Sorrento announces positive trial results using lymphatic administration of etanercept by Sofusa, achieving significant improvements in measures of rheumatoid arthritis at 50% of the standard dose for patients (7 of 7) with an inadequate response to subcutaneous injections
Sorrento has now completed its first human Phase 1b proof-of-concept study where the first 7 of 7 patients with an initial inadequate response to subcutaneous injections of etanercept achieved significant improvements in disease activity when they switched to lymphatic administration of Sofusa.
Findings will be presented at the American College of Rheumatology (ACR) 2022 Convergence Conference on November 13, 2022 in the form of 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 the completion of its first phase 1b proof-of-concept study using the administration of lymphatic drugs Sofusa (Sofusa) .
STI-SOFUSA-1003 is a Phase 1b proof-of-concept study designed to assess safety and also test the hypothesis that Sofusa’s unique biodistribution profile may improve clinical response, reduce the amount of drug needed to obtain an answer, or both. To be eligible for the study, participants had to be on a stable dose of 50 mg etanercept and not respond adequately to subcutaneous etanercept therapy.
Preliminary results indicate that 100% of patients (7 out of 7) who completed the first cohort of the study (12 weeks) achieved a significant improvement in their activity in rheumatoid arthritis at 50% of the subcutaneous dose ( 25mg). The ACR Abstract Screening Committee accepted an abstract titled “Lymphatic Administration of Etanercept Achieves Significant Improvements in Measures of Rheumatoid Arthritis at 50% of the Standard Dose for Patients with an Inadequate Response to Injections diseases”, available at https://acrabstracts.org/summary/the-administration-lymphatic-of-etanercept-provides-significant-improvements-of-measurements-of-rheumatoid-polyarthritis-to-50 -of-the-standard-dose-for-patients-with-an-inadequate-response-to-subcutaneous-injection/
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., CTO of Sofusa Sorrento Business Unit. “We are very encouraged by these results and appreciate the acceptance of our publication by the ACR. The Sofusa platform fulfills the promise we expected when we acquired this platform. The technology, combined with our proprietary G-MAB library and antibody manufacturing capabilities, gives us an engine to develop a pipeline of novel lymphatic therapies for autoimmune diseases, cancers and infectious diseases,” said Henry Ji, Ph.D., President and CEO of Sorrento. “It also gives hope to the many patients who are not getting an adequate response to current biologic therapies delivered by traditional injections and infusions,” he continued.
About Sofusa Sorrento 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 preclinical, analytical, clinical development and device manufacturing capabilities. The Sofusa platform is a new micro-needle technology that delivers small and large molecule drugs through the skin and into the lymphatic capillaries, resulting in significantly higher drug concentrations for immune system drug targets on longer periods than traditional injections or infusions. Drug targets for many immune system diseases (eg, autoimmune diseases and cancer) reside in the lymphatic system and lymph nodes. In multiple preclinical models, Sofusa’s proprietary nanotopography draped microneedle system has consistently demonstrated the ability to enhance therapeutic responses by delivering more than 40 times higher drug concentration to targeted lymph nodes compared to traditional subcutaneous injections. or intravenous infusions. The Sofusa Business Unit is currently conducting proof-of-concept studies in humans in autoimmune diseases and cancer.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial-stage biopharmaceutical company developing novel therapies to treat cancer, pain (non-opioid treatments), autoimmune diseases and COVID-19. Sorrento’s multi-modal, multi-pronged approach to fighting cancer is enabled by its extensive immuno-oncology platforms, including key assets such as next-generation tyrosine kinase (“TKI”) inhibitors, fully human antibodies (“G-MAB™ library”), cell therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”) and oncolytic viruses (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and coronavirus vaccines, including STI-1558, COVISHIELD™ and COVIDROPS™; and diagnostic testing solutions, including COVIMARK™.
Sorrento’s commitment to therapies that improve the lives of patients is also demonstrated by our efforts to advance a non-opioid pain management small molecule (TRPV1 agonist), resiniferatoxin (“RTX”) and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a new viscous gel formulation of a corticosteroid widely used for epidural injections to treat lumbosacral radicular pain or sciatica, and to market the ZTlido® (topical lidocaine system) 1.8% for the treatment of postherpetic neuralgia (PHN) . RTX has been cleared for a phase II trial in intractable pain associated with cancer and a phase II trial in patients with osteoarthritis. Positive final results from the CLEAR program of the pivotal Phase III trial for SEMDEXA™, its new 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.
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This press release and all statements made for and during any presentation or meeting contain forward-looking statements relating 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. which could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the Sofusa lymphatic drug delivery system, including preliminary results from the Phase 1b proof-of-concept study; the potential ability of the Sofusa Lymphatic Drug Delivery System to improve clinical response, reduce the amount of drug needed 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 relating to Sorrento’s technologies and prospects, including, but not to limit, risks related to the safety and effectiveness of the Sofusa lymphatic drug delivery system and to obtain regulatory approval for the Sofusa lymphatic drug delivery system; clinical development risks, including risks relating to the progress, timing, cost and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; the risks that the results of a clinical study may not meet any or all of the clinical study endpoints and that data generated from such studies may not support regulatory submission or approval; the risks that the results of prior tests, studies and trials will not be replicated in ongoing or future studies and trials; risks associated with the manufacture and supply of pharmaceutical products; the risks of using the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in executing its product candidate strategies; risks related to the global impact of COVID-19; and other risks 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 fiscal year ended December 31, 2021 and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission and Exchange Commission, including the risk factors set forth in those documents. 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 statements in this press release unless the law requires it.
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