Another RSV Vaccine Candidate Fast-Tracked

Icosavax, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) virus-like particle (VLP) vaccine candidate, in older adults 60 years of age and above.

Niranjan Kanesa-thasan, Chief Medical Officer of Icosavax, commented in a press release on February 21, 2023, "IVX-A12 is differentiated as the most advanced vaccine candidate against these two leading causes of pneumonia in older adults."

In October 2022, Icosavax initiated a Phase 1, randomized, observer-blinded, placebo-controlled, multicenter study of IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®, in up to 120 healthy older adults aged 60 to 75 years.

Icosavax anticipates announcing topline interim results from this Phase 1 trial in mid-2023, with subjects after that followed through 12 months after vaccination.

The company plans to initiate a Phase 2 trial for IVX-A12 in the second half of 2023.

According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need. An investigational drug that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

As of February 21, 2023, the FDA has not approved any RSV vaccine candidates conducting late-stage studies. Furthermore, the FDA has approved and is reviewing RSV monoclonal antibody therapies.