Developing a COVID-19 Vaccine Alternative

Just prior to IDWeek, Invivyd announced that the FDA has cleared the company’s Investigational New Drug (IND) application for VYD2311, which is a monoclonal antibody investigational candidate designed as a vaccine alternative for the prevention of COVID-19. The FDA also provided feedback supporting advancement of Invivyd’s REVOLUTION clinical program.¹

With monoclonal antibodies they perform differently than traditional vaccines in terms of their ability to offer protection. Invivyd’s Chief Scientific Officer Robert Allen, PhD, offers insights on this novel approach. 

“We've cut out one of the steps in immunization. Typically, with vaccination, you're going to use a protein or mRNA immunogen, to create an antigen to which you would develop an immune response. Part of that immune response, and a very important part of that immune response would be your humoral immune response, which is its antibody response to a foreign pathogen. And in the case of Invivid, we're providing monoclonal antibodies that have been preengineered with activity and very strong neutralizing activity against a pathogen of interest—in this case, SARS-CoV-2. Moreover, we're able to with our program to consider pathogens that represent a wide breadth of variants that have existed in the past, exist in the present, and then also could exist in the future.”

They do this by seeing what is happening in the clinic as well as the wastewater. “And if we see something that raises our concern or our interest, we can position that into a synthetic antigen or a synthetic pseudo virus to see how well our antibody neutralizes even something that hasn't existed at high levels in the population yet. With that in mind, it basically provides patients with, we think, a future tested, durable response alternative to vaccination.”

Addressing the Immunocompromised Population

The immunocompromised population that is a patient population that has seen limited benefits to COVID-19 vaccination.

If you look at the immunocompromised population, many of these individuals are in the midst of dealing with an overarching concern, be that a transplant or some sort of oncogenic process…the last thing they need is to have a respiratory virus interrupt their treatment, or interrupt their recovery, or even the steady state they've achieved with their current meds,” Allen said.

Allen says VYD2311 has shown continued protection against circulating COVID-19 variants, so clinicians may be able to consider other viruses for patients. “I think that the immunocompromised population, if you could take something like SARS-CoV-2 off the differential when an individual presents with, say, a respiratory symptom, you know that they've already received this [VYD2311]. The variants that are out there are still being neutralized effectively by this antibody, then you can move on to something else and effectively treat.”

About VYD2311

VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the US. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.

Reference

1.Invivyd Announces U.S. IND Clearance and Alignment with U.S. FDA on Pivotal Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID. Invivyd press release. October 6, 2025. Accessed October 17, 2025.
https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-us-ind-clearance-and-alignment-us-fda-pivotal