Candidate: STI-1499dpi (DNA plasmid injection)

Category: ANTIBODY, VAX

Type: Next-generation, gene-encoded antibody vaccine based on SmartPharm’s Gene Mab™ non-viral gene therapy platform, which combines a novel DNA plasmid with long duration of expression and a delivery system for use with standard hypodermic injection that the company says is safe and effective.

Status: Sorrento has agreed to acquire SmartPharm for an undisclosed price, the companies said July 24. The acquisition is expected to close in August.

Sorrento Chairman, President, and CEO Henry Ji, PhD, told MIT Technology Review in June that his company was exploring with SmartPharm the idea of using a DNA plasmid injection to the muscle via standard hypodermic needle to deliver antibodies rather than deal with the complexity and cost associated with traditional manufacturing of antibodies, as well as the uncertainties involved in vaccine making. Gene injections also allow for carrying information for more than one antibody at a time, which could stop a virus from developing resistance. “You can make DNA very readily, it’s dirt cheap, and you let the muscle make the antibody.”

SmartPharm says its GeneMab platform allows patients to produce the needed neutralizing antibody in their bodies over a matter of weeks or months, potentially offers a more scalable and cost-effective way of providing population protection against COVID-19 than directly giving them monoclonal antibodies.

The company reasons that a single administration of STI-1499dpi could allow the recipient’s own muscle cells to produce the antibody for a prolonged period of time after a single injection, potentially providing extended protection against COVID-19 for periods of time that might provide an alternative to vaccines. SmartPharm has also said its DNA plasmids can be manufacturing in bacterial fermenters in tandem with Sorrento’s in-house cGMP capabilities for a fraction of the cost associated with traditional antibody manufacturing.

Sorrento and SmartPharm said March 23 they will partner to develop a vaccine against COVID-19 by using monoclonal antibodies against SARS-CoV-2 discovered and/or generated by Sorrento that will be encoded into a gene for delivery using SmartPharm’s non-viral nanoparticle platform.

Plans for the collaboration may include candidate development as well as filing of an IND application in the next few months, the companies added. Sorrento has entered into a research testing agreement with The University of Texas Medical Branch at Galveston for preclinical testing of the company’s COVID-19 therapeutic product candidates.


COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA

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