clothing is borrowed from Vaxxinity’s “proprietary library of synthetic T helper cells”. These “mimic highly promiscuous epitopes” that the body recognises as a threat. Instead of manufacturing mAbs outside the body, this approach “teaches your body to become [a] bioreactor and produce these antibodies on its own”.
This approach can be applied to the blocking of CGRP. The UB-313 vaccine “teaches your body” to target and suppress this, which is associated with a reduction in migraine frequency. CGRP is also connected to other functions in the body, so there might be safety concerns. However, Hu is confident in the data that is already available, which shows “very good safety”.
Compared to mAbs, vaccines have a greater durability and lower cost. Furthermore, the synthetic peptide-based vaccines are easier, and more stable, to scale up.
“Generally, our cost of goods is less than 1% that of mAbs.”
Although there are drugs that have been shown to work quickly and effectively, they are simply too expensive. Hu describes “Vaxxinity’s vision” as allowing patients to “reclaim their lives”. With an infrequent and less expensive treatment, she hopes they will be the go-to solution.
“The convenience and longer lasting effectiveness makes the vaccine attractive”.
With other chronic diseases on the table, this technology has the potential to support millions of patients. To hear more from Mei Mei Hu on Vaxxinity’s progress and plans at the World Vaccine Congress in Washington 2023, get your tickets now.