The antibody injection from Sorrento Therapeutics, nasal drops in opposition to Covid

Medical worker Christina Mathers attends to an unconscious patient who is holding the patient’s hand in the COVID-19 intensive care unit at the United Memorial Medical Center in Houston, Texas on December 21, 2020.

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Sorrento Therapeutics is working on new antibody therapeutics that it hopes will be a game changer in the fight against Covid-19.

The company recently won a $ 34 million contract from DARPA, co-funded by JPEO, to develop an intramuscular injection that delivers gene-encoded neutralizing antibodies to Covid-19 and its variant strains. The award was given to Sorrento’s wholly owned subsidiary SmartPharm Therapeutics and will fund development through a Phase 2 clinical trial.

It is hoped that the injection could provide rapid protection against and / or treatment of SARS-CoV-2 infections and Covid-19 so that patients can produce their own protective antibodies within days of receiving the injection. Sorrento will apply for additional funding to support the program pending successful clinical trials.

The company has begun manufacturing the neutralizing antibody STI-2020 in protein form to produce 100,000 doses, which are expected to be available early next year, pending emergency approval by the FDA.

If successful, the new antibody-encoded plasmid DNA injection could provide an alternative method of protecting populations for months or more. It can be an important therapeutic for people for whom vaccines do not work as well as the elderly or immunocompromised.

The injection is a formulation of the highly effective SARS-CoV-2 neutralizing antibody STI-2020. The company said it could potentially be stored at refrigerator temperatures to avoid some of the cold chain management challenges associated with the use of Pfid-19 vaccines currently being developed, such as the first Pfizer-BioNTech approved in the US.

At the same time, the company has submitted a new drug application to the FDA for a clinical phase 1 study to test the safety and effectiveness of COVI-DROPS. Antibody nasal drops are said to boost immunity to Covid-19 by blocking the infection and spreading the virus. The intranasal drops are a formulation of the antibody STI-2099. In previous animal studies, COVI-DROPS reduced the severity of the disease and shortened the duration of the disease in infected hamsters.

Dr. Slobodan Paessler, Scientific Director of Animal Biosafety Laboratory 3 at the University of Texas Medical Department, has been researching antibodies from Sorrento Therapeutics in hamsters since March to find product candidates. As a molecular virologist, his laboratory is known for conducting research on viral pathogenesis, vaccine development, and developing animal models to test new vaccine candidates and antiviral drugs.

“My studies have shown that hamsters infected with the Covid-19 virus develop severe lung and nasal infections, but when treated with COVI-DROPS it prevents all tissue damage and signs of the disease. It’s an exciting one Discovery and Sorrento have a right to be hopeful, “he said.

“When you think about how such a nasal drop can enable a patient to treat themselves at home, you can see the tremendous benefit.”

If tests are approved in human patients and the drops prove effective, therapy may one day mark a turning point in treatment for the coronavirus that has killed 322,611 Americans to date. There are currently over 18 million cases in the United States, and an average of more than 200,000 Americans are diagnosed with Covid-19 every day, according to John Hopkins University.

Possible antibody treatments in development

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, said, “Our research so far has shown that COVI-DROPS work within 24 hours. The antibodies neutralize viral infection of susceptible cells in the nasal passages and along the airways.”

Upcoming studies will show how many months of protection it could provide from a single dose, and therefore complement approved vaccines.

Dr. Henry Ji, Chairman, President and Chief Executive Officer, stands in the Sorrento Therapeutics laboratory in San Diego, California on May 22, 2020.

Ariana Drehsler | AFP | Getty Images

The reason for both Sorrento’s therapies could be a game changer as existing antibody treatments are expensive and difficult for states to administer. They require an intravenous infusion, which requires patients to go to health centers. However, because they are likely to be contagious, existing IV facilities, such as patients receiving chemotherapy, cannot be used. They must also be given early in the course of the disease – within 10 days of the onset of symptoms – and not when patients are so sick that they are hospitalized.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed ​​of the US government, told CNBC’s Squawk Box last week that the federal government is distributing about 65,000 doses of antibody drugs from Eli Lilly and Regeneron to states every week. But only 5% to 20% of the doses are given to patients. As he explained, it is a challenge for some health systems to set up the infrastructure for the delivery of these drugs.

Companies developing similar antibody therapies include Auris Medical, Eli Lilly, and Regeneron. The nasal mucous membrane is the first barrier against continuously inhaled substances such as allergens and pathogens.

Scientists from the University of Pennsylvania and the biotech company Regeneron are investigating whether the technology developed for gene therapy can be used to manufacture a nasal spray that prevents infection with the new coronavirus.

Regeneron’s antibodies are in clinical trials themselves but have received emergency approval for use in patients with mild or moderate Covid-19 who are at high risk of serious illness – and which have recently been used to treat President Donald Trump in particular.

The researchers hope the nasal spray will be injected through the nostrils, enter the nasal epithelial cells, and hijack their protein-making machinery so that they can make Regeneron’s antibodies.

In Europe, researchers from the University of Birmingham, UK, already announced in November The team at the Healthcare Technologies Institute developed the product using compounds that have already been approved by regulatory agencies in the UK, Europe and the US. This suggests that they are safe for humans.