Moderna shares R&D updates at third annual vaccines day

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine. 

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia. 

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…

Read more
  • 0

Takeda publishes Phase 3 Livtencity data in peer-reviewed journal

Takeda Pharmaceutical (TSE:4502/NYSE:TAK) has announced that it has published data from the SOLSTICE Phase 3 trial for Livtencity (maribavir) in post-transplant recipients with cytomegalovirus (CMV) infection in the peer-reviewed journal of Clinical Infectious Diseases.

The drug was statistically superior to conventional therapies at week 81. The trial met its primary endpoint. A total of 55.7% (131/235) of adult patients taking Livtencity achieved confirmed CMV DNA level under the lower limit of quantification.

It was also statistically significant to conventional therapies in a composite achievement of CMV DNA level less than the lower limit of quantification (LLOQ). In addition, the drug supported symptom control at week 8 with maintenance through week 161. The conventional therapies in the study included one or more of the antivirals ganciclovir, valganciclovir, foscarnet or cidofovir.

Last month, FDA approved Livtencity for use in patients at least …

Read more
  • 0

FDA approves novel treatment for post-transplant CMV infection 

FDA has approved Takeda Pharmaceutical’s (NYSE:TAK) Livtencity (maribavir) for use in patients at least 12 years old with post-transplant cytomegalovirus (CMV) infection or disease that does not respond to available antiviral therapy. The indication covers patients weighing at least 35 kilograms.

Livtencity blocks virus replication by blocking the activity of the human cytomegalovirus enzyme pUL97.

According to data gathered by Takeda, the infection is present in 16–56% of solid organ transplants and 30–70% of hematopoietic stem cell transplants.

CMV infections cause an increased risk of complications and death for transplant recipients, said Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” Farley said in a press release. “Today’s approval helps meet a significant unmet medic…

Read more
  • 0

BioNTech and Moderna set their sights on treating cancer

Nodular melanoma. Image courtesy of Wikipedia.

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company.

BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different cancer vaccines based on mRNA,” said Türeci, BioNTech’s chief medical officer.

Such therapy could be available to people within a “couple of years,” Türeci said, stressing that it is difficult to predict regulatory timelines involving emerging therapies. 

BioNTech is currently working on several novel immunotherapies for oncology targeting melanoma, prostate cancer and cancers associated with human papillomavirus. 

Moderna is also exploring the possibility of…

Read more
  • 0