PFE announced encouraging data from a phase II study evaluating its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, in healthy infants.
The proof-of-concept phase II study is a four-dose series evaluating the safety and immunogenicity of PF-06482077 for the prevention of invasive disease and otitis media in healthy infants caused by Streptococcus pneumoniae serotypes contained in the vaccine. Preliminary data from the initial three doses of PF-06482077 in infants demonstrated a similar safety profile to Pfizer’s blockbuster 13-valent pneumococcal conjugate vaccine, Prevnar 13.
Please note that the company’s 20vPnC candidate includes all the 13 serotypes contained in Prevnar 13 along with seven additional serotypes. Data from the phase II study showed that the candidate led to immune responses for all 20 serotypes.
The company stated that the findings are encouraging enough to support PF-06482077’s development in infants to late stage. It will start discussions with regulatory authorities for initiating a phase III study in infants following the availability of data on the fourth dose.
Pfizer is also developing PF-06482077 in adult patients. Concurrently with this press release, it announced that enrollment in three phase III studies evaluating the candidate in adult patients has been completed. The studies are evaluating the candidate in adult patients as a preventive treatment for invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes The company plans to submit a biologics license application seeking approval of the candidate in adults by the end of 2020, following the successful completion of late-stage studies.
PF-06482077 was granted Breakthrough Therapy designation as a vaccine for adults in 2018. It also enjoys Fast Track designation.
Pfizer’s shares have declined 15.7% so far this year compared with the industry decrease of 0.6%.
culled from Yahoo News
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