- Recently reported positive six-month immunogenicity data for IVX-121 against RSV; first clinical evidence of potential differentiation on durability with company’s VLP platform -
- Phase 1 study of IVX-A12 (a bivalent of IVX-121 for RSV and IVX-241 for hMPV) progressing and on track for topline results in mid-2023 -
- IVX-A12 Phase 2 initiation expected in 2H 2023 -
“We enter 2023 energized by the recent six-month immunogenicity data from our IVX-121 Phase 1/1b study, which we believe provides the first clinical evidence of potential differentiation on durability using Icosavax’s VLP platform technology,” said
Pipeline Updates:
- Recently reported positive durability data for VLP vaccine candidate IVX-121 against respiratory syncytial virus (RSV) at six-month timepoint. In December,
Icosavax announced that data from its Phase 1/1b study of IVX-121 showed sustained immunologic response at six months, with geometric mean titers (GMT) against RSV-A through day 180 persisting at 64-98% of the GMTs at day 28 in older adults. These data provided the first clinical evidence of potential differentiation on durability with the company’s VLP platform technology. Subjects will continue to be followed in a Phase 1b extension out to 12 months. - IVX-A12 progressing in a Phase 1 trial against RSV and hMPV in older adults. In October,
Icosavax announced the initiation of a Phase 1 trial of IVX-A12 – the only bivalent vaccine candidate targeting RSV and human metapneumovirus (hMPV) to reach clinical development. The trial continues to enroll subjects and the company remains on track to announce topline results from this study in mid-2023, with plans thereafter to initiate a Phase 2 trial of IVX-A12 in 2H 2023.
Corporate Updates:
- Appointed
Jennifer Raymond as Senior Vice President, Technical Operations. InJanuary 2023 ,Icosavax appointedJennifer Raymond as SVP, Technical Operations. Jennifer is a pharmaceutical executive with more than 20 years in biologics manufacturing including vaccines and monoclonal antibodies. She joinsIcosavax most recently from GreenLight Biosciences, where she was SVP of CMC and Manufacturing, having previously served in roles of increasing responsibility at GSK, Novartis Vaccines and Diagnostics,Elan Pharmaceuticals , and Merck. - Executed patent license for influenza neuraminidase antigens from the
University of Washington (UW). InDecember 2022 ,Icosavax entered into a patent license granted byUW for use of modified neuraminidase antigens developed byUW and theNational Institutes of Health in the influenza field.Icosavax looks forward to providing future updates on its influenza program and development strategy as the company executes on its vision to develop combination VLP vaccines targeting the viral causes of respiratory disease in older adults.
Near-Term Milestone Expectations:
- IVX-121 (RSV) Phase 1b extension, 12-month immunogenicity data expected in mid-2023
- IVX-A12 (RSV+hMPV) Phase 1 topline interim data expected in mid-2023
- IVX-A12 (RSV+hMPV) Phase 2 initiation expected in 2H 2023
- Flu program candidate selection expected in 2023
- COVID-19 bivalent candidate selection expected in 2023
Cash Position:
- Cash, cash equivalents, restricted cash, and short-term investments as of
September 30, 2022 were$222.5 million , whichIcosavax expects to be sufficient to fund operations through at least 2024.
About
For more information, visit www.icosavax.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the company’s current beliefs and expectations and include, but are not limited to: the company’s goal to progress its preclinical and clinical programs, the timing of company milestone achievement, the company’s cash balance and the company’s expectations regarding the prophylactic and commercial potential of its vaccine candidates and its platform technology. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the company’s business, including, without limitation: the early stage of the company’s development efforts; the company’s novel and unproven technology and the uncertainties associated with the development of the company’s novel candidates and their potential use as part of a pan-respiratory vaccine; potential delays in the commencement, enrollment, and completion of, and receipt of data from, clinical trials; the company’s dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate immunogenicity or efficacy of the company’s vaccine candidates that may limit their development, regulatory approval, and/or commercialization as monovalent or combination vaccines; the possibility of disappointing results in later clinical trials despite promising results in earlier preclinical research or clinical trials; the potential for challenges in the manufacturing and scale up process, including without limitation challenges that reduce drug product stability or potency; competing approaches limiting the commercial value of the company’s vaccine candidates and the company’s VLP platform technology; regulatory developments in
Media Contact:
jessica@litldog.com
858.344.8091
Investor Contact:
laurence@gilmartinir.com
619.916.7620
![](https://ml.globenewswire.com/media/NDg4MDk3MDktODIzNi00YzhhLTkzZjktMWQ0YWQ5NjYwZDhmLTEyMjE5OTc=/tiny/Icosavax-Inc-.png)
2023 GlobeNewswire, Inc., source