- T-VIVA-19 (targeted virus vaccine against COVID-19) is a recombinant fusion protein of the SARS-CoV-2 spike protein S1 domain and human IgG Fc.
- Novel protein to progress as priority vaccine candidate development program.
- Sorrento’s existing cGMP manufacturing facility bulk drug substance production capacity estimated able to satisfy up to 100 million doses a month, with on-site scale-up potential to meet additional demand as needed.
SAN DIEGO, CA, USA I July 01, 2020 I Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it has published a pre-print publication (https://www.biorxiv.org/content/10.1101/2020.06.29.178616v1.full.pdf) describing initial pre-clinical results from its COVID-19 vaccination program, which introduced a novel targeted protein vaccine against COVID-19, referred to as T-VIVA-19.
T-VIVA-19 is a recombinant fusion protein of the spike protein S1-domain and the Fc portion of the human IgG1 antibody (rS1-Fc). The rS1-Fc was injected into either the vein or the thigh muscle of a mouse. The mice were given a booster shot three weeks later (by the same route as the initial injection) and immune responses to SARS-CoV-2 were examined.
Immunization with the rS1-Fc protein via intramuscular and intravenous injections induced antibodies against the SARS-CoV-2 protein in all mice within the first week of administration. Antibodies were observed to be enhanced upon the administration of a booster. Approximately 80% of the mice’s sera possessed neutralizing antibodies and completely prevented virus infection in in vitro cell cultures using 100 TCID50 viruses and VERO cells.
Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, said, “If successful and approved, we plan to produce the T-VIVA-19 vaccine in our therapeutic antibody cGMP production facility in San Diego. Due to the potentially low dose administration of T-VIVA-19, which may be one milligram per person or less, we believe our existing cGMP manufacturing facility is capable of producing bulk drug substance rS1-Fc for up to 100 million doses a month. Unlike other vaccine candidates, our rS1-Fc protein production could utilize our existing therapeutic antibody manufacturing processes, and we therefore believe it would be simple and easy to scale up.”
Sorrento plans to take the T-VIVA-19 vaccine candidate through the regulatory steps for clinical trial clearance, while preparing for large scale manufacturing and commercial distribution in parallel.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”, “Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™.
Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
SOURCE: Sorrento Therapeutics
Post Views: 39
- T-VIVA-19 (targeted virus vaccine against COVID-19) is a recombinant fusion protein of the SARS-CoV-2 spike protein S1 domain and human IgG Fc.
- Novel protein to progress as priority vaccine candidate development program.
- Sorrento’s existing cGMP manufacturing facility bulk drug substance production capacity estimated able to satisfy up to 100 million doses a month, with on-site scale-up potential to meet additional demand as needed.
SAN DIEGO, CA, USA I July 01, 2020 I Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it has published a pre-print publication (https://www.biorxiv.org/content/10.1101/2020.06.29.178616v1.full.pdf) describing initial pre-clinical results from its COVID-19 vaccination program, which introduced a novel targeted protein vaccine against COVID-19, referred to as T-VIVA-19.
T-VIVA-19 is a recombinant fusion protein of the spike protein S1-domain and the Fc portion of the human IgG1 antibody (rS1-Fc). The rS1-Fc was injected into either the vein or the thigh muscle of a mouse. The mice were given a booster shot three weeks later (by the same route as the initial injection) and immune responses to SARS-CoV-2 were examined.
Immunization with the rS1-Fc protein via intramuscular and intravenous injections induced antibodies against the SARS-CoV-2 protein in all mice within the first week of administration. Antibodies were observed to be enhanced upon the administration of a booster. Approximately 80% of the mice’s sera possessed neutralizing antibodies and completely prevented virus infection in in vitro cell cultures using 100 TCID50 viruses and VERO cells.
Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, said, “If successful and approved, we plan to produce the T-VIVA-19 vaccine in our therapeutic antibody cGMP production facility in San Diego. Due to the potentially low dose administration of T-VIVA-19, which may be one milligram per person or less, we believe our existing cGMP manufacturing facility is capable of producing bulk drug substance rS1-Fc for up to 100 million doses a month. Unlike other vaccine candidates, our rS1-Fc protein production could utilize our existing therapeutic antibody manufacturing processes, and we therefore believe it would be simple and easy to scale up.”
Sorrento plans to take the T-VIVA-19 vaccine candidate through the regulatory steps for clinical trial clearance, while preparing for large scale manufacturing and commercial distribution in parallel.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”, “Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™.
Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
SOURCE: Sorrento Therapeutics
Post Views: 39
