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Infographic – Israel Halts Covid-19 Spread with Vaccines

Chart: Covid-19 cases in Israel

Click on image for full-size view (Statista)

17 Apr. 2021. Israel is emerging as the world’s leader in vaccinating its population, and seeing results in declines of new Covid-19 cases. This weekend’s infographic, compiled by business research company Statista from Our World in Data,  portrays that country’s progress against Covid-19, marking when its vaccination program began and today’s status.

The chart shows Israel started its Covid-19 vaccinations in December 2020, and as of 11 Apr. vaccinated 57 percent of its population in Israel proper. The country benefits from a centralized health care system and standard health care records, as well as continued mask mandates and little reported vaccine hesitancy. In addition, Israelis can display their vaccination records on a mobile app, which allows them to use gyms and swimming pools, and go to concerts.

Israel still faces challenges, however. The country has so far escaped the B.1.35 variant from South Africa that some clinical trials show is more resistant to current vaccines. And vaccinations in the West Bank territories, outside of Israeli settlements, are going much slower; the chart above excludes the occupied territories. The Palestinian Authority relies on vaccines supplied from the Covax facility, and donations from United Arab Emirates and other wealthier Arab states.

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AI Drug Discovery Company Acquired in $270M Deal

Four fist bump

(Mohamed Hassan, Pixabay. https://pixabay.com/photos/paper-business-finance-document-3213924/)

16 Apr. 2021. A biotechnology company using protein dynamics to develop precision cancer therapies is acquiring a drug discovery company based on machine learning algorithms. Relay Therapeutics in Cambridge, Massachusetts is buying ZebAI Therapeutics in Waltham, Mass. in a deal that could bring ZebAI shareholders as much as $270 million if all terms of the agreement are fulfilled.

ZebAI applies machine learning, a form of artificial intelligence, to discover new small-molecule or low molecular weight drugs. The company’s algorithms explore interactions between proteins in the body and large-scale libraries of small molecule chemical entities found in commercial and other available databases, including experimental data. Those interactions train the company’s algorithms for discovering new drugs, as described in a paper published in Journal of Medicinal Chemistry in June 2020. In the paper, a team from ZebAI analyzed some 2,000 molecules in DNA-encoded molecular libraries against three protein targets, returning a 29 percent hit rate, and finding potent inhibitors for each of the three proteins.

Earlier in 2020, ZebAI began a collaboration with Google Accelerated Science that applies artificial intelligence to research, for improving discovery of small molecule drug candidates with machine learning. Their initiative called Chemistry of the Genome or Chemome, engages academic researchers to follow-up on new protein/small molecule discoveries and provide a better understanding of those chemical interactions for therapies.

Relay Therapeutics discovers therapies for diseases considered difficult to treat, using methods based on protein movement and dynamics. Most conventional research, says the company, treats proteins as static entities, but Relay’s technology, called Dynamo, discovers drugs by analyzing the dynamics of proteins, which combines the structure of protein molecules, with chemistry, biophysics, and computational techniques.

Applies technology to precision cancer therapies

The company applies the Dynamo technology to precision cancer treatments addressing specific molecular targets, rather than cancers found in specific organs or tissue. One of its lead candidates, code-named RLY-1971, binds to and stabilizes SHP2 proteins that drive proliferation of cancer cells and support resistance to targeted therapies. Relay believes RLY-1971 can block the route some cancers use to avoid other cancer treatments, thus overcome resistance by some cancers to therapy.

Another Relay therapy candidate in an early-stage clinical trial is code-named RLY-4008, designed to limit the protein fibroblast growth factor receptor 2, or FGFR2. The FGFR2 protein plays a key role in bone growth, but is also implicated in several solid tumor cancers. Relay says in preclinical studies, RLY-4008 shows promise in cancer of bile ducts, and the company is testing the drug in clinical trials against specific molecular targets, while not affecting other fibroblast growth factor receptor proteins.

“The combination of ZebiAI’s approach with our Dynamo platform,” says Relay Therapeutics president Sanjiv Patel in a company statement, “has the potential to predict more drug-like chemical starting points, reduce cycle time to compound optimization, and ultimately, increase the number and range of programs that can be developed in parallel.”

The acquisition agreement calls for Relay Therapeutics to pay ZebAI shareholders $20 million in cash and $65 million in Relay common stock. ZebAI shareholders are also eligible for another $85 million for achieving certain platform and program milestones, payable as well in Relay stock. In addition, if Relay Therapeutics makes any collaboration deals for work involving ZebAI’s technology in the next three years, ZebAI shareholders will receive in cash 10 percent of the proceeds from those agreements up to $100 million.

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Lilly Asks FDA to Revoke Covid-19 Therapy Clearance

SARS-CoV-2 and cell

Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)

16 Apr. 2021. Drug maker Eli Lilly and Co. asked the Food and Drug Administration to revoke its authorization for bamlanivimab alone to treat for Covid-19 infections. The pharmaceutical maker says its synthetic monoclonal antibody bamlanivimab by itself does not neutralize emerging SARS-CoV-2 variants as well as bamlanivimab combined with etesevimab, another of its antibodies.

Bamlanivimab was authorized by FDA as a treatment for infections from the original strain of SARS-CoV-2 causing mild to moderate symptoms. As reported by Science & Enterprise in February, FDA also authorized bamlanivimab combined with etesevimab to treat non-hospitalized people with Covid-19 infections showing mild to moderate symptoms, but considered at high risk for severe symptoms of the disease.

Lilly says bamlanivimab with etesevimab neutralizes more of the newer strains of the SARS-CoV-2 virus responsible for Covid-19 infections, including the B.1.427/B.1.429 strain that now accounts for half of the virus in California and is spreading to other states. The company developed the dual-antibody cocktail for the eventual emergence of viral mutations that resist one of the antibodies working alone.

The company says it expected new variants to arise, and the request to revoke the authorization will encourage transition to the bamlanivimab/etesevimab combination. “With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize,” says Lilly’s chief scientist Daniel Skovronsky in a company statement, “and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together.”

Lilly is collaborating with fellow drug maker Amgen to manufacture bamlanivimab and etesevimab to meet global needs. The company says it plans to submit the dual-antibody cocktail to health authorities worldwide for regulatory review, and expects a full transition to the two-drug combination by June of this year.

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Novavax Joins Alternative Second Shot Vaccine Trial

Syringes

(Pikist)

15 Apr. 2021. Vaccine developer Novavax is taking part in a clinical trial testing effects of different Covid-19 vaccines in first and second immunizations. The Gaithersburg, Maryland company is joining the clinical trial conducted by the Vaccine Research Group at University of Oxford in the U.K., along with vaccines against the SARS-CoV-2 virus made by BioNTech/Pfizer, Moderna, and Oxford/AstraZeneca.

Most vaccines protecting against the SARS-CoV-2 virus use two doses, a primer dose to prepare the immune system, and a booster dose some weeks later. Vaccines are authorized today to be given to individuals with the same vaccine in both doses, not mixed. And the two-dose vaccines have not yet been tested in humans as mixed combinations. The trial, called Comparing Covid-19 Vaccine Schedule Combinations, or Com-Cov2, aims to discover if the vaccines’ efficacy is different when they’re mixed in the two doses, as well as any adverse effects.

The mid-stage Com-Cov2 trial began in the spring of 2020, with Novavax’s candidate vaccine code-named NVX-CoV2373 now one of the alternatives being tested. NVX-CoV2373 is made with a technology that generates nanoscale particles of synthetic proteins designed specifically against the genetic code of their targets. In this case, the target is the protein on the surface of the SARS-CoV-2 virus’s spike that penetrates and infects host cells. The two-dose vaccine is combined with the company’s vaccine adjuvant called Matrix-M, an additive that boosts immune responses, allowing for lower doses of the primary vaccine.

Enrolling people with one vaccine dose so far

Com-Cov2 is enrolling 1,050 individuals age 50 and over in the U.K. who received their first dose of either the Oxford/AstraZeneca or BioNTech/Pfizer vaccine in the previous eight to 12 weeks, but not their second dose. Each person in both groups is then randomly assigned to receive either the same vaccine or one of the Moderna or Novavax vaccines. The Oxford researchers are looking primarily for production of immunoglobulin G antibodies produced by participants after 28 days. The study team is also tracking local or systemic reactions to the vaccines, as well as adverse effects, immediately and seven days after the shots. And the researchers are measuring T-cell responses from the vaccines, as well as antibodies produced.

“Novavax’s addition to this important study,” says Novavax’s chief medical officer Filip Dubovsky in a company statement, “reflects the urgency of finding innovative ways to protect as many people as possible in a dynamic pandemic landscape. The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus.”

Novavax’s NVX-CoV2373 is being tested in late-stage clinical trials in the U.K., and the U.S. and Mexico. The U.S./Mexico trial began in December 2020 is still ongoing. In the U.K. trial, as reported in Science & Enterprise in January 2021, NVX-CoV2373 recorded an efficacy rate of 96 percent for the original SARS-CoV-2 variant and 86 percent for the B.1.1.7 variant active in the U.K., and now the dominant strain in the U.S. A mid-stage study in South Africa showed an overall efficacy rate of 49 percent against the B.1.35 variant dominant in that country, but 60 percent among individuals testing negative for HIV infections.

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Disclosure: The author owns shares in Pfizer.

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Synthetic DNA Company Raises $24M in Early Funds

DNA illustration

(Nogas1974, Wikimedia Commons)

15 Apr. 2021. A company with a technology it says is simpler and more like natural processes to produce synthetic DNA is raising $24 million in its first venture round. Molecular Assemblies Inc. in San Diego says it produces synthetic nucleic acids with fewer steps, non-toxic enzymes, and at a lower cost than most current processes.

Molecular Assemblies aims to provide synthetic DNA on demand as a raw material for biotechnology solutions in the life sciences and industry. The company says it uses a water-based technology to produce synthetic DNA with non-toxic enzymes more like natural processes, which means a more sustainable technique with less toxic waste. Molecular Assemblies claims its simpler process requires fewer post-processing steps which means a lower cost of production. And the company says it can produce longer strands of synthetic DNA than most other current methods.

While the company’s first markets are in the life sciences, Molecular Assemblies envisions other markets for synthetic DNA with industrial chemicals, in biofuels, agricultural applications, and bio-based materials like synthetic leather and spider silk. The company also believes synthetic DNA can advance emerging hybrid bio-electronic chips that program genetic outcomes with integrated circuits using DNA.

Producing vaccines and therapies on demand

A more immediate need, however, is storing exploding volumes of computer data. Advances in informatics, such as artificial intelligence, the Internet of things, and autonomous vehicles, are expected to create massive data volumes that stretch current data storage facilities like conventional data centers beyond their limits. As reported by Science & Enterprise in November 2020, Molecular Assemblies is taking part in the DNA Data Storage Alliance, an industry coalition to advance DNA as a data storage medium.

While the company was founded in 2013, its business activity accelerated in the past 12 months. In June 2020, Molecular Assemblies began a collaboration with synthetic protein company Codexis in Redwood City, California to produce engineered enzymes for synthetic DNA. Codexis is also an investor in Molecular Assemblies’ first venture round. In March of this year, Molecular Assemblies joined with GE Research in a Defense Advanced Research Projects Agency, or Darpa, program to produce synthetic nucleic acids for producing DNA-and RNA-based vaccines and therapies on demand.

“We have made significant progress in advancing our proprietary enzymatic DNA synthesis technology,” says Molecular Assemblies CEO Michael Kamdar in a company statement. “Over the past year, we’ve entered into a transformative partnership with Codexis and joined a new project with GE Research to enable the production of nucleic acid-based vaccines and therapeutics, anywhere in the world.”

Molecular Assemblies is raising $24 million in its first venture funding round, with investments by Agilent Technologies, iSelect Fund, Codexis, Alexandria Venture Investments, Argonautic Ventures, and LYFE Capital. The company expects to apply the round’s proceeds to advancing its technology closer to commercial scale.

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Mobile App Studied to Measure Kidney Disease Anemia

Red blood cells illustration

(Arek Socha, Pixabay. https://pixabay.com/illustrations/blood-cells-red-medical-medicine-1813410/)

14 Apr. 2021. A smartphone app designed to non-invasively estimate hemoglobin levels is being assessed for its ability to measure anemia in chronic kidney disease patients. Sanguina Inc. in Atlanta, developer of the AnemoCheck Mobile app, is partnering on the project with drug maker AstraZeneca and NephroNet, an advocacy organization for kidney disease research.

AnemoCheck Mobile is an app that estimates hemoglobin levels in blood by analyzing photos taken by a smartphone camera of an individual’s fingernails. Hemoglobin is a protein in red blood cells that carries oxygen to the body, and individuals with anemia have severely or continuously low hemoglobin levels. Conventional methods for measuring blood hemoglobin levels require blood samples, specialized equipment, or separate lab analysis, usually with a high cost in money and time.

The AmenoCheck Mobile app analyzes photos of an individual’s fingernails to estimate hemoglobin levels. Fingernails are an easily accessible part of the body’s surface without melanocytes, cells that provide coloring to the skin. As a result, any change in skin color can be attributed to changes in hemoglobin. Fingernail images taken by the camera are assessed with an algorithm developed by Sanguina, based on research by the app’s developers while at Emory University and Georgia Tech. The app calibrates skin tone levels for each individual, then can track even small changes in skin pallor under the nail over time. A December 2018 article in the journal Nature Communications describes the app and test results estimating hemoglobin levels compared to conventional blood tests.

Anemia common in people with chronic kidney disease

The collaboration with AstraZeneca and NephroNet aims to evaluate AmenoCheck Mobile for measuring anemia in people with chronic kidney disease. Chronic kidney disease is long-term damage often from diabetes or high blood pressure that prevents kidneys from functioning properly, thus impairing their filtering of blood. Anemia is a common complication of chronic kidney disease, particularly in more advanced cases. Sanguia cites data from the National Health and Nutrition Examination Survey showing some 39 million adults in the U.S. had chronic kidney disease in 2017, with about one in six individuals with chronic kidney disease also having anemia.

The study calls for Sanguia to train the AmenoCheck Mobile algorithm for people with chronic kidney disease. Then after the training, researchers will test the app’s hemoglobin estimates against conventional blood test measurements. The company says people in minority ethnic and racial communities will be recruited for the study, since they are at higher risk for chronic kidney disease.

“”This partnership,” says Sanguina CEO and founder, Erika Tyburski, in a company statement released through Cision, “will allow us to further test and demonstrate the unique capabilities of AnemoCheck Mobile so that we can empower patients with innovative solutions to help manage their health. As someone who has experienced anemia, I know personally the impact it has on quality of life and peace of mind. I look forward to helping improve other patients’ lives for the better.”

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Nine Campuses Join Rural Food Research Fund

Grain storage structure

Grain storage structure in Iowa (A. Kotok)

14 Apr. 2021. Nine universities in the U.S. are taking part in a program supporting research and entrepreneurs developing food and agricultural solutions in rural areas. Big Idea Ventures in New York says the nine universities are joining its $125 million Generation Food Rural Partners fund to support and commercialize campus research discoveries that benefit rural economic development.

Big Idea Ventures is a venture capital investor with start-up accelerators for new companies developing alternative food and agriculture products. The company also funds first full venture rounds of enterprises beyond the immediate start-up phase. In January 2021, BIV began the Generation Food Rural Partners fund, that sponsors university research in alternative protein sources, food technologies, agricultural innovations, and invests in new companies to commercialize those advances. And while the new start-ups may locate in the vicinity of university campuses, those locations must be in rural communities. The fund expects to invest $125 million in these projects.

The Generation Food Rural Partners fund selected its first campus collaborator in January, the College of Agriculture and Life Sciences at North Carolina State University in Raleigh. Yesterday, BIV announced nine more university departments or research centers joining the program:

Louisiana State University, College of Agriculture, in Baton Rouge

Oregon State University, College of Agricultural Sciences, in Corvallis

Penn State University in University Park, through its Invent Penn State initiative

Purdue University in West Lafayette, Indiana

Tufts University, School of Nutrition Science and Policy, in Boston, Mass.

University of Hawai‘i, Manoa campus

University of Illinois at Urbana-Champaign, College of Agricultural, Consumer and Environmental Sciences

University of Massachusetts – Amherst, Institute for Applied Life Sciences

Worcester Polytechnic Institute in Mass., Center for Advanced Research in Drying

BIV says the Generation Food Rural Partners or GFRP fund’s 10 campus partners conduct research supporting the company’s focus on food, protein, and agricultural innovation. The company expects to assign specialists to campus venture centers to review research at those universities and identify developments with the greatest commercial potential. New businesses formed to commercialize those developments then become candidates for financing from the fund.

“We believe GFRP will drive additional research and encourage entrepreneurs to establish their companies near our venture centers in rural America,” says Andrew Ive, BIV’s founder and managing partner in a company statement. “Our rural communities have always been the center of our country’s food production and this is one way to help those communities continue to grow economically into the future.”

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Gene Therapy Company Exploring DNA Circuit Technology

Circuit graphic

(Gerd Altmann, Pixabay)

13 Apr. 2021. Spark Therapeutics, a developer of gene therapies, is gaining access to a technology that programs DNA sequences like integrated electronic circuits. The agreement with Spark Therapeutics in Philadelphia could bring Senti Biosciences in South San Francisco, California more than $645 million if all terms of the deal are fulfilled.

Spark Therapeutics, a subsidiary of global drug maker Roche, is a pioneer in developing therapies addressing inherited diseases. The company is collaborating with Senti Biosciences on designing more precisely targeted gene therapies against unspecified cell targets in the central nervous system, eyes, and liver. With that partnership, Spark gains an option to license Senti Bio’s DNA circuit technology for those applications.

Up to now, Senti Bio designed therapies with computer-like logic from synthetic genes programmed to operate like software in engineered immune system cells. The company’s DNA circuit therapies allow for cells to be programmed with instructions from synthetic genes, providing more control over delivery of therapies to address varying levels of severity, and even multiple illnesses at once.

Moreover, says the company, DNA circuits can be designed, built, and tested with much the same iterative development approach as integrated circuits. And, says Senti Bio, DNA circuits can act as “smart sensors” for disease indicators to deliver treatments to precise locations in the body, and build in safeguards against adverse effects.

Smart sensors are designed to contain DNA circuits called synthetic promoters that precisely control expression of therapeutic genes. “We view gene circuits,” says Senti Bio CEO Tim Lu in a company statement, “as a critical component of any advanced cell and gene therapy, regardless of therapeutic area or delivery modality.”

Option to license synthetic promoter DNA circuits

Spark Therapeutics plans to adapt Senti Bio’s technology, including smart sensors, for gene therapies that deliver treatments to specific types of cells or meeting precise therapeutic conditions. The agreement calls for Senti Bio to design, build, and test synthetic promoter DNA circuits for gene therapies targeting specified, but undisclosed, central nervous system, eye, and liver disorders.

“We look forward to leveraging Senti Bio’s high-throughput synthetic promoter capabilities,” says Spark’s chief scientist Federico Mingozzi in a company statement, “to develop novel gene therapies directed toward specific cell types in the central nervous system, eye or liver.”

The deal gives Spark Therapeutics an option to exclusively license synthetic promoter circuits developed under the agreement. Should Spark go ahead with licensing, the company will be responsible for further preclinical and clinical development, as well as commercialization of gene therapies using Senti Bio’s synthetic promoters.

Spark is paying Senti Bio an unspecified initial fee, and funding its research under the agreement. In addition, Senti Bio is eligible for payments once the option is exercised, and for achieving specified development, regulatory, and sales milestones, as well as royalties on sales. Total value of these payments may exceed $645 million.

Senti Bio is a three year-old company, founded by researchers in biology and engineering at Harvard University, Boston University, and MIT. Science & Enterprise reported on the company’s start-up in February 2018 and second venture funding round in January 2021.

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Vaccine Stops Lyme Bacteria in Preclinical Test

Adult deer tick

Adult deer tick (U.S. National Park Service)

13 Apr. 2021. A study with lab mice shows an experimental vaccine with engineered bacteria produces antibodies and protects against microbes causing Lyme disease. A team from the biotechnology company Intravacc in Bilthoven, The Netherlands, and University of Amsterdam medical center describe the vaccine and test results in the 1 April issue of the journal Vaccine.

Lyme disease is an infection from Borrelia burgdorferi bacteria spread by bites from deer and black legged ticks already infected by the bacteria. Symptoms include fever, headache, fatigue, and a characteristic skin rash, and if caught quickly can be treated with antibiotics. If left untreated, however, Lyme disease can spread to the joints, heart, and nervous system. Centers for Disease Control and Prevention says some 30,000 cases of Lyme disease are reported each year in the U.S., while Intravacc cites data showing an estimated 85,000 cases per year in EU countries.

Intravacc develops vaccines with a technology that produces spherical containers resembling outer membranes of bacteria. The company generates these outer membrane vesicles, as they’re called, from meningococcal bacteria, engineered for vaccine delivery and rendered non-toxic to humans. Intravacc says its outer membrane vesicles act as a delivery vehicle for vaccines, as well as an adjuvant or booster. For its Lyme disease vaccine, the outer membrane vesicle expresses the outer surface protein of Borrelia burgdorferi to invoke an immune response against the bacteria.

High concentrations of antibodies

Researchers from Intravacc and University of Amsterdam injected groups of eight lab mice with the Intravacc Lyme disease vaccine, or empty outer membrane vesicles or OMVs for comparison, in three installments each 14 days apart. The results show mice receiving the Intravacc vaccine had high concentrations of anti-Borrelia immunoglobulin G antibodies, while the comparison mice with empty vesicles produced no antibodies.

The team also vaccinated groups of eight mice with the Intravacc vaccine or empty outer membrane vesicles, then injected the mice under the skin, similar to tick bites, with live Borrelia bacteria. After 20 days, blood and organs from all but one of the vaccinated mice showed no Lyme disease infections, while all of the comparison mice developed infections. In addition, vaccinated mice had lower Borrelia bacterial loads than the comparison mice.

The authors conclude the tests show the Intravacc vaccine generates antibodies against Borrelia bacteria and protects against Lyme disease infections in mice, but further preclinical tests are needed with actual tick bites rather than simulated needle injections. Nonetheless, say the authors, the vaccine appears promising for eventual human trials.

“We show that it is possible to couple OMV to external antigens,” says Intravacc CEO Jan Groen in a company statement, “and that the bacterium can also be modified to express the antigens.” Groen adds that “the platform can be utilized for vaccine development for virtually any disease.”

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Antibody Cocktail Prevents Covid-19 Disease Symptoms

Intradermal injection

Intradermal injection (British Columbia Institute of Technology, Wikimedia Commons, https://commons.wikimedia.org/wiki/File:Intradermal_injection.jpg)

12 Apr. 2021. A clinical trial shows two synthetic antibodies given together reduce the risk of symptomatic infections among household members of Covid-19 patients. Other findings from the trial show the antibody cocktail, made by Regeneron Pharmaceuticals Inc. in Tarrytown, New York, helps prevent individuals already infected with SARS-CoV-2 viruses from developing Covid-19 disease symptoms. The results are released by Regeneron and are not peer reviewed.

In the trial, Regeneron tested its antibody therapy for Covid-19, code-named Regen-Cov, as a preventive drug against SARS-CoV-2 infections. Regen-Cov is a combination of the company’s synthetic antibodies casirivimab and imdevimab authorized by the Food and Drug Administration in November 2020 as a treatment for non-hospitalized Covid-19 patients with mild to moderate symptoms.

The company designed the casirivimab and imdevimab cocktail to be given as an intravenous infusion for neutralizing the SARS-CoV-2 virus responsible for Covid-19 infections. The antibodies attach to separate receptor binding domains of the SARS-CoV-2 spike protein that enters and begins infecting cells. Notably, Regeneron reformulated Regen-Cov for the trial to be given as an injection under the skin, instead of an infusion as given as a therapy.

The late-stage clinical trial enrolled 3,750 participants without Covid-19 symptoms at 134 sites mainly in the U.S., all household contacts of people with Covid-19 infections. The study, conducted with National Institute of Allergy and Infectious Diseases, or NIAID, at National Institutes of Health, includes participants in different age groups randomly assigned to receive 1,200 milligrams of Regen-Cov or a placebo.

Among participants in the trial are 1,505 individuals without SARS-CoV-2 infections, divided almost evenly between Regen-Cov or placebo recipients. The results show, after 29 days, 11 Regen-Cov recipients or 1.5 percent developed SARS-CoV-2 infections, compared to 59 placebo recipients, or 7.8 percent. When calculated in terms of infection risk, Regen-Cov recipients show an 81 percent lower risk than placebo recipients.

No Regen-Cov recipients hospitalized

In addition, Regen-Cov recipients who developed Covid-19 symptoms cleared their symptoms in 1.2 weeks on average, compared to 3.2 weeks for placebo recipients. And infected Regen-Cov recipients experienced high viral loads for less than three days on average, compared to nine days for those receiving a placebo.

Also among participants in the trial are 204 participants with recent SARS-CoV-2 infections, but not exhibiting Covid-19 symptoms, randomly assigned to receive Regen-Cov or a placebo. Among Regen-Cov recipients, 29 percent later developed Covid-19 symptoms, compared to 42 percent of placebo recipients, a 31 percent lower risk of symptoms, and a difference large enough for statistical reliability. None of the Regen-Cov recipients required hospitalization for their symptoms, while six of the placebo group were hospitalized.

Among the 1,505 non-infected participants, adverse events were reported in 20 percent of Regen-Cov and 29 percent of placebo recipients, with one percent of each group reporting serious adverse effects. In the group of 204 SARS-CoV-2 infected participants, about one-third (34%) of Regen-Cov recipients, and nearly half (48%) of placebo recipients experienced adverse effects, with none of the Regen-Cov and three percent of placebo group rated as serious.

Regeneron says among the non-infected participants, 41 percent are of Hispanic origin and nine percent are Black Americans, with 31 percent having at least one high-risk factor of severe Covid-19 disease, such as obesity or age 50 and over. Among the infected participant sample, 35 percent are of Hispanic origin five percent are Black, and 32 percent exhibit at least one high-risk severe disease factor.

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