- Vaxcyte said Monday its experimental pneumococcal vaccine succeeded in a second mid-stage trial, setting the stage for the biotechnology company to bring the shot into Phase 3 testing.
- The newly reported results come from a Phase 2 study testing the shot’s safety and ability to produce an immune response in adults aged 65 and older. Vaxcyte said its vaccine sparked a “robust” response against all 24 bacterial strains it was tested against, confirming results it observed a study of younger adults last year. Those responses were largely comparable to what’s been seen with Pfizer’s Prevnar 20.
- Vaxcyte plans to advance the vaccine into a Phase 3 trial that it said will deliver study results in 2025. The company’s stock rose about 20%, to more than $43 a share, in early trading Monday.
Vaxcyte is aiming to prove that its shot can top vaccines that are already on the market. Its vaccine, meant to prevent bacterial pneumonia and other pneumococcal infections like meningitis, has been designed to protect against more strains than Pfizer’s Prevnar 20 and Merck and Co.’s Vaxneuvance.
Vaxneuvance, for instance, covers 15 bacterial strains, while Pfizer’s shot protects against 20. Vaxcyte’s — like an experimental shot under developement at GSK — is intended to protect against 24, and, at least so far, has emerged as a challenger to its larger rivals.
Last year, the company said its vaccine matched the performance Prevnar 20 in protecting against 20 bacteria strains and exceeded it against four others among healthy adults. On Monday, the company strengthened its case and showed that the shot can spur a strong immune response in the elderly as well.
Specifically, in patients 65 years or older, Vaxcyte said the dose of the shot it plans to advance into late-stage testing was “non-inferior” to Prevnar 20 against 18 of 20 strains the two shots are both designed to cover. The vaccine proved superior to Prevnar 20 against four addditional strains it’s been uniquely tailored to protect against, the company said.
Pooled results from the two studies also indicated the vaccine’s safety profile is similar to Prevnar 20 across all doses tested.
The data impressed Wall Street analysts and led to another stock surge for Vaxcyte, whose shares are now worth nearly triple their debut price in 2020. The data are “better than expectations,” wrote Evercore ISI analysts Umer Raffat and Jon Miller. SVB Securities analyst David Risinger added that the vaccine has “best-in-class potential,” while Jefferies’ Roger Song wrote that the shot could become “a new standard of care” in a vaccine market worth about $10 billion.
Vaxcyte plans to meet with the Food and Drug Administration later this year to discuss its coming Phase 3 program. It’s also evaluating the vaccine in infants, and has a newer version covering 31 strains in preclinical testing.
Editor’s note: This story has been updated to remove mention of when Vaxcyte plans to begin Phase 3 testing. The company has not yet disclosed an expected start date.