Sorrento Publishes Positive Initial Results of SOFUSA® Lymphatic Drug Delivery System in a Phase 1b Rheumatoid Arthritis Study Using Enbrel

• Rheumatoid Arthritis (RA) is one of many chronic autoimmune conditions affecting over 20 million people in the United States (NIH, 2017).
  
  
• Sofusa is a revolutionary technology which delivers biologic therapies through the skin and into the lymphatic system.
• Current biologic treatments for RA are delivered by either subcutaneous (SC) injection or intravenous (IV) infusion and response rates for treatment with biologic drugs for RA (e.g., etanercept) plus methotrexate are approximately 35-40%.
• The first patient treated with Sofusa with Enbrel achieved a dramatic improvement in disease activity in just 12 weeks receiving only 50% of the Enbrel subcutaneous dose weekly:
  • Disease activity as measured by DAS28-ESR decreased 34.1% from 4.58 at Baseline to 3.02 at Week 12 demonstrating a change from moderate to low disease activity. The lowest DAS28-ESR achieved was 2.10 at Week 10 after 10 weekly doses which corresponds to a disease activity level of remission.
  • The number of tender joints decreased from Week 0 to Week 12 by 70.6% (full 68-Joint Count) and 90.9% (28-Joint Count).

SAN DIEGO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today released a patient case report on the lymphatic delivery of Enbrel using the Sofusa Lymphatic Delivery System (SOFUSA), which has been submitted for preprint as CASE REPORT: Lymphatic delivery of Enbrel^® using The Sofusa^® Lymphatic Delivery System (SOFUSA) achieves improvement in rheumatoid arthritis disease activity measures in a patient non-responsive to Enbrel subcutaneous injections ().

The development of tumor necrosis factor (TNF) inhibitors has greatly improved the treatment of RA, but many patients either do not respond or relapse after therapy. TNF is produced by a variety of immune cells that reside within lymph nodes and the lymphatic system. A Phase 1b open label study is examining the changes in RA disease progression by administering Enbrel, a TNF inhibitor, to the lymphatic system and draining lymph nodes using the SOFUSA device. The first patient to participate in this ongoing study was a 43-year-old female who had an inadequate response to Enbrel after 11 months of once weekly 50mg Enbrel SC injections.

After 12 weeks of receiving SOFUSA with Enbrel at 25 mg weekly, disease activity as measured by DAS28-ESR decreased 34.1% from 4.58 at Baseline to 3.02 at Week 12 demonstrating a change from moderate to low disease activity. Similarly, DAS28-CRP decreased 37.5% from 4.99 at Baseline to 3.12 at Week 12 demonstrating a change from high disease activity to moderate disease activity. The lowest DAS28-ESR achieved was 2.10 at Week 10 after 10 weekly doses which corresponds to a disease activity level of remission. A study extension has been IRB approved to evaluate the potential for further dose reductions in patients who respond well to 25 mg weekly dosing.

Joint counts were performed every 2 weeks and a consistent decrease in the number of tender and swollen joints was recorded for the entire 12-week dosing period. The number of tender joints decreased from Week 0 to Week 12 by 70.6% (full 68-Joint Count) and 90.9% (28-Joint Count). Similarly, the number of swollen joints decreased from Week 0 to Week 12 by 44.4% (full 66-Joint Count) and 28.6% (28-Joint Count).

“Our hypothesis for this study was that delivering Enbrel directly into the lymphatics would improve clinical response. While this is only the first patient, the improvement is quite remarkable and suggests that delivering therapy directly into the lymphatics may be one of the factors associated with improved response to biologic therapies delivered systemically. It was also quite interesting to see the correlation between lymphatic flow and clinical response. We are looking forward to enrolling more patients in this study” – Roel Querubin, MD, Principal Investigator, Atlanta Research Center for Rheumatology.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers 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 fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.

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 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 post-herpetic neuralgia. RTX has completed a Phase 1b trial for intractable pain associated with cancer and a Phase 1b trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido^® was approved by the FDA on February 28, 2018.

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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 Delivery System, including for the treatment of Rheumatoid Arthritis; the ability of the Sofusa Lymphatic Delivery System to reduce required dosing of a drug; the potential for the Sofusa Lymphatic Delivery System to improve safety and efficacy and to reduce required dosing as compared to traditional systemic or subcutaneous injections or infusions; the clinical testing of a SOFUSA product candidate; the preliminary results of the first patient in the Phase 1b study to date; the continued enrollment and potential commencement of future clinical trials for a SOFUSA product candidate; the potential for pre-clinical study results to be replicated or continue to show improved clinical safety or efficacy in the current clinical trial and future clinical trials; the potential for preliminary data results to be replicated or continue to show improved clinical safety or efficacy as the ongoing trial continues; the potential for delivery of biologic therapies directly into the lymphatic system to improve response to such biologic therapies; and Sorento’s potential position in the therapeutics industry. 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 and its subsidiaries', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting clinical studies and seeking regulatory approval for the Sofusa Lymphatic Drug Delivery Device, including the timing for receipt of any such approval; conducting and receiving results of clinical trials; 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 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 the company in the execution of its COVID-19 therapeutic 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, 2020, 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.

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Alexis Nahama, DVM (SVP Corporate Development)

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