This week, Sanofi (SNY – Free Report) and Glaxo’s (GSK – Free Report) COVID-19 adjuvanted recombinant protein-based COVID-19 vaccine candidate demonstrated strong immune responses in a phase II study. Pfizer (PFE – Free Report) signed a deal to supply 1.8 billion more doses of its COVID-19 vaccine, Comirnaty in Europe.
Recap of the Week’s Most Important Stories
Pfizer To Supply 1.8B More Doses of COVID-19 Vaccine to EU: Pfizer announced that the European Commission has signed a new agreement to purchase an additional 900 million doses of its COVID-19 vaccine, Comirnaty, with option to request up to an additional 900 million doses. Until now, 600 million doses have already been committed to the EU through 2021.With this latest order, total doses ordered by the EU becomes 2.4 billion since the onset of the pandemic. The new doses are expected to be delivered beginning December 2021 through 2023.
Sanofi/Glaxo’s COVID-19 Vaccine Shows Strong Immune Responses: Glaxo and Sanofi adjuvanted recombinant protein-based COVID-19 vaccine candidate demonstrated strong neutralizing antibody responses in all adult age groups in a phase II study. The data showed 95% to 100% seroconversion rates in adults of all age groups and neutralizing antibodies that were comparable to those generated by natural infection
The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology. A phase III study,which is expected to enrol more than 35,000 adult participants,is expected to start soon.
Glaxo and partner Medicago announced interim phase II data for their adjuvanted COVID-19 vaccine candidate. The study data showed that immunogenicity, as measured by neutralizing antibody responses, were 10 times higher than in people recovering from COVID-19. After two shots, the vaccine induced robust neutralizing antibody and cellular immune responses in all participants, irrespective of their age. These data were part of an ongoing phase II/III study on the candidate.
Lilly’s Fifth Tirzepatide Study Meets All Key Goals: Lilly’s (LLY – Free Report) SURPASS-4 phase III study on dual GIP and GLP-1 receptor agonist, tirzepatide met its primary and key secondary endpoints. The top-line data from the study showed that tirzepatide led to superior A1C (a measure of blood glucose) and body weight reductions across all three doses compared to titrated insulin glargine in adults with type II diabetes who have increased cardiovascular (CV) risk. The highest dose of tirzepatide led to an A1C reduction of 2.58% and weight loss of 11.7 kg at 52 weeks compared to A1C reduction of 1.44% and weight gain of 1.9 kg for insulin glargine. This is the fifth and final global registration study for tirzepatide in type II diabetes to have been successfully completed. With this,the SURPASS program has now met regulatory submission requirements for evaluating cardiovascular risk for diabetes medications.
The FDA accepted Lilly’s biologics license application (BLA) seeking approval for sintilimab injection for the first-line treatment of nonsquamous non-small cell lung cancer (NSCLC). Sintilimab, a PD-1 inhibitor, is marketed by the brand name of Tyvyt in China by Lilly and Innovent. The drug is approved in China for second or later line relapsed or refractory classic Hodgkin’s lymphoma and also for first-line treatment of nonsquamous NSCLC. The FDA is expected to give its decision in May 2022. The BLA filing was based on data from the phase III ORIENT-11 study.
Merck Pneumococcal Vaccine Pediatric Studies Succeeds: Merck (MRK – Free Report) announced that two phase III pediatric studies on its investigational 15-valent pneumococcal conjugate vaccine, V114, met their primary immunogenicity and safety endpoint.
One late-stage study — PNEU-DIRECTION— evaluated V114 in healthy infants who may have previously started a pneumococcal vaccination series with currently available 13-valent pneumococcal conjugate vaccine (PCV13). In the study, immune responses in those who received a four-dose series of PCV13, and those who received a mixed dose schedule of PCV13 followed by V114, were generally comparable for the 13 serotypes, or strains of pneumococcal disease, targeted by both vaccines.
In the second study, PNEU-PLAN, V114 was used as a catch-up regimen in healthy children who were either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a licensed pediatric PCV. In the study, immune responses were generally comparable to PCV13 for the 13 shared serotypes and higher for serotypes 22F and 33F included only in V114.
A biologics license application (BLA) is under review in the United States and EU for V114, with FDA’s decision expected on Jul 18, 2021. A supplemental BLA for approval in children is expected to be field before the end of the year.
The NYSE ARCA Pharmaceutical Index rose 1.1% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the past six months, Lilly recorded the maximum gain (39.1%) while Merck declined the most (0.4%).
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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