Final Up to date on December 13, 2022 by GlobeNewsWire
– In new information from Section 1/1b research, IVX-121 confirmed sustained immunologic response at six months; geometric imply titers (GMT) in opposition to RSV-A via day 180 persisting at 64-98% of the GMTs at day 28 in older adults –
– First scientific proof of potential differentiation on sturdiness with firm’s VLP platform expertise –
– IVX-121 continues to be typically effectively tolerated with no security considerations noticed on this six-month observe up –
– IVX-A12 (a bivalent of IVX-121 for RSV and IVX-241 for hMPV) progressing in Section 1, and the one clinical-stage candidate concentrating on these two main causes of pneumonia in a single mixture –
SEATTLE, Dec. 13, 2022 (GLOBE NEWSWIRE) — Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical firm leveraging its revolutionary virus-like particle (VLP) platform expertise to develop vaccines in opposition to infectious illnesses, with an preliminary concentrate on life-threatening respiratory illnesses and a imaginative and prescient of making pan-respiratory vaccines for older adults, at present offered a six-month immunogenicity replace from its Section 1/1b trial of IVX-121 in opposition to Respiratory Syncytial Virus (RSV). These new information exhibit a sustained neutralizing antibody (nAb) response in opposition to RSV, lasting for not less than six months after a single administration of IVX-121.
“We’re delighted to share the six-month immunogenicity information from our Section 1/1b trial of IVX-121. The potential for long-lasting immune responses was a part of our founding speculation and preclinical rationale for creating mixture VLP vaccines, so it’s thrilling to see this supportive preliminary scientific information on sturdiness from our platform,” mentioned Adam Simpson, Chief Government Officer of Icosavax. “We proceed to consider that there’s a want for higher vaccines, particularly the potential for mixture respiratory vaccines with longer-lasting safety and low reactogenicity.”
IVX-121 (RSV) Section 1/1b six-month immunogenicity replace
IVX-121 continued to be typically well-tolerated with no security considerations noticed on this six-month observe up and no vaccine associated severe opposed occasions (SAEs).
Information proven and described beneath illustrate the continued neutralizing antibody responses to a single administration of IVX-121 at three dosage ranges (25, 75, 250 ug), within the teams with out adjuvant. Samples had been taken at baseline, day 28, and day 180, with neutralizing antibodies measured in worldwide items (IU/mL) utilizing the WHO worldwide reference customary.
Determine 1 – RSV-A nAb, GMT expressed in IU/mL
In these day 180 immunogenicity information throughout IVX-121 unadjuvanted dosage teams, the sample of sturdiness was comparable in each younger and older grownup teams.
Within the older grownup portion of this research (Section 1b), GMTs for RSV-A nAbs that had been beforehand reported at as much as 7,561 IU/mL at day 28 had been noticed to persist at as much as 6,184 IU/mL via day 180. GMTs for RSV-A at day 180 had been maintained inside a spread of 64-98% relative to the beforehand reported GMTs at day 28. GMTs for RSV-B confirmed larger variability however had been maintained above baseline via day 180.
Icosavax plans to supply a 12-month immunogenicity replace from an extension of this Section 1b trial in mid-2023. The corporate additionally intends to current extra information from its Section 1/1b scientific trial of IVX-121 at a future medical assembly.
About Icosavax
Icosavax is a biopharmaceutical firm leveraging its revolutionary VLP platform expertise to develop vaccines in opposition to infectious illnesses, with an preliminary concentrate on life-threatening respiratory illnesses and a imaginative and prescient for mixture and pan-respiratory vaccines. Icosavax’s VLP platform expertise is designed to allow multivalent, particle-based show of advanced viral antigens, which it believes will induce broad, strong, and sturdy safety in opposition to the precise viruses focused. Icosavax’s pipeline consists of vaccine candidates concentrating on Respiratory Syncytial Virus (RSV) and human metapneumovirus (hMPV), in addition to applications in extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza. Icosavax was shaped in 2017 to advance the breakthrough VLP expertise from the Institute for Protein Design on the College of Washington with the aim to find, develop, and commercialize vaccines in opposition to infectious illnesses. Icosavax is situated in Seattle.
For extra data, go to www.icosavax.com.
Ahead-Trying Statements
Statements contained on this press launch concerning issues that aren’t historic details are forward-looking statements. The forward-looking statements are primarily based on the corporate’s present beliefs and expectations and embody however are usually not restricted to: the potential for the corporate’s VLP platform to lead to secure and efficient vaccines in opposition to infectious illnesses, together with IVX-121 for RSV and IVX-A12 for hMPV and RSV, and to be effectively suited to mixture vaccines; and the corporate’s capacity to advance its growth applications and obtain the famous growth milestones in 2023. Precise outcomes might differ from these set forth on this press launch because of the dangers and uncertainties inherent within the firm’s enterprise, together with, with out limitation: the early stage of the corporate’s growth efforts; the chance that outcomes of a scientific trial at a specific time level might not predict remaining outcomes and that an consequence might materially change as follow-up of topics continues and following extra complete critiques of the info; the potential of disappointing ends in later scientific trials regardless of promising ends in earlier preclinical analysis or scientific trials; potential sudden opposed unwanted side effects or insufficient immunogenicity or efficacy of IVX-121 or IVX-A12 which will restrict their growth, regulatory approval, and/or commercialization; the corporate’s strategy to the event of vaccine candidates, together with its IVX-A12 mixture bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven strategy; potential delays within the growth course of together with with out limitation within the enrollment, conduct of, and receipt of information from, scientific trials; the corporate’s dependence on third events in reference to manufacturing, analysis, and scientific testing; the potential for challenges encountered within the manufacturing and scale up course of; competing approaches limiting the business worth of the corporate’s vaccine candidates; and different dangers described within the firm’s prior filings with the Securities and Change Fee (SEC), together with underneath the heading “Threat Components” within the firm’s quarterly report on Kind 10-Q for the quarter ended September 30, 2022 and any subsequent filings with the SEC. You’re cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date hereof, and the corporate undertakes no obligation to replace such statements to replicate occasions that happen or circumstances that exist after the date hereof. All forward-looking statements are certified of their entirety by this cautionary assertion, which is made underneath the secure harbor provisions of the Personal Securities Litigation Reform Act of 1995.
Media Contact: Jessica Yingling, Ph.D. Little Canine Communications Inc. jessica@litldog.com858.344.8091
Investor Contact:Laurence WattsGilmartin Group, LLClaurence@gilmartinir.com619.916.7620
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