Glaxo needs a quick recovery from its RSV vaccine stumble

After the spin-out of its consumer business Glaxosmithkline will be all about R&D, so news of a halt on one of its most valuable pipeline projects is a blow. An “observation from a routine safety assessment” prompted recruitment and vaccination to be voluntarily paused across three studies testing Glaxo's maternal RSV candidate GSK3888550A. Exactly what was seen is not being disclosed, but the tolerance of risk in this population must be extremely low. The pivotal Grace trial was due to read out in the second half of this year, so the 10,000-participant study must be close to full enrollment. Encouragingly, a second RSV project is unaffected: GSK3844766A is being developed for older adults – considered a much larger market than maternal – and remains on track to generate pivotal data before mid-year. The two recombinant protein vaccines contain the same RSV antigen, although ‘766A is adjuvanted. Several developers are racing to bring the first vaccine against the respiratory virus to market, so Glaxo needs a quick resumption. The delay cements Astrazeneca and Sanofi’s lead with their long-acting antibody nirsevimab, which was granted a speedy review by EU regulators this week.

Late-stage RSV pipeline 
Project Company Description Details 
Nirsevimab (SP0232) Sanofi/ Astrazeneca Fusion antibody Filed; accepted under accelerated assessment in EU 
GSK3844766A Glaxosmithkline Protein subunit vaccine, adjuvanted Aresvi 004 in adults ≥60, data due H1 2022
RSVPreF3 (GSK3888550A) Glaxosmithkline Protein subunit vaccine, unadjuvanted Trials on pause; Grace maternal protection trial was due to read out H2 2022
RSVpreF (PF-06928316) Pfizer Protein subunit vaccine Data from Renoir (adults ≥60) and maternal protection trial due H1 2022
Ad26.RSV.preF Johnson & Johnson Adenovirus type 26 viral vector vaccine  Evergreen in adults ≥60, data due H2 2022
Clesrovimab (MK-1654) Merck & Co Fusion antibody MK-1654-007 in high-risk infants; ph2/3 MK-1654-004 in healthy infants, data due 2022
Rilematovir (JNJ-53718678) Johnson & Johnson Oral RSV F-protein fusion inhibitor Daisy in hospitalised children; Primrose in adult outpatients; trials started late 2021
Source: company statements.   

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