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Monday, 08/23/2021 3:56:38 PM

Monday, August 23, 2021 3:56:38 PM

Post# of 14953
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 (https://www.medrxiv.org/).

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.