Sorrento Therapeutics Inc. (NASDAQ:SRNE) has announced that the FDA has given its investigational new drug (IND) STI-6129 clearance as a CD38 target antibody-drug conjugate.
Sorrento receives approval for its STI-6129 IND application
The drug uses various technology platforms that the company is currently developing that include the CD38 antibody that is identified for the G-MAB antibody collection. They also include the C-LOCK conjugation tech and the payload Duostatin 5 technology.
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Henry Ji, the CEO and Chairman of Sorrento, said that the IND clearance from the FDA to continue with human trials for STI-6129 is a huge milestone for the company. He added that STI-6129 and the CD38 CAR-T program has the potential of offering therapeutic alternatives needed by patients. Henry added that the company is looking forward to evaluating the efficacy and safety of STi-6129 in studies.
The company is planning to commence the first phase of clinical trials in relapsed/refractory amyloid light chain patients. The aim of the study will be identifying the second phase dose depending on the efficacy, safety, and pharmacokinetic profile of STI-6129.
Sorrento’s STI-1499 coronavirus could prevent against mutant viruses
The company is developing a coronavirus treatment that has attracted mixed reactions from various sections. Sorrento is creating an antibody cocktail that can block the interaction of the S1 protein with the ACE receptor employed in viral entrance in human cells. The cocktail antibody Sorrento is trying to create against the COVID-19 causing virus will be effective even if the virus mutates.
The STI-1499 antibody will be dubbed COVIDSHIELD has shown positive results in early-stage clinical trials. The antibody was given in low dose, which is an indication that it works extraordinarily well in low dose. This gives it a chance of being scaled up quickly to treat millions of people at an effective cost. Sorrento is ready to move to commercialization, and the company said that it could produce up to 100,000 doses every month. However, the target for the company is to produce up a million doses per month.