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R MZL) and Its Plan for a Pivotal Phase III Study

2023-07-05

临床2期临床结果临床3期临床1期上市批准

Abivertinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor that irreversibly targets BTK. BTK inhibitors BTK inhibitors are a large category in cancer treatment, with multiple indications and generating over $10.6 billion per year revenue in 2022. In this phase IIa study conducted in China, a total of 27 R/R MZL patients treated with Abivertinib were assessed and the overall response rate (ORR) was 59.3 % (16/27 patients) and among them, 3 patients had complete responses (CR) with a CR rate of 11.1% (3/27patients) and disease control rate (DCR) was 92.6%. To date, progression free survival (PFS) and duration of response (DOR) have not been reached. Sorrento has communicated with the China Health Authority (National Medical Products Administration or NMPA) regarding the design of a pivotal phase III registration study of R/R MZL in China. SAN DIEGO, July 05, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ) today announced positive results from a China phase IIa study of Abivertinib on R/R MZL and its plan for a pivotal study. Abivertinib is a pyrrolopyrimidine-based, mutant EGFR and BTK dual inhibitor with potential across multiple indications. BTK inhibitors BTK inhibitors are a large category in cancer treatment, with multiple indications and generating over $10.6 billion per year revenue in 2022.(1) Abivertinib inhibits BTK with IC50 value of 0.4 nM. Previously, a positive phase Ib study result of Abivertinib on B cell lymphoma was reported.(2) The phase IIa study on R/R MZL, a rare type of B cell lymphoma, was conducted in China in 27 R/R MZL patients. Abivertinib showed significant treatment benefits in 27 patients who were relapsed or refractory after multiple lines of treatment with an ORR of 59.3% (11.1% CR and 48.2% partial responses). This ORR is higher than the ORR of Ibrutinib (46%), which was first approved for the treatment of R/R MZL.(3) The DCR was 92.6% and to date, both PFS and DOR have not been reached. In the phase IIa study, Abivertinib was well-tolerated, and no severe bleeding, arrhythmia (atrial fibrillation/flutter) or hypertension were seen in these Abivertinib-treated patients. Given these early results, Abivertinib has a promising safety and efficacy pro date, which has the potential for it to be preferable to the approved drug Ibrutinib.(3) Sorrento has communicated with the NMPA, and a consensus has been reached for a pivotal phase III registration study for the treatment of R/R MZL. The pivotal study will be a multicenter phase III study to assess the efficacy and safety of Abivertinib for treatment of relapsed/refractory marginal zone lymphoma relapsed/refractory marginal zone lymphoma. Sorrento will continue communicating with the NMPA to finalize the phase III protocol. “We are very encouraged by the significant positive results of Abivertinib for the treatment of R/R MZL, which would be a second indication of Abivertinib for cancer treatment in addition to the potential treatment of resistant EGFR mutant positive non-small cell lung cancer,” said Dr. Henry Ji, Ph.D., Chairman and CEO of Sorrento. About Sorrento Therapeutics, Inc. 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 next-generation tyrosine kinase inhibitors (“TKIs”), 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 STI-1558 and COVI-MSC™, and diagnostic test solutions, including COVIMARK™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a TRPV1 agonist 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 postherpetic neuralgia (PHN). RTX has been cleared for a phase II trial for intractable pain associated with cancer and a phase II trial in osteoarthritis patients. Positive final results from the phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, 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. For more information visit 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 Sorrento's products, technologies and prospects, Sorrento's plans and expectations regarding a pivotal registration study for the treatment of R/R MZL in China and its communications with the NMPA regarding the design of a pivotal phase III registration study for R/R MZL in China, Abivertinib’s potential to provide significant treatment benefits, Abivertinib’s promising safety and efficacy pro Abivertinib’s potential to be a preferable choice to the approved drug Ibrutinib. 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 technologies and prospects, including, but not limited to risks related to safety and efficacy of Abivertinib and seeking regulatory approval for Abivertinib; 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, including those for Abivertinib, may not be replicated in continuing or 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 Sorrento in the execution of its product candidates’ strategies; risks relating to the voluntary proceedings under Chapter 11 in the Bankruptcy Court (the "Chapter 11 Cases"), Sorrento's ability to continue operating in the ordinary course while the Chapter 11 Cases are pending, the timing and outcome of the Chapter 11 Cases, Sorrento's ability to obtain timely approval by the Bankruptcy Court of the motions filed in the Chapter 11 Cases, employee attrition and Sorrento's ability to retain senior management and other key personnel due to the distractions and uncertainties of the Chapter 11 Cases, Sorrento's ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 11 Cases, the Bankruptcy Court's rulings in the Chapter 11 Cases, the length of time that Sorrento will operate under Chapter 11 protection and the continued availability to Sorrento of operating capital during the pendency of the Chapter 11 Cases, risks associated with any third party motions in the Chapter 11 Cases, increased administrative and legal costs related to the chapter 11 process, exposure to potential litigation and inherent risks involved in a bankruptcy process, the potential adverse effects of the Chapter 11 Cases on Sorrento's liquidity or results of operations, or Sorrento's ability to timely periodic reports or meet periodic reporting requirements with the SEC; 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, 2022 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. Media and Investor Relations Contact: Brian Cooley Email: mediarelations@sorrentotherapeutics.com Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™, Fujovee™ and Ovydso™ are trademarks of Sorrento Therapeutics, Inc. SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. All other trademarks are the property of their respective owners. ©2023 Sorrento Therapeutics, Inc. All Rights Reserved. References: (1). Marketwatch; Press Release: Global Bruton's Tyrosine Kinase (BTK) Inhibitors Market [2023] | New Report Anticipates Industry to Surpass USD 25770 Million in Revenue by 2030, 4 May 2023 (2). Yang M., Qian J., Huang J., and etc., A phase 1 study of the BTK inhibitor abivertinib (AC0010) in patients with relapsed or refractory B-cell lymphoma, EHA Library, 06/14/2019; 266315, PF515 (3). Ibrutinib label,