Q3 2023 Summary
Published Jan 15, 2025, 2:40 AM UTC- Invivyd has completed enrollment in their Phase 3 CANOPY trial with approximately 750 participants, including about 300 immunocompromised individuals, and expects initial primary endpoint data by the end of 2023 or early Q1 2024, which could support a potential EUA submission for VYD222.
- The company has general alignment with the FDA on using titer values as a surrogate endpoint for the EUA submission, increasing confidence in achieving authorization for VYD222, especially given the unmet medical need for immunocompromised patients.
- There is a significant market opportunity with over 9 million immunocompromised individuals in the U.S., including an initial targeted population of approximately 485,000 high-risk patients such as stem cell transplant recipients, solid organ transplant recipients, and blood cancer patients, which suggests strong potential uptake of VYD222 upon authorization.
- Regulatory risk due to reliance on surrogate endpoints and immunobridging: The company is depending on immunobridging and surrogate endpoints, comparing serum neutralizing titers to historical data from a previous trial, which may present regulatory risks if the FDA does not accept this approach for EUA approval.
- Limited market potential by focusing solely on pre-exposure prophylaxis (PrEP): Invivyd is pursuing the PrEP indication only for VYD222 and will not generate any post-exposure prophylaxis (PEP) data, potentially restricting the market size and revenue opportunities.
- Cash runway limited to Q4 2024, raising concerns about financial sustainability: The company has approximately $265 million in cash and expects it to fund operations into the fourth quarter of 2024, excluding any potential VYD222 revenue. Delays in EUA approval or commercialization could necessitate additional financing.
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EUA Submission Timing and FDA Confidence
Q: What are the gating factors for submission, and confidence in FDA approval based on titers?
A: We have fully enrolled the study and expect preliminary primary endpoint data by the end of this year or early Q1 next year. The gating factors are collecting that information and, assuming positive results, combining it with the rest of the data package, including clinical, nonclinical, and CMC data. We are confident in using titer values as an endpoint, having reached general alignment with the FDA on this surrogate endpoint for EUA submission. -
CANOPY Phase 3 Trial Completion
Q: What Day 28 serum neutralizing titers are needed for EUA submission confidence?
A: The primary endpoint at Day 28 is the immunobridging endpoint of serum neutralizing titers compared to historical data from the adintrevimab trial. The EUA submission package includes clinical, nonclinical, and CMC data, with pivotal data from CANOPY being a key component. -
Acceptance of Surrogate Endpoints Beyond FDA
Q: Do payers and KOLs accept surrogate endpoints like the FDA does?
A: While using surrogate endpoints for monoclonal antibodies is new, it is not new in infectious diseases with vaccines. We believe there will be acceptability of this data beyond the FDA with practitioners and payers. -
Commercial Launch Strategy and Target Population
Q: Can you discuss manufacturing scale and focus on immunocompromised patients?
A: We are ensuring we have the appropriate market access plan, including coding, though it's premature to provide specifics. Our initial launch focus is on approximately 485,000 high-risk immunocompromised individuals, such as stem cell transplant recipients, solid organ transplants, and blood cancer patients. This targeted approach allows for efficient market entry. -
Pre-Commercial Manufacturing Ramp and Inventory
Q: How extensively do you plan to build inventory?
A: We've begun preparing commercial material at risk, balancing cost-effectiveness with cash management. We are using a gated approach to ramp up inventory as we see data or approach EUA submission and launch. We are optimizing dose availability with our partner WuXi. -
Sales Force Size for Targeted Population
Q: What is the expected size of the sales force for your targeted approach?
A: It's a relatively concentrated market, so we believe a relatively small commercial footprint is needed to reach the immunocompromised and most at-risk group. We plan to utilize a key account model to efficiently target these individuals. -
Updating Neutralization Assays and Indication Focus
Q: How often do you update neutralization assays, and will you seek pre and post exposure authorization?
A: We update neutralization against circulating variants in real time as soon as we get the data, without a set schedule. We are pursuing the pre-exposure prophylaxis (PrEP) indication only and will not generate post-exposure prophylaxis (PEP) data. -
Phase 1 Data and Redosing Implications
Q: Any updates on Phase 1 data and thoughts on redosing?
A: There are no recent updates from the Phase 1 data. We will consider the totality of data from that study and CANOPY to make conclusions and recommendations about redosing.