IMPDH

SHANGHAI, NANJING, China and SAN JOSE, Calif., Jan. 31, 2024 /PRNewswire/ -- On Jan. 30, 2024, PNAS published the research paper titled "Single-cell analysis of refractory anti-SRP necrotizing myopathy treated with anti-BCMA CAR T-cell therapy." The paper analyzed results using the fully human B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR)-antologous T cell (BCMA CAR-T) injection (Equecabtagene Autoleucel injection, R&D code: CT103A) for the treatment of IMNM, which showed durable pathogenic antibody clearance, and potentially persistent clinical efficacy with good tolerability and safety. This study provides a potentially new therapeutic option for antibody-mediated autoimmune disorders. IMNM is an autoimmune-mediated skeletal muscle disorder belonging to an idiopathic inflammatory disease. IMNM mediated by human anti-signal recognition particle (SRP) antibody, an IMNM-specific autoantibody, is mainly characterized by symmetrical weakness of limb proximal muscles, prominent dysphagia, and significantly elevated serum creatine kinase, with features of acute onset, severe conditions, and rapid progression. Traditional pharmacological approaches have varying and often limited effects. This study is an investigator-initiated, open-label, exploratory clinical study to evaluate the safety and efficacy of infusion of Equecabtagene Autoleucel in the treatment of relapsed/refractory antibody-mediated idiopathic inflammatory diseases of the nervous system (NCT04561557). The investigator team is led by Professor Wang Wei from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. A 25-year-old male patient with a 7-year history of SRP antibody-positive refractory IMNM was enrolled in this study. The patient had been subject to repeated relapses and persistent injuries even after receiving multiple prior therapies including steroids, calcineurin inhibitors, folic acid antagonists, CD20 monoclonal antibodies, interleukin-6 (IL-6) receptor antagonists, inosine monophosphate dehydrogenase (IMPDH) inhibitors, alkylating agents, plasmapheresis, intravenous immunoglobulin injection, and mesenchymal stem cell infusion. Before enrollment, the patient was still paralyzed and bedridden. He was not able to lift his arms overhead and his serum creatine kinase was up to 4806 IU/L (Normal range ≤ 190 U/L) even under regular combination therapies with steroids, IL-6 receptor antagonists, folic acid antagonists, and intravenous immunoglobulin injection. Safety: The patient developed only grade 1 cytokine release syndrome (CRS), but had no immune effector cell-associated neurotoxicity syndrome (ICANS). Only transient hemocytopenia was observed. No new safety risks were found compared to the safety profile in the studies of multiple myeloma indication. Efficacy: During the 18-month follow-up after infusion of Equecabtagene Autoleucel, the patient's clinical symptoms and imaging characteristics continuously improved. Three months after infusion of Equecabtagene Autoleucel, the patient's strength of extremities improved significantly. He could lift his arms without much effort, and regained his ability to walk. Manual Muscle Testing-8 (MMT-8) score improved from 96 points at baseline to 137 points at the last visit (18 months after infusion). Serum creatine kinase level decreased from 4778 IU/L before infusion to 260 IU/L at the last visit, and myoglobin level decreased from 837 ng/mL before infusion to 66.2 ng/mL at the last visit. Significant improvements were also observed in other quality of life scales. There was no concomitant use of other immunomodulatory therapies during the follow-up. PK/PD: The expansion of CAR-T cells in the patient was good after infusion of Equecabtagene Autoleucel. The serum SRP antibody level declined rapidly and remained at a very low level. The principal investigator of this study, Professor Wang Wei from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology said: "This is the first time globally to apply BCMA CAR-T cell therapy to treat IMNM, which is another important breakthrough in the field of autoimmune diseases after the successful treatment of neuromyelitis optica spectrum disorders (NMOSD) with BCMA CAR-T. We look forward to the further development of CAR-T therapy in the field of autoimmunity, bringing hope of cure to patients." In addition to the research results published this time, IASO Bio and the investigator team are continuing to explore the safety and efficacy of Equecabtagene Autoleucel in the treatment of other autoimmune disorders including NMOSD, myasthenia gravis (MG), and chronic inflammatory demyelinating polyneuropathy (CIDP), for the hope of changing the treatment paradigm of autoimmune disorders. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . SOURCE IASO Bio

Westport, CT, July 13, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company") and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced the enrollment of adult patients for its Phase II trial for merimepodib, a broad-spectrum, orally administered antiviral drug candidate for the treatment of COVID-19, at four key trial sites. The trial sites are located in Austin, TX, Rochester, MN, Jacksonville, FL, and Scottsdale, AZ. Merimepodib is intended to be orally administered and has demonstrated broad-spectrum in-vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. "Three of our four trial sites where our partners are enrolling patients are in the recognized hot spots of Texas, Arizona, and Florida. The patients in this trial are hospitalized and requiring oxygen; therefore, providing effective treatment is of the utmost importance to all," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc., the majority shareholder of ViralClear Pharmaceuticals, Inc. "Arizona, Florida, and Texas are unfortunately seeing spikes in COVID-19 cases resulting in hospitals reaching near capacity. We would like to thank our clinical partners for the steady progress with the trial and expect to report the trial data later this summer". The Phase II randomized, double-blind, placebo-controlled study is designed to enroll adult patients with advanced Coronavirus Disease 2019 (COVID-19). A description of this clinical trial can be accessed via . Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed a reduction in SARS-CoV-2 replication to undetectable levels. Peer-reviewed publication of these findings can be found at F1000 Research: About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (). The Company's first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. About ViralClear Pharmaceuticals and Merimepodib (MMPD) BioSig's subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered and has demonstrated broad-spectrum in vitro anti-viral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, "The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro", was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. ("ViralClear") as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. Forward-looking Statements This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133