GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech

Zinger Key Points
  • No safety concern was observed; the TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up.
  • There are an estimated four billion people globally infected with HSV.

GSK Plc GSK shelved on Wednesday its herpes simplex virus (HSV) vaccine development program.

The recombinant protein vaccine, dubbed GSK3943104, did not meet the study’s primary efficacy objective.

GSK added that the vaccine candidate will not progress to phase three studies.

No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up.

“Given the unmet medical need and burden associated with genital herpes, innovation in this area is still needed,” the company said. “GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV program.”

There are no approved vaccines for HSV, and GSK’s decision to stop developing GSK3943104 eliminates a key contender in the race to market.

Moderna Inc MRNA is developing mRNA-1608, an investigational vaccine for herpes simplex virus type 2. The candidate is currently in phase 1/2 trial that is fully enrolled with  300 participants in the U.S. Data is expected in June 2025.

Pfizer Inc. PFE partner BioNTech SE BNTX is developing BNT163, a prophylactic vaccine candidate being studied in a phase one clinical trial. 

The German company initiated the phase one trial in December 2022, with an estimated enrollment of 248 participants. Data is expected in 2025.

There are an estimated four billion people globally infected with HSV.

GSK Price Action: GSK stock is down 1.12% at $43.61 at last check Wednesday.

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