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Icosavax, Inc. (Nasdaq: ICVX) is a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, initially focused on life-threatening respiratory diseases. , with the vision of creating a pan-respiratory disease. The geriatric vaccine developer today announced positive results from a Phase 1 clinical trial of IVX-A12 against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in the elderly. announced the interim topline results. IVX-A12 consists of Icosavax’s RSV pre-fusion F protein VLP vaccine candidate, IVX-121, and Icosavax’s hMPV pre-fusion F protein VLP vaccine candidate, IVX-241.
“IVX-A12 is a potential first-in-class combination vaccine candidate designed to address unmet medical needs in the elderly population, and these interim data on hMPV in the elderly population are also relevant in this area. We believe it will break new ground.” As previously seen with the pre-fusion F-antigen approach against RSV, we will leverage our VLP technology to develop a combination vaccine that presents pre-fusion F-antigens against both hMPV and RSV. However, we expect that it may lead to significant protection against the two main causes of pneumonia. As we pursue our goal of developing a broader viral respiratory vaccine, we plan to accelerate progress toward a Phase 2 trial of IVX-A12 in the elderly in mid-2023,” said Aicosa. Bucks Chief Executive Adam Simpson said.
IVX-A12 Phase 1 Study Design
The ongoing Phase 1 clinical trial of IVX-A12 is a randomized, observational study designed to evaluate the safety and immunogenicity of various dose levels and ratios of RSV and hMPV VLPs in IVX-A12. This is a patient-blind, placebo-controlled, multicenter study. Does not use CSL Seqirus’ proprietary adjuvant MF59®.
The trial enrolled 140 healthy older adults aged 60 to 75, of whom 123 were evaluable for immunogenicity. Subjects received a single dose of her IVX-A12 or a placebo at one of her three combination dose levels below.
- Total VLP content 150 µg (IVX-121 (RSV) 75 µg and IVX-241 (hMPV) 75 µg) with or without MF59®
- Total VLP content 225 µg (IVX-121 75 µg and IVX-241 150 µg) with or without MF59®
- Total VLP content 300 µg (IVX-121 75 µg and IVX-241 225 µg) without MF59®
Phase 1 study of IVX-A12 aims to follow subjects for 12 months after vaccination to assess safety and immunogenicity against both RSV and hMPV and to assess potential immunological interference is to
Topline interim results
In this Phase 1 study, IVX-A12 was generally well tolerated across all dose groups at Day 28.
- Evoked local and systemic adverse events (AEs) were generally mild or moderate in severity and were not dose-limiting reactogenicity.
- Across the five treatment groups of IVX-A12 with or without adjuvant, the percentage of subjects experiencing a systemic AE within 7 days ranged from 25% to 41%, similar to 35% of placebo.
- The most common local and systemic AEs were injection site tenderness, headache and myalgia.
- There were no vaccine-related serious adverse events (SAEs), clinical events of particular interest, or AEs leading to discontinuation.
In this Phase 1 study, IVX-A12 induced potent immune responses against both RSV and hMPV on day 28 in the elderly across dose levels, with or without adjuvant.
- There was no evidence of immune interference when RSV and hMPV VLPs were administered in combination.
- Across dose groups, IVX-A12 induced a geometric mean titer (GMT) of RSV-A neutralizing antibody titers (nAbs) on day 28 up to approximately 16,100 IU/mL, compared with Placebo was about 2,600 IU/mL. IVX-A12 induced GMT. Up to approximately 8,300 IU/mL for the RSV-B nAb compared to approximately 2,500 IU/mL for placebo on day 28.
- This IVX-A12 study observed higher RSV A and RSV B nAb levels (IU/ml) at 28 days post-vaccination than observed in previous Phase 1 clinical studies of IVX-121 (RSV) alone it was done.
- Across dose groups, IVX-A12 induced a GMT of up to approximately 3,300 assay units/mL for hMPV-A nAbs on day 28, compared to approximately 900 assay units/mL for placebo. IVX-A12 induced a GMT of up to 3,300 assay units/mL in the hMPV-B nAb. Approximately 23,900 assay units/mL compared to approximately 11,500 assay units/mL for placebo on day 28. There is no standardized international unit in the field of hMPV.
- Higher baseline nAbs against RSV-A and RSV-B were observed, presumably reflecting off-cycle RSV seasons following the COVID-19 pandemic.
- The geometric mean fold increase (GMFR) at day 28 was ~4-fold for RSV-A and ~3-fold for RSV-B across all treatment arms. In a prespecified sub-analysis of data from subjects with the lowest tertile baseline nAbs titers, the corresponding GMFRs of RSV-A and RSV-B were up to 11-fold and 7-fold, respectively.
- GMFR at day 28 was up to 5-fold higher for hMPV-A and up to 4-fold higher for hMPV-B. In a prespecified sub-analysis of data from subjects with the lowest tertile baseline nAB titers, the corresponding GMFRs of hMPV-A and hMPV-B were up to 9-fold and 8-fold, respectively.
“Topline interim data from our Phase 1 trial show that IVX-A12 is generally well tolerated, eliciting strong responses to both RSV and hMPV in the elderly, with no evidence of immune interference. This is an important result as IVX-A12 is the only vaccine candidate in clinical development targeting both RSV and hMPV in the elderly, a vulnerable population at high risk of severe disease. ,” said Chief Medical Officer Dr. Niranjan Kanesa Tasan. Aiko Sabax.
Based on these results, Icosavax now plans to initiate a Phase 2 trial of IVX-A12 in RSV and hMPV in mid-2023. The company plans to evaluate his two formulations of his IVX-A12 in this upcoming clinical trial.
Pending the results of the planned Phase 2 trial, Icosavax plans to conduct an IVX-A12 hMPV human challenge clinical trial, in which Icosavax will test a bivalent vaccine candidate incorporating a stabilized pre-fusion F protein for the disease. We believe it is the most appropriate proof-of-concept model for evaluating prevention. RSV and hMPV, respectively. This hMPV human challenge model is currently under development and builds on established precedents in the RSV field.
The IVX-121 (RSV) component of IVX-A12 (RSV/hMPV) has previously demonstrated positive immunogenicity and tolerability in Phase 1/1b trials, and these Phase 1b A subset of older adult subjects continues to be followed. In December 2022, Icosavax reported positive durability data at 6 months, with 12-month immunogenicity data expected in mid-2023.
Registered Direct Offer
As announced separately, Icosavax has priced a registered direct offering of $67.8 million to select healthcare investors. The company now expects its cash balance to be sufficient to fund operations through the second half of 2025.
conference calls and webcasts
Icosavax will host a conference call and live webcast on May 22, 2023 at 6:00 PM ET/3:00 PM PT to discuss IVX-A12 Phase 1 topline interim results It’s a schedule. Those interested in listening to the live conference call can do so using the webcast link found in the “Investors” section of the company’s website. www.icosavax.com. A replay of the webcast will be available on the investor relations section of the company’s website for 30 days after the call ends.
Icosavax is a biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases, with a vision of combination and pan-respiratory vaccines. increase. Icosavax’s VLP platform technology is designed to enable multivalent particle-based display of complex viral antigens, resulting in broad, potent and durable protection against specific target viruses. believed to be induced. ICOSAVAX’s flagship program is a combination vaccine candidate targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), and its pipeline includes influenza and severe acute respiratory syndrome coronavirus type 2. (SARS-CoV-2) includes additional programs. Icosavax was founded in 2017 to advance his groundbreaking VLP technology at the University of Washington Institute of Protein Design for the discovery, development and commercialization of vaccines against infectious diseases. Icosavax is located in Seattle.
For more information, please visit: www.icosavax.com.
Statements contained in this press release that are not historical facts are forward-looking statements. Forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the following: Our expectations regarding the opportunity, prophylactic and commercial potential of our vaccine candidates and technology platforms. The company’s planned development activities, including clinical trials and data readouts, and their timing. Actual results may differ from those set forth in this press release due to risks and uncertainties inherent in the Company’s business, including but not limited to: Early stage of the company’s development efforts. The risk that the results of a clinical trial at a particular time point may not be predictive of the final outcome, and that results may change significantly as follow-up of subjects continues and a more comprehensive review of the data is performed. The Company’s approach to vaccine candidate development, including the development of a bivalent RSV/hMPV VLP combination vaccine candidate, a novel and unproven approach. Potential delays in the development process, including but not limited to initiation, enrollment, conduct of clinical trials, and receipt of data from clinical trials. Difficulties in developing hMPV challenge models and the risk that planned challenge studies may produce negative or inconclusive results based on such or other models. Unexpected adverse side effects or insufficient immunogenicity or efficacy of our vaccine candidates, which may limit development, regulatory approval and/or commercialization; The Company’s reliance on third parties for manufacturing, research and clinical trials. Recent and anticipated regulatory approvals of third-party RSV vaccines have made conducting clinical trials more difficult and costly, allowing the company to successfully develop, obtain regulatory approval and commercialize its vaccine candidates. risks that may adversely affect the ability of Potential challenges encountered in manufacturing and scale-up processes, including but not limited to challenges that reduce drug product stability and potency. Competing approaches limit the commercial value of the company’s vaccine candidates. Regulatory developments in the United States and other countries. The risk that a firm will deplete its capital resources sooner than expected. and the securities of the Company, including the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and subsequent filings with the Securities and Exchange Commission (SEC). Other risks described in previous filings with the Trade Commission (SEC). SEC. These forward-looking statements speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events occurring or existing after the date hereof. All forward-looking statements are fully qualified by this cautionary statement, which is made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Media Contact: Dr. Jessica Yinling,Little Dog Communications Co., Ltd.[email protected]858.344.8091
Investor Contact: Laurence WattsGilmartin Group, LLC[email protected]619.916.7620
Source: Icosavax, Inc.