Icosavax Granted FDA Fast Track Designation for RSV & hMPV Vaccine Candidate

Icosavax, Inc. recently announced the US FDA has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, in older adults 60 years of age and older.

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.

“We are delighted to have received the Fast Track designation for IVX-A12, which we believe highlights the unmet medical need that could be addressed by developing a bivalent vaccine combination of RSV and hMPV,” said Niranjan Kanesa-thasan, Chief Medical Officer of Icosavax. “IVX-A12 is differentiated as the most advanced vaccine candidate against these two leading causes of pneumonia in older adults. RSV is estimated to cause approximately 177,000 hospitalizations and 14,000 deaths each year in this population in the US alone, and data support similar morbidity and mortality for hMPV. We will utilize the benefits of this important regulatory milestone to work to optimize the IVX-A12 development plan. In addition, we look forward to the upcoming topline results of our Phase 1 study, and thereafter to the planned initiation of our Phase 2 trial.”

In October 2022, Icosavax announced the initiation of a Phase 1, randomized, observer-blinded, placebo-controlled, multi-center 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 thereafter followed through 12 months after vaccination. The company currently plans to initiate a Phase 2 trial for IVX-A12 in 2H 2023.

Icosavax is a biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision for combination and pan-respiratory vaccines. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and an emerging program in influenza. Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax is located in Seattle. For more information, visit www.icosavax.com.