Pfizer, Valneva Commercialize Lyme Disease Vaccine Candidate

Pfizer and specialty vaccine company, Valneva SE, recently announced a collaboration to develop and commercialize Valneva’s Lyme disease vaccine candidate.

For more coronavirus updates, visit our resource page, updated twice daily by Xtelligent Healthcare Media.

VLA15 is a multivalent protein subunit vaccine that is currently in Phase 2 clinical trial after showing strong immunity in safety data in pre-clinical and Phase 1 studies. VLA15 is currently the only active Lyme disease vaccine program in clinical development today and covers six stereotypes that are prominent in North America and Europe. 

Lyme disease, caused by Borrelia, is considered the most common vector borne illness in the Northern Hemisphere. According to the CDC, nearly 300,000 Americans are diagnosed with Lyme disease each year

The vaccine will target the outer surface of protein A (OspA) of Borrella, which is an established mechanism of action for Lyme disease vaccine, Pfizer said in the announcement. OspA is one of the strongest surface proteins present in a tick. 

“Lyme disease is the most commonly reported tick-borne illness in the United States and is growing in its prevalence and geographic reach. We look forward to working closely with Valneva to continue advancing the VLA15 program and potentially bring a new solution to patients for this significant unmet need,” Nanette Cocero, global president of Pfizer Vaccines, said in the announcement. 

Pfizer’s “vaccine heritage, scientific expertise, and global commercial capabilities will help allow the VLA15 program to reach its maximum potential in helping protect children and adults from Lyme disease,” Cocero added.

FDA granted Fast Track designation to the program in July 2017. Since that time, Valneva has completed patient enrollment and follow-up for two Phase 2 studies of its Lyme disease vaccine in more than 800 people. 

Phase 2 results are expected in mid-2020.

Valneva is eligible to receive a total of $308 million consisting of $130 million upfront payment, $35 million in development milestones, and $143 million in early commercialization milestones, Pfizer stated.

Additionally, Valneva will fund 30 percent of all development costs through completion of the development program, and in return Pfizer will pay Valneva tiered royalties starting at 19 percent.

“This collaboration is extremely exciting as it provides the opportunity for the rapid development and launch of a vaccine that has the potential to address a major unmet medical need. It validates Valneva’s strong vaccine R&D capabilities. We believe that Pfizer is the best partner for our Lyme disease vaccine given their outstanding development and commercial capabilities. Our team is thrilled about the prospect of working with such a successful partner,” said Thomas Lingelbach, chief executive officer at Valneva.

In the middle of March, a JAMA Network Open study found that researchers built an artificial intelligence (AI) model that can help identify regions of the US where Lyme disease cases may go unreported.

Although Lyme disease has been diagnosed in almost every state, with most reported cases occurring in the Northeast and upper Midwest, developers have not expanded the geographic scope to all areas of the country. The AI model would allow states and countries to develop more complex Lyme disease prevention and control plans. 

If caught early, Lyme disease can be effectively treated with antibiotics, researchers said. However, longer-term infections often lead to more serious symptoms, including joint stiffness, brain inflammation, and nerve pain.

“We believe our analysis can help predict the trajectory of where Lyme disease will spread,” Maria Pilar Fernandez, a post-doctoral researcher at Columbia and lead author of the study, said in the announcement. 

“Identifying high-risk areas can lead to surveillance in counties and areas where infections are likely to emerge. It also allows authorities to alert physicians and the public, which can lead to early treatment, when it is most effective.”