Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere.
In the same week it announced dosing had been finished in its pandemic mRNA vaccine test, Pfizer also said it had penned a $308 million Lyme disease vaccine R&D pact with French biotech Valneva.
The deal focuses on development of Valneva’s Lyme disease vaccine candidate, VLA15, which is currently in phase 2. VLA15 is the only active Lyme disease vaccine program in clinical development today and covers six serotypes that are prevalent in North America and Europe.
Collectively, around half a million people across the two regions are infected with the bacteria Borrelia, causing in many long-term debilitating disorders if not treated quickly. It’s predominately spread to humans by infected Ixodes ticks.
The multivalent protein subunit vaccine targets the outer surface protein A (OspA) of the Borrelia bacteria: OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.
VLA15 has “demonstrated strong immunogenicity and safety data in preclinical and phase 1 studies,” Valneva said, and was given a fast-track label by the FDA back in 2017. Phase 2 enrollment is done, and the French biotech expects to post data from that study in the coming months.
It gets $130 million upfront, $35 million in development milestones and $143 million in early sales milestones, should it gain approval.
Under the nuts and bolts of the deal, Valneva will fund 30% of all development costs through completion of the development program, while Pfizer will pay Valneva tiered royalties starting at 19%. Pfizer will then lead late-stage development and have “sole control” over selling the vaccine.
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Valneva already sells vaccines to protect against cholera and Japanese encephalitis and has R&D programs in chikungunya.
Thomas Lingelbach, CEO at Valneva, said: “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.”
The biotech has had pharma partners before, though back in 2016 one didn’t work out when it gave up on its vaccine against hospital-acquired infection Pseudomonas aeruginosa. The vaccine was positioned to be picked up by GlaxoSmithKline, but weak phase 2/3 data torpedoed both that possibility and Valneva’s interest in forging ahead with development.
It will hope to have better luck with Pfizer.
Nanette Cocero, global president of Pfizer Vaccines, added: “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.”
“As both a research company, and a manufacturer of pediatric and adult vaccines including a vaccine for tick-borne encephalitis in Europe, we believe that 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.”