The field of companies seeking a respiratory syncytial virus (RSV) vaccine includes several pharmaceutical giants with substantial resources and cash to invest in research.The four-year-old Icosavax scientists believe that their company’s technology can make it unique, and biotechnology is now US$182 million For clinical trials that can help establish this situation.
Icosavax’s public market debut was last week’s largest life science IPO. In addition to supporting the clinical research of the main RSV project, the company is also committed to clinical testing of a vaccine that may be able to address the new coronavirus variant.
Seattle-based Icosavax’s vaccine is made of virus-like proteins designed and designed by the company. These virus-like particles (VLP) are designed to trigger an immune response, but because they do not contain any viral genetic material, they cannot replicate and cause infection. RSV infection can become very serious, especially for young children and the elderly.according to Centers for Disease Control and Prevention, RSV causes approximately 58,000 children aged 5 and under to be hospitalized each year. Among adults 65 years and older, RSV infection resulted in approximately 177,000 hospitalizations and 14,000 deaths.
Icosavax’s RSV program IVX-121 has reached the first stage of RSV testing. Companies that further advance the clinical development of RSV vaccines include GlaxoSmithKline, Pfizer, Modern, Jensen, and Mesa vaccineBut Icosavax said that one of the characteristics of VLP technology is the ability to produce vaccines that can deal with multiple pathogens. The company is pairing its RSV vaccine candidate with the VLP of human metapneumovirus (hMPV), another dangerous respiratory virus, and no vaccine is available. This bivalent vaccine candidate, named IVX-A12 by the company, is preparing for clinical trials.
“We believe that the induction of nAbs (neutralizing antibodies) is the key to the efficacy of RSV and hMPV vaccines in the elderly, and the display of multivalent VLPs of RSV and hMPV antigens before fusion on our VLP candidates will induce stronger nAbs than other vaccine technologies Response, “The company is in IPO application.
The company explained in the document that IVX-A12 is designed to protect the more vulnerable elderly, because RSV and hMPV are common causes of pneumonia in the elderly. Clinical trials to evaluate the vaccine are scheduled to start in Belgium in the second half of this year; preliminary data are expected in the first half of next year.
Based on the clinical trial results of the bivalent vaccine candidate, Icosavax expects that it can submit an investigational new drug application to the FDA in the first half of next year. The Phase 1 clinical study aims to recruit about 100 healthy adults who will be followed up for seven months. The vaccine will be tested in multiple doses with and without an adjuvant, which is an ingredient that enhances the immune response. According to the document, this design will allow the company to evaluate the immune response to the various components of the vaccine.
During the pandemic, Icosavax used its VLP platform to develop a vaccine candidate against SARS-CoV-2. The study produced two candidate vaccines. The main candidate IVX-411 contains the ACE2 receptor binding domain (RBD) from the original viral spike protein. In the results of preclinical studies, Publish Last October, in the “Cell” magazine, this vaccine can trigger neutralizing antibodies to provide protection for the new coronavirus. Icosavax started a phase 1/2 study in Australia in June. It is expected that there will be proof of concept data in the first half of next year.
In April, Icosavax completes US$100 million in Series B financing. CEO Adam Simpson told MedCity News at the time that the VLP vaccine provides a broad response and may be applicable to variants of the new coronavirus. The company’s second coronavirus candidate IVX-421 combines the RBD protein with Icosavax as a “critical mutation” from the SARS-CoV-2 beta strain. The research on this candidate is preclinical; the company plans to test whether IVX-421 can induce a stronger immune response against the original virus and beta strain compared to IVX-411. The company said that based on the test results of the two vaccines, it may include IVX-421 in its clinical trial plan.
According to the IPO document, Icosavax has budgeted $120 million for the development of IVX-A12 through Phase 2b testing. Approximately US$35 million will be used to develop other vaccines, including IVX-411, and the company plans to advance the development of this vaccine by completing phase 1/2 and phase 2 clinical trials. Icosavax estimates that its cash holdings plus IPO proceeds will last until at least 2024.
Picture from Icosavax
