May 25 Quick Takes: Moderna to submit pediatric COVID vaccine data to regulators in early June; plus FDA guidance on bispecifics, TG, Asylia, Pieris, Nordic, Ziphius and Kyma
Moderna Inc. (NASDAQ:MRNA) will be the next company to bring a COVID-19 vaccine forward for authorization in adolescents, with plans to submit data from the Phase II/III TeenCOVE study of its COVID-19 vaccine to regulators early next month after reporting 93% efficacy in patients ages 12-17. Earlier this month, FDA authorized Comirnaty from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) in children ages 12-15 and announced that its Vaccines and Related Biologics Products Advisory Committee will convene on June 10 to provide a status update on its approach to granting EUAs for vaccines intended for adolescent populations.
As a flood of bispecific antibodies advances through the clinic, FDA released final guidance on development of bispecifics that highlights differences between the regulatory, clinical and scientific considerations of bispecifics and standard mAbs. The guidance clarifies that FDA’s guidance on fixed-dose combination therapies does not apply to bispecifics, which are structured as a single therapy against two targets, and states that depending on the bispecific antibody, a clinical comparison with monospecific antibodies against the same target may be required. On top of standard quality requirements, other measures that could affect pharmacology of bispecifics include relative binding activity for each target and on- and off-target rates. ...