Sorrento Therapeutics is working on new antibody therapeutics it hopes will be a gamechanger in the fight against Covid-19.
Recently it won a $34 million contract from DARPA co-funded by JPEO to develop an intramuscular injection that delivers gene-encoded neutralizing antibodies against Covid-19 and its variant strains. The award was given to Sorrento’s wholly-owned subsidiary SmartPharm Therapeutics, and it will fund development through a Phase 2 clinical study.
It is hoped that the injection could enable rapid protection from and/or treatment of SARS-CoV-2 infection and Covid-19 so patients can produce their own protective antibodies within days of getting the injection. Sorrento will seek further funding in support of the program pending successful clinical studies.
The company has initiated manufacturing of the neutralizing antibody STI-2020 in the protein form to produce 100,000 doses to be available early next year, in anticipation of an emergency use authorization from the FDA.
If successful, the new antibody-encoded plasmid DNA injection could provide an alternative method of protecting populations for months or longer. It can be an important therapeutic for people where vaccines do not work as well, such as the elderly or immunocompromised.
The injection is a formulation of the highly potent SARS-CoV-2 neutralizing antibody STI-2020. The company said it can potentially be stored at refrigerator temperatures, avoiding some of the cold chain management challenges associated with the deployment of Covid-19 vaccines currently developed, such as the first approved in the U.S., from Pfizer–BioNTech.
At the same time, the company has filed an investigational new drug application with the FDA for a Phase 1 clinical trial to test the safety and efficacy of COVI-DROPS, antibody nose drops that it claims boosts immunity against Covid-19 by blocking the infection and spread of the virus. The intranasal drops are a formulation of the antibody STI-2099. In previous animal studies, COVI-DROPS reduced the severity of and shortened the duration of the disease in infected hamsters.
Dr. Slobodan Paessler, scientific director of the Animal Biosafety Laboratory 3 at the University of Texas Medical Branch has been researching Sorrento Therapeutics antibodies in hamsters since March to help find product candidates. A molecular virologist, his lab is known for conducting research on viral pathogenesis, vaccine development and on development of 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 nose infections but when treated with the COVI-DROPS all tissue damage and signs of the disease is prevented. It is an exciting discovery and Sorrento has a good right to be hopeful,” he said.
“If you think of how such a nose drop can allow a patient to treat themselves at home you can see the huge advantage.”
If testing is approved in human patients and the drops prove effective, the therapy can one day mark a turning point in the treatment of the coronavirus that has so far killed 322,611 Americans. Currently there are over 18 million cases in the U.S., and an average of more than 200,000 Americans are diagnosed with Covid-19 every day, according to data compiled by John Hopkins University.
Potential antibody treatments in development
According to Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, “Our research has shown so far that COVI-DROPS work within 24 hours. The antibodies neutralize virus infection of susceptible cells in the nasal passages and along the respiratory tract.”
Upcoming studies will reveal how many months of protection it could provide from a single dose, and therefore complement vaccines that are approved.
The reason both of Sorrento’s therapies could be a gamechanger is because existing antibody treatments are costly and difficult for states to administer. They require intravenous infusion where patients must go to health centers for this to be done. But since they are likely contagious, existing IV facilities, like where patients receive chemotherapy, can’t be used. They also need to be given early in the course of the disease—within 10 days of symptom onset — not when patients are so sick, they are hospitalized.
Moncef Slaoui, chief scientific adviser to the U.S. government’s Operation Warp Speed, told CNBC’s “Squawk Box” last week that the federal government is distributing about 65,000 doses of antibody drugs made by Eli Lilly and Regeneron every week to states. But only 5% to 20% of the doses are getting administered to patients. As he explained, it’s a challenge for some health-care systems to set up the infrastructure to deliver these drugs.
Companies pursuing the development of similar antibody therapies include Auris Medical, Eli Lilly and Regeneron. The nasal mucosa is the first barrier against continuously inhaled substances, such as allergens and pathogens.
Scientists at the University of Pennsylvania and biotech firm Regeneron are investigating whether technology developed for gene therapy can be used to make a nasal spray that will prevent infection with the new coronavirus.
Regeneron’s antibodies are themselves in clinical testing but have received emergency approval for patients with mild or moderate Covid-19 who are at high-risk of getting severe disease —and were notably used recently to treat President Donald Trump.
Researchers are hoping that the nasal spray could be squirted through the nostrils, enter nasal epithelial cells, and hijack their protein-making machinery so that they make Regeneron’s antibodies.
In Europe, researchers from the University of Birmingham, U.K., announced back in November that they had also developed a nasal spray that could potentially protect against the disease.The team from the Healthcare Technologies Institute developed the product using compounds that have already been approved by regulatory authorities in the U.K., Europe and the U.S. This suggests that they are safe for humans.