The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Suvax, a subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection. SUDV is a type of ebolavirus for which there is no current treatment or vaccine.
With two respiratory syncytial virus (RSV) vaccines approved by the U.S. FDA in 2023 and a third nearing its May PDUFA date, decades of research has finally provided infants and older adults protection from the disruptive and sometimes deadly virus. But what about people in the middle, particularly those with certain chronic medical conditions? New York-based Pfizer Inc. rolled out phase III data April 9 showing that its approved RSV vaccine, Abrysvo (RSVpreF), met primary endpoints in adults ages 18 to 59 who were at high risk of RSV.
“Hot and cold tumors may need different types of immunotherapy,” Jay Berzofsky told the audience as the American Association for Cancer Research’s (AACR) 2024 annual meeting kicked off this weekend. In an educational session on cancer vaccines, Berzofsky, who is head of the National Cancer Institute’s Molecular Immunogenetics and Vaccine Research section, explained that when immunotherapy fails in hot tumors, it fails despite the existence of an immune response, due to an immunosuppressive microenvironment.
Evaxion Biotech A/S and a collaborator have successfully concluded a series of large nonrodent animal infection studies testing antigens from Evaxion’s preclinical EVX-B1 vaccine candidate against Staphylococcus aureus. The EVX-B1 antigens were shown to significantly reduce disease burden.
Phase II/III results from Gritstone Bio Inc. with Granite, a personalized neoantigen cancer vaccine for colorectal cancer, turned up the opposite of what some investors expected, and the company’s shares (NASDAQ:GRTS) ended April 2 at $1.20, down $1.15, or 49%.
Blackstone Life Sciences made an investment of up to $750 million in Moderna Inc.’s influenza program created with its mRNA technology. The new funding is designed to help propel the program forward and may help bolster a stock that has struggled in the past 12 months.
Defence Therapeutics Inc. has announced the successful testing of a second-generation anticancer vaccine, ARM-002, using its lead anticancer molecule Accutox. When tested as a therapeutic vaccine in a melanoma cancer model, ARM-002 led to an 80% complete response when combined with an anti-PD-1 immune-checkpoint inhibitor.
Galectin-3 (Gal-3) is used as a marker of activated microglia, and thus a protein that drives inflammation. Patients with Alzheimer’s disease (AD) have shown increased levels of Gal-3 in their cerebrospinal fluid (CSF) compared to healthy controls, as well as increased expression in their brain tissue.
Merck & Co. Inc. has announced plans to initiate clinical development of a new investigational multi-valent human papillomavirus (HPV) vaccine designed to provide broader protection against multiple HPV types.
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