Sorrento finds a coronavirus antibody that blocks viral infection 100% in preclinical lab experiments

Coronavirus Outbreak

The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccine. Suggested reading by the Muslim Times: FDA authorizes the drug remdesivir for emergency use in COVID-19 patients 

Source: Tech Crunch

By Darrell Etherington@etherington / 9:00 am EDT•May 15, 2020

Therapeutics company Sorrento has made what it believes cold be a breakthrough in potential treatment of SARS-CoV-2, the virus that leads to COVID-19. The company released details its preclinical research on Friday, announcing that it has found an antibody that provides “100% inhibition of SARS-CoV-2 virus infection of healthy cells after four days incubation.” These results are from a preclinical study that still has to undergo peer review, and in an in vitro laboratory study (meaning not in an actual human being) but still a promising development as the company continues to work on production of an antibody “cocktail” that could provide protection against SARS-CoV-2 even in case of mutations in the virus.

Sorrento says that they believe this antibody, which is labelled STI-1499, stood out among billions of candidates it has been screening from its extensive human antibody library for its ability to completely block the interaction of the SARS-CoV-2’s spike protein with a human cell target receptor. That means it prevents the virus from attaching to the host’s healthy cell, which is what leads to incubation and infection.

The nature of the antibody’s efficacy means that Sorrento currently believes it will be the first antibody to be included in the cocktail it is developing, which will be made up of a large number of different antibodies that show efficacy in blocking the attachment of the spike protein, in order to provide multiple avenues of protection that are designed to remain effective even if the virus mutates in transmission from person to person, or within the same individual. One of the big outstanding questions that researchers are working on answering currently is just how mutagenic SARS-CoV-2 actually is, since many coronaviruses like the common cold show a tendency to mutate pretty quickly, rendering long-lasting cures and treatments difficult to develop.

Sorrento’s COVID-SHIELD is meant to address this through a potent mix of different antibodies that provide protection against different strains of the virus, but the company says it will also be pursuing development of the STI-1499 antibody on its own as a dedicated, standalone therapy. The company is already in discussion with regulators about how to expedite development of that potential treatment, and is ramping its production capacity as well with the goal of producing as many as one million doses at the same time it pursues FDA approval for its use.

It’s definitely worth cautioning that no treatment or vaccine is likely to be a ‘magic bullet’ in treating SARS-CoV-2 or COVID-19, but this is still a promising development, and one to watch as it undergoes clinical trials and the therapeutic development and regulatory process.


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Categories: Health

14 replies

  1. Sorrento claims it has COVID-19 cure

    May 15, 2020 9:17 AM ET|About: Sorrento Therapeutics,… (SRNE)|By: Douglas W. House, SA News Editor

    Sorrento Therapeutics (NASDAQ:SRNE) gallops 56% premarket on robust volume in reaction to reports that it has discovered an antibody, dubbed STI-1499, that, it says, can provide 100% inhibition of COVID-19 and flush out the SARS-CoV-2 virus from the body within four days.

    “We want to emphasize there is a cure,” says CEO Henry Ji. “If we have the neutralizing antibody in your body, you don’t need the social distancing. You can open up a society without fear.”

    The antibody, one of “hundreds” it screened, blocks the coronavirus’ spike proteins from attaching to ACE2, a receptor on the surface of healthy cells that serves as a “doorknob” to open the cell to infection.

    Ji says STI-1499 can be used as preventative therapy since there are no unwanted side effects, adding that it may be more effective than a vaccine.

    The company is partnering with NY-based Mount Sinai to develop an antibody cocktail, Covi-Shield, comprised of three different antibodies, including STI-1499, for prophylactic use. It says it can produce up to 200K doses per month and is looking to produce “tens of millions” to meet demand.

  2. EXCLUSIVE — A California-based biopharmaceutical company claims to have discovered an antibody that could shield the human body from the coronavirus and flush it out of a person’s system within four days, Fox News has exclusively learned.

    Later Friday, Sorrento Therapeutics will announce their discovery of the STI-1499 antibody, which the San Diego company said can provide “100% inhibition” of COVID-19, adding that a treatment could be available months before a vaccine hits the market.

    “We want to emphasize there is a cure. There is a solution that works 100 percent,” Dr. Henry Ji, founder and CEO of Sorrento Therapeutics, told Fox News. “If we have the neutralizing antibody in your body, you don’t need the social distancing. You can open up a society without fear.”

    “This puts its arms around the virus. It wraps around the virus and moves them out of the body.”

    — Dr. Henry Ji, CEO and founder, Sorrento Therapeutics
    The health care and pharmaceutical industries have been scrambling to develop viable vaccines and antibody treatments as the number of COVID-19-related deaths is expected to hit 100,000 by June 1.

    Many medical researchers are scrambling to find antibodies, optimistic that they could provide a remedy or preventative care in less time than it would take to develop a vaccine. Antibody treatments have been used for the past 100 years as a means to stave off infections, but their effectiveness has had mixed results. Finding a successful antibody or convalescent plasma treatment for COVID-19 could present challenges.

    “Doctors are taking blood plasma from patients who have recovered from COVID-19 and infusing it into those who are critically ill. The plasma is laden with antibodies, and the approach shows some promise,” former Food and Drug Administration Commissioner Scott Gottlieb wrote in a recent Wall Street Journal op-ed. “The constraint: There isn’t enough plasma from recovered patients to go around.”

  3. Sorrento Therapeutics (SRNE) – Get Report shares as much as doubled as the biopharma company said it was zeroing in on a potential breakthrough drug to treat the coronavirus.

    The San Diego biopharma said in a statement that in laboratory research, a new treatment provides “100% inhibition” of SARS-CoV-2.

    Sorrento contends it has found a particularly effective antibody after screening out billions of candidates.

    “Among the antibodies showing neutralizing activity, one antibody stood out for its ability to completely block SARS-CoV-2 infection of healthy cells in the experiments,” the company said in a statement.

    “STI-1499 completely neutralized the virus infectivity at a very low antibody dose, making it a prime candidate for further testing and development. Initial biochemical and biophysical analyses also indicate STI-1499 is a potentially strong antibody drug candidate.”

    Still, Sorrento’s findings are still awaiting peer review by other scientists and the research has not been tested on human beings, according to reports.

    Sorrento wants to convert its research into a drug separate from another treatment it is now developing, Covid-Shield, an “antibody cocktail” that features a mix of different antibodies.

    Sorrento says a separate drug based on the newly discovered STI-1499 antibody could be developed and made available before a vaccine hits the market.

    “We want to emphasize there is a cure,” Dr. Henry Ji, Sorrento’s chief executive, told Fox News.

    “There is a solution that works 100%. If we have the neutralizing antibody in your body, you don’t need the social distancing. You can open up society without fear.”

    A spokesperson for Sorrento was not immediately available for comment.

    Separately, Sorrento last week said it planned to team up with Mount Sinai Health System to develop an “antibody cocktail” that could be used to both prevent coronavirus infections as well as treat those who have become ill.

  4. Tiny biotech company Sorrento Therapeutics (SRNE) claimed Friday its experimental coronavirus treatment is a cure for Covid-19. Meanwhile, another company gained authorization for a coronavirus test.

    In preclinical testing of cells, Sorrento’s antibody drug provided “100% inhibition” of SARS-CoV-2 — the new coronavirus that causes Covid-19 — within four days. Sorrento expects this antibody to be the first in a drug cocktail that would create a “protective shield” against infection.

    But Sorrento is far from the only company working on an antibody-based approach to a coronavirus treatment. Bigger players like Eli Lilly (LLY) and Regeneron Pharmaceuticals (REGN) also have programs in this arena.

    Further, Sorrento has only so far conducted testing in cells. In order to eventually gain Food and Drug Administration approval, Sorrento will need to test its coronavirus treatment in animals. Then, it will have to ask the FDA for permission to begin testing for safety and effectiveness in humans.

    “It’s just hype,” Brad Loncar, Chief Executive of Loncar Investments, said in an email. Loncar provides the index for two exchange-traded funds that track biotech companies. “There are many companies working on antibodies that are far ahead.”

    Still, shares of Sorrento charged up 157%, near 6.70, in afternoon trading on the stock market today. Sorrento representatives didn’t immediately return a request for comment.

    Antibody-Based Coronavirus Treatment
    An antibody drug is unique in coronavirus treatment research. Experts say the antibodies could either treat Covid-19 or provide preemptive immunity.

    Sorrento researchers screened and tested billions of antibodies to narrow their coronavirus treatment candidates down to hundreds. They found a dozen that could prevent the viral protein from grabbing onto a key receptor in the body. The virus uses that receptor to enter human cells. There, it replicates.

    The STI-1499 antibody completely blocked SARS-CoV-2 from infecting healthy cells, Sorrento said in a news release. Sorrento expects this to be the first antibody in a cocktail it’s planning to call Covi-Shield. The biotech company plans to seek an accelerated regulatory review.

    “Our STI-1499 antibody shows exceptional therapeutic potential and could potentially save lives following receipt of necessary approvals,” Chief Executive Henry Ji said in a written statement. “We at Sorrento are working day and night to complete the steps necessary to get this product approved.”

    Sorrento says it can produce up to 200,000 doses each month and plans to make 1 million doses while seeking approval.

  5. Sorrento Therapeutics of San Diego said Friday that an antibody it has been developing proved highly effective in blocking the novel coronavirus in laboratory experiments — a possible first step in the creation of a drug cocktail to battle COVID-19.

    The antibody, known as STI-1499, performed well even though it was used at a concentration 10- to 100-fold lower than antibodies used to treat other diseases, the company said.

    STI-1499 is one of more than a billion antibodies that Sorrento Therapeutics has been examining in an effort to find an effective treatment against a virus that has killed more than 85,000 people in the U.S.

  6. Quote— STI-1499 is one of more than a billion antibodies that Sorrento Therapeutics has been examining in an effort to find an effective treatment against a virus that has killed more than 85,000 people in the U.S.—-

    Thank you Zia for sharing a hopeful news
    Let us pray to God — May God guide them to the right path of drug. Amin

  7. Sorrento Therapeutics believes it has found the first antibody to be used in a cocktail that it’s calling COVI-SHIELD. They say it is so effective it could even be used as a stand-alone therapy.

    About two months ago, the Sorrento team started analyzing hundreds of antibodies from their library and found about a dozen that blocked the virus that leads to COVID-19 from infecting human cells. Now, from that dozen, they say they’ve found one that is 100% effective after a period of four days of incubation.

    “Given the very effective data that we’ve seen, how potent this antibody is, we are very confident this could actually work out,” said. Dr. Mark Brunswick from Sorrento Therapeutics.

    They haven’t tested it on humans yet, but they plan to use this antibody with a combination of a few others to provide a cocktail that could work on people if the virus mutates.

    “So, if the virus mutates, you have different angles with different antibodies attached to it, so that way one of the mutations, one of the antibody, the other two still works,” said Dr. Henry Ji from Sorrento.

    Sorrento plans to start ramping up production, but some scientists caution only 10% of drugs that enter clinical trials get approved by the FDA.

    “What’s key to remember though about the results from Sorrento is that this is laboratory data, they haven’t actually tested this drug in actual human beings. So once that happens, it’ll be great, but we need to see safety and efficacy data,” said Dr. Lipi Roy, NBC News medical contributor.

    After working around the clock almost seven days a week, Lisa Kerwin from Sorrento said the discovery gave her hope.

  8. Sorrento Therapeutics and Mount Sinai Health System in New York City have joined forces to develop an antibody cocktail they hope will shield against Covid-19 infection for up to two months. The treatment, called COVI-SHIELD, is designed to be administered as often as necessary, with each dose expected to provide antiviral protection for health care and other essential workers.

    If approved by the FDA, it is anticipated that COVI-SHIELD will be offered as a prophylactic for those returning to work and as a therapeutic to those who have been exposed to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes Covid-19. It can also be used for the population at large as a treatment for those who may have been exposed to the disease.

    “We’re working with pharma and biotech partners, such as Sorrento, to bring much needed therapies to the clinic,” said Erik Lium, executive vice president and chief commercial innovation officer of the Mount Sinai Health System.

    The company is now completing all investigational new drug 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. If successful, it would ramp up production so it could produce millions of doses by year-end in its New Jersey and European manufacturing facilities.

    Sorrento Therapeutics says that each dose of COVI-SHIELD will deliver a cocktail of three neutralizing antibodies that together would recognize three unique regions of the SARS-CoV-2 Spike protein to ward off the disease.

    This therapy is designed to be resistant to future virus mutations and, if approved, should be made available in support of testing, tracing, vaccination and other therapeutic approaches to allow for efficient management of viral infection by protecting those most at risk for up to two months at a time.

  9. Mount Sinai Health System (“Mount Sinai”) and Sorrento Therapeutics (Nasdaq: “SRNE,” “Sorrento”) have inked a deal to investigate an antibody cocktail called COVI-SHIELD™ that potentially can treat COVID-19 patients. This investigational product leverages the work conducted by Mount Sinai researchers who screened about 15,000 individuals who may have had and recovered from COVID-19 for the presence of anti-COVID-19 antibodies. The team leveraged the diagnostic test developed by Mount Sinai’s own Florian Krammer, PhD, and associated authorization for use in Mount Sinai under an FDA Emergency Use Authorization. This partnership grants Sorrento access to plasma containing antibodies against COVID-19 for the purpose of identification and production of monoclonal antibodies with potential for neutralizing activity against SARS-CoV-2.

    The Background

    Under the leadership of 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, a team screened approximately 15,000 individuals who may have had and recovered form COVID-19 for the presence of antibodies. Dr. Cordon-Cardo’s team leveraged the diagnostic test developed by Florian Krammer, which TrialSite News profiled. Dr. Krammer’s test was approved or use under an FDA Emergency Use Authorization.

    Co-Development of COVI-SHIELD

    Sorrento and Mount Sinai have joined forces to collaborate to develop antibody products that could serve as a “protective shield” against SARS-CoV-2 coronavirus infection, possibly blocking and neutralizing the activity of the virus in naïve-at-risk populations as well as those individuals recently infected. The development of COVID-SHEILD is based on the work Mount Sinai was able to accomplish thanks to the testing technology developed by Professor Kramer and the screening operation led by Dr. Cordon-Cardo. If approved, each dose of the product would deliver a cocktail of three antibodies which together would recognize the three unique regions of the SARS-CoV-2 Spike protein. No terms associated with this deal where shared with the public.

    Implicating the partnership’s significant potential, Erik Lium, Executive Vice President and Chief Commercial Innovation Office of the Mount Sinai Health System, commented, “We look forward to advancing the development of an effective antibody cocktail with Sorrento.”

    Although the joint press release doesn’t mention exclusivity, Dr Lium noted, “We’re working with pharma and biotech partners, such as Sorrento to bring much needed therapies to the clinic,” which implies the health system could collaborate with others as well. The health system provides a link for those interested in licensing the Mount Sinai serologic assay.

    COVID-SHIELD: Serious Potential

    This investigational pursuit would lead to an antibody cocktail therapy establishing a high barrier to development of treatment resistance while offering a protective therapy for the population at large if the collaborative parties can successfully develop and secure approval. It is anticipated that COVID-SHIELD would be offered as a prophylactic for those returning to work and as a therapeutic to those who have bene exposed to SARS-CoV-2. COVI-SHIELD prevention and treatment is designed to be administered as often as necessary, with each dose expected to offer antiviral protection for up to two months—of course, all conditioned-on approval by the regulatory authorities.

    Such a product, if approved, represents serious potential for public health (and economic upside). Sorrento’s Chairman and CEO, Dr. Henry Ji, commented that with the opening up of the economy will more than likely come along local flareups of COVID-19 along with the unfortunate mutations associated with viruses possibly rendering future approved therapies ineffective. Hence the Chairman noted, “It is our intention to develop a triple antibody prophylactic and therapeutic agent that would shield healthcare workers and at-risk patients. This therapy is designed to be resistant to future virus mutations, and if approved, should be made available in support of testing, tracing, vaccination and other therapeutic approaches to allow for efficient management of viral infection by protecting those most at risk for up to two months at a time.”

  10. Shares of Sorrento Therapeutics Inc. rallied Tuesday, after a Wall Street analyst suggested the biopharmaceutical company was a good bet to successfully develop an “antibody cocktail” that could shield people from the COVID-19 virus.

    The stock SRNE, 3.94% rose 3.3% in active afternoon trading Tuesday. Trading volume was 53.7 million shares, which exceeded the full-day average of about 41.1 million shares.

    The gain follows a hectic week of trading, that followed up the 158% blast off on massive volume of 507.6 million shares on May 15 after the company provided an upbeat assessment of the results of a preclinical experiment of its COVID-19 virus antibody, STI-1499.

    The San Diego-based company said that STI-1499 demonstrated complete inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a “very low antibody concentration.” Sorrento reiterated that it aims to generate an “antibody cocktail” product that could act as a “protective shield” against coronavirus infection.

    Analyst Jason Kolbert at Dawson James Securities initiated coverage of Sorrento with a buy rating, which for Dawson James means the stock is expected to produce a total return of at least 20% over the next 12 to 18 months.

    But Kolbert expects a lot more than that, as he set a stock price target of $24.

  11. SAN DIEGO, June 10, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that an Application for Emergency Use Authorization (EUA) is under review at the U.S. Food and Drug Administration (FDA) for its COVI-TRACKTM in vitro diagnostic test kit for the independent detection of IgG and IgM antibodies in sera of patients exposed to the SARS-CoV-2 virus.

    The rapid antibody test allows for results to be available in eight minutes or less. The easy to use assay develops three clear lines that confirm the assay validity and the qualitative detection and differentiation of IgM and IgG antibodies to the SARS-CoV-2 virus.

    Analytical validation was performed by testing sample cohorts from healthy donors and confirmed positive COVID-19 patient samples by RT-PCR testing, and the assay demonstrated a specificity greater than 97% and diagnostic sensitivity of greater than 94%. Upon issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. Sorrento has secured manufacturing capacity to support the production of up to five million test kits per month.

  12. Then on June 6, Sorrento reported that it had another potential cure called Covidtrap (STI-4398), and Sorrento said it proved successful in a preclinical trial. Even with these positive results, however, Sorrento has yet to start a phase 1 clinical trial for either candidate. Also, the company still has far too many obstacles to overcome before it can even hope to be considered one of the front-runners in this race.

  13. Reuters) – Eli Lilly and Co could have a drug specifically designed to treat COVID-19 authorized for use as early as September if all goes well with either of two antibody therapies it is testing, its chief scientist told Reuters on Wednesday.

    Lilly is also doing preclinical studies of a third antibody treatment for the illness caused by the new coronavirus that could enter human clinical trials in the coming weeks, Chief Scientific Officer Daniel Skovronsky said in an interview.

    Lilly has already launched human trials with two of the experimental therapies.

    The drugs belong to a class of biotech medicines called monoclonal antibodies widely used to treat cancer, rheumatoid arthritis and many other conditions. A monoclonal antibody drug developed against COVID-19 is likely to be more effective than repurposed medicines currently being tested against the virus.

    Skovronsky said the therapies – which may also be used to prevent the disease – could beat a vaccine to widespread use as a COVID-19 treatment, if they prove effective.

    “For the treatment indication, particularly, this could go pretty fast,” he said in an interview. “If in August or September we’re seeing the people who got treated are not progressing to hospitalization, that would be powerful data and could lead to emergency use authorization.”

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