DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded Neutralizing Antibodies

• Initial funding of up to $34 million for the project “Gene Mabs: A Scalable, Economic, Gene-Encoded Protective Antibody Platform Against Coronavirus” (HR0011-21-9-0015) to support the development of an STI-2020-encoded Gene MAb^TM through Phase 2 clinical studies.
• STI-2020-encoded Gene MAb is in development for intramuscular injection against the SARS-CoV-2 virus and its variant strains to produce potent STI-2020 nAbs in the body.
• STI-2020-encoded Gene MAb products can potentially be stored at refrigerator temperatures, avoiding some of the cold chain management challenges associated with the deployment of COVID-19 vaccines currently in development.  
• Sorrento has a cGMP facility in place to meet initial production demand and Sorrento expects that STI-2020-encoded Gene MAb can be produced in large quantity to meet potentially high demand.

SAN DIEGO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- SmartPharm Therapeutics, Inc. (“SmartPharm”), a wholly-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), and developer of next-generation, non-viral gene therapy technologies, announced today that it has been awarded a contract from the Defense Advanced Research Projects Agency (DARPA) co-funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop a rapid countermeasure to COVID-19. The contract would provide SmartPharm up to USD $34 million for development through Phase 2 clinical studies of a gene-encoded antibody (“Gene MAb”) that could enable rapid protection from and/or treatment of SARS-CoV-2 infection and COVID-19. Sorrento will seek further funding in support of the COVID Gene MAb program toward EUA (emergency use authorization) approval and large-scale manufacturing pending successful clinical studies.

For this Gene MAb approach, the SmartPharm/Sorrento team will produce plasmid DNA encoding the SARS-CoV-2 neutralizing antibody STI-2020 (COVI-AMG). The FDA is currently reviewing IND filings for STI-2020 as an IV-delivered neutralizing antibody and STI-2099 as an intranasal-delivered neutralizing antibody for the treatment of COVID-19. The expected higher potency of the STI-2020 antibody makes it an ideal candidate for Gene MAb delivery against COVID-19.

The DARPA/JPEO contract supports the accelerated development of a Gene MAbs neutralizing antibody that can be delivered by a simple intramuscular injection, enabling the recipient to produce the protective antibody, potentially within days of the injection. Such an approach would permit the rapid translation of fully characterized potent neutralizing antibodies into clinical use, which Sorrento believes will be important for responding to potential mutations of SARS-CoV-2 that may emerge. It would also enable broader deployment of the Gene MAb approach as a prophylactic solution, as it can be conveniently administered into the muscle like an annual flu vaccine. If successful, it could provide an alternative method of protecting populations where vaccines do not work as well, such as the elderly or immunocompromised.