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FDA: Merck COVID Pill Effective, Experts Will Review Safety

AHA Publisher — Wed, 01 Dec 2021 08:00:16 +0000

Matthew Perrone via CBN News – Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice. The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals. Given those risks, the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases. Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients. Given the safety concerns, FDA said Merck agreed the drug would not be used in children. Other side effects were mild and rare, with about 2% of patients experiencing diarrhea. Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies. “While the clinical safety database was small, there were no major safety concerns identified,” FDA reviewers concluded. Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants. FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks. All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K. The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans. The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to stop the virus from reproducing. But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or even spur more virulent strains of the virus. Pregnant women were excluded from Merck’s study, and both women and men in the study were instructed to use contraception or abstain from sex. For its part, Merck says results from two company studies in rodents show the drug does not cause mutations or damage to DNA at the doses studied. FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalization and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems. However, on Friday morning Merck announced updated results from the same study that showed a smaller benefit from the drug. The FDA said it is still reviewing the updated data and would present a new assessment of the drug’s effectiveness next Tuesday. Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results. Nearly 7% of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10% of patients hospitalized who were taking the placebo and nine deaths. Merck didn’t study its drug in people who were vaccinated for COVID-19. But the FDA will ask advisers to recommend which patients may stand to benefit the most from the drug, based on vaccination status and underlying health problems. While Merck’s drug is likely to be the first pill for coronavirus in the U.S., more are expected to follow. Rival drugmaker Pfizer has submitted its own antiviral for FDA review after initial study results showed it cut the combined rate of hospitalization and death by nearly 90%. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns that have been raised with Merck’s drug. To read the original article click here.

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Landmark Discovery May Lead to Safe, Effective Antiviral Drugs Against COVID-19

AHA Publisher — Fri, 09 Apr 2021 07:00:03 +0000

Argonne National Laboratory via News-Medical – The COVID-19 vaccines currently rolling out are providing hope that the spread of the disease can be halted. But infection rates are still high, and for those who contract COVID-19, the search for effective treatments remains important. Researchers examining the atomic structure of SARS-CoV-2, the virus that causes COVID-19, have made a landmark discovery that could contribute critical information to the design of safe and effective antiviral drugs in the fight against the virus. “Understanding enzymes goes hand in hand with understanding their atomic structures -; and the higher resolution the better, because subtle differences can affect the interpretation. We wanted the best data possible, so we went to the APS.” (Natalie Strynadka, University of British Columbia) Using a powerful X-ray beam to study SARS-CoV-2 proteins in crystallized form, a team from the University of British Columbia (UBC) has observed -; for the first time ever -; the virus’s main protease, an important enzyme of the virus, performing its function. This widely pursued antiviral target is a central enzyme that allows the virus to cut up large proteins called polyproteins into smaller functional units, a process necessary for the virus to be replicated and infect other human cells. “What we’ve captured at high resolution is one of the important steps in that process that has never been visualized before in any viral protease of this class,” said Natalie Strynadka, the UBC biochemistry professor who led the research team with colleague Mark Paetzel. The research was published in Nature. The breakthrough was made possible by the Advanced Photon Source (APS), a U.S. Department of Energy (DOE) Office of Science User Facility at DOE’s Argonne National Laboratory. The APS produces X-rays that are roughly a billion times brighter than those used by doctors and dentists, allowing researchers to examine the structure of the coronavirus protease in very fine detail at the atomic level. Data was captured at the General Medical Sciences and Cancer Institutes Structural Biology Facility at beamline 23-ID-B at the APS. The newly uncovered information may be of particular interest to scientists worldwide who are racing to develop antiviral treatments for COVID-19. If the main protease is inhibited by a small molecule drug, the polyproteins won’t be clipped into functional pieces, effectively blocking viral replication and subsequent transmission. “We now have a much better blueprint of these mechanistic structures that will inform making the best inhibitor possible,” Strynadka said. ”Better knowing the structure as we now do helps guide drug research, narrowing the field of potential targets instead of having to screen billions of potential molecules.” Michael Becker, a protein crystallographer with Argonne’s X-ray Science Division, said Strynadka’s research stands out because the team was focused on understanding the mechanism of the protease. “This understanding will improve everyone else’s work in designing drugs,” Becker said. ”Because the more deeply you understand how something works, the better the chance you have of controlling or stopping it.” Remote access capabilities at Argonne made it possible for the researchers in British Columbia to collect data in real time and to manipulate the APS beamline located about 2,200 miles away in Illinois. UBC team members Jaeyong Lee and Liam Worrall shipped crystals of the SARS-CoV-2 main protease preserved in liquid nitrogen from Canada to Argonne. Workers at the APS were on hand to answer questions, ensure the working order of the equipment, and load the samples. “The remote interface is fantastic. It’s almost like being there,” Strynadka said. ”We’re very thankful for the use of the APS. Canada does have a national synchrotron facility, but it currently doesn’t have the same capability as the APS, which is a very high-level facility with micro-focused beams. Understanding enzymes goes hand in hand with understanding their atomic structures -; and the higher resolution the better, because subtle differences can affect the interpretation. We wanted the best data possible, so we went to the APS.” To read the original article click here.

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Cannabis Compound Inhibits SARS-CoV-2 Replication in Human Lung Cells

AHA Publisher — Mon, 22 Mar 2021 07:00:34 +0000

Sally Robertson, B.Sc. via New-Medical – Researchers in the United States have conducted a study showing that a cannabis plant compound inhibited infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human lung cells. SARS-CoV-2 is the agent responsible for the coronavirus disease 2019 (COVID-19) pandemic that continues to sweep the globe posing a threat to global public health and the worldwide economy. Marsha Rosner from the University of Chicago in Illinois and colleagues found that cannabidiol (CBD) and its metabolite 7-OH-CBD potently blocked SARS-CoV-2 replication in lung epithelial cells. The CBD inhibited viral gene expression and reversed many of the effects the virus has on host gene transcription. The compound also induced the expression of interferons – cell signaling proteins that are produced by host cells as an early response to viral invasion. Furthermore, the incidence of SARS-CoV-2 infection was up to an order of magnitude lower in a cohort of patients who had been taking CBD, compared with matched patients who had not been taking CBD. “This study highlights CBD, and its active metabolite, 7-OH-CBD, as potential preventative agents and therapeutic treatments for SARS-CoV-2 at early stages of infection,” says Rosner and the team. A pre-print version of the research paper is available on the bioRxiv* server, while the article undergoes peer review. Rapid Spread of SARS-CoV-2 Highlights the Need for New Treatments Since the COVID-19 outbreak first began in Wuhan, China, in late December 2019, the rapid spread of SARS-CoV-2 has led to more than 119.5 million infections and caused more than 2.64 million deaths. Although recently-approved vaccines are now being rolled out in many countries, the virus is still spreading rapidly. Rosner and colleagues say this highlights the need for alternative approaches, particularly among populations with limited access to vaccines. However, “to date, few therapies have been identified that block SARS-CoV-2 replication and viral production,” write the researchers. More About SARS-CoV-2 and CBD The SARS-CoV-2 virus primarily enters host cells through the binding of a surface viral protein called spike to the human host cell receptor angiotensin-converting enzyme 2 (ACE2). The viral genome is then translated into two large polypeptides that are cleaved by the viral proteases MPro and PLPro to produce the proteins required for viral replication, assembly, and budding. Rosner and colleagues say that, although limited, some studies have reported that certain cannabinoids have antiviral effects against hepatitis C virus and other viruses. Furthermore, an oral solution of CBD is already approved by the US food and Drug Administration for the treatment of epilepsy. What Did the Current Study Involve? To test the effect of CBD on SARS-CoV-2 replication, the researchers pretreated A549 human lung carcinoma cells expressing ACE-2 (A549-ACE2) with 0-10μM CBD for 2 hours before infecting them with SARS-CoV-2. Analysis of the cells 48 hours later showed that CBD had potently inhibited viral replication in the cells. Since CBD is often consumed as part of a Cannabis sativa extract, the team investigated whether other cannabinoids could also inhibit SARS-CoV-2 infection, especially those with closely related structures. Remarkably, the only agent that potently inhibited viral replication was CBD; limited or no antiviral activity was exhibited by the other structurally similar cannabinoids tested. Furthermore, the CBD metabolite 7-OH-CBD, the active ingredient in the CBD treatment of epilepsy, also effectively inhibited SARS-CoV-2 replication in the A549-ACE2 cells. CBD Effectively Eliminated Viral RNA Expression When the researchers assessed whether CBD might prevent proteolytic cleavage by Mpro or PLpro, they found CBD had no effect on the activity of either protease. This led the team to hypothesize that CBD targets host cell processes. Consistent with this hypothesis, RNA sequencing of infected A549-ACE2 cells treated with CBD for 24 hours revealed significant suppression of SARS-CoV-2-induced changes in gene expression. The CBD effectively eliminated viral RNA expression, including RNA coding for the spike protein. Both SARS-CoV-2 and CBD triggered significant changes in cellular gene expression, including the expression of several transcription factors. Further analysis of host cell RNA showed that the virus-induced changes were almost completely reversed, but rather than the cells returning to a normal cell state, the CBD+virus-infected cells resembled those treated with CBD alone. What About Interferon Signaling? Given that infection with SARS-CoV-2 is known to suppress the interferon signaling pathway, the researchers tested whether CBD could suppress viral infection by introducing this pathway. Some genes were induced by CBD in both the absence and presence of SARS-CoV-2, including genes that encode interferon receptors and mediators of the interferon signaling pathway. In addition, CBD effectively reversed the viral induction of cytokines that can trigger a deadly hyperinflammatory response called the “cytokine storm” during the later stages of infection. “Thus, CBD has the potential not only to act as an antiviral agent at early stages of infection but also to protect the host against an overactive immune system at later stages,” says Rosner and the team. SARS-CoV-2 Incidence Was Lower in Patients Who Took CBD Finally, the team assessed the incidence of SARS-CoV-2 infection among 82 patients who had been prescribed CBD prior to SARS-C0V-2 testing and matched patients who had not been prescribed CBD. Strikingly, the incidence of SARS-CoV-2 was only 1.2% among the patients prescribed CBD, compared with 12.2% among the matched patients who had not been taking CBD. “The substantial reduction in SARS-CoV-2 infection risk of approximately an order of magnitude in patients who took FDA-approved CBD highlights the potential efficacy of this drug in combating SARS-CoV2 infection,” says Rosner and colleagues. “We advocate carefully designed placebo-controlled clinical trials with known concentrations and highly-characterized formulations in order to define CBD’s role in preventing and treating early SARS-CoV-2 infection,” they conclude. *Important Notice bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. To read the original article click here.

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13 Emerging and Promising Covid Treatments

AHA Publisher — Thu, 09 Jul 2020 07:00:09 +0000

Abigail Klein Leichman via Israel21c – “We believe humanity needs a toolbox of different solutions for Covid-19,” says Immanuel Lerner, CEO of Pepticom, one of the companies detailed below. In parallel to vaccine research, there’s an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus. Scientists across the globe are working on vaccines to prevent Covid-19 infection. (Click here to read about six Israeli vaccine candidates.) But in the meanwhile, and even after initial vaccines are approved, there is an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus. Most potential treatments target the life-threatening lung inflammation typical of serious Covid-19 cases. It’s caused by a phenomenon called a “cytokine storm.” Cytokines are proteins that trigger inflammation as a natural response to infection. In response to a virus overload, in this case in the lungs, the immune system activates a storm of cytokines. Too many cytokines lead to too much inflammation, which can damage the lungs and cause respiratory distress. Israeli hospitals were among the first anywhere to use dexamethasone, a steroid drug, to stop cytokines storms and reduce lung inflammation in severely ill Covid-19 patients. However, steroids can suppress the immune response too strongly. Additionally, an Israeli hospital is among the first to do a randomized, double-blind, placebo-controlled clinical trial of ivermectin, a drug to treat parasitic infections in people and animals, to see if it can shorten the duration of the disease if given to Covid-19 patients immediately after diagnosis. Israelis are also formulating novel therapeutics of their own. Below we summarize 13 potential Israeli treatments using a variety of approaches – such as placenta-derived cells, peptides, blood plasma of recovered patients, and the cannabis compound CBD. There is plenty of room for more than one treatment. “We believe humanity needs a toolbox of different solutions for Covid-19,” says Immanuel Lerner, CEO of Pepticom, one of the companies detailed below. Pluristem On June 11, Pluristem Therapeutics of Haifa announced a multicenter Phase 2 US Food and Drug Administration (FDA) efficacy and safety study of its PLX-PAD cells for treating severe Covid-19 complicated by acute respiratory distress syndrome (ARDS). PLX, an injected regenerative placenta-derived cell therapy, stimulates the immune system’s natural regulatory T cells and M2 macrophages, possibly preventing or reversing a cytokine storm. PLX cells potentially reduce the incidence and/or severity of Covid-19 pneumonia and pneumonitis. Pluristem has treated Covid-19 patients under compassionate use programs in the United States and Israel. Initial data from 18 patients showed that 75% were off mechanical ventilation within 28 days. “PLX cells are available off-the-shelf and once commercialized, can be manufactured in large-scale quantities, offering a key advantage in addressing a global pandemic,” the company said. Silkim Jerusalem-based Silkim Pharma recently submitted Coronzot, its novel treatment for Covid-19 patients with moderate to severe symptoms, to the FDA’s Investigational New Drug (IND) program. IND designation would give Silkim permission to start human clinical trials and to ship Coronzot across state lines before a marketing application has been approved. Coronzot’s novel mechanism targets a pivotal factor in cytokine storms. It removes an inflammatory overaccumulation of labile iron and replaces it with a minute amount of gallium or zinc. This not only suppresses the storm but also inhibits viral proteins that attack the lungs and heart. Gallium inhibits virus replication and promotes apoptosis (self-destruction) of already invaded cells. Zinc helps suppress inflammatory reactions and enzymes that enable coronavirus replication. The company is actively engaged in the FDA process. “We look forward to finalizing the IND and then moving towards conducting clinical studies of Coronzot for Covid-19,” said Silkim Pharma CEO Dror Chevion. RedHill Biopharma RedHill Biopharma, based in Raleigh, North Carolina and Tel Aviv, is “moving rapidly to advance our development program with opaganib for Covid-19,” according to a June 10 statement by Dr. Mark L. Levitt, RedHill medical director. RedHill acquired opaganib from US-based Apogee Biotechnology, which developed this oral drug to fight cancer, inflammation and viruses. RedHill has seen encouraging preliminary findings from six Israeli Covid-19 patients given opaganib under compassionate use to reduce lung inflammation. All were weaned from supplemental oxygen and discharged from the hospital without having to receive mechanical ventilation. RedHill plans a multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study on 270 US patients with severe Covid-19 pneumonia. “We are expanding the development program to Russia and additional European countries, in parallel with the US clinical study, in order to accelerate the collection of robust data on the potential efficacy of opaganib against Covid-19,” said Levitt. The company is working with government agencies worldwide to allow more patients access to the investigational drug through clinical studies and compassionate use programs. InnoCan InnoCan Pharma Israel and Tel Aviv University tech-transfer company Ramot are collaborating to develop a new CBD-loaded exosome technology to fight lung inflammation. Exosomes, small particles created from stem cells, can act as “homing missiles” targeting specific damaged organs and facilitating cell-to-cell communication. Combining the cell-healing properties of exosomes with the anti-inflammatory properties of the cannabis-derived compound CBD is expected to have a strong synergetic effect. The treatment is administrated by inhalation. Stero Biotechs Stero Biotechs of Bnei Brak has started a small clinical trial at Rabin Medical Center in Petah Tikva on the tolerability, safety and efficacy of a CBD-enhanced steroid treatment for hospitalized Covid-19 patients. “Steroid treatment is usually the first or second line of treatment for hospitalized patients. CBD enhances the therapeutic effect of steroid treatment and treats the bio-mechanism affected by the virus,” the company explained. Eybna and CannaSoul Two Israeli cannabis R&D firms, Eybna Technologies and CannaSoul Analytics, are developing a proprietary terpene formulation for modulating cytokine storms. Terpenes are organic compounds found in cannabis and other plants. Studies suggest they can be effective antiviral agents. CannaSoul’s Cytokine Storm Assay (from its Myplant-Bio subsidiary) will aid in optimizing and customizing Eybna’s novel NT-VRL inhaled formulation for treatment and prevention of viral infections in high-risk populations and actively ill patients. “The FDA considers this assay as a good predictor for cytokine storm response and immunotoxicity, and it is commonly required in the development of biological treatments,” according to CannaSoul Chairman and CSO Prof. Dedi Meiri. “The NT-VRL formulation intended to be used via inhalation,” said Eybna CEO Nadav Eyal. “This delivery method dramatically increases the terpenes’ bioavailability by directly contacting the infected cells in the respiratory system.” CannaSoul aims to identify other cannabis molecules capable of suppressing a cytokine storm in response to Covid-19 without completely suppressing the immune system. It is also studying how cannabis molecules could modulate the ACE2 receptor, which allows the virus to inject its genetic expression into human cells. Kamada Based in Rehovot, Kamada has begun supplying its experimental plasma-derived Hyperimmune IgG therapy for compassionate use in severe Covid-19 cases in Israel. The treatment is based on plasma donated by recovered Israeli Covid-19 patients. One critically ill patient at Hadassah Medical Center showed initial improvement after having the experimental IgG therapy but ultimately did not survive. During the third quarter of this year, Kamada expects to start a Phase 1/2 clinical study in hospitalized Covid-19 patients in Israel and hold a pre-IND meeting with the FDA to expand clinical development in the United States in partnership with Kedrion Biopharma. Kedrion is collecting plasma from recovered American Covid-19 patients at 23 FDA-approved centers across the United States. This will be used by Kamada to manufacture additional batches of the product. “To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of Covid-19,” said Kamada CEO Amir London. Israel Institute for Biological Research The government-run Israel Institute for Biological Research (IIBR) announced in May that analogues of two drugs for Gaucher’s disease proved effective against SARS-CoV-2. This drug cocktail is made up of the FDA-approved Cerdelga and an analogue of a second drug in advanced stages of the approval process. The IIBR study on cell cultures demonstrated that the two-drug treatment significantly reduced the replication capacity of the coronavirus and the destruction of the infected cell. This potential treatment is currently being tested in animals infected with the coronavirus. The IIRB also isolated several key coronavirus antibodies that successfully neutralized aggressive coronavirus in lab tests. These could form the basis of a future treatment following further testing. Pepticom Based in Jerusalem, Pepticom computationally designs novel peptide drug candidates using artificial intelligence. The company raised $5 million last year. Three months ago, Pepticom began implementing its proprietary AI technology on various coronavirus proteins to identify novel peptides that inhibit interaction between the spike protein of SARS-Cov-2 and the ACE2 receptor – thereby stopping the virus from entering the cell. CEO Immanuel Lerner says three such proteins have already been identified and are being validated in the lab. “Using AI is a fast way to find these peptides, which are less expensive and easier to produce than antibodies,” Lerner tells ISRAEL21c. “Many parties are interested in looking at our results and finding ways to develop this further.” Bonus BioGroup In April, Bonus BioGroup initiated a preclinical study of MesenCure, its unique drug for treating acute and life-threatening respiratory distress in coronavirus and pneumonia patients. MesenCure consists of activated mesenchymal stromal (stem) cells from healthy adult donors. The activation of these MSCs is intended to boost their ability to reduce lung inflammation, promote regeneration of the diseased lung tissue, and alleviate respiratory and other symptoms in the lungs. The development of MesenCure relies on more than a decade of related experience and technologies that Bonus BioGroup has used in developing its lead product, a tissue-engineered bone graft also based on MSCs. “With the current coronavirus outbreak, Bonus BioGroup has started tissue culture studies into the potential of these MSCs, further activated, to alleviate inflammation, including in the lungs, and possibly attenuate the cytokine storm in COVID-19 patients,” the company explained. The preclinical study in several animal models is expected to be completed in the third quarter of 2020. The company said preliminary results indicate that “following the treatment with MesenCure, the microscopic appearance of the treated lungs was similar to a healthy lung, and a significant improvement in additional related parameters was achieved.” Bonus BioGroup presented these results to 1,800 scientists, physicians, and public opinion leaders at the virtual conference of the International Society for Cell & Gene Therapy in May. NanoGhost Technion-Israel Institute of Technology Prof. Marcelle Machluf developed a drug-delivery technology that uses reconstructed mesenchymal stem cells as nano-vesicles to transport medicine directly to a target. NanoGhost is the startup she established to commercialize the technology, which has proven successful in treating pancreatic, lung, breast, prostate, and brain cancer in mice. The NanoGhost technology has been patented in the United States and Europe, with additional patents pending in India and China. Now, Machluf is adapting her technology to create decoy NanoGhosts that attract and entrap the coronavirus, making for a less severe infection. She explains it in the video below. Enlivex Enlivex Therapeutics of Ness Ziona is developing Allocetra, a novel immunotherapy medication to treat organ dysfunction and acute multiple organ failure associated with sepsis and Covid-19, as well as solid tumors. Allocetra rebalances a severely unbalanced immune system by engaging with the immune system’s own regulation mechanisms. It is designed to restore safe immune balance following a cytokine storm. Enlivex is starting to recruit Covid-19 patients in Israel and in the United States to test the potential effect of Allocetra on moderate to severe cases. A patent from the Japan Patent Office is expected during the third quarter of 2020. Weizmann Institute of Science Organic chemist Nir London of the Weizmann Institute of Science in Rehovot is co-leading a collaborative project to identify small molecules that can bind to and inhibit a protease enzyme that the SARS-CoV-2 virus needs to reproduce. London and his research team had previously developed an advanced method for identifying potential inhibitors for numerous proteins. “So far, we have made close to 800 compounds and...

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