CORAT Therapeutics GmbH obtained regulatory authorization for clinical phase Ib/II trial with the SARS-CoV-2 neutralizing human antibody COR-101.
The study (ClinicalTrials.gov ID: NCT04674566) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, first-in-human, phase Ib/II study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of COR-101 in hospitalized patients with moderate to severe COVID-19.
We are very happy to have reached this crucial step in COR-101 development. Many thanks to the support of the State of Lower Saxony and our private investors. We feel confident that COR-101 can fill the gap in the medical need for the treatment of hospitalized COVID-19 patients that have moderate and severe symptoms, where no other specific treatment is available at this time worldwide. The development of specific therapeutics to treat COVID-19 diseases is next to vaccination and testing an important pillar to effectively fight the pandemic.”
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A second financing round was closed with NBank Capital, the investment company of NBank. Additional investors came from the private sector in Braunschweig. CORAT Therapeutics is in close coordination with the regulatory authorities and expects the green light for the start of clinical testing shortly.
“The development of a drug against Corona must not fail because of money. We need drugs against Corona just as urgently as vaccines. The Braunschweig biotech company CORAT Therapeutics GmbH is close to the goal of testing a drug on patients that has been highly effective in all experiments to date. That is why we as a state are providing further risk capital so that valuable time is not lost. We will continue to provide intensive support for this Lower Saxony success story.”
Dr. Bernd Althusmann, Minister of Economics
Read the press release of State of Lower Saxony here.
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COR-101 decreased SARS-CoV-2 virus load in the lung by more than 99%
COR-101 induced recovery after 2 days, compared to 7 days untreated
CORAT Therapeutics GmbH today reports the successful conclusion of hamster disease model tests of their lead candidate COR-101 against COVID-19. It induced recovery of SARS-CoV-2 infected hamsters within two days. In contrast, without treatment, the hamsters only started to reach the same health status after a full week. Treatment with COR-101 substantially reduced the weight loss after infection, which indicates the general health state. But since the main life-threatening effects of the virus are happening in the lung, the virus titer was measured directly in this organ which mainly contributes to lethality of SARS-CoV-2.
We are especially happy to report that COR-101 drastically reduced the amount of SARS-CoV-2 in the lung. Already after three days, an average of less than 1 % of the virus titer of the untreated control group could be detected after treatment with COR-101. This confirms the excellent neutralizing capability that we already measured in the laboratory. It demonstrates that COR-101 efficiently neutralizes the virus in a living organism and prevents disease progression. Further, in contrast to plasma therapy and the currently emergency approved antibodies in the US, our recombinant antibody is especially designed not to induce overshooting immune responses which contribute to the lethality in the lung. We achieved this by carefully removing the respective signals from the molecule before starting its production
Dr. Andreas Herrmann, CEO of CORAT Therapeutics
CORAT Therapeutics currently intensively works to get regulatory approval for the start of the first-in-man studies next month. In contrast to all vaccine studies so far, these clinical studies will include COVID-19 patients from the start, since the treatment aims to directly protect infected patients. Therefore, preliminary efficacy is chosen as secondary endpoint of the study. It is also expected that this effect can be clinically demonstrated much quicker than in the vaccine studies. COR-101 is a fully human monoclonal IgG antibody that binds a very broad area of the virus surface. Its mode of action recently has been discovered by solving the atomic structure of its interaction with SARS-CoV-2. The results showed that it covers a much larger surface than other antibodies currently in development. “This also may explain why COR-101 is more resistant to mutations of the virus surface than other antibodies. It is capable to neutralize even a virus version with seven mutations in the receptor binding region of the SARS-CoV-2 spike protein”, comments Dr. Herrmann.
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Because SARS-CoV-2 is a novel virus, many people have not yet developed antibodies against the pathogen. Vaccines can protect healthy people, but they cannot cure people affected by COVID-19. Furthermore, not everyone responds to the vaccine. Passive immunisation by administering antibodies can help here for both, curing those people affected and prevent infection and/or onset of the disease for healthy people that come into contact with the virus. We therefore developed such a drug against the SARS-CoV-2 virus based on a human antibody, which was produced using biotechnological methods, i.e. in the test tubs. The structure of this antibody and its mode of action in neutralizing Coronavirus infection have now been published (https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3754550).
Our antibody COR-101 is a fully human antibody of the same type that our body normally generates after infection or vaccination but produced by biotechnological methods. Together with Joop van den Heuvel and Thomas Kluenemann from the Helmholtz Centre for Infection Research, the atomic structure of the interaction between the antibody COR-101 and the SARS-CoV-2 spike protein has now been elucidated. The results show that COR-101 blocks exactly that binding site on the surface of the virus which the virus needs for docking to human cells. Moreover, COR-101 covers an extraordinarily large area and with very high binding strength. As a result, the virus can no longer attack and penetrate the cells and multiply.
“We know that a vaccine does not work in every person, and this is especially observed in older people. There are patients with other diseases that cannot be vaccinated as well. Unfortunately, these are precisely the two groups of people, who usually have a higher risk of developing COVID-19. At this point, our antibody COR-101 comes in. Since COR-101 permanently occupies the essential contact point between the virus and our body, the virus can no longer use its “spike” proteins to infect us. Therefore, we expect COR-101 to be able to help all those, who already have COVID-19 but whose immune system was unable to initiate the necessary immune response in time. We will also examine whether COR-101 can protect both medical staff and risk groups from infection.”
Dr. Andreas Herrmann, Managing Director of CORAT Therapeutics
Unlike the typical vaccines currently under investigation, antibody drugs do not require sophisticated freezing logistics, they are very stable and robust molecules. A century ago, doctors carried vials of antibodies in their pockets for weeks without refrigeration, so that they were always ready for use against tetanus or diphtheria, for example. COR-101 is therefore expected to have much simpler and cheaper logistics for the distribution than RNA vaccines.
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In an event with Economics Minister Dr. Althusmann, Dr. Sabine Johannsen, State Secretary for Science and Culture and Stefan Muhle, State Secretary in Lower Saxony’s Ministry of Economics, Labour, Transport and Digitisation, CORAT Therapeutics won this year’s startup Award „Durchstarterpreis“ for corona solutions of the State of Lower Saxony.
Worldwide, hundreds of millions of people will not have access to COVID-19 vaccine by 2021, so an antibody-based drug for the treatment of COVID-19 patients suffering from a severe course of the disease will save thousands of lives and prevent later complications. CORAT could make a significant contribution to the treatment of corona patients worldwide.
From the Statement of the Jury
The “Durchstarterpreis” honours the best start-ups from Lower Saxony and is awarded by the Lower Saxony Ministry of Economics, Labour, Transport and Digitisation, the Lower Saxony Ministry of Science and Culture, the Investment and Promotion Bank NBank and the Lower Saxony Entrepreneurial Associations (UVN). This year, the winners were selected from 92 applicants from all economic sectors.
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15.11.2020 – CORAT Therapeutics CEO Dr. Andreas Herrmann today proudly reports the conclusion of the production campaign providing the first larger batch of COR-101 ready for the patients. COR-101 is a fully human antibody developed in Braunschweig which efficiently blocks the cell entry of the SARS-CoV-2, thereby preventing infection with the Coronavirus.
Because COR-101 directly attacks the virus, its clinical use will focus on helping the patients who cannot be cured by vaccination as this is the most urgent medical need in the pandemic. However, it is expected that it will also protect the uninfected, which will be tested in a second step.
Human antibodies are molecules produced by our own body to fight infections. COR-101 is one of these antibodies. It can be made in large quantities by biotechnological manufacturing, to immediately help to neutralize the coronavirus in those patients who cannot built enough of their own antibodies in time.
„We are extremely happy and would like to thank everybody who helped to make this happen so quickly. With acute case numbers rising fast, CORAT hopes to make a difference by providing an option soon to directly treat the Coronavirus-Infected. We hope that the clinical studies now can commence very soon.“
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Lower Saxony’s Minister of Economics Dr. Bernd Althusmann and Lower Saxony’s Minister of Science Björn Thümler, together with Prof. Josef von Helden, Chairman of the Board of the Innovation Network Lower Saxony, once again honoured visionary ideas, cooperation stories and economic successes from Lower Saxony with the Lower Saxony Innovation Award on 28.9.2020. This year, a particularly strong connection to current social problems became clear: two of the three prize winners are working on solutions to overcome the corona pandemic.
“The development already shows the great potential of Lower Saxony’s locations to play a leading role in a pandemic platform in the future, which aims to be able to react much faster to infectious diseases with a pandemic risk in the future. The competencies for the very rapid development of drug candidates also against future virus pandemics were demonstrated using the example of SARS-CoV-2.”
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With support from the German Federal State of Lower Saxony, CORAT Therpeutics was formed as a dedicated body to promote the further development of the antibody based COVID-10 medicine.
“What is being developed here in Braunschweig may save lives all over the world. Therefore, we decided to provide CORAT Therapeutics a financial base for the rapid development of a COVID-19 drug.”
Minister of Economy Dr. Bernd Althusmann
Today YUMAB GmbH announces the first financing round of its spin-off CORAT Therapeutics GmbH to advance the development of COVID-19 antibody drug candidates. Financial investments are provided by the German Federal State of Lower Saxony and a group of private investors from Braunschweig. CORAT Therapeutics will pursue the clinical development of the lead antibody drug candidate COR-101.
“In addition to the scientific ability to develop an effective drug against COVID-19, it is now important to provide a financial scope for a young biotech company to be able to work successfully. We contribute this expertise through our associated company NBank-Capital. Together with a Braunschweig investor group, we provide the financial requirements to develop an effective drug against COVID-19 here in Lower Saxony.”
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