To 'keep pace with viral evolution,' Invivyd is also evolving (again)

06 Mar 2023
www.fiercebiotech.com
Emergency Use Authorization
To 'keep pace with viral evolution,' Invivyd is also evolving (again)
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Source: FierceBiotech
New CEO David Hering hopes Invivyd can move on with VYD222 and “keep pace with viral evolution.”
Invivyd, which was launched in the early days of the pandemic under the name Adagio to find treatments for COVID-19, is hoping the third monoclonal antibody is the charm.
The company announced the selection of a candidate called VYD222 to move forward into the clinic, at the expense of previous focus NVD200, according to a Monday press release. The new star in Invivyd’s pipeline is one of the components of the older treatment and was also engineered from the biotech’s original mAb adintrevimab.
Invivyd hopes to use “global COVID-19 regulatory frameworks” to swiftly move VYD222 through development as a therapeutic treatment for the disease caused by the SARS-CoV-2 virus. The company said that as of the start of the year, there were no mAb treatments authorized or approved in the U.S. to prevent or treat COVID-19.
That’s true, because the FDA has pulled back authorizations for these treatments, which came from the likes of Merck & Co., Gilead Sciences, Eli Lilly and more, as the virus mutated and became resistant to them. Invivyd is hoping to target immunocompromised individuals and other vulnerable populations with its treatments.
“The lack of commercially available mAbs in the U.S. is an unacceptable situation for the estimated 8 million people with impaired immune systems who don’t respond to vaccination and means a return to the isolation many of us experienced early in the pandemic,” Invivyd Chief Medical Officer Pete Schmidt, M.D., said in a statement.
Invivyd refocused on NVD200 in September last year, positioning the mAb for clinical trial entry in the first quarter of this year. It’s no longer listed on the biotech’s pipeline, and VYD222 will take its place.
Clinical research for adintrevimab, meanwhile, has concluded and Invivyd still plans to file for an emergency use authorization "dependent on variant susceptibility," according to a statement sent to Fierce Biotech. Adintrevimab made it through phase 2/3 testing but only showed efficacy against older variants of the SARS-CoV-2 virus. The company hoped to position the therapy for an authorization anyway. Since then, Invivyd has seen executive turnover—including the loss of CEO Tillman Gerngross, Ph.D.—a rebrand and other upheaval.
New CEO David Hering hopes the company can now move on with VYD222 and “keep pace with viral evolution.”
Editor's Note: This story was updated at 2:05 p.m. ET on March 6, 2023, to include a statement on adintrevimab's status.
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