Celltrion Demonstrates Safety in Phase 1 Clinical Trial of Variant-Targeting Antibody Therapy

Confirmed Neutralizing Ability Against Omicron Pseudo Virus

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Chunhee Lee] Celltrion has confirmed the safety of its antibody therapeutic candidate 'CT-P63,' developed to respond to COVID-19 variant viruses, through a Phase 1 clinical trial.

On the 3rd, Celltrion announced that it confirmed the safety of CT-P63 after conducting a global Phase 1 clinical trial. Since September last year, Celltrion has been conducting Phase 1 trials on 24 healthy subjects in Poland. As a result, no adverse events caused by drug administration occurred in the treatment group, proving safety, tolerability, and pharmacokinetics (PK).

In addition, Celltrion also conducted a pseudovirus neutralization test through the U.S. National Institutes of Health (NIH) to verify the efficacy against the Omicron variant, which has become the dominant strain worldwide. The results confirmed the neutralizing ability of CT-P63 against the Omicron variant virus. Pseudoviruses are viruses created in laboratories to mimic real viruses for experimental purposes. Celltrion plans to secure results from animal efficacy tests of CT-P63 against the Omicron variant within the first quarter of this year.

CT-P63 is an antibody therapeutic candidate developed to respond to COVID-19 variants. It has demonstrated neutralizing ability against major variants such as Alpha, Beta, Gamma, and Delta. From the early stages of COVID-19 therapeutic development, Celltrion recognized the need to address viral mutations and secured a potential cocktail candidate antibody pool consisting of 38 neutralizing antibodies. Among them, CT-P63, candidate number 32, showed excellent neutralizing ability, leading to the current Phase 1 clinical trial.

Celltrion's COVID-19 antibody treatment 'Rekkirona' (Photo by Celltrion Healthcare)

The company expects that developing a cocktail therapeutic combining CT-P63, which has excellent variant virus response, with 'Rekkirona,' actively used domestically and internationally for mild to moderate COVID-19 patients, will enable broader response to COVID-19 variant viruses.

Celltrion plans to enter a large-scale global clinical trial for the cocktail antibody inhalation formulation combining Rekkirona and CT-P63 within the first quarter, following the completion of drug administration and result analysis of the Rekkirona inhalation Phase 1 trial recently conducted in Australia in collaboration with the U.S. biotech company Inhalon Biopharma.

Within the first quarter, safety and efficacy of the cocktail inhalation formulation will be confirmed through animal experiments, and by the second quarter, intermediate results of the large-scale global clinical trial will be secured. The goal is to obtain concrete evidence proving the safety and efficacy of the cocktail inhalation formulation and proceed with consultations with regulatory authorities.

The inhalation formulation not only neutralizes the virus through antigen binding at the spike protein, the main mechanism of antibody action, but also has a 'trapping' mechanism where the inhaled antibody adheres to the respiratory mucosa to filter viruses entering through the respiratory tract. The antibody-virus binding alone can neutralize the virus, making it an optimized platform for variant viruses.

In terms of efficacy, it is known that the antibody delivery rate to the lungs via inhalation is up to several hundred times better compared to intravenous injection. Regarding patient convenience, since the drug is delivered directly to the lungs through the respiratory tract, it is expected to be a much more competitive alternative than intravenous injection, which requires about an hour of administration at a hospital.

A Celltrion official said, “Following Rekkirona, which has received formal product approval domestically and internationally, CT-P63 under development confirmed safety in Phase 1 clinical trials and demonstrated neutralizing ability against major variants including Omicron,” adding, “We will do our best to develop the cocktail inhalation antibody therapeutic combining Rekkirona and CT-P63 and accelerate the development of antibody therapeutics responding to various variant viruses.”

This content was produced with the assistance of AI translation services.