Sorrento Reports Positive Trial Results Utilizing Sofusa Lymphatic Delivery of Etanercept, ...

• Sorrento has now completed its first Phase 1b human proof of concept study where the first 7 out of 7 patients with an inadequate initial response on etanercept subcutaneous injections achieved significant improvements in disease activity when switched to Sofusa lymphatic delivery.
• Results will be presented at the American College of Rheumatology (ACR) Convergence 2022 Conference on November 13, 2022 as an abstract and poster entitled “Lymphatic Delivery of Etanercept Achieves Significant Improvements in Rheumatoid Arthritis Disease Measures at 50% of the Standard Dose for Patients with an Inadequate Response to Subcutaneous Injections”.

SAN DIEGO, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced completion of its first Phase 1b proof of concept study using the Sofusa Lymphatic Drug Delivery System (Sofusa).

STI-SOFUSA-1003 is a Phase 1b proof of concept study designed to evaluate safety, and also test the hypothesis that Sofusa’s unique biodistribution profile could improve clinical response, reduce the amount of drug required to achieve a response, or both. To be eligible for the study, participants had to be on a stable dose of 50mg of etanercept and not responding adequately to the etanercept subcutaneous treatment.

Preliminary results indicate that 100% of the patients (7 of 7) who have completed the first cohort of the study (12 weeks) achieved a significant improvement in their Rheumatoid Arthritis Disease Activity at 50% of the subcutaneous dose (25mg). The ACR Abstract Selection Committee has accepted an abstract entitled “Lymphatic Delivery of Etanercept Achieves Significant Improvements in Rheumatoid Arthritis Disease Measures at 50% of the Standard Dose for Patients with an Inadequate Response to Subcutaneous Injections”, available at https://acrabstracts.org/abstract/lymphatic-delivery-of-etanercept-achieves-significant-improvements-in-rheumatoid-arthritis-disease-measures-at-50-of-the-standard-dose-for-patients-with-an-inadequate-response-to-subcutaneous-injectio/

Full results of the Phase 1b proof of concept study will be presented at the ACR Convergence 2022 Conference on November 13, 2022 by Russell Ross, Ph.D., Chief Technical Officer for Sorrento’s Sofusa Business Unit. “We are very encouraged by these results, and appreciative of the ACR’s acceptance of our publication. The Sofusa platform is fulfilling the promise that we expected when we acquired this platform. The technology, combined with our proprietary G-MAB library and antibody manufacturing capabilities, gives us an engine for developing a pipeline of novel lymphatic therapies for autoimmune diseases, cancers, and infectious diseases,” stated Henry Ji, Ph.D., President and CEO of Sorrento. “This also gives hope to the many patients who are not achieving an adequate response on current biologic therapies delivered by traditional injections and infusions,” he continued.

About Sorrento’s Sofusa Business Unit

The Sofusa Business Unit is a wholly owned division of Sorrento based in Atlanta, Georgia and is focused on lymphatic drug development with pre-clinical, analytical, clinical development, and device manufacturing capabilities. The Sofusa platform is a novel microneedle technology that delivers both small and large molecule drugs through the skin and into lymphatic capillaries resulting in significantly higher drug concentrations to immune system drug targets over greater time periods than traditional injections or infusions. Drug targets for many diseases of the immune system (e.g., autoimmune diseases and cancer) reside in the lymphatic system and lymph nodes. In multiple pre-clinical models, Sofusa’s proprietary nanotopography-draped microneedle system has consistently demonstrated the ability to improve therapeutic responses by delivering over 40-fold increases in drug concentration to targeted lymph nodes when compared to traditional subcutaneous injections or intravenous infusions. The Sofusa Business Unit is currently conducting human proof of concept studies in autoimmune disease and in cancer.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as next-generation tyrosine kinase inhibitors (“TKIs”), fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including STI-1558, COVISHIELD™ and COVIDROPS™; and diagnostic test solutions, including COVIMARK™.

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the Sofusa Lymphatic Drug Delivery System, including the preliminary results of the Phase 1b proof of concept study; the potential ability for the Sofusa Lymphatic Drug Delivery System to improve clinical response, reduce the amount of drug required to achieve a response, or both; and Sorrento’s ability to develop a pipeline of novel lymphatic therapies for autoimmune diseases, cancers, and infectious diseases. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to safety and efficacy of the Sofusa Lymphatic Drug Delivery System and seeking regulatory approval for the Sofusa Lymphatic Drug Delivery System; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations
Contact: Brian Cooley
Email: mediarelations@sorrentotherapeutics.com

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

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