Pipeline Updates:
- Exercised option for patent license for influenza vaccine from the
University of Washington (UW) andU.S. Department of Human and Health Services (HHS).Icosavax has exercised its option for a non-exclusive patent license granted byUW and HHS for use of its computationally designed, two component VLP platform in the influenza field, as the company executes on its strategy to develop combination VLP vaccines targeting the viral causes of pneumonia in older adults. A precursor vaccine candidate on the two-component VLP platform is currently being investigated in a Phase 1 study being run by theNIH , having previously been tested preclinically, including in non-human primates.Icosavax looks forward to providing future updates on its influenza program and development strategy. - Evaluating IVX-411, a SARS-CoV-2 VLP vaccine candidate, against the Omicron variant. As part of its ongoing 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 SARS-CoV-2 Omicron variant. In addition,
Icosavax has initiated preclinical development of a potential Omicron VLP vaccine candidate, for evaluation as a possible back-up COVID-19 vaccine candidate. - Completed dosing of younger adults in the Phase 1 portion of the Phase 1/1b clinical trial for IVX-121.
Icosavax has completed dosing in the Phase 1 (younger adults) portion of its ongoing Phase 1/1b clinical trial of IVX-121, a VLP vaccine candidate displaying the prefusion stabilized respiratory syncytial virus (RSV) F antigen, and the Phase 1b (older adults) portion of this trial has been initiated. Additionally, the company has completed its pre-IND meeting for the IVX-A12 combination bivalent RSV and human Metapneumovirus (hMPV) VLP vaccine candidate and is on track to begin its Phase 1 trial for IVX-A12 in 2H 2022.
Corporate Updates:
- Appointed
Robin Robinson , Ph.D., toScientific Advisory Board (SAB).Icosavax has expanded itsSAB with the appointment ofDr. Robinson , who previously served for eight years as the first Director for theBiomedical Advanced Research and Development Authority (BARDA) and, prior to public 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 pandemic response. - Recently appointed
John Shiver , Ph.D., to Board of Directors. As announced onJanuary 5, 2022 ,Icosavax has appointedJohn Shiver , Ph.D., to its Board.Dr. Shiver has more than 30 years of experience in vaccine and pharmaceutical research and development, including at two of the most prominent vaccine companies in the world,Sanofi Pasteur and Merck & Co., Inc. He has guided scientific teams to create novel vaccine and monoclonal antibody candidates to prevent or treat more than 40 infectious and non-infectious diseases, including RSV, influenza, pneumococcus, CMV, HIV, HPV, cancer, and asthma, and contributed to the licensure of 14 products. - Expanded
Seattle headquarters. The company recently signed a lease on a new facility of approximately 25,000 square feet, which provides substantially greater research and development capabilities to support the expansion of Icosavax’s computationally designed VLP technology including antigen design capabilities and potential additional indications.
“As we enter 2022,
Near-Term Milestone Expectations
- IVX-411 (COVID-19) Phase 1/2 interim, top-line data in 1Q 2022
- IVX-121 (RSV) Phase 1/1b interim, top-line 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 a licensed influenza vaccine, in previously vaccinated SARS-CoV-2 subjects, in 2H 2022
Preliminary Cash Position
Icosavax has an unaudited preliminary cash position, including restricted cash, of$281 million as ofDecember 31, 2021 . The company currently expects its cash balance to be sufficient to fund operations through at least 2024.
About
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the company’s current beliefs and expectations and include, but are not limited to: the company’s goal to progress its preclinical and clinical programs including an influenza candidate for use as part of a pan respiratory vaccine, the timing of company milestone achievement, the company’s cash balance and the potential of the company’s VLP technology. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the company’s business, including, without limitation: the early stage of the company’s development efforts; the company’s novel and unproven technology and the uncertainties associated with the development of an influenza candidate for use as part of a pan respiratory vaccine; potential delays in the commencement, enrollment, and completion of clinical trials and preclinical studies; the company’s dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval, and/or commercialization; results from preclinical studies or early clinical trials not necessarily being predictive of future results; competing approaches limiting the commercial value of the company’s vaccine candidates; regulatory developments in
Media Contact:
jessica@litldog.com
+1.858.344.8091
Investor Contact:
laurence@gilmartinir.com
+1.619.916.7620
Source:
2022 GlobeNewswire, Inc., source