COVID-19 Antibody Therapeutics Tracker
Legacy Manually Cleaned
The last update will be made in Aug. 1, 2021, after which, we will no longer maintain this dataset.
About this dataset
As the COVID-19 pandemic is the global healthcare crisis, scientists worldwide are collaborating to prevent or treat COVID-19. Antibody therapeutics hold enormous promise for treatment of COVID-19. Chinese Antibody Society is collaborating with our partner The Antibody Society to track the antibody-based therapeutics targeting COVID-19, to contribute our expertise to the globally joint efforts against the pandemic. In connection with the collaboration, The Antibody Society has published a “Coronavirus in the Crosshairs” series of articles addressing different aspects of therapeutics against COVID-19, and is continuous publishing new information and analysis. This tracker will be updated daily with the latest in developments for antibody therapeutics. If you notice an issue with this data or wish to submit an update, please contact us by email: Management@chineseantibody.org
References
This dataset has been described in the following mansucript. You are requested to cite the this article
when you use the COVID-19 Antibody Therapeutics Tracker” from our paper:
Stats at a Glance
217
Total Entries
62
Targets under investigation
2
Antibodies approved for treatment
203
or more research groups and/or institutions
Data Table
ID | Name | Target | Format | Status | Organization | Country | Descriptions | Derivation | Discovery platform |
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Nov 21,2020: Regeneron Pharmaceuticals today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.
Oct 28,2020: Regeneron announced that its new crown neutralizing antibody cocktail therapy REGN-COV2 has reached the primary and critical secondary endpoints in an ongoing Phase 2/3 clinical trial. REGN-COV2 significantly reduces the patient's viral load and the need for further medical care (including hospitalization, emergency room visits, emergency care and/or doctor's office/telemedicine visits).
Sep 14, 2020: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and the University of Oxford today announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.
REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. It was selected in part based on its emerging safety profile in humans, pre-clinical data showing it could protect against viral escape mutations, and prevention and treatment studies in non-human primates showing it reduced the amount of virus and associated damage in the lungs. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
July 6, 2020: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19. A Phase 3 trial (NCT04452318) will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.
June 15, 2020: Regeneron preported their antibody discovery and preclinical data as two papers on Science.
June 11,2020: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initiation of the first clinical trials of REGN-COV2 (NCT04425629, NCT04426695), its investigational dual antibody cocktail for the prevention and treatment of COVID-19.
The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled trials will be conducted at multiple sites.
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies and have scaled them up for clinical use with the company's in-house VelociMab® and manufacturing capabilities. The two antibodies bind non-competitively to the critical receptor binding domain (RBD) of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment, as demonstrated in upcoming Science publications of preclinical research.
The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the Phase 3 studies.
Nov 9,2020: the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
Oct 26,2020: Based on an updated dataset from the trial, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab. This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease. In this updated dataset, differences in safety outcomes between the groups were not significant.
Oct 7, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19 – and plans to make these therapies broadly available to patients.
For monotherapy, Lilly is focused on the 700 mg dose of LY-CoV555 since similar clinical effects were seen across all dose levels tested in BLAZE-1. Lilly anticipates it could supply as many as one million doses of 700 mg LY-CoV555 monotherapy in Q4 2020, with 100,000 available in October. With respect to the supply of combination therapy, Lilly anticipates it will have 50,000 doses available in Q4 2020. The supply of combination therapy will increase substantially beginning in Q1 2021, as additional manufacturing resources come online throughout the year, including Lilly's recently announced manufacturing collaboration with Amgen (NASDAQ: AMGN). Lilly is also pursuing additional partnerships to provide antibodies to resource-limited countries.
Based on the combination therapy data, along with the previously disclosed findings for LY-CoV555 monotherapy, Lilly has engaged global regulators, including the FDA regarding potential EUA. Lilly has now submitted an initial request for EUA for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. We expect to submit a subsequent request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured. Lilly anticipates having data to support a biologics license application (BLA) submission for combination therapy as early as Q2 2021.
Sep 16 2020: Eli Lilly and Company (NYSE: LLY) today announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).
The prespecified primary endpoint, change from baseline in viral load at day 11, was met at the 2800 mg dose level, but not the others. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Additional analyses of viral data demonstrated that LY-CoV555 improved viral clearance at an earlier time point (day 3) and reduced the proportion of patients with persistently high viral load at later time points.
Aug. 3, 2020: Eli Lilly and Company (NYSE: LLY) today announced the initiation of BLAZE-2, a Phase 3 trial (NCT04497987) studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S. (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities). LY-CoV555, the lead antibody from Lilly's collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19.
AbCellera has identified over 500 unique fully human antibody sequences from one of the first U.S. patients who recovered from COVID-19. Other clincials trials: NCT04427501, NCT04501978, NCT04518410, NCT04411628
Oct 6 2020: Independent Data Monitoring Committee recommended on September 30, 2020 that the study continue into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in
Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021
Sep 1, 2020:Vir and GSK announced that the first patient was dosed last week in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation.
VIR-7831 and VIR-7832 are monoclonal antibodies that have demonstrated the ability to neutralize SARS-CoV-2 live virus. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved. VIR-7831 and VIR-7832 are based on the S309 antibody. Planned Phase 2 trial in three to five months (July to September, 2020).
On June 9, Vir Biotechnology discloses that it inked a collaboration agreement with GlaxoSmithKline aimed at developing and commercializing products for the prevention, treatment and prophylaxis of SARS-CoV-2-related diseases. The partnership will focus on three principal programs: antibodies targeting the virus, vaccines and products based on CRISPR screening of host targets expressed in connection to exposure to SARS-CoV-2. All three include the possibility of including other coronaviruses. For the next four years, the companies will conduct R&D activities under mutually agreed plans and budgets for each of the three programs.
May 29, 2020 Vir Biotechnology, Inc. announced that is has finalized a process development and manufacturing agreement with Biogen Inc. 4. Apr 14, 2020 Vir announces that it will work with Samsung Biologics for large-scale production.
Mar 29, 2020 Xencor, Inc. announced it has entered into a technology license agreement with Vir Biotechnology, Inc., in which Vir will have non-exclusive access to Xencor’s Xtend™ Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19. https://investors.xencor.com/news-releases/news-release-details/xencor-and-vir-biotechnology-enter-license-agreement-use-xtendtm.
April 6, 2020, GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. During the agreement period, generally, subject to certain rights granted to WuXi Biologics (Hong Kong) Limited (“WuXi”) under existing agreements between WuXi and VIR, the parties will have an exclusive research collaboration with respect to antibody products directed to SARS-CoV-2 or to any other coronavirus. https://www.gsk.com/en-gb/media/press-releases/gsk-and-vir-biotechnology-enter-collaboration-to-find-coronavirus-solutions.
Jun 09, 2020: AstraZeneca has licensed coronavirus-neutralising antibodies from Vanderbilt University, US, and plans to advance a pair of these mAbs into clinical development as a potential combination therapy for the prevention and treatment of COVID-19. Following rapid mobilisation of its global research efforts, AstraZeneca has evaluated the ability of more than 1,500 mAbs to bind to the SARS-CoV-2 virus and inhibit its capacity to infect healthy cells in a laboratory setting. Based on these pre-clinical results, the Company has signed an exclusive license to six candidate antibodies currently in Vanderbilt’s portfolio that target the SARS-CoV-2 virus. Two mAbs from these six will progress into clinical evaluation as a combination approach within the next two months.
July 17,2020: Celltrion Group today announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19. The in-human study follows positive pre-clinical results for the treatment candidate and subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure.The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital. The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year.
Celltrion has identified the library of antibodies sourced from the blood of recovered patients in Korea, which are thought to be involved in neutralising the virus and may contribute to recovery from COVID-19. Plan to start human trial in July, 2020. On APRIL 13 2020, Celltrion announced that the company has successfully selected the most potent antibody candidates to neutralize SARS-CoV-2, the virus causing COVID-19. Through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion initially identified and secured 300 different types of antibodies that bind to the SARS-CoV-2 antigen. These were then screened based on their ability to bind to the virus spike protein. Celltrion was then able to capture a total of 38 potent neutralizing antibodies, of which, 14 are powerful neutralizing antibodies against SARS-CoV-2. Following the selection of antibody candidates which demonstrate high potency in neutralizing SARS-CoV-2, Celltrion will begin cell-line development. Once this is completed, Celltrion aims to roll out mass production of the therapeutic antibody and, together with the KCDC, Celltrion will conduct efficacy and toxicity testing in mice and non-human primates.
With approval from the Health Sciences Authority (HSA), Tychan, a Singapore-based clinical-stage biotechnology company, has completed recruiting and will start dosing healthy volunteers next week for Phase 1 clinical trials to evaluate TY027, a monoclonal antibody (mAb) that specifically targets SARS-CoV-2, the virus that causes COVID-19.
Tychan developed TY027 in partnership with the Whole-of-Government engagement amongst the Ministry of Defence, Ministry of Health, the Economic Development Board and other government agencies. TY027 is being explored for the treatment of patients with COVID-19 to slow the progression of the disease and accelerate recovery, as well as for its potential to provide temporary protection against infection with SARS-CoV-2.
The Phase 1 trial, to be conducted by SingHealth Investigational Medicine Unit, will take about six weeks to evaluate the safety, tolerability and pharmacokinetics of TY027. Upon reaching the key milestones of the Phase 1 trial, Tychan will seek approval from HSA for TY027 to be administered to a larger population of volunteer patients in subsequent trials to establish the efficacy of the mAb.
September 3 2020: last update posted: The primary purpose of this Phase 1 study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants. The estimated primary completion date is October 15, 2020.
August 27: BeiGene snagged exclusive rights to develop and commercialize Singlomics Biopharmaceuticals’ Covid-19 antibodies outside of Greater China, thus expanding the company’s search for a potential treatment. Under the license agreement, BeiGene can develop, manufacture and commercialize Singlomics’ DXP-593 and DXP-604 in “ex-China territory.” The Beijing-based biotech is set to begin a Phase I study in Australia next month, enrolling up to 30 healthy volunteers. A second multinational Phase I/II study is expected to begin by early October in patients with mild to moderate Covid-19.
A joint research team from Beijing Advanced Innovation Center for Genomics (ICG) at Peking University (PKU) has successfully identified multiple highly potent neutralizing antibodies against the novel coronavirus SARS-CoV-2, the causative virus of the respiratory disease COVID-19, from convalescent plasma by high-throughput single-cell sequencing. Published on Cell, the team reported rapid identification of SARS-CoV-2 neutralizing antibodies by high-throughput single-cell RNA and VDJ sequencing of antigen-enriched B cells from 60 convalescent patients. From 8,558 antigen-binding IgG1+ clonotypes, 14 potent neutralizing antibodies were identified with the most potent one, BD-368-2, exhibiting an IC50 of 1.2 ng/mL and 15 ng/mL against pseudotyped and authentic SARS-CoV-2, respectively. BD-368-2 also displayed strong therapeutic and prophylactic efficacy in SARS-CoV-2-infected hACE2-transgenic mice. Additionally, the 3.8Å Cryo-EM structure of a neutralizing antibody in complex with the spike-ectodomain trimer revealed the antibody’s epitope overlaps with the ACE2 binding site. Moreover, we demonstrated that SARS-CoV-2 neutralizing antibodies could be directly selected based on similarities of their predicted CDR3H structures to those of SARS-CoV neutralizing antibodies. Altogether, we showed that human neutralizing antibodies could be efficiently discovered by high-throughput single B-cell sequencing in response to pandemic infectious diseases.
On Jun 07, 2020: Junshi Biosciences Announces Dosing of First Healthy Volunteer in Phase I Clinical Study (NCT04441918) of SARS-CoV-2 Neutralizing Antibody JS016 in China.
JS016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain and can effectively block the binding of viruses to host cell surface receptor ACE2.
On May 26, Nature reported two potent neutralizing mAbs CA1 and CB6. The ND50 of CB6 to live SARS-CoV-2 virus is 0.036ug/ml. CB6-LALA inhibited SARS-CoV-2 infection in rhesus monkeys at both prophylactic and treatment settings. Further structural studies revealed that CB6 recognizes an epitope that overlaps with angiotensin converting enzyme 2 (ACE2)-binding sites in SARS-CoV-2 receptor binding domain (RBD), thereby interfering with the virus/receptor interactions by both steric hindrance and direct interface-residue competition. JS016 appears to be CB6-LALA.
On May 06, 2020. Lilly has agreed to pay $10 million upfront and committed up to $245 million for ex-China rights to co-develop and sell neutralizing antibodies from China’s Junshi Biosciences. Junshi’s lead candidate, dubbed JS016, is a recombinant fully human monoclonal antibody. The pair aims to apply to start a clinical trial in the U.S. in the second quarter.
In April, Boehringer Ingelheim announced a multifaceted plan to help fight COVID-19, which included collaborating with academic researchers to find potential treatments. Now one of those research programs has uncovered 28 antibodies that the company plans to move into further testing.
A team of researchers led by Cologne University Hospital and the German Center for Infection Research studied the antibody response to COVID-19 in 12 people who recovered from the virus, as well as immune cells from 48 healthy people collected before the pandemic. By examining more than 4,000 B cells, they pinpointed antibodies with the strongest neutralizing effect on SARS-CoV-2, the virus that causes COVID-19, they reported (PDF) in the journal Cell.
June 17, 2020: YUMAB GmbH previously announced it identified fully human monoclonal antibodies with neutralizing activity against live coronavirus strain SARS-CoV-2. The company deployed its advanced antibody discovery platform to rapidly identify a panel of antibody lead candidates with neutralizing activity and favourable properties for fast track drug development. YUMAB 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 continue the pre-clinical development of the lead antibody drug candidate to potentially begin clinical development by the end of 2020.
Per the company, this study will enroll patients rapidly, which will lay out a path for a larger study, data from which can be used for potential Emergency Use Authorization (EUA) filing before the end of this year. Sorrento already started cGMP manufacturing to deliver 50,000 doses of STI-1499 in anticipation of a potential EUA, if approved.
Notably, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2 while preventing infection of healthy cells in pre-clinical in-vitro studies. Moreover, the antibody developed by the candidate has been 100% effective against the highly contagious strain of SARS-CoV-2, namely the D614G variant, in preclinical studies.
July 1, 2020: Sorrento Therapeutics initiated a phase I clinical trial (NCT04454398) to Evaluate STI-1499 (COVI-GUARD) in Hospitalized Patients With COVID-19.
June 5, 2020:SAN DIEGO, June 5, 2020 /PRNewswire/ -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced it has completed a preclinical batch of the STI-4398 (COVIDTRAP) protein and is reporting the positive results from preclinical testing of its ability to neutralize and inhibit SARS-CoV-2 virus from infecting ACE2-expressing cells, VERO/E6.
May 8, 2020, Sorrento Therapeutics, Inc. and Mount Sinai Health System have agreed to join forces in the investigation and development of an antibody cocktail (COVI-SHIELD™) to potentially treat COVID-19. Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai and his team screened approximately fifteen thousand individuals who may have had and recovered from COVID-19 for the presence of anti-COVID-19 antibodies. The screening used a diagnostic test developed by Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai, and authorized for use in Mount Sinai's laboratory under an FDA Emergency Use Authorization. Sorrento will have access to plasma containing antibodies against COVID-19 for the purpose of identification and production of monoclonal antibodies with potential neutralizing activity against SARS-CoV-2.Sorrento is completing all IND filing requirements for the triple antibody combination therapy and expects to commence phase 1 trials of the drug candidate in the third quarter of 2020.
BRII-196 can completely block viral entry and neutralize live SARS-CoV-2 infection in cell culture assays. It binds to a highly conserved epitope on the Spike protein and has the potential of becoming an effective therapy against the COVID-19 pandemic.
BRII-198 binds to a different epitope on the Spike protein and has additive to synergistic effect when combined with BRII-196. It has the potential of becoming an effective therapy against the COVID-19 pandemic.
Sep 14,2020: HiFiBiO started cooperation with ABL Bio for developing CoV-2 neutralizing antibody HFB30132A.
August 17, 2020 – HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, today announced a collaboration with the Coronavirus Immunotherapy Consortium (CoVIC), a global, academic-industry, non-profit research alliance headquartered at the La Jolla Institute for Immunology (LJI). CoVIC was established to accelerate discovery, optimization, and delivery of life-saving antibody-based therapeutics against SARS-CoV-2. It has received support from the COVID-19 Therapeutics Accelerator, which was launched in March 2020 by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard with additional funding from a range of donors.
Using a combination of its proteomics and proprietary single-cell profiling technology, HiFiBiO has developed multiple SARS-CoV-2 neutralizing antibodies with the potential for both therapeutic and prophylactic applications. With an aligned commitment to deliver accessible therapies to vulnerable individuals globally, the company has submitted 10 distinct antibodies in the format of mono- or bispecific antibodies to CoVIC for in vitro and in vivo testing. HiFiBiO will gain a first look into the performance of its antibodies compared to dozens of other submitted antibodies and synergies among them for combinational therapies.
Additionally, HiFiBiO Therapeutics is preparing an Investigational New Drug (IND) application with the US Food and Drug Administration for HFB30132A, a novel SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. The highly differentiated antibody has been rapidly identified, engineered, and evaluated in all key preclinical studies, where it has demonstrated outstanding efficacy, exposure, and safety profile. A planned Phase I single-IV administration ascending dose study will assess the safety and tolerability of HFB30132A in healthy volunteers later this summer.
On Jun 5 2020, AbbVie (NYSE:ABBV), Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) announced they have entered into a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus. 47D11 was discovered from the H2L2 Harbour Mice® platform. 47D11 binds a conserved epitope on the spike receptor binding domain and cross-neutralizes SARS-CoV and SARS-CoV-2.Data show that 47D11 neutralizes SARS-CoV and SARS-CoV-2 through a yet unknown mechanism that is different from receptor binding interference. Alternative mechanisms of coronavirus neutralization by receptor binding domain-targeting antibodies have been reported including spike inactivation through antibody-induced destabilization of its prefusion structure, which may also apply for 47D11. Harbour BioMed has partnered with academic medical system Mount Sinai Health to develop biotherapies for Covid-19 and cancer. The partners entered into a multi-year, multifaceted agreement, which will focus on fully human antibodies.
Aug. 27, 2020-- BeiGene, Ltd. and Singlomics (Beijing DanXu) Biopharmaceuticals Co., Ltd., today announced that the companies have executed an exclusive license agreement for BeiGene to develop, manufacture and commercialize globally outside of greater China Singlomics’ investigational anti-COVID-19 antibodies, including DXP-593 and DXP-604. Utilizing high-throughput single-cell sequencing of convalescent blood samples from recovered patients with COVID-19, Singlomics has identified multiple antibodies that have been shown to be highly potent in pre-clinical studies in neutralizing SARS-CoV-2, the virus that causes COVID-19.
A Phase 1 randomized, double-blind, and placebo-controlled clinical trial is expected to begin enrolling up to 30 healthy subjects in Australia in September. The Phase 1/2 multinational trial in patients with mild to moderate COVID-19 is also expected to begin enrollment by early October. More information on the trials will be available on www.clinicaltrials.gov.
Under the terms of the agreement, Singlomics has granted BeiGene exclusive rights in ex-China territory to develop, manufacture, and commercialize its preclinical assets DXP-593 and DXP-604, as well as for a series of antibody sequences that could target the COVID-19 virus. BeiGene plans to develop one or more of these antibodies globally outside of greater China, while Singlomics will retain rights in greater China. Singlomics will receive an upfront payment and be eligible to receive payments upon the achievement of regulatory and commercial milestones. Singlomics will also be eligible to receive tiered royalties, up to double-digits, on future product sales.
On June 9, Vir Biotechnology discloses that it linked a collaboration agreement with GlaxoSmithKline aimed at developing and commercializing products for the prevention, treatment and prophylaxis of SARS-CoV-2-related diseases. The partnership will focus on three principal programs: antibodies targeting the virus, vaccines and products based on CRISPR screening of host targets expressed in connection to exposure to SARS-CoV-2. All three include the possibility of including other coronaviruses. For the next four years, the companies will conduct R&D activities under mutually agreed plans and budgets for each of the three programs.
May 29, 2020 Vir Biotechnology, Inc. announced that is has finalized a process development and manufacturing agreement with Biogen Inc. 4. Apr 14, 2020 Vir announces that it will work with Samsung Biologics for large-scale production.
Mar 29, 2020 Xencor, Inc. announced it has entered into a technology license agreement with Vir Biotechnology, Inc., in which Vir will have non-exclusive access to Xencor’s Xtend™ Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19. https://investors.xencor.com/news-releases/news-release-details/xencor-and-vir-biotechnology-enter-license-agreement-use-xtendtm.
April 6, 2020, GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. During the agreement period, generally, subject to certain rights granted to WuXi Biologics (Hong Kong) Limited (“WuXi”) under existing agreements between WuXi and VIR, the parties will have an exclusive research collaboration with respect to antibody products directed to SARS-CoV-2 or to any other coronavirus. https://www.gsk.com/en-gb/media/press-releases/gsk-and-vir-biotechnology-enter-collaboration-to-find-coronavirus-solutions.
Earlier this year, IDBiologics licensed IDB003, one of the monoclonal antibodies identified in Dr. Crowe’s lab, and is developing it to treat SARS-CoV-2, the virus causing the COVID-19 illness. IDBiologics intends to initiate a Phase 1 clinical trial of IDB003 in the third quarter this year.
June 15, 2020: Adimab published a paper on Science reporting 200 SARS-CoV-2 binding antibodies that target multiple conserved sites on the spike (S) protein from the memory B cell repertoire of a convalescent SARS donor.
In the paper disclosed on Biorxiv : The team describe the generation of antibody libraries from 17 different COVID-19 recovered patients and screening of neutralizing antibodies to SARS-CoV-2. After 3 rounds of panning, 456 positive phage clones were obtained with high affinity to RBD (receptor binding domain). Then the positive clones were sequenced and reconstituted into whole human IgG for epitope binning assays. After that, all 19 IgG were classified into 6 different epitope groups or Bins. Although all these antibodies were shown to have ability to bind RBD, the antibodies in Bin2 have more superiority to inhibit the interaction between spike protein and angiotensin converting enzyme 2 receptor (ACE2). Most importantly, the antibodies from Bin2 can also strongly bind with mutant RBDs (W463R, R408I, N354D, V367F and N354D/D364Y) derived from SARS-CoV-2 strain with increased infectivity, suggesting the great potential of these antibodies in preventing infection of SARS-CoV-2 and its mutations. Furthermore, these neutralizing antibodies strongly restrict the binding of RBD to hACE2 overexpressed 293T cells. Consistently, these antibodies effectively neutralized pseudovirus entry into hACE2 overexpressed 293T cells. In Vero-E6 cells, these antibodies can even block the entry of live SARS-CoV-2 into cells at only 12.5 nM. These results suggest that these neutralizing human antibodies from the patient-derived antibody libraries have the potential to become therapeutic agents against SARS-CoV-2 and its mutants in this global pandemic.
MTx today announces a collaboration with Northway for fast-track cGMP manufacturing of its lead antibody candidate for the treatment of COVID-19. MTX-COVAB is a fully human, highly potent antibody isolated from clinically selected convalescent COVID-19 donors with picomolar neutralizing activity against wild-type SARS-CoV-2, as well as newly described mutants. The selected antibody will undergo an accelerated development path as an immunotherapy and for the prevention of COVID-19.
Under the terms of the manufacturing agreement, Northway will develop the cell line and the manufacturing process, and will further produce cGMP batches of MTx's antibody for clinical studies. Northway is also perfectly positioned to execute commercial production once MTX-COVAB receives marketing authorization. This will enable MTx to supply the market in time for the anticipated second wave of the pandemic.
Northway produces antibodies and other mammalian cell-based therapeutics up to the 2.000 L scale in single-use bioreactors at its current facilities. A larger-scale production facility using stainless-steel bioreactors will be made operational by the start of 2021 to facilitate ramping-up of capacity to meet MTx's demand. This project leverages the innovative discovery research and applied cGMP manufacturing know-how of the two partners.
MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage.
Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.
Aug 11,2020: Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin therapeutics, today announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of a defined number of initial doses of the company’s multi-specific DARPin anti-COVID-19 candidate, MP0420. MP0420 builds on a unique three-in-one DARPin architecture to enhance potency and with the potential to prevent viral escape, in addition to manufacturing process advantages. Initial clinical studies planned for Q4 2020
MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage.
Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.
Aug 11,2020: Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin therapeutics, today announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of a defined number of initial doses of the company’s multi-specific DARPin anti-COVID-19 candidate, MP0420. MP0420 builds on a unique three-in-one DARPin architecture to enhance potency and with the potential to prevent viral escape, in addition to manufacturing process advantages. Initial clinical studies planned for Q4 2020
The result is ExeVir, a biotech with technology spun off from VIB and €23 million to take a lead drug into the clinic by the end of the year. That timeline puts ExeVir well behind the front-runners in the race to get an anti-SARS-CoV-2 antibody to market, but the startup and its backers think their VHH approach has advantages.
The researchers report today in the journal Cell that Ab8 is highly effective in preventing and treating SARS-CoV-2 infection in mice and hamsters. Its tiny size not only increases its potential for diffusion in tissues to better neutralize the virus, but also makes it possible to administer the drug by alternative routes, including inhalation. Importantly, it does not bind to human cells—a good sign that it won’t have negative side-effects in people. Abound Bio, a newly formed UPMC-backed company, has licensed Ab8 for worldwide development.
Founded in April 2018, Biotheus is a biomedical research company focusing on the discovery and development of next generation antibody-based therapeutics. With their headquarters located in Zhuhai and research laboratories in Hong Kong and Suzhou, the company has R&D capabilities including antibody discovery, process development and analytical assessment platforms with a pilot plant that would facilitate IND (Investigational New Drug)-enabling activities.
Using SmartPharm’s technology, Sorrento has identified STI-2020dna (DNA plasmid injection), an antibody encoded DNA plasmid candidate derived from Sorrento’s proprietary STI-1499 (COVI-GUARD™) and matured and optimized for DNA plasmid delivery to generate antibodies in vivo directed against the SARS-CoV-2 virus and its highly contagious D614G variant. STI-2020dna is currently undergoing preclinical in vivo studies and has the potential to generate long-lasting anti-viral protection with a single intra-muscular administration.
After screening over 200 antibodies that demonstrated strong binding activity towards SARS CoV-2 S protein as part of YH007, Chief Scientific Officer and Director of Antibody Discovery at Biocytogen, Dr. Yi Yang has announced two promising antibodies, Ab1 and Ab5, both of which were derived from the RenMab™ Mouse Platform. He describes these new monoclonal antibodies which, “have completely different epitopes and can neutralize wild-type and the multiple currently known drug-resistant mutant strains” of SARS CoV-2. Furthermore, “compared with single use, the combination of Ab1 and Ab5 (cocktail therapy) has more significant effects in preclinical animal in vivo efficacy studies.” To this end, Biocytogen is currently developing a proprietary therapeutic coronavirus “cocktail therapy,” comprised of fully-human antibodies targeting the S protein, which should enhance the prophylactic and therapeutic potential in the case of the constantly evolving and mutating coronavirus. Biocytogen is a scientific service-providing, pre-clinical antibody discovery, and drug development team that has worked with over 70% of the world’s Top 20 pharmaceutical companies and stands at the crux of therapeutic antibody R&D.
The MAbCo19 project will rapidly deliver human neutralizing monoclonal antibodies as prophylactic and therapeutic tools against Covid-19. Human antibodies have already proven to be powerful solutions for diseases like HIV, RSV and very recently provided the first cure for Ebola.
The project will exploit cutting edge technology, where B-cells from Covid-19 convalescent patients will be selected for their ability to produce high-affinity antibodies. The genes encoding these antibodies will be cloned in appropriate expression (antibody-production) systems, followed by preclinical evaluation of their protective efficacy and further rational engineering to achieve maximum therapeutic efficiency.
This special project is a Dr. Rappuoli’s “TLS Lab” initiative realized in cooperation with Istituto Nazionale per le Malattie Infettive Spallanzani, Tuscan Universities and AchilleS Vaccines. It is co-financed by EU Malaria Fund.
The drug candidate has confirmed its antiviral neutralization ability through a potency test, and the two companies are planning to start on non-clinical and clinical trials. Both companies will jointly pay the development costs required to develop antibody therapy, and Genexine plans to lead the commercialization of the developed product or the technology through its existing global network. The two companies will also jointly own all rights, including intellectual property and commercialization rights.
"According to a recent study, the severity of T-cell reduction among patients infected with Covid-19 can have a more dire effect on the patient's condition, and, in severe cases, can lead to death," Genexine CEO Sung Young-chul said. "The company expects to effectively combat Covid-19 by administering both GX-I7, which enhances patients' immune function by raising T cell levels, and the Y Biologics drug candidate."
Y Biologics CEO Park Young-woo said, "By using the company's Ymax-ABL human antibody library and antibody discovery source technology, we have already secured 15 kinds of Covid-19 neutralizing antibodies with some antibodies showing excellent neutralizing ability even at very low concentrations of picomolar (pM) levels in a titer test."
Using fully human scFv phage display library, Jecholabs will screen antibodies with high affinity to S1 and S2 domains of the spike protein and evaluate their in vitro cell neutralizing potency through the cell based model system established in the lab. GMP production will be conducted by Jecho Biopharm to support clinical studies to serve the current urgent needs from the patients.
UPDATE March 23rd: Using our established fully human scFv phage display library, we have isolated dozens of monoclonal antibodies recognizing specifically the receptor binding domain (RBD) of the SARS-C0V-2 spike protein and are evaluating their in vitro virus neutralizing potency through the cell based model system established in the lab.
Jecho Labs’ headquarters and main facilities are in Frederick Maryland, USA, near the National Institute of Health (NIH).
The therapeutic drugs and vaccines for treating COVID-19 are being rapidly developed in the world. We plan to develop the neutralizing antibodies against the novel coronavirus and its mutants by using “in vitro Immunization System” that was established in collaboration with Tokyo University of Science. We aim to start the clinical trials with the pharmaceutical companies in FY2021.
Subsequent work through the Company’s subsidiary, Immugenyx, LLC (“Immugenyx”), had produced positive preliminary results prior to the emergence of COVID-19. In light of the emergence of the current major pandemic, work has been refocussed on COVID-19 with the aim of producing an effective treatment for those infected with the virus, and Immugenyx is currently taking the necessary steps to take this forward effectively. The work involves transplanting cells from blood samples from patients who have already recovered from COVID-19 into the ApbHC. This process will allow the Company’s scientists to recreate a set of anti-SARS-CoV-2 virus antibodies which could be used for the treatment of COVID-19 sufferers.
On 2 June 2020 the Australian government announced that Melbourne-based Affinity Biosciences Pty Ltd (Affinity) would receive funding from the Australian Medical Research Futures Fund (MRFF) as part of a ‘biologics’ medicine consortium to discover potential antibody therapies for COVID-19.
Affinity is an antibody discovery business normally focussed on discovering novel cancer therapeutics. In March, with the COVID-19 pandemic gaining momentum Affinity pivoted to screen its proprietary library of one hundred billion human antibodies to discover those that might neutralise SARS-CoV-2, the virus that causes COVID-19. After a number of successful campaigns conducted in parallel, Affinity discovered a number of antibodies that are highly effective in neutralising the infectivity of SARS-CoV-2 in the laboratory.
Affinity is working with renowned international and Australian academics and institutes to move the program forward as rapidly as possible.
As part of those efforts, Affinity will participate in a consortium of leading Australian biotech businesses and institutes to assist the Australian consortium to evaluate antibodies that block the SARS-CoV-2 virus from infecting human cells.
The two principal investigators for the collaboration are Ilya Trakht, Ph.D., Associate Research Scientist and Sergei Rudchenko, Ph.D., Assistant Professor of Medical Sciences at Columbia University Vagelos College of Physicians and Surgeons. Dr. Trakht’s project will study T cell and antibody responses in a variety of ways, including at the cellular level by stimulating T cells in vitro with CoV-2 antigens and by generating fully human monoclonal antibodies against CoV-2. The project, directed by Dr. Trakht, has the potential to lead to the isolation and characterization of therapeutically relevant fully human monoclonal antibodies to CoV-2. Dr. Rudchenko’s project will generate DNA aptamer-based anti-idiotypes to certain of the monoclonal antibodies identified by Dr. Trakht. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and to lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19.
Israel, July 17, 2020 - Medigus Ltd., a technology company developing minimally invasive tools and an innovator in direct visualization technology, today announced the signing of an investment agreement and a reseller agreement with Polyrizon Ltd., a private company engaged in developing biological gels for the purpose of protecting patients against biological threats.
As part of the reseller agreement Medigus receives an exclusive global license to resell the Polyrizon products, focusing on a unique Biogel for the protection from COVID-19 virus. The term of the license will be for four years, commencing upon receipt of sufficient FDA approvals for the lawful marketing and sale of the products globally. Medigus shall have the right to purchase the Polyrizon products on a cost plus 15% basis for the purpose of reselling the products worldwide. In consideration for the license, Polyrizon shall be entitled to receive annual royalty payments equal to 10% of Medigus annualized operating profit arising from the sale of the products.
June 9, 2020 I Twist Bioscience Corporation (Nasdaq: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Serimmune Inc., a leader in understanding the functional antibody repertoire's role in human disease, today announced a collaboration to identify and evaluate SARS-CoV-2 therapeutic antibody candidates from Twist libraries.
The collaboration will evaluate existing Twist antibody candidates that bind with high affinity to either SARS-CoV-2 S1 spike protein or the human ACE2 cellular receptor, using Serimmune's Serum Epitope Repertoire Analysis (SERA) platform, which maps the antigenic targets of antibody repertoires. Epitopes identified in the first phase will then be used to re-screen Twist's proprietary synthetic antibody discovery libraries to identify and evaluate new candidates while at the same time further increasing the specificity of antibody candidates. Twist will be responsible for advancing all antibodies resulting from the collaboration.
"Beginning with our first efforts in January, Serimmune has focused on understanding the role of antibody response in SARS-CoV-2 infection. Having evaluated a diverse set of samples from subjects with diverse symptoms, we are beginning to more fully understand the immunogenic epitopes associated with natural infection," said Noah Nasser, CEO of Serimmune. "Twist's fully human antibody libraries contain a vast and diverse collection of potential therapeutic candidates, and we look forward to providing valuable SARS-CoV-2 epitope information to help them select and advance the most promising candidates to treat this devastating disease."
"We are working feverishly to move our antibody leads through characterization, while at the same time implementing the best tools to optimize the properties of each antibody," said Emily Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Serimmune's platform will allow us to accelerate our efforts in a targeted and methodical manner to further increase the specificity of our antibodies, continuing our sprint in delivering new therapeutics to treat COVID-19."
Totient leverages tertiary lymphoid structures (TLSs) to identify novel tissue-specific antigens and develop matching high-affinity antibody therapeutics. As the broader scientific community mobilizes to address the coronavirus pandemic, Totient has partnered with Ginkgo to adapt and scale its platform, which has been validated in oncology and autoimmunity, to aid in the effort to discover COVID-19 antibodies. Totient's population-scale antibody discovery platform reconstructs anti-SARS-CoV-2 antibodies from bronchoalveolar lavage fluid (BALF) samples.
Ginkgo has already synthesized and analyzed over 200 antibodies Totient identified from the lungs of Covid-19 patients, testing them against pseudovirus in cell lines. Totient is looking for a partner to bring into the clinic in early 2021.
Called nanobodies because they are about a quarter of the size of antibodies found in people and most other animals, these molecules can nestle into the nooks and crannies of proteins to block viruses from attaching to and infecting cells.
The lab-made one created by the UCSF team is so stable it can be converted into a dry powder and aerosolized, meaning it would be much easier to administer than Covid-19 treatments being developed using human monoclonal antibodies. While the work is still very preliminary, the goal is to deliver the synthetic nanobody via simple inhaled sprays to the nose or lungs, allowing it to potentially be self-administered and used prophylactically against Covid-19 — if it’s shown safe and effective in both animal tests and clinical trials.
The nearly $4 million grant funds rapid development of an oral SARS-CoV-2 treatment and preventative product candidates through FDA Investigational New Drug (IND) submission and initial engineering work for a large-scale cGMP manufacturing plant. By spring 2021 the program aims to initiate Phase 2 clinical trials and complete siting and engineering work for a 1-billion-dose-per-year production facility, with cGMP manufacturing to commence in summer 2021.
Most antibodies bind to the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The Columbia researchers showed that their antibodies target one of two locations on the S protein: either the receptor binding domain (RBD), which helps the virus latch onto and infect human cells, or the N-terminal domain (NTD).
Among nine of the most potent antibodies, four are specifically directed at the RBD and three at the NTD. But in what they believe is an unprecedented discovery, the Columbia team found two powerful neutralizing antibodies that recognize a site on the top of the S protein that crosses from one RBD to another.
Physicians are already using antibody-containing plasma from recovered COVID-19 patients to treat patients. But because convalescent serum contains a variety of antibodies, each patient may need a different plasma product with varying concentrations or strengths of neutralizing antibodies. So purified antibodies that can be mass produced by drugmakers could be a better option, the team argues.
Specializing in biotechnology, the Nantes start-up Xenothera is working on an antibody-based treatment. These so-called "glyco-humanized" antibodies are produced by animals, but resemble those of humans. At the head of the company, Odile Duvaux, claims to have already declined this technology in the treatment of cancer with a conclusive clinical trial around the rejection of transplants. On April 15, 2020, Xenothera announces its partnership with the LFB laboratory, which develops, manufactures and markets blood-derived drugs and therapeutic proteins for patients with serious and rare pathologies. Code name: XAV-19. XAV-19 is a preparation of hyperimmune polyclonal antibodies against the SARS-CoV-2 virus. It is composed of humanised glyco-optimised antibodies whose therapeutic activity is focused on three effects: neutralisation of the virus by blocking its entry into the patient’s cells, the absence of risk of ADE (antibody-dependent enhancement, a mechanism of aggravation of the pathology due to the patient’s antibodies) and reduction of the inflammatory response. XAV-19 results from the know-how of XENOTHERA that has been developing humanised polyclonal antibodies since 2015, and that already has a first product in clinical trial. XAV-19 will be administered to hospitalised patients to prevent aggravation of their condition and transition to the stage of acute respiratory distress syndrome which requires intensive care medical management.
Two clinical trials of SAB-185 has been initiated in July 2020 for Ambulatory Participants With COVID-19 and Healthy Participants (NCT04469179, NCT04468958).
May 28,2020: SAB Biotherapeutics Confirms Neutralizing Antibodies to SARS-CoV-2 and Begins Clinical Manufacturing of Novel COVID-19 Therapeutic Candidate.
April 16, 2020: SAB is rapidly advancing the development of an antibody therapeutic to treat COVID-19. We’re on track to have a candidate ready as early as summer 2020. SAB’s cows are immunized every 28 days, and plasma can be collected from each animal three times a month for a monthly total of about 35-45 L DiversitAb platform was used to generate SAB-185, a transgenic cow-derived human polyclonal antibody therapy that is more consistent and easier to scale up than convalescent plasma from recovered COVID-19 patients.
The key effectors in convalescent plasma are neutralizing antibodies, which can block the entrance of the virus into the cells, thus achieving its anti-viral effects. Purified neutralizing polyclonal and monoclonal antibodies could be safer and more potent and are expected to have much higher efficacy than convalescent plasma. With the acquisition of these key intellectual property technologies, ImmuneCyte will be further engaged in the development of anti- COVID-19 polyclonal and monoclonal neutralizing antibodies for COVID-19 treatment.
May 31, 2020: Biocon Biologics India has started clinical trials of its novel biologic itolizumab for treating cytokine storms, which is one of the leading causes of death among critical covid-19 patients.
The drugmaker said that the Phase III randomized, double-blind and placebo-controlled COVACTA trial of Actemra (tocilizumab) in patients hospitalized with severe Covid-19 pneumonia failed to meet its primary endpoint of improvement on a seven-category ordinal scale over the course of 28 days. The study was supported by the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Tocilizumab was first approved in Japan in 2005, and it is currently marketed for rheumatoid arthritis in adults, juvenile rheumatoid arthritis, as well as treatment of chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. Since severe or life-threatening cytokine release is part of the pathology of COVID-19, tocilizumab may help ameliorate symptoms of the disease.
As listed on clinicaltrials.gov on September 7, 2020, sixty clinical trials are currently registerd: four are complete(NCT04320615,NCT04331795,NCT04492501,NCT04519385), seven are active not recruiting, thirty-two are recruiting, one is enrolling by invitation, eleven are not recruiting yet, two are suspended (NCT04370834), two are terminated (NCT04403685,NCT04346355), one was withdrawn.
NCT04369469 is a global Phase 3 study to investigate ULTOMIRIS® (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
TACTIC-R (NCT04390464) is a randomised, parallel arm, open-label platform trial for investigating potential treatment for COVID-19 disease. TACTIC-R will assess the efficacy of the immunomodulatory agents Baricitinib and Ravulizumab as potential treatments for COVID-19 disease against Standard of Care alone.
July 3, 2020: Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo).
Another phase 3 study is not recruiting yet (NCT04534725).
NCT04343651 is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
April 29, 2020: Kiniksa recently announced evidence of treatment response with mavrilimumab from an open-label treatment protocol in 6 non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation in Italy. All 6 of these patients showed an early resolution of fever and improvement in oxygenation within 1-3 days, none of the patients progressed to require mechanical ventilation, and 3 of the patients were discharged from the hospital within 5 days. Mavrilimumab was well-tolerated. An additional 7 non-mechanically ventilated patients with COVID-19 pneumonia and hyperinflammation have since been treated with mavrilimumab. The results from these patients are consistent with the first 6 patients treated. One of the 7 patients was electively intubated and subsequently returned to low-level supplemental oxygen. All 13 patients improved clinically, and 12 out of 13 patients returned home. Kiniksa has engaged with the U.S. Food and Drug Administration (FDA) and is preparing for a potential registrational development program for mavrilimumab in COVID-19 pneumonia and hyperinflammation. In parallel, academic investigators in the U.S. and Italy are planning investigator-initiated placebo-controlled studies. March 31, 2020, Kiniksa Pharmaceuticals announced early evidence of treatment response with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in a treatment protocol in patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation. The treatment protocol was conducted by Professor Lorenzo Dagna, MD, FACP, Head, Unit of Immunology, Rheumatology, Allergy and Rare Diseases IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University in Milan, Italy within a COVID-19 Program directed by Professor Alberto Zangrillo, Head of Department of Anesthesia and Intensive Care of the Scientific Institute San Raffaele Hospital and Professor in Anesthesiology and Intensive Care, Università Vita-Salute San Raffaele. Reference to utility of blocking GM-CSF: Zhou Y, Fu B, Zheng X, et al. Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus. Pre-Print. 2020.
July 27, 2020: Apogenix announced that it has received regulatory approval to start a clinical phase II trial with asunercept in COVID-19 patients in Russia. The ASUNCTIS trial will be a multi-center, randomized, controlled, open-label trial to assess the efficacy and safety of asunercept in patients with severe COVID-19 disease. The plan is to include additional study centers in other European countries, in particular Spain. Published data indicate that the CD95 ligand (CD95L) - the target of asunercept - plays a role in the induction of life-threatening lymphopenia, lung epithelial damage, and inflammatory cell death in COVID-19 patients. By blocking CD95L, asunercept could reduce these complications reported in COVID-19 patients.
EMA PRIME designation for glioblastoma. Endpoints met in Phase 2 study in glioma (as announced in Jan 2014). Granted orphan drug designation from the US Food and Drug Administration (FDA) in 2013 for the treatment of Myelodysplastic syndromes; granted orphan drug designation in 2009 for the treatment of glioblastoma in Europe and in the US.
NCT04582318 is a Phase 1/2 study in Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19 started Nov 8 2020. NCT04465955 Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) recruiting when posted on July 10, 2020.NCT04014777 Phase 1 study recruiting when posted on July 10, 2019. Under a collaboration agreement, Merck will have a one-time right to exercise an option to license NGM621 following human proof of concept.
A pre-publication copy of the manuscript can be accessed at https://www.sciencedirect.com/science/article/pii/S0171298520304459. This study was funded by AIL - Associazione italiana contro le leucemie-linfomi e mieloma (AIL) and by the Italian Association for Cancer research (AIRC, project 5x1000, ID 21147 to AR).
Oct. 12, 2020: ZyVersa Therapeutics, Inc. (ZyVersa), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, is pleased to announce that Frontiers in Immunology has just published a review article titled, The Inflammasome in Times of COVID-19. This article addresses how inflammasome signaling pathways contribute to the hyperactive immune response leading to poor outcomes in patients with COVID-19 infection. It summarizes data on the mechanism of inflammasome activation by COVID-19 infection and the role of inflammasomes in development of common COVID complications, acute respiratory distress syndrome, ventilator-induced lung injury, and disseminated intravascular coagulation. It also addresses potential mechanisms by which inflammasomes may contribute to the damaging effects of inflammation in the cardiac, renal, digestive, and nervous systems of COVID-19 patients. Finally, it addresses inflammasomes as potential drug targets.
The company has secured three clinical candidates in IND-enabling stage and funding from MAB Discovery GmbH, originally generating the licensed antibodies from a novel antibody discovery platform. After 10 years of more than 50 successful monoclonal antibody discovery projects with large Pharma and mid- and large-size Biotech companies, MAB Discovery sold its antibody production platform and laboratory to BioNTech in 2019.
IcanoMAB will use the proceeds to advance the clinical candidates to allow IND-enabling activities and respective partnering activities with selected third parties.
One antibody targets IL-1R7, the signaling domain of the IL-18 receptor. IL-18 has originally been identified as the main inducing factor of IFN-y. In contrast to the IL-18 binding protein (IL-18BP), our IL-1R7 antibody blocks the release of IFN-γ but does not affect the protective/ regenerative activities of IL-18 and IL-37. IL-37 is an anti-inflammatory cytokine that binds to IL-1R5 and IL-18BP and induces signaling via a different co-receptor, IL-1R8. Additionally, inflammasome inhibitors reduce protease activation of IL-18 precursor protein and would be ineffective in the acute IL-18 release situation.
Our data to date support aan effective blockade of IL-18 signaling with subsequent blockade of IFN-y release in primary human cells and the initiation of IND-enabling activities. Initial clinical studies will target acute treatment for severely ill Covid-19 patients and / or patients with Macrophage Activation Syndrome.
JN Nova Pharma and the NRC’s team from the Human Health Therapeutics Research Centre are co-developing a platform therapeutic approach based on multi-functional fusion protein(s) to address complex manifestations of COVID-19. The goal is to both prevent SARS-Cov2 cellular invasion into these tissues and to mitigate pathology triggered by the host response to the virus, including over-activation of immune system and lung and heart failure. Building on previous joint work in the domain of brain diseases, this collaboration will also address severe neurological complications of COVID-19.
JN Nova Pharma will be a development partner for therapeutic modalities arising from this project, enabling accelerated translation through biomanufacturing and towards clinical trials. The first therapeutic lead ‘out the door’ is expected to commence efficacy and biomanufacturability tests in September 2020.
The Company plans to use Canadian manufacturing groups to produce COVID-19 therapeutics for clinical trials in 2021.
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