The cancellation of the strategic alliance sees Valneva pay GSK €9m ($10.25m) immediately and a potential further €7m in milestone payments. As a result, Valneva will take on full control of its main R&D assets.
GSK entered the partnership through the trade it made with Novartis, which saw the former scoop up the latter’s vaccine division. Novartis had previously gained access to 10 vaccine projects in a €270m deal with Intercell – a company which later merged with Valneva.
Emmanuel Hanon, Head of R&D at GSK Vaccines, explained why the company was willing to exit the deal, “As part of GSK’s ongoing initiative to allocate capital to fewer, highest priority areas, we have elected to come to an early termination so that both parties can make clear plans for the future.”
Valneva is currently at an advanced stage with the clinical development of its Lyme disease vaccine, VLA15, which is currently in Phase II trials.
The vaccine is currently the only one in development for the condition and the company expects the readout from the trials to arrive mid-2020, before taking the asset onto Phase III.
The company also has a vaccine candidate for chikungunya, VLA1553, which has progressed through Phase I trials.
Thomas Lingelbach, CEO of Valneva, told investors that the severance of the agreement allows the company full flexibility to find new partners to take its programs further. However, he stated that the company is “not in a hurry” and “not under pressure” to make such a deal.
Valneva stated that the Phase II trial for VLA15 is fully funded until completion, and a spokesperson for the company told us that the company “does not need a partner to develop these vaccines [further].”
Lingelbach further explained that ending the partnership will enable the company to progress its Lyme disease candidate through the clinic at a faster rate.
“[Making sure] we are ready to go right after the final Phase II is of the utmost importance and this is what the current deal does not really provide for,” he said.
The spokesperson told us that the current plan is for a three-year Phase III trial to be initiated in 2021 or 2022, which could include study participants ages 12 and up, in addition to adults.
“If approved, the vaccine might be recommended for at risk people including those living in endemic areas, people planning to travel to endemic areas to pursue outdoor activities and people at risk who have a history of Lyme disease for protection from the other strains,” the spokesperson explained, regarding potential commercialization plans.
Both of Valneva’s lead vaccine candidates have received US Food and Drug Administration fast track designation.
Valneva currently has a commercial portfolio, with two approved vaccines in the form of Ixiaro, for the prevention of Japanese encephalitis virus, and Dukoral, an oral cholera vaccine. In first quarter results for 2019, the company stated that it had achieved €32.8m in product sales.