Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients

Primary objectives Part 1:
- To evaluate the safety and tolerability of COR-101 compared to placebo
Secondary objectives Part 1:
* To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19
* To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

开始日期2021-04-21

申办/合作机构

CORAT Therapeutics GmbH

100 项与 COR-101 相关的临床结果

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100 项与 COR-101 相关的转化医学

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100 项与 COR-101 相关的专利（医药）

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项与 COR-101 相关的文献（医药）

2026-02-01·CLINICAL THERAPEUTICS

Phase I Study Evaluating a Monoclonal Fc-Silenced SARS-CoV-2 Antibody in Patients With Moderate-to-Severe COVID-19

Article

作者: Schwab, Matthias ; Salih, Helmut R ; Fricke, Harald ; Bitter, Thomas ; Cuevas, Mandy ; Wirtz, Hubert ; Dhaen, Marie-Ann ; Walz, Juliane S ; Hust, Michael ; Marconato, Maddalena ; Göpel, Siri ; Heitmann, Jonas S ; Hackenbruch, Christopher ; Bitzer, Michael ; Dings, Christiane ; Schneider, Jochen ; Herrmann, Andreas ; Jäger, Simon ; Кirieieva, Tetiana ; Jung, Gundram ; Lehr, Thorsten ; Gavrylov, Anatoliy ; Frenzel, André ; Klein, Constantin ; Dübel, Stefan

PURPOSE:

The evolution of Severe Acute Respiratory Syndrome Coronavirus 2 challenged the effectiveness of vaccines, while monoclonal antibodies (mAbs) were discontinued due to emergent resistance. This study evaluated the safety and explored the preliminary efficacy of COR-101, a novel mAb with a silenced Fc region designed to minimize antibody-dependent enhancement in hospitalized patients with moderate-to-severe disease.

METHODS:

Thirty-three participants were enrolled across Germany and Ukraine in a randomized, double-blind, placebo-controlled Phase Ib/II trial. Patients received either a single dose of COR-101, or placebo, as add-on therapy to the standard of care.

FINDINGS:

COR-101 was well tolerated, with no treatment-related severe adverse events (AEs), grade ≥3 AEs, or acute infusion reactions. Four unrelated severe AEs were observed, and 2 patients died due to coronavirus disease 2019. COR-101 showed dose-proportional pharmacokinetics, long half-life, and serum concentrations above IC₅₀. Patients were treated in different dose groups, and in exploratory analysis, viral clearance was observed at day 28 in 80%, 55.6%, 16.7%, and 42.9% of patients in the 4.0, 10.0, 25.0 mg/kg, and placebo groups, respectively. The predominant virus variant changed from alpha to delta and omicron, resulting in reduced in vitro neutralization, potentially explaining the observed reduced efficacy.

IMPLICATIONS:

COR-101 demonstrated a favorable safety profile, but exploratory data showed limited efficacy against omicron, highlighting the tolerability of Fc-silenced mAbs and the need for adaptive therapeutic strategies against rapidly evolving viral pathogens (ClinicalTrials.gov identifier: NCT04674566).

2021-07-01·Cell reports1区 · 生物学

A SARS-CoV-2 neutralizing antibody selected from COVID-19 patients binds to the ACE2-RBD interface and is tolerant to most known RBD mutations

1区 · 生物学

ArticleOA

作者: Kristian Daniel Ralph Roth ; Rico Ballmann ; Luka Čičin-Šain ; Leila Abassi ; Andreas Gerstner ; Marlies Becker ; Federico Bertoglio ; Kathrin Eschke ; Günter Roth ; Maren Schubert ; Joop Van den Heuvel ; Sebastian Casu ; Allan Koch ; André Frenzel ; M. Zeeshan Chaudhry ; Jakob Trimpert ; Julia Adler ; Thomas Klünemann ; Stephan Steinke ; Margitta Scholz ; Kai-Thomas Schneider ; Janin Korn ; Susanne Zock-Emmenthal ; Philipp Kuhn ; Hendrikus S.P. Garritsen ; Michael Hust ; Dorina Schäckermann ; Esther Veronika Wenzel ; Gustavo Marçal Schmidt Garcia Moreira ; Peggy Riese ; Nora Langreder ; Yeonsu Kim ; Philip Alexander Heine ; Maximilian Ruschig ; Ulfert Rand ; Viola Fühner ; Doris Meier ; Andreas Hermann ; Stefan Dübel ; Giulio Russo ; Thomas Schirrmann

The novel betacoronavirus severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) causes a form of severe pneumonia disease called coronavirus disease 2019 (COVID-19). To develop human neutralizing anti-SARS-CoV-2 antibodies, antibody gene libraries from convalescent COVID-19 patients were constructed and recombinant antibody fragments (scFv) against the receptor-binding domain (RBD) of the spike protein were selected by phage display. The antibody STE90-C11 shows a subnanometer IC₅₀ in a plaque-based live SARS-CoV-2 neutralization assay. The in vivo efficacy of the antibody is demonstrated in the Syrian hamster and in the human angiotensin-converting enzyme 2 (hACE2) mice model. The crystal structure of STE90-C11 Fab in complex with SARS-CoV-2-RBD is solved at 2.0 Å resolution showing that the antibody binds at the same region as ACE2 to RBD. The binding and inhibition of STE90-C11 is not blocked by many known emerging RBD mutations. STE90-C11-derived human IgG1 with FcγR-silenced Fc (COR-101) is undergoing Phase Ib/II clinical trials for the treatment of moderate to severe COVID-19.

Viruses-Basel

Evaluation of the Neutralizing Antibody STE90-C11 against SARS-CoV-2 Delta Infection and Its Recognition of Other Variants of Concerns

Article

作者: Frenzel, André ; Gödecke, Natascha ; Kontermann, Roland E. ; Bertoglio, Federico ; Kurolt, Ivan-Christian ; Greweling-Pils, Marina ; Schubert, Maren ; Schirrmann, Thomas ; Abassi, Leila ; Dübel, Stefan ; Hust, Michael ; Seifert, Oliver ; Heine, Philip Alexander ; Čičin-Šain, Luka ; Katzmarzyk, Maeva ; Nowack, Helena ; Mačak Šafranko, Željka ; Khan, Fawad ; Markotić, Alemka ; Jacobsen, Henning

As of now, the COVID-19 pandemic has spread to over 770 million confirmed cases and caused approximately 7 million deaths. While several vaccines and monoclonal antibodies (mAb) have been developed and deployed, natural selection against immune recognition of viral antigens by antibodies has fueled the evolution of new emerging variants and limited the immune protection by vaccines and mAb. To optimize the efficiency of mAb, it is imperative to understand how they neutralize the variants of concern (VoCs) and to investigate the mutations responsible for immune escape. In this study, we show the in vitro neutralizing effects of a previously described monoclonal antibody (STE90-C11) against the SARS-CoV-2 Delta variant (B.1.617.2) and its in vivo effects in therapeutic and prophylactic settings. We also show that the Omicron variant avoids recognition by this mAb. To define which mutations are responsible for the escape in the Omicron variant, we used a library of pseudovirus mutants carrying each of the mutations present in the Omicron VoC individually. We show that either 501Y or 417K point mutations were sufficient for the escape of Omicron recognition by STE90-C11. To test how escape mutations act against a combination of antibodies, we tested the same library against bispecific antibodies, recognizing two discrete regions of the spike antigen. While Omicron escaped the control by the bispecific antibodies, the same antibodies controlled all mutants with individual mutations.

项与 COR-101 相关的新闻（医药）

2022-07-13

·corat-therapeutics.com

€ 38.7 Mio. German government funding for the clinical development of a Corona medication

CORAT Therapeutics GmbH receives € 38.7 Mio. funding for the clinical development of COR-101, a drug to treat hospitalized COVID-19 patients with moderate to severe symptoms Clinical processing of COR-101 is financially secured Preparation for market entry in 2023 Braunschweig, July 13, 2022 – The biopharmaceutical startup CORAT Therapeutics GmbH (“CORAT”), based in Braunschweig, Germany, has been awarded additional funding of up to €38.7 Mio. from the German government for the pivotal clinical trial of its antibody-based drug, called COR-101, optimized for the treatment of hospitalized COVID-19 patients with moderate to severe disease. CORAT Therapeutics GmbH (“CORAT”) has received approval for additional funding of up to € 38.7 Mio. from the “Clinical Development of Care-Related COVID-19 Drugs and Their Manufacturing Capabilities” program of the German Federal Ministry of Education and Research. This funding will support the clinical trials in up to 50 sites in six different countries, as well as the scaling and validation of the manufacturing process in preparation for market entry and supply. On this basis, CORAT is convinced to be able to apply for approval in 2023.CORAT CEO Dr. Andreas Herrmann commented: “The pandemic is not over yet. Omicron can apparently infect people several times in a row and still is a life-threatening virus that goes on to claim thousands of lives per week. We are pleased that the additional funding will allow us to accelerate our clinical trial with COR-101.”Lower Saxony’s Minister of Economic Affairs, Dr. Bernd Althusmann, commented: “I am delighted that the funding support from the federal government, which had already been announced in 2021, has now been made available. The state of Lower Saxony, together with private investors, participated in the financing of CORAT’s development of the therapeutic for the treatment of COVID-19 diseases already in June 2020. The current funding commitment from the federal government follows on from this and will help to create the urgently needed financial framework for the further development of this innovative research project.” Background CORAT Therapeutics GmbH, based in Braunschweig, Germany, is developing an antibody preparation for the treatment of hospitalized COVID-19 patients with moderate to severe symptoms. The preparation consists of novel, fully human, neutralizing antibodies against COVID-19, which are designed to stop the spread of SARS-CoV-2 in the human body. The lead product, COR-101, reduced viral load in the lungs by more than 99% in the hamster COVID-19 model, and induced recovery after two days compared with seven days without treatment.Currently, the drug is tested in clinical trials. The upcoming international Phase IIb study will enroll more than 450 hospitalized patients with moderate and severe COVID-19 symptoms at approximately 50 international sites. Press release (PDF): english – german

临床2期临床申请临床结果

2021-07-07

·corat-therapeutics.com

CORAT Therapeutics GmbH announces partnership with Dermapharm Holding SE

For the fast and efficient delivery of its innovative drug COR-101 against COVID-19, CORAT Therapeutics GmbH announces the partnership with Dermapharm Holding SE, a manufacturer of branded pharmaceuticals. With its own development, production facilities as well as distribution capabilities, Dermapharm Holding SE is a strong industrial partner for the further development of the SARS-CoV-2 antibody COR-101, which is currently in the clinical phase. The partnership is intended to accelerate clinical development and facilitate the expansion of COR-101 production to make the drug available to patients more quickly. Currently, there is no approved, effective, antiviral-specific treatment for hospitalised patients with moderate to severe COVID-19 symptoms. While vaccines will remain the most important tool in fighting the pandemic, they will not be able to completely prevent the occurrence of severe cases of the disease. Therefore, this therapy is another tool that is needed. By acquiring the equity investment in CORAT we are not only providing the funds needed to accelerate the development process, but also our expertise in manufacturing antibody drugs. Press release (PDF): english – german

疫苗

2021-06-03

·corat-therapeutics.com

CORAT Therapeutics secures additional funding for Phase II clinical evaluation of its COVID-19 treatment

CORAT secures 12,7 Mio € from Lower Saxony State, private investors, and the German Ministry of Research and Education (BMBF). NBank Capital and private investors from Braunschweig, each having participated in previous financing rounds, renewed their investments. The current round of financing includes additional new investors from Braunschweig. Additionally, CORAT Therapeutics GmbH is to receive up to seven million euros from the federal funding program „Research and development of urgently needed therapeutics against SARS-CoV-2“ to support clinical development of COR-101. CORAT has completed all the necessary development steps on schedule so far. Now, it is important to maintain the fast development and to continue with the necessary clinical trials without delay. The government of Lower Saxony is excited to continue this success story. Press release (PDF): english – german

临床2期

100 项与 COR-101 相关的药物交易

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