Immunome has dosed the first subject in a Phase Ib clinical trial of a three-antibody cocktail, IMM-BCP-01, to treat Covid-19.
IMM-BCP-01 acts on the non-overlapping regions of SARS-CoV-2 virus’ Spike protein, including well conserved, subdominant epitopes.
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It is intended to target three distinct, non-overlapping epitopes of SARS-CoV-2, to neutralise the virus and launch several viral clearance mechanisms at the same time, including complement fixation and phagocytosis.
In vitro, the cocktail demonstrated to neutralise all SARS-CoV-2 variants tested so far.
The single-dose, dose-escalation trial will enrol newly diagnosed Covid-19 patients.
Analysing safety is the primary endpoint of the trial while pharmacokinetics (PK) and virology will be the secondary assessments.
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By GlobalDataThe company anticipates topline findings from the trial in the second half of this year.
Immunome president and CEO Purnanand Sarma said: “We are pleased that we have begun studying IMM-BCP-01 in patients with Covid-19.
“Based on the encouraging preclinical research, including data showing that our antibody cocktail demonstrated effectiveness against the Omicron variants BA.1 and BA.2 in live virus testing and Omicron BA.1 in-vivo in hamsters, we believe that IMM-BCP-01 can play an important role in addressing Covid-19.”
In March this year, the US Food and Drug Administration (FDA) lifted the clinical hold placed on an Investigational New Drug (IND) application for the company’s IMM-BCP-01 to treat Covid-19.
The regulatory agency issued a clinical hold letter in January this year and sought further data linked to the making and administration of the antibody cocktail at trial sites.
