Icosavax’s $ 182 million initial public offering is key for RSV, but the Covid vaccine is also on the horizon
The field of companies looking for a respiratory syncytial virus (RSV) vaccine includes several pharmaceutical giants with ample resources and money to invest in research. Four-year Icosavax scientists believe their company’s technology could stand out from the rest, and the biotech now has $ 182 million for the clinical trials that could help build this case.
Icosavax’s IPO was the largest life sciences IPO last week. In addition to supporting clinical research for its leading RSV program, the company is moving toward clinical testing of a vaccine that may target variants of the novel coronavirus.
Seattle-based Icosavax’s vaccines are made with proteins the company designs and develops to resemble viruses. These virus-like particles (VLPs) are supposed to trigger an immune response, but because they do not contain the genetic material of a virus, they cannot replicate and cause infection. And RSV infection can get serious, especially in young children and the elderly. According to the Centers for Disease Control and Prevention, RSV results in approximately 58,000 hospitalizations of children aged 5 years and younger annually. In adults 65 and over, RSV infection results in approximately 177,000 hospitalizations and 14,000 deaths.
Icosavax’s RSV program, IVX-121, has passed Phase 1 testing in RSV. Companies more advanced in RSV vaccine clinical development include GlaxoSmithKline, Pfizer, Moderna, Janssen, and Meissa Vaccines. However, Icosavax says that one of the characteristics of VLP technology is the ability to make a vaccine that can fight multiple pathogens. The company is combining its RSV vaccine candidate with a VLP for human metapneumovirus (hMPV), another dangerous respiratory virus for which a vaccine is also not available. This bivalent vaccine candidate, which the company is calling IVX-A12, is being prepared for clinical trials.
“We believe that the induction of nAbs (neutralizing antibodies) is key to the effectiveness of RSV and hMPV vaccines in older adults and that the multivalent VLP display of the pre-fused RSV and hMPV antigens on our VLP candidates will induce a stronger nAb response than other vaccine technologies. “Said the company in the IPO filing.
IVX-A12 is said to protect the elderly, who are more vulnerable, as RSV and hMPV are both common causes of pneumonia in older adults, the company explained in the filing. A clinical trial evaluating this vaccine is scheduled to begin in Belgium in the second half of this year; preliminary data are expected in the first half of next year.
Depending on the clinical trial results of the bivalent vaccine candidate, Icosavax expects to file an application for a new drug with the FDA in the first half of next year. Approximately 100 healthy adults will participate in this phase 1 clinical trial and will be followed up for seven months. The vaccine tests multiple doses with and without an adjuvant, an ingredient that boosts the immune response. This design will allow the company to assess immune responses to each component of the vaccine, the application said.
During the pandemic, Icosavax used its VLP platform to develop vaccine candidates for SARS-CoV-2. This research has spawned two vaccine candidates. The lead candidate IVX-411 contains the ACE2 receptor binding domain (RBD) from the spike protein of the original virus. According to preclinical research published in the journal Cell last October, this vaccine was able to produce neutralizing antibodies that offered protection against the novel coronavirus. Icosavax started a phase 1/2 study in Australia in June. Proof-of-concept data is expected in the first half of next year.
In April, Icosavax closed a Series B financing round of $ 100 million. CEO Adam Simpson told MedCity News at the time that VLP vaccines offer a broad response that could apply to variants of the novel coronavirus. The company’s second coronavirus candidate, IVX-421, contains an RBD protein containing what Icosavax calls “critical mutations” from the beta strain of SARS-CoV-2. Research on this candidate is preclinical; the company plans to test whether IVX-421 is able to induce a stronger immune response against the native virus and beta strains compared to IVX-411. Depending on the results of testing both vaccines, the company said it could add IVX-421 to clinical study plans.
According to the IPO filing, Icosavax has earmarked $ 120 million to develop IVX-A12 through Phase 2b testing. Approximately $ 35 million will be invested in the development of other vaccines, including IVX-411, which the company plans to advance through the completion of Phase 1/2 and Phase 2 clinical trials. Icosavax estimates that its cash on hand, along with the proceeds from its IPO, will last until at least 2024.
Image by Icosavax