Clinical-stage vaccine company Vaxcyte Inc. (PCVX:NASDAQ), which concentrates its efforts on creating and developing vaccines for the prevention and treatment of bacterial diseases, yesterday announced "positive topline results from the Phase 1/2 clinical proof-of-concept study evaluating the safety, tolerability, and immunogenicity of VAX-24, the company's investigational 24-valent pneumococcal conjugate vaccine (PCV), in healthy adults aged 18-64."
The firm advised that the topline data gathered in the trial show that across all doses studied, VAX-24 met the studies safety and tolerability goals and demonstrated a safety profile similar to Prevnar Prevnar 20™ (PCV20) and added that no serious vaccine-related adverse events or new onset chronic illnesses were observed.
Vaxcyte explained that VAX-24 is being evaluated for use in preventing invasive pneumococcal disease (PID) in adults between the ages of 18 and 64. The company advised that in the Phase 1/2 trial. VAX-24 successfully met or exceeded all required immunogenicity standards for all 24 serotypes at the conventional 2.2mcg dose and stated that it now plans to move ahead with a Phase 3 program in both adult and pediatric patients.
"We believe this presents an opportunity to set a new bar for immunogenicity standards for pneumococcal vaccines," Pickering added.
The firm noted that the Phase 1/2 clinical "Proof-of-Concept" trial was structured as a randomized, dose-finding study to evaluate the safety, tolerability, and immunogenicity of VAX-24 in healthy adults 18-64 years of age who were given a single injection of VAX-24 of either 1.1, 2.2 or 2.2mcg/4.4mcg.
These results were then compared with PCV20 administered in 64 healthy adults aged 18-49. The firm noted that at all three dosage levels, VAX-24 met the standard superiority criteria for all four serotypes unique to VAX-24.
The company's co-founder and CEO, Grant Pickering, stated, "We are thrilled with these positive topline results from our Phase 1/2 proof-of-concept study, which met all of our objectives. The findings indicate a potential best-in-class profile for VAX-24 and validate our carrier-sparing approach to enable the development of broader-spectrum PCVs."
"The study results demonstrate that VAX-24 has the potential to provide broader coverage and better immune responses relative to the standard of care. We believe this presents an opportunity to set a new bar for immunogenicity standards for pneumococcal vaccines," Pickering added.
Vaxcyte's EVP and COO Jim Wassil commented, "We are very excited to share these strong clinical results from our proof-of-concept study, which validate the potential for VAX-24 to improve upon the standard-of-care for adults by potentially providing 10-15 percent incremental protection for this serious disease. The 24 serotypes included in VAX-24 cover a significant portion of the IPD currently in circulation and are associated with high case-fatality rates, antibiotic resistance, and meningitis."
The firm said that it anticipates that the full six-month safety data from the Phase 2 (18-64) adult studies will be ready in H1/23. In addition, the company noted that it expects to receive six-month topline safety, tolerability, and immunogenicity data from the Phase 2 portion of the trial for adults 65 and older in H1/23.
Vaxcyte intends to engage in discussions with regulatory officials regarding a Phase 3 program which it expects to commence in H2/23. The company noted that it also expects to submit an infant Investigational New Drug (IND) application and initiate a Phase 2 infant study of VAX-24 in H1/23.
Vaxcyte stated that the U.S. Food and Drug Administration (FDA) had granted Fast Track Designation for VAX-24 for use in adults in August 2022.
The company also expects to file a new IND application for VAX-XP in H2/23. VAX-XP is a PCV candidate with 31 strains. Preliminary topline data from this Phase 1/2 study in adults is expected to be available in 2024.
The company explained that "pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria, which can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis."
Vaxcyte is a clinical-stage vaccine firm based in San Carlos, California, that is focused on developing broad-spectrum conjugate and novel protein vaccines designed to prevent contagion, treat, and stop the spread of bacterial infectious diseases. The company's leading pipeline candidate called VAX-24 is "a 24-valent, broad-spectrum pneumococcal conjugate vaccine being developed for the prevention of invasive pneumococcal disease (IPD)." The firm's pipeline includes several other programs, including its broader spectrum PCV VAX-XP and preclinical programs targeting periodontitis and Group A Strep infections.
Vaxcyte started off yesterday with a market cap of around $1.22 billion, with approximately 59.32 million shares outstanding and a short interest of about 4.17%. PCVX shares opened more than 70% higher yesterday at $35.15 (+$15.57, +70.80%) over Monday's $20.58 closing price and reached a new 52-week high price yesterday morning of $36.10. The stock traded between $32.99 and $36.10 per share and closed for trading at $33.11 (+$12.53, +60.88%).
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