SEATTLE, Jan. 07, 2022 (GLOBE NEWSWIRE) – Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company leveraging its innovative Viral-Like Particle (VLP) platform technology to develop vaccines against infectious diseases , provided a company update today and shared planned milestones for 2022.

Pipeline Updates:

  • Option exercised for a patent license for the influenza vaccine from the University of Washington (UW) and the United States Department of Human and Health Services (HHS). Icosavax has exercised its option for a non-exclusive patent license granted by UW and HHS for the use of its two-component computer-designed VLP platform in the field of influenza, as the company executes its development strategy of VLP combination vaccines targeting viral causes of pneumonia in the elderly. A precursor vaccine candidate on the two-component VLP platform is currently under investigation in a Phase 1 study conducted by the NIH, which has already been tested preclinically, including in non-human primates. Icosavax looks forward to providing future updates on its influenza program and development strategy.
  • Evaluation of IVX-411, a candidate vaccine against SARS-CoV-2 VLP, against the Omicron variant. As part of its continued response to emerging variants, the company plans to evaluate preclinical and clinical sera to determine whether antibodies from animals and subjects immunized with IVX-411 neutralize the Omicron SARS-CoV-2 variant. In addition, Icosavax has initiated preclinical development of a potential vaccine candidate Omicron VLP, for evaluation as a rescue vaccine candidate against COVID-19.
  • Dose completed for young adults in the Phase 1 portion of the Phase 1 / 1b clinical trial for IVX-121. Icosavax has completed dosing in the Phase 1 (young adults) portion of its ongoing Phase 1 / 1b clinical trial of IVX-121, a VLP vaccine candidate with respiratory syncytial virus (RSV) F antigen stabilized by pre-fusion, and the phase 1b (old adults) part of this trial has been initiated. Additionally, the company has completed its pre-IND meeting for the bivalent RSV IVX-A12 combination and human metapneumovirus (hMPV) VLP vaccine candidate and is on track to begin its Phase 1 trial for IVX-A12 in 2H. 2022.

Company Updates:

  • Appointed Robin Robinson, Ph.D., to the Scientific Advisory Board (SAB). Icosavax expanded its SAB with the appointment of Dr Robinson, who previously served for eight years as the first director of the Biomedical Advanced Research and Development Authority (BARDA) and, before entering the civil service, was head of vaccines at Novavax , Inc. As the company advances its VLP vaccine candidates, Dr. Robinson brings significant experience interacting with government agencies during the response to a pandemic.
  • Recently appointed John Shiver, Ph.D., to the Board of Directors. As announced on January 5, 2022, Icosavax has appointed John Shiver, Ph.D., to its Board of Directors. Dr Shiver has over 30 years of experience in vaccine and pharmaceutical research and development, including at two of the world’s largest vaccine companies, Sanofi Pasteur and Merck & Co., Inc. He has guided research and development scientific teams to create a new vaccine. and monoclonal antibody candidates to prevent or treat over 40 infectious and non-infectious diseases, including RSV, influenza, pneumococcus, CMV, HIV, HPV, cancer and asthma, and has contributed to the ‘approval of 14 products.
  • Seattle head office expansion. The company recently signed a lease for an approximately 25,000 square foot new facility, which offers significantly greater research and development capabilities to support the expansion of Icosavax’s compute-engineered VLP technology, including antigen design and any additional indications.

“As we move into 2022, Icosavax has several anticipated short-term clinical milestones, including leading data reads from our IVX-411 program in SARS-CoV-2 as well as our IVX-121 program in RSV. . We are also delighted to have exercised our influenza option, which is a further step in our strategy to develop combination and pan-respiratory vaccines using our VLP technology, ”said Adam Simpson, CEO of Icosavax. “I am delighted with the achievements and execution of the company in 2021 and look forward to providing further updates over the coming year. “

Short-term milestone expectations

  • IVX-411 (COVID-19) Phase 1/2 intermediate, leading data in Q1 2022
  • IVX-121 (RSV) Phase 1 / 1b intermediate, leading data in 2Q 2022
  • IND submission for IVX-A12 (RSV + hMPV) and initiation of a phase 1 trial for IVX-A12 in 2H 2022
  • Subject to positive data from the IVX-411 (COVID-19) Phase 1/2 trial, initiation of an additional Phase 2 trial for IVX-411, co-administered with an authorized influenza vaccine, in previously vaccinated subjects against SARS-CoV-2, as of 2H 2022

Preliminary treasury

  • Icosavax has an unaudited preliminary cash position, including restricted cash, of $ 281 million as at December 31, 2021. The company currently expects its cash balance to be sufficient to fund operations through At least 2024.

About Icosavax

Icosavax is a biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, initially focusing on life-threatening respiratory diseases and a vision for combination and pan-respiratory vaccines. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust and long-lasting protection against specific targeted viruses. Icosavax’s pipeline includes candidate vaccines targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and an emerging influenza program. Icosavax was formed in 2017 to advance the revolutionary VLP technology of the Institute for Protein Design at the University of Washington with the goal of discovering, developing and commercializing vaccines against infectious diseases. Icosavax is located in Seattle.

Forward-looking statements

Statements in this press release regarding matters that are not historical facts are forward-looking statements. Forward-looking statements are based on the current beliefs and expectations of the company and include, without limitation: the company’s objective to advance its preclinical and clinical programs, including an influenza candidate for use in connection with ” a pan-respiratory vaccine, the timeline for achieving company milestones, the company’s cash balance, and the potential of the company’s VLP technology. Actual results may differ from those presented in this press release due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the initial stage of the Company’s development efforts; the company’s new and unproven technology and uncertainties associated with the development of an influenza candidate for use in a pan-respiratory vaccine; potential delays in the initiation, recruitment and completion of clinical trials and preclinical studies; the company’s reliance on third parties for manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates which may limit their development, regulatory approval and / or commercialization; the results of preclinical studies or early clinical trials are not necessarily predictive of future results; competing approaches limiting the commercial value of the Company’s vaccine candidates; regulatory developments in the United States and other countries; the Company’s ability to obtain and maintain intellectual property protection for its product candidates and to maintain its rights under intellectual property licenses; the company’s ability to finance its operating plans with current cash, cash equivalents and investments; the company’s ability to maintain uninterrupted business operations during the COVID-19 pandemic, including with respect to clinical trials, manufacturing and the supply chain; and other risks described in the company’s previous files with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the company’s quarterly report on Form 10-Q for the quarter closed on September 30, 2021 and any subsequent filing with the second. In addition, the company’s preliminary cash balance disclosed in this press release reflects only information available to the company at that time, has not been reviewed or audited by the independent registered public accounting firm of the company and may differ from the audited final cash balance. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company makes no commitment to update any such statements to reflect events that occur or the circumstances. that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Media contact:
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
[email protected]

Investor contact:
Laurence Watts
Gilmartin Group, LLC
[email protected]

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