Companies are developing COVID-19 treatments using monoclonal antibodies, Y-shaped immune proteins that target the pandemic coronavirus.
By Jon CohenSep. 30, 2020 , 5:15 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
A second company has now produced strong hints that monoclonal antibodies, synthetically produced versions of proteins made by the immune system, can work as treatments in people who are infected with the pandemic coronavirus but are not yet seriously ill.
The biotech Regeneron Pharmaceuticals has developed a cocktail of two monoclonal antibodies that attach to the surface protein of that coronavirus, SARS-CoV-2, and attempt to block it from infecting cells. Yesterday at an investor and mediawebcast, the firm revealed early results.
The company showed slides with detailed data from 275 infected people in a placebo-controlled trial that ultimately plans to enroll 2100 individuals who are asymptomatic or, at worst, moderately ill. The analysis divides patients into two groups: those who had detectable antibodies against SARS-CoV-2 at the trials start and those who did not, a so-called seronegative group. The monoclonal cocktail showed little effect on people who already had antibodies against the virus. But it appeared to help the seronegative patients, powerfully reducing the amount of virus found in nasopharyngeal swabs and alleviating symptoms more quickly. These are provocative results, says Myron Cohen of the University of North Carolina, Chapel Hill, who was not involved with the study but is helping Regeneron test its monoclonal cocktail as a preventive.
Cohen notes that Regenerons data look similar to those in a press release from Eli Lilly 2 weeks ago about early results from a trial of its single monoclonal antibody against SARS-CoV-2. Both of these reports go in the same direction, Cohen says. But he cautions that neither has been published, both trials are ongoing, and more data are needed to understand howor whetherthese experimental medicines can best help patients. Lilly, oddly, did not see an impact at the highest dose of antibody tested, and Regeneron saw no difference between its low- and high-dose preparations used in the study.
James Crowe, a viroimmunologist at Vanderbilt University who is working with AstraZeneca to develop COVID-19 monoclonal antibodies, welcomed Regenerons detailed preliminary results. I applaud Regeneron for releasing so much information, Crowe says. Theyre contributing to public health by releasing this as soon as possible. But he notes even people who did well on the monoclonal cocktail still had low levels of virus detectable after their treatment, which in theory could cause problems. I was surprised that there was any virus at all given that these are such potent antibodies, he says, adding that the residual virusdetected in the swab tests may not be capable of copying itself.
The monoclonal antibodies from the two companies are clones of potent SARS-CoV-2 antibodies that can neutralize the virus in test tube studies. Researchers plucked the genes for these antibodies from humans who recovered from COVID-19 or from mice artificially infected with the virus. The companies then put the genes in Chinese hamster ovary cells to bulk manufacturethe antibodies, which were given to the COVID-19 patients as infusions.
At the webcast that announced Regenerons results, George Yancopoulos, president and co-founder of the company, emphasized how the target population for the monoclonal cocktail are SARS-CoV-2 infected people who have not yet mounted their own immune response and have exceedingly high levels of the virus. What we really want to do is turn them into patients who have already started to effectively fight the virus, Yancopoulos said.
In the Regeneron data, the most dramatic drops in SARS-CoV-2 were seen in seronegative patients who had the highest levels of virus at the trials start. In comparison with patients who received the placebo, the results were clearly statistically significant.
Daniel Skovronsky, Lillys chief scientific officer, says the Regeneron data are quite confirmatory of their own. I dont expect there to be large differences between good neutralizing antibodies, Skovronsky says. Antibodies will work best in people who cant clear the virus on their own. One key difference between the two studies, he says, is that Lilly enrolled fewer seronegative people and still found an impactalthough the company, in contrast to Regeneron, is withholding details until it publishes results. Lilly also stressed that people receiving its antibody were shown to have fewer hospitalizations or emergency room visits: five out of 302 (1.7%) treated patients versus nine out of 150 (6%) in the placebo group. Yes, these are small numbers by some measures, Skovronsky says, but by other measures, there are significant differences in hospitalization.
Regeneron hasnt yet accumulated enough data to show the same protection. Its trial had only 12 patients who had COVID-19related medically attended visits. Although there was a trend toward more of these in the placebo group than treatment arms, only one was hospitalized.
Regenerons data raise difficult questions about when to use its cocktail. People who test positive for SARS-CoV-2 arent routinely screened for antibodies to it or for levels of the virus. If the decision is going to be made to deploy such a therapeutic solution in the patients who might benefit the most and need it most, were going to have to solve the problem of using the right point-of-care diagnostic tools, either for serology or high viral load, Yancopoulos said, noting that their partnersincluding Rocheare developing these types of assays.
Skovronsky says Lilly has a simpler plan: Offer monoclonals to people who test positive for the virus if they are in high-risk groups for developing severe disease, which include the elderly and people with underlying diseases such as diabetes or who are overweight. Running extra tests before treating people, as Regeneron suggests, is just not going to meet the needs of the population, he says
Both Lilly and Regeneron say they are discussing their data with regulators to see whether their monoclonal antibodies might warrant moving to widespread use more quickly through mechanisms like the U.S. Food and Drug Administrations emergency use authorization process. Additional studies of their monoclonal treatments are underway in hospitalized COVID-19 patients and, separately, as preventives in uninfected people.
Monoclonal antibodies are more difficult to make than many drugs and often are extremely expensive, which means that supply could outstrip demand and many countries might not be able to afford them. The U.S. governments Operation Warp Speed has invested $450 million in Regeneron to produce up to 300,000 doses of its cocktail by the end of the year, which would be distributed to Americans free of charge. A substantial fraction of those are already available, Yancopoulos saidalthough its not yet clear what constitutes a single dose of the companys cocktail. Nonetheless, Regeneron, which is partnering with Roche to increase production capability, says it hopes to ramp up to produce 250,000 doses per month.
Skovronsky says if the lowest dose Lilly is testing works, it could have up to 1 million doses by the end of the year. Lilly is partnering with Amgen to scale up production to several million doses next year. Were rooting for Regenerons success, just as Regeneron is rooting for Lillys success, he says. None of us can make enough antibodies to meet the need.
Go here to see the original:
'Provocative results' boost hopes of antibody treatment for COVID-19 - Science Magazine
- Hematologist/Stem Cell Biologist to Direct Hematology and Cellular Therapy at Cedars-Sinai - Newswise - December 1st, 2020
- Boston Celtics Kemba Walker will miss time after stem cell injection in left knee, will be re-evaluated in J - MassLive.com - December 1st, 2020
- Stem cell therapy in coronavirus disease 2019: current evidence and future potential - DocWire News - December 1st, 2020
- Hematologist Discusses the Impact a Myeloma CAR T-Cell Approval Would Have on the Treatment Landscape - DocWire News - December 1st, 2020
- Sphingosine 1-phosphate Receptor Modulator ONO-4641 Regulates Trafficking of T Lymphocytes and Hematopoietic Stem Cells and Alleviates Immune-Mediated... - December 1st, 2020
- New Drug Could Improve Effectiveness of Stem Cell Therapy - Pain News Network - December 1st, 2020
- Are stable producer cells the future of viral vector manufacturing and when will allogeneic cell therapy take hold? - BioPharma-Reporter.com - December 1st, 2020
- How Stem Cell Therapy Market Will Dominate In Coming Years? Report Covering Products, Financial Information, Developments, Swot Analysis And... - December 1st, 2020
- The Promise of Using Cell Cultures To Fight SARS-CoV-2 - Technology Networks - December 1st, 2020
- Coronavirus Updates: The Latest Treatments and Vaccines - GovTech - December 1st, 2020
- HCT Deemed More Favorable for MDS That Is High Risk - Cancer Therapy Advisor - December 1st, 2020
- Mini kidneys bioprinted in the lab - Lab + Life Scientist - December 1st, 2020
- Canine Stem Cell Therapy Market Analysis, Overview, Growth, Demand and Forecast Research Report to 2026 - The Haitian-Caribbean News Network - December 1st, 2020
- Stem Cell Therapy Market Size, Share & Trends Analysis Report By Product Types, And Applications Forecast To 2026 - Cheshire Media - December 1st, 2020
- Animal Stem Cell Therapy Market Potential Growth, Size, Share, Demand and Analysis of Key Players Research Forecasts to 2026 - The Haitian-Caribbean... - December 1st, 2020
- Stem Cell Therapy Market Size, Growth, Demand, Opportunities & Forecast To 2025 - Cheshire Media - November 29th, 2020
- Mapping out the mystery of blood stem cells - Science Codex - November 26th, 2020
- Scientists Reveal a New Drug That Directs Stem Cells To Desired Sites - Science Times - November 26th, 2020
- Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in... - November 26th, 2020
- The stem/progenitor landscape is reshaped in a mouse model of essential thrombocythemia and causes excess megakaryocyte production - Science Advances - November 26th, 2020
- Novartis bags Mesoblast's stem cell therapy for ARDS, including in Covid-19, in a deal worth up to $1.2B+ - Endpoints News - November 24th, 2020
- Global Stem Cells Market is estimated to account for US$ 18289.9 Mn by end of 2027, Says Coherent Market Insights (CMI) - Business Wire - November 24th, 2020
- Adherence to Allogeneic Stem Cell Transplantation to Improve Survival in Myelodysplastic Syndromes - Hematology Advisor - November 24th, 2020
- Anakinra: efficacy in the management of fever during neutropenia and mucositis in autologous stem cell transplantation (AFFECT-2)-study protocol for a... - November 24th, 2020
- Physical activity is associated with less comorbidity, better treatment tolerance and improved response in patients with multiple myeloma undergoing... - November 24th, 2020
- CAR T-cell therapy treatment helps cancer patient beat near impossible odds - ABC News - November 24th, 2020
- Correlation of whole-bone marrow dual-time-point (18)F-FDG, as measured by a CT-based method of PET/CT quantification, with response to treatment in... - November 24th, 2020
- Late Effects of Therapy Plague Many Patients Who Survived AML as Youths, Young Adults - AJMC.com Managed Markets Network - November 24th, 2020
- Rescue Therapy with Bendamustine and Other Agents May Result in High Response Rates in Relapsed or Refractory NHL - Curetoday.com - November 24th, 2020
- Genenta to Appoint Stephen Squinto, Experienced Biotech Executive and Investor, as Chairman - BioSpace - November 24th, 2020
- Exploring First-line Therapies in Peripheral T-Cell Lymphomas - Targeted Oncology - November 24th, 2020
- Israeli Scientists Discover Oxygen Beauty Treatment That Can Make You Look 25 Years Younger - All You Need to - India.com - November 24th, 2020
- Novartis licenses phase 3 COVID-19 cell therapy from Mesoblast - FierceBiotech - November 22nd, 2020
- Benefits of Hematopoietic Stem Cell Transplantation in Advanced Myelodysplastic Syndromes - Hematology Advisor - November 22nd, 2020
- YOUR HEALTH: Your body may already have the answer to knee pain - WQAD.com - November 22nd, 2020
- Providing CAR T-Cell Therapy for Patients With DLBCL During COVID-19 - Targeted Oncology - November 22nd, 2020
- BioRestorative Therapies Emerges from Chapter 11 Reorganization - OrthoSpineNews - November 22nd, 2020
- Stem Cell Therapy Market 2020 Trends, Market Share, Industry Size, Growth, Sales, Opportunities, Analysis and Forecast To 2026 - The Daily... - November 22nd, 2020
- Animal Stem Cell Therapy Market 2020 Impact of COVID-19 | Size, Share & Latest Trends, Analysis Report by Manufacturers, Application, Type and... - November 22nd, 2020
- Canine Stem Cell Therapy Market 2020 impact of COVID-19 on Industry Size, Share, Global Analysis, Development Status, Regional Trends, Opportunity... - November 22nd, 2020
- Stem Cell Therapy Market, Share, Application Analysis, Regional Outlook, Competitive Strategies & Forecast up to 2026 - The Daily Philadelphian - November 22nd, 2020
- gift of life marrow registry announces new center for cell and gene therapy - The Boca Raton Tribune - November 22nd, 2020
- Global Canine Stem Cell Therapy Industry Market Analysis, Key Company Profiles, Types, Applications and Forecast To 2026 - Royal Sutton News - November 22nd, 2020
- Increasing Progenitor Cell Proliferation in the Sub-Ventricular Zone: A Therapeutic Treatment for Progressive Multiple Sclerosis? - DocWire News - November 22nd, 2020
- Glycostem initiates phase I/IIa (pivotal) trial to evaluate the safety and efficacy of oNKord in patients with Acute Myeloid Leukemia (AML) -... - November 22nd, 2020
- Impact Analysis of Covid-19 On Global Stem Cell Therapy Market Continues to Expand to Support Development and Top Players: Magellan, Medipost Co.,... - November 22nd, 2020
- Adrenoleukodystrophy Treatment Market: Rising awareness about rare diseases to drive the market - BioSpace - November 22nd, 2020
- AgeX Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update - The Baytown Sun - November 16th, 2020
- Mesenchymal stem cells in the treatment of COVID-19-progress and challenges - DocWire News - November 16th, 2020
- The Animal Stem Cell Therapy market to fill the growth bill in the next decade - The Think Curiouser - November 16th, 2020
- Malaysia Animal Stem Cell Therapy Market Size 2020 | Opportunities, Regional Overview, Top Leaders, Revenue and Forecast to 2027 - Eurowire - November 16th, 2020
- Addenbrooke's becomes first regional centre to offer CAR-T cell treatment for cancer patients - Cambridge Network - November 16th, 2020
- Stem Cell Therapy Market 2020 Industry Size, Trends, Global Growth, Insights And Forecast Research Report 2025 - The Daily Philadelphian - November 16th, 2020
- Mesenchymal stem cells in therapy of coronavirus disease 2019 - a review - DocWire News - November 16th, 2020
- Global cryotherapy market size to reach USD 6.72 billion by 2026 - GlobeNewswire - November 16th, 2020
- Stem Cell Therapy Market 2020 Future Growth Factors and Opportunities by 2025 - PRnews Leader - November 16th, 2020
- Stem Cell Therapy Market 2020 Trends, Growth Insight, Share, Competitive Analysis, Statistics, Regional and Global Industry Forecast To 2025 - PRnews... - November 16th, 2020
- BeyondSpring Announces Positive Topline Results from its PROTECTIVE-2 Phase 3 Registrational Trial of Plinabulin in Combination with Pegfilgrastim for... - November 16th, 2020
- Stem Cell Banking Market To See Massive Growth By 2027| Cryo-Save AG, StemCyte India Therapeutics, SMART CELLS PLUS, Vita 34, LifeCell - PRnews Leader - November 9th, 2020
- It's time for Kentucky to talk to expectant parents about benefits of cord blood banking - Courier Journal - November 9th, 2020
- Global Stem Cell Therapy Market 2020 : Analysis of Expansion Strategy on Industry, Growth Factors and Expected CAGR Of Top Leaders, Upcoming... - November 9th, 2020
- Stem Cell Banking Market 2020 analysis with Key Players, Applications, Trends and Forecasts by 2028|Esperite, Caladrius Biosciences, Via Cord, CBR... - November 9th, 2020
- Doctors Consider Convalescent T Cell Therapy for COVID-19 - The Scientist - November 7th, 2020
- Canine Stem Cell Therapy Market Analysis, Latest Trends and Regional Growth Forecast by Types and Applications 2020 - TechnoWeekly - November 7th, 2020
- Cancer Stem Cell Therapy Market: Industry Trends and Developments 2020-2025 - Zenit News - November 7th, 2020
- Stem Cell Therapy Market 2020: Size, Professional Survey, and Forecast to 2025 - PRnews Leader - November 7th, 2020
- The Adipose Tissue Derived Stem Cells market to grow in the wake of incorporation of the latest technology - The Think Curiouser - November 7th, 2020
- Novel Targeted Drugs are Changing the Treatment of Diffuse Large B-Cell Lymphoma - Curetoday.com - November 7th, 2020
- Equillium Announces Positive Interim Data of Itolizumab in the First-line Treatment of Acute Graft-Versus-Host Disease - GlobeNewswire - November 7th, 2020
- Orchard Therapeutics Announces New OTL-201 Clinical Data in Sanfilippo Syndrome Type A (MPS-IIIA) Accepted for Oral Presentation at 62nd American... - November 7th, 2020
- bluebird bio to Present Data from Gene and Cell Therapy Programs During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition -... - November 7th, 2020
- Voters approve stem cell research bonds, but other health care measures defeated - State of Reform - State of Reform - November 5th, 2020
- Stem cells key to ALS therapy - Agoura Hills Acorn - November 5th, 2020
- Development and validation of a novel stem cell subtype for bladder cancer based on stem genomic profiling. - UroToday - November 5th, 2020
- New-onset Post-transplant Diabetes and Therapy in Long-term Survivors After Allogeneic Hematopoietic Stem Cell Transplantation - DocWire News - November 5th, 2020
- Emerging Trends in Global Canine Stem Cell Therapy Market Report 2020,Deeply Analyzes Share, Types, Applications and Future Demands by Key Players-... - November 5th, 2020
- Dr. Braunschweig on Selecting Between Transplant and CAR T-Cell Therapy in DLBCL - OncLive - November 5th, 2020
- Canine Stem Cell Therapy Market Size, Share Analysis by Manufacturers, Regions, Type and Application to 2026 - PRnews Leader - November 5th, 2020
- Stem Cell Therapy Market Insights Global Analysis and Forecast by (2020 2027) - The Think Curiouser - November 5th, 2020
- Animal Stem Cell Therapy Consumption Market To Observe Exponential Growth By 2020-2027 | Verified Market Research - Eurowire - November 5th, 2020