Vaxcyte Inc. characterized its latest phase II data with VAX-24 as positive but Wall Street wasn’t so sure about the dose-finding outcomes with the 24-valent pneumococcal conjugate vaccine (PCV), and shares of the San Carlos, Calif.-based firm (NASDAQ:PCVX) closed March 31 at $37.76, down $31.70, or 46%.
As U.S. regulatory uncertainty swirls around the vaccine space and health care in general, Vaxcyte Inc. stands poised for a readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine (PCV). The San Carlos, Calif.-based firm will offer top-line safety, tolerability, and immunogenicity data, to be followed by top-line data with the booster dose by the end of this year.
On news that drove shares up by 36% on Sept. 3, San Carlos, Calif.-based Vaxcyte Inc. priced a $1.3 billion follow-on offering a day later. It is the fourth highest amount raised through a follow-on offering of shares in BioWorld’s records, as well as the second largest financing of all types for 2024, behind New York-based Pfizer Inc.’s $3.1 billion global sale of shares in March.
Phase I/II results described by one analyst as “stunning” put Vaxcyte Inc. in position for a phase III trial with VAX-31, the firm’s 31-valent pneumococcal conjugate vaccine candidate designed to prevent invasive disease. San Carlos, Calif.-based Vaxcyte’s shares (NASDAQ:PCVX) closed Sept. 3 at $110.15, up $29.39, or 36.4%, on positive top-line results from the study testing the safety, tolerability and immunogenicity of the product in 1,015 healthy adults ages 50 and older.
Becoming the first pneumococcal conjugate vaccine specifically designed for adults 18 and older, Merck & Co. Inc.’s 21-valent candidate, Capvaxive (V-116), gained U.S. FDA approval on its June 17 PDUFA date. The Rahway, N.J.-based company expects to take significant market share based on positive phase III findings from the Stride-3 trial. Analysts have estimated the product could reach $2 billion in annual global sales.
The $27.9 billion raised through biopharma follow-on offerings in the early months of 2024 has hit industry records never seen before. So far in three-and-a-half months in 2024, the industry has raised more than was raised during 21 of the past 24 full years.
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
Vaxcyte Inc. has received FDA clearance of its IND application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease.
SK Bioscience Ltd. and Sanofi Pasteur SA announced June 30 positive results from a phase II study for its 21-valent pneumococcal conjugate vaccine (PCV) candidate called GBP-410, or SP-0202 under Sanofi.
Although strides have been made in the space, biopharma’s hunt for a wider net to cast in vaccines for pneumococcal disease has recruited the likes of Vaxcyte Inc., GSK plc and Merck & Co. Inc., each racing for a candidate with improved valence.
