Wiki source code of Sorrento Therapeutics

Version 5.1 by Asif Farooqui on 2022/11/06 07:21
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7 = Summary =
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9 * Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain, autoimmune disease and COVID-19.
10 * Sorrento recently acquired Virex Health and taken majority ownership of Zhengzhou Fortune Bioscience Co.
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15 Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19.
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18 Recent developments
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21 Sorrento Successfully Completes Phase 1 Study, an Oral Treatment and Prevention of COVID-19
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23 [[https:~~/~~/investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-successfully-completes-phase-1-study-and-proceeding>>url:https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-successfully-completes-phase-1-study-and-proceeding]]
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26 Oct. 17, 2022; Sorrento Successfully Completes Phase 1 Study and Is Proceeding to Implement Global Registrational Trials with STI-1558, an Oral Mpro Inhibitor as a Standalone Oral Treatment and Prevention of COVID-19 without the Need for a Ritonavir Booster. The study done on n 58 healthy volunteers.
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29 A phase 1 trial in participants infected with SARS-CoV-2 has been initiated in China (MPR-COV-101CN), and a total 56 participants will be enrolled to assess the safety, tolerability, and efficacy in 3 MAD dose cohorts (300 mg BID, 600 mg BID and 800 mg BID daily for 7.5 days). Eight participants infected with SARS-CoV-2 in the first MAD dose cohort of 300 mg BID have been dosed.
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33 Acquired a Majority Ownership in Zhengzhou Fortune Bioscience
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35 [[https:~~/~~/investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-announces-it-has-acquired-majority-ownership-diagnostic>>url:https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-announces-it-has-acquired-majority-ownership-diagnostic]]
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37 Feb. 17, 2022; Sorrento Therapeutics, Inc. announced the acquisition of a majority ownership of Zhengzhou Fortune Bioscience Co., Ltd. (“FortuneBio”). This acquisition is in response to dramatically increasing demands worldwide and planned product build-up in anticipation of potential additional approvals for Sorrento’s COVISTIXTM COVID-19 VIRUS Rapid Antigen Detection Test.
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40 FortuneBio specializes in the manufacture of lateral flow diagnostic tests with numerous approved products marketed in over 20 countries for pregnancy tests, fecal occult blood test, and drug abuse test kits. FortuneBio has an ISO 13885 facility and is capable of producing tens of millions of lateral flow tests per month. FortuneBio is currently expanding production capabilities to meet COVISTIX demand worldwide.
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44 Sorrento Completes Acquisition of Virex Health
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46 [[https:~~/~~/investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-completes-acquisition-virex-health-will-commercialize>>url:https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-completes-acquisition-virex-health-will-commercialize]]
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49 February 1, 2022; Sorrento Therapeutics, Inc. announced that it has completed the acquisition of Virex Health, Inc., a Boston, MA based company (“Virex”), spun out of the labs of Professors Mark Grinstaff and Scott Schaus at BU, on February 1, 2022. The proprietary Virex Technology utilizes enzymatic and electrochemical amplification to detect picogram level biological analytes, such as SARS-CoV-2 and its variants, Flu A/B, as well as markers for liver cancer, inflammation and hormone monitoring.
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54 Financial Highlights
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58 December 31, 2021 Results.
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60 [[https:~~/~~/investors.sorrentotherapeutics.com/static-files/a641bd98-736e-434f-823d-fc2305ee0423>>url:https://investors.sorrentotherapeutics.com/static-files/a641bd98-736e-434f-823d-fc2305ee0423]]
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62 Revenues were $52.9 million for the year ended December 31, 2021, as compared to $40.0 million for the year ended December 31, 2020. Revenues in its Sorrento Therapeutics segment increased from $13.7 million to $24.4 million for the year ended December 31, 2021 compared to the prior year and were primarily attributed to higher contract manufacturing service revenues. Revenues in its Scilex segment increased from $26.3 million to $28.5 million for the year ended December 31, 2021 compared to the prior year due to increased product sales of ZTlido.
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65 Cost of revenues for the years ended December 31, 2021 and 2020 were $13.0 million and $9.9 million, respectively, and relate to product sales, the sale of customized reagents and providing contract manufacturing services. The costs generally include employee-related expenses, including salary and benefits, direct materials and overhead costs including rent, depreciation, utilities, facility maintenance and insurance. Cost of revenues for its Sorrento Therapeutics segment increased by $1.6 million and was driven by the increase in revenues. Cost of revenues for its Scilex segment increased by $1.5 million as compared to the prior year and was attributable to higher sales volumes of ZTlido.
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68 Research and development expenses for the years ended December 31, 2021 and 2020 were $206.9 million and $111.3 million, respectively. Research and development expenses primarily include expenses associated with isolating and advancing human antibody drug candidates derived from its libraries, as well as advancing its RTX, COVID-19, SP-102, Oncolytic Virus, antibody drug conjugate (?ADC?) and oncology programs. Such expenses consist primarily of salaries and personnel-related expenses, stock-based compensation expense, clinical development expenses, preclinical testing, lab supplies, consulting costs, depreciation and other expenses.
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70 Research and development expenses for its Sorrento Therapeutics segment increased by $96.3 million as compared to the prior fiscal year and were primarily driven by higher headcount and increased clinical development costs spent on advancing its various research and development programs.
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73 Research and development expenses for its Scilex segment decreased by $0.8 million as compared to the prior fiscal year and were primarily driven by lower clinical development costs.
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78 Company Overview
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81 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 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  COVI-AMG™, COVIDROPS™, COVISHIELD™, FUJOVEE™ (Abivertinib) and OQORY™ (Covi-MSC), and diagnostic test solutions, including COVITRACK™ and COVIMARK™. The COVISTIX™ COVID-19 Virus Rapid Antigen Detection Test is approved under Emergency Use Authorization (EUA) in Mexico by COFEPRIS and in Brazil by ANVISA and cleared for commercialization.
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83 [[https:~~/~~/investors.sorrentotherapeutics.com>>url:https://investors.sorrentotherapeutics.com]]
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86 Manufacturing
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88 The company's manufacturing facilities as below
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90 [[https:~~/~~/sorrentotherapeutics.com/manufacturing/>>url:https://sorrentotherapeutics.com/manufacturing/]]
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93 Judicial Manufacturing (Antibodies, Cell Therapies)
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95 State-of-the-art cGMP antibody and cell therapy manufacturing facility located in San Diego, CA, initially designed to be a multi-product facility for the manufacture of bulk purified proteins and antibodies for use as therapeutics. The redesigned facility meets applicable cGMP requirements for manufacture of Investigational New Drugs, and now includes capabilities for cellular therapies.
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99 Bioserv Aseptic Fill and Finish Contract Manufacturing Facility
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101 Now part of Sorrento’s core capabilities, Bioserv, a cGMP contract manufacturing service organization was acquired and integrated. With facilities/cleanrooms and mature quality systems, Bioserv provides aseptic and non-aseptic fill/finish services including lyophilization for the biotechnology, pharmaceutical and diagnostic industries, as well as labeling/kitting and long-term controlled room temperature, cold and frozen storage.
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104 bioserve
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106 Camino Santa Fe Oncolytic Virus Production Facility
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108 Sorrento’s viral production facility includes process development and analytical testing laboratories as well as cGMP clean rooms. Operations supported include cell culture, purification, fill and finish processes as well as analytical assay development and quality control testing. The facility is licensed by the CA Food and Drug Branch and has successfully manufactured drug substances and drug products for pre-clinical, PHASE I and PHASE II clinical trials.
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112 ADC Conjugation, Payload and Linker Synthesis Facility
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114 Sorrento operates its cGMP facility for Antibody Drug Conjugate (ADC) production in Suzhou, China, under the Levena Biopharma brand name. The site has been in operation since 2016 and can support clinical cGMP production of drug linkers as well as antibody conjugation. With full analytical support capabilities and a facility equipped to handle highly potent API (isolator), the site has supported over 20 clinical batches for clinical trials worldwide.
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118 Sofusa Research and Manufacturing Facility
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120 SOFUSA manufacturing capabilities in Atlanta, GA include precision nanofabrication techniques alongside assembly and testing of device components. The operation is able to support manufacturing of custom devices to support both preclinical studies and Phase I and II clinical trials. In addition, the SOFUSA research center is a fully functional small animal lab with state-of-the-art imaging capabilities (NIRF, IVIS, PET-CT) to fully characterize the impact of lymphatic delivery relative to traditional injections and infusions.
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123 Subsidiaries and Partnership
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125 <gorup img>
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128 Company History
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130 <table>
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133 References
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136 = References =
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