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.
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.
The 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.
