CT-P63 / Celltrion - LARVOL DELTA

Emerging anti-spike monoclonal antibodies against SARS-CoV-2. (PubMed, Expert Opin Biol Ther) - "Strategies to potentially mitigate this are discussed. Based on prior successful experience, immunocompromised patients will certainly benefit from the utilization of mAbs for the prevention and treatment of COVID-19; thus, we need to design potential interventions to ensure the sustained activity of these agents."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Late Breaking Abstract - A randomized study to evaluate safety and pharmacokinetics of CT-P63 in healthy subjects (ERS 2022) - "CT-P63 was proved to be well-tolerated in healthy subjects and no major safety concerns were identified. No positive ADA result was reported in all subjects and CT-P63 showed the similar PK profiles like other monoclonal antibodies."

Clinical • Late-breaking abstract • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TP63

Preclinical assessment and randomized Phase I study of CT-P63, a broadly neutralizing antibody targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). (PubMed, Emerg Microbes Infect) - P1 | "Serum CT-P63 concentrations rapidly peaked before declining in a biphasic manner and systemic exposure was dose proportional. Overall, CT-P63 was clinically safe and showed broad-spectrum neutralizing activity against SARS-CoV-2 variants in vitro and in vivo."

Clinical • Journal • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TP63

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Celltrion | Not yet recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TP63

To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Celltrion | N=2200 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TP63

Celltrion Submits Investigational New Drug (IND) Application to Initiate a Global Phase III Clinical Trial Evaluating an Inhaled COVID-19 Antibody Cocktail Therapy (Businesswire) - "Celltrion Group announced today it has submitted an Investigational New Drug (IND) application to conduct a global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19; the trial is expected to enrol 2,200 patients globally. The inhaled COVID-19 antibody cocktail is a combination of monoclonal antibodies with regdanvimab (CT-P59) and CT-P63 and has been developed to target newly emerging mutations of SARS-CoV-2..."

IND • Infectious Disease • Novel Coronavirus Disease

To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P3 | N=2200 | Not yet recruiting | Sponsor: Celltrion

Combination therapy • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TP63

Celltrion announces positive results for its cocktail therapy candidates including neutralisation data against Omicron variant (Businesswire) - "We are confident that our antibody platform including Regkirona and CT-P63 will provide significant benefit for patients with COVID-19....'We plan to discuss large- scale clinical trial for our nebulised cocktail therapy (CT-P63 in combination with Regkirona™) with regulatory agencies worldwide in the near future.'"

Regulatory • Infectious Disease • Novel Coronavirus Disease

Celltrion accelerates development of nebulised cocktail therapy (CT-P63 in combination with CT-P59) using its antibody platform to tackle new COVID-19 variants (Businesswire) - "Celltrion Group announced today that the company has accelerated development of a nebulised formulation of its neutralising antibody cocktail treatment, to respond to emerging mutants from SARS-CoV-2....Celltrion enrolled 24 healthy volunteers in its global phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63 and the company anticipates results by the end of the year....After verifying safety results in phase I clinical trial, Celltrion plans to confirm the extensive neutralising capacity of the cocktail therapy with Regkirona and CT-P63 on new variants as a follow up trial, with a nebulised formulation of Regkirona."

New trial • P1 data • Infectious Disease • Novel Coronavirus Disease

Celltrion enters clinical trial of Covid-19 cocktail therapy in Europe (Korea Biomedical Review) - "Celltrion said that it has started the clinical trial of a cocktail therapy of Regkirona, a Covid-19 antibody treatment, in the European Union....Celltrion registered the phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of CT-P63 in Poland. The company plans to conduct the trial on 24 healthy adults starting from late September and aims to complete the test by December....Primary endpoint of the phase 1 clinical trial is to confirm the safety and tolerability of a single escalating dose of CT-P63 and identify its side effects....'After verifying safety in phase 1 study, we plan to proceed with additional clinical trials by using a combination treatment between CT-P63 and Regkirona.'"

Trial completion date • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Celltrion

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TP63

'Delta mutation is on the rise' K-corona treatment and vaccine, busy checking mutant response [Google translation] (E-Today) - "Celltrion analyzed the efficacy of 'Rekkirona (CT-P59)', an antibody treatment for COVID-19 against the delta mutant virus from India at the cell line level, confirmed that its neutralizing ability was reduced, and is currently analyzing the efficacy through animal tests....'We plan to announce the results as soon as they arrive one by one by the beginning of the month,'...Celltrion plans to confirm the neutralizing ability against the delta mutant virus from India at the cell line level...also for the new antibody 'CT-P63'...showed relatively good neutralizing ability in the UK, South Africa, California, New York, Nigeria, and Brazil mutant viruses...We plan to start the project within the third quarter and announce the results in the fourth quarter at the earliest. After that, clinical trials in combination with Rekkirona are also planned."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Celltrion In the third quarter of this year, South African mutant COVID-19 treatment enters clinical trial [Google translation] (Maeil) - "Celltrion [068270] announced a plan to enter a clinical trial for a treatment for a mutated Corona 19 virus originating in South Africa with its new 32nd antibody 'CT-P63' in the third quarter of this year. Celltrion's Dr. Dong-gyun Ryu announced the neutralizing effect of 'Rekkirona'...on the mutation of Corona 19 at '2021 Bio Korea'...'Rekkirona maintained neutralizing ability against the British mutant virus and showed a decrease in neutralizing ability against the South African mutant,'...'CT-P63 is one of the novel antibodies, and it has confirmed the neutralizing ability of the COVID-19 mutation and the potentially resistant virus of Rekkirona'. He said, 'We will enter phase 1 clinical trial within the third quarter of this year'...'We are developing a cocktail treatment of CT-P59·63 or a new antibody for the treatment of patients with vaccine- and treatment-resistant virus infections along with Rekkirona.'"

New P1 trial • Preclinical • Infectious Disease • Novel Coronavirus Disease