On Monday, Sorrento Therapeutics received clearance from the FDA to initiate a Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to severe pulmonary symptoms. That trial could begin as soon as August.
"If we can help a patient get out of the hospital quickly, that will achieve part of our goal," Dr. Henry Ji, the chairman, president, and CEO of Sorrento Therapeutics, told Cheddar.
Dr. Mark Brunswick, who also works at Sorrento Therapeutics as the company's SVP of Regulatory Affairs, explained how Abivertinib attacks COVID-19.
"One of the implications of this virus when it goes to late stages is it induces a cytokine storm. The immune system basically goes berserk, secreting cytokines that overwhelm the body, and the body eventually shuts down. What this drug does is it controls the cytokine storm."
Brunswick, who worked in the FDA for more than nine years, says their company is targeting for-profit hospitals during the next phase of trials.
"Because we want to get this done quickly, we are concentrating on for-profit hospitals because they tend to have an IRB (Institutional Review Board), rather than the university-based hospitals, which have a much slower institutional review system." Brunswick added that, under this system, "You have one IRB that can approve multiple different hospitals to then allow many more patients to get treatment rather than each hospital having to review everything on their own."
As Sorrento Therapeutics continues to test Abivertinib, which already completed a registration trial for lung cancer and has been administered to over 600 patients worldwide, Ji is relying on support from the U.S. government to continue funding his project.
"If you look at all the other companies [involved in fighting] COVID-19, you see the government support is tremendously strong," Ji said, noting the Trump administration has offered to fund large-scale trials and attempts to stock up before product approval.
"We're very confident we will have the necessary support from our government," said Ji.
