Sorrento Therapeutics SRNE Stock News

Sorrento Therapeutics Inc (NASDAQ: SRNE) is heading up in the market this morning, and for good reason. The company announced that the FDA has cleared it to move forward with a new clinical trial. Here’s what’s going on:

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SRNE Stock Heads Up On FDA IND Approval

In the press release, Sorrento Therapeutics said that it received clearance from the FDA for its IND for STI-6129. STI-6129 is a CD38-targeting antibody drug conjugate. The company said that the conjugate takes advantage of several technology platforms under development.

In particular, SRNE said that one of these technologies is a CD38 specific antibody identified from its fully human G-MAB antibody library. The conjugate also includes the company’s proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugate technology.

Through the study, the company will assess the treatment in patients with advanced relapsed and/or refractory systemic amyloid light chain amyloidosis. The primary objective of the study is to identify a Phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetics profile.

In a statement, Dr. Henry Ji, Chairman and CEO at SRNE, had the following to offer:

That the FDA cleared our STI-6129 IND application to proceed to human trials is another important milestone for Sorrento. Together with our CD38 CAR-T program, this has the potential to provide additional therapeutic options for patients in need. We are looking forward to further evaluating the safety and efficacy of STI-6129 in clinical trials.

The above statement was followed up by Dr. Hui Li, head of the ADC business unit at SRNE. Here’s what he had to say:

This is Sorrento’s first ADC utilizing our site-specific C-LOCK conjugation technology that is advancing into clinical evaluation. STI-6129 demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates, and we look forward to potentially expanding its utilization into additional ADC programs.

This News Is Big

There’s good reason for investors to be excited here. STI-6129 has yielded strong preclinical results. As such, the company’s treatment shows incredible promise.

Should the data surrounding the treatment continue to be positive, Sorrento Therapeutics could be sitting on the goose that lays the golden eggs. After all, the amyloidosis is valued at more than $3.6 billion annually and is only growing.

Should SRNE be effective in treating this condition, entering this market would be a big win, creating a strong potential opportunity for investors.

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