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March 14, 2022

Immunome’s Covid-19 antibody cocktail had its IND clinical hold lifted by FDA

Immunome submitted a detailed report comprising the required information to the FDA.

Immunome’s antibody cocktail IMM-BCP-01 to treat Covid-19 had its clinical hold for an Investigational New Drug (IND) application lifted by the US Food and Drug Administration (FDA).

Immunome filed an IND application with the regulatory agency to commence a placebo-controlled dose-escalation clinical trial of IMM-BCP-01 in Covid-19 patients.

In January this year, the FDA issued a clinical hold letter in response to the IND application submitted by the company. 

The regulatory agency had sought additional data linked to the making and administration of the antibody cocktail at trial centres. 

The FDA also offered guidance on the trial protocol for the treatment, including selection criteria for participants.

Immunome later submitted a detailed report comprising the required information to the FDA in this regard.

A combination of three antibodies, IMM-BCP-01 acts on the non-overlapping regions of the SARS-CoV-2 virus’ spike protein. 

Immunome president and CEO Purnanand Sarma said: “We believe in the potential of IMM-BCP-01 and its ability to aid in the ongoing fight against SARS-CoV-2, especially as the new variants continue. 

“We are pleased to report the clinical hold has now been lifted. We look forward to advancing the programme into the clinic.”

In in vitro testing, the antibody cocktail demonstrated to lower viral load in lungs of Covid-19 infected hamsters and widely neutralised various viral variants including Delta. 

The biopharmaceutical firm leverages the human memory B cell platform for the discovery and development of antibody therapies that can potentially revolutionise disease treatment. 

Its discovery engine detects new treatment antibodies and their targets by harnessing the immune system’s components, memory B cells, obtained from patients whose bodies are equipped to fight the disease.

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