A multimillion dollar windfall for Icosavax Inc. will help allow the company to launch a COVID-19 vaccination program using its virus-like particle candidate (VLP), IVX-411, that displays the SAR-CoV-2 receptor-binding domain.

A $10 million grant from the Bill & Melinda Gates Foundation, designed to support the program through a phase I trial in young and older adults, is backed by preclinical data showing the vaccine candidate induces neutralizing antibody titers after one administration. The company also received $6.5 million from Open Philanthropy to support the candidate’s development along with the company’s platform technology.

The COVID-19 study is set to start in the middle of 2021 with some help from Amgen Inc., which will manufacture a key intermediate for the initial clinical studies.

IVX-411 was developed at the University of Washington’s School of Medicine using a design invented at the school’s Institute for Protein Design. The self-assembling protein nanoparticle has 60 copies of the SARS-CoV-2 spike glycoprotein receptor binding domain. Preclinical data showed INVX-411 prompted neutralizing antibody titers in mice that is effective with a single administration but showed even more improvement with a second dose. The preclinical data also showed hefty B-cell responses following immunization, hinting there could be protection from escape mutations.

Synthetic biology

It was little more than a year ago that Icosavax launched with a $51 million series A for advancing another candidate, IVX-121, a computationally designed self-assembling virus-like particle, through phase Ib studies.

IVX-121, based on the same fundamental technology as IVX-411, incorporates a stabilized prefusion F antigen licensed from the NIH’s National Institute of Allergy and Infectious Diseases for treating respiratory syncytial virus (RSV) in older adults. Preclinical research on IVX-121 led Icosavax to believe the candidate could increase protective immunogenicity of RSV F when compared to only the DS-Cav1 antigen. The company said it expects to enter the clinic with IVX-121 in 2021.

The virus is a respiratory pathogen affecting mainly infants, elderly and high-risk adults.

Adam Simpson, CEO, Icosavax

“This flu hits older adults disproportionately hard,” Adam Simpson, Icosavax’s CEO, told BioWorld. He added that SARS-CoV-2 also has a similar effect on an older population.

The VLPs, with a display of antigens that resembles viruses, contain no genetic material, making them non-infectious and a less risky alternative to live-attenuated or inactivated vaccines. Simpson called the VLPs “a great example of synthetic biology, cutting-edge science” whose technology allows the company to manufacture at scale.

The series A funding round that launched the company was led by Qiming Venture Partners USA along with Adams Street Partners, Sanofi Ventures and Nanodimension.

Its management is composed of veterans, many of them from Takeda Pharmaceutical Co. Ltd. Douglas Holtzman, Icosavax’s chief scientific officer, was vice president of discovery at Takeda, where he worked on dengue and norovirus vaccine candidates. He also was involved in globalizing Takeda’s Japan-based vaccines business.

Chairing the company’s board is Tadataka Yamada, who has been executive vice president, chief medical and scientific officer at Takeda, whose board he also sat on. Yamada oversaw a nearly $4 billion budget for Takeda’s R&D efforts. He came to Takeda from the Bill & Melinda Gates Foundation Global Health Program, which had a $9 billion budget. Before that, he chaired Glaxosmithkline plc’s R&D department and was a member of the board.

Cassia Cearley, also a Takeda vet, is Icosavax’s senior vice president of operations. She also notched time at Aptinyx Inc., where she was vice president of research.

Icosavax’s scientific advisory board also has a Takeda alum, Ralf Clements, who is also a company development advisor. He was senior vice president of development for Takeda’s global vaccine unit.

Niranjan Kanesa-thasan, Icosavax’s chief medical officer, is one of the non-Takeda members of the management team but has spent more than two decades at large companies, including stints as vice president in the vaccine development efforts of Glaxosmithkline and Novartis AG.

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