Icosavax Announces Results from IVX-411 Drug Product Investigation and Outlines Additional Corporate Milestones
29 Jul 2022
Vaccine
SEATTLE, July 28, 2022 (GLOBE NEWSWIRE) -- Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision of creating pan-respiratory vaccines for older adults, today announced the results from an end-to-end drug product investigation of IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain (RBD). This investigation was initiated following the company’s Phase 1/2 topline interim data results in which the immunologic response observed for IVX-411 was inconsistent with expectations based on known data for the company’s platform and VLP technology.
The investigation involved a review of in vitro antigen stability and characterization (drug substance intermediate, drug substance, and drug product), and in vivo potency, as well as a review of data and protocols relating to the transport, storage, and administration of the vaccine. Icosavax tested a range of relevant samples, including a lab-scale VLP reference that was associated with robust and durable neutralizing titers in Non-Human Primate studiesi, and the Icosavax clinical VLP lot (GMP drug product) stored at 2-8 °C to assess its stability.
Investigation Results:
Results of the investigation confirmed the company’s initial hypothesis that the reduced potency observed for IVX-411 was antigen-specific (i.e., related to the Receptor Binding Domain (RBD) antigen), and data to date indicate that this antigenic instability is not observed in other Icosavax vaccine candidates, including for RSV and hMPV.
Specifically:
The RBD antigen component (Component A) of IVX-411 becomes unstable during manufacturing and subsequent storage at 2-8 °C
An in vivo assessment in mice demonstrated that instability of the RBD antigen on the VLP surface translated to a loss of potency for IVX-411 consistent with that seen in the company’s Phase 1/2 results
“The results of our comprehensive IVX-411 investigation confirmed our original hypothesis that the lower-than-expected immunogenicity for IVX-411 was likely attributable to an antigen specific stability issue. These findings, combined with subsequent corroboration from the positive results of our Phase 1/1b study of IVX-121, reinforce the potential for potency of well-structured antigens displayed on Icosavax’s two component VLP platform,” said Adam Simpson, Chief Executive Officer of Icosavax. “Looking ahead, we plan to incorporate the learnings from this investigation into our current and future programs as well as our antigen design capability. In addition, consistent with the evolution of the field, we intend to focus on a bi-valent strategy for COVID-19 candidate development, providing us with optionality to include such a candidate as a potential future component of our VLP combination vaccines.”
Adam Simpson continued, “Today we have also announced additions to our near-term milestones, which I believe highlight the expected continued progress and potential value-creating opportunities for Icosavax.”
Near-Term Milestone Expectations:
IND submission and initiation of a Phase 1 trial for IVX-A12 (RSV+hMPV) expected in 2H 2022
IVX-121 (RSV) Phase 1b extension, 6-month immunogenicity data expected by early 2023
IVX-121 (RSV) Phase 1b extension, 12-month immunogenicity data expected in mid-2023
IVX-A12 (RSV+hMPV) Phase 1 topline interim data expected in mid-2023
IVX-A12 (RSV+hMPV) Phase 2a initiation expected in 2H 2023
COVID-19 bivalent candidate selection expected in 2023
Flu program candidate selection expected in 2023
About Icosavax
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 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 durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), as well as programs in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza. Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax is located in Seattle.
For more information, visit www.icosavax.com.
Indications
Targets
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.