Sorrento Receives FDA IND Clearance to Initiate a Phase I Clinical Trial of its CD38 Antibody-Drug Conjugate STI-6129 for Patients with Amyloidosis

索伦托获得 FDA IND 批准启动 CD38抗体药物联合 STI-6129治疗淀粉样变性的临床试验

2020-05-27 02:30:28 BioSpace

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SAN DIEGO, May 26, 2020 -- Sorrento Therapeutics, Inc.. today announced it has received clearance from the U.S. Food and Drug Administration for its investigational new drug application for STI-6129, a CD38-targeting antibody drug conjugate . STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB™ antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugation technology. “That the FDA cleared our STI-6129 IND application to proceed to human trials is another important milestone for Sorrento,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “Together with our CD38 CAR-T program, this has the potential to provide additional therapeutic options for patients in need. We are looking forward to further evaluating the safety and efficacy of STI-6129 in clinical trials.” Sorrento intends to initiate a phase I multicenter, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile.  “This is Sorrento’s first ADC utilizing our site-specific C-LOCK conjugation technology that is advancing into clinical evaluation,” said Dr. Hui Li, head of Sorrento’s ADC business unit, Levena Biopharma. “STI-6129 demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates, and we look forward to potentially expanding its utilization into additional ADC programs.” About Sorrento Therapeutics, Inc.  Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. 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”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and COVI-KILLER™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com. 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 the potential therapeutic benefits of STI-6129; the planned phase I clinical trial for STI-6129 and the objectives thereof; regulatory approvals of STI-6129; the safety and efficacy of STI-6129; and the completion of clinical trials of STI-6129. 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 and its subsidiaries', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting and receiving results of clinical trials for STI-6129; the clinical and commercial success of the treatment of the advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis using STI-6129; the viability and success of using STI-6129 for treatments in therapeutic areas, including amyloid light chain (AL) amyloidosis; 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 of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its therapeutic product candidates strategies; risks related to Sorrento’s debt obligations; risks related to the global impact of COVID-19; 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, 2019, 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: Alexis Nahama, DVM (SVP Corporate Development) Telephone: 1.858.203.4120 Email: mediarelations@sorrentotherapeutics.com Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, COVI-GUARD™, COVI-SHIELD™, COVIDTRAP™, ACE-MAB™, COVI-KILLER™ and COVI-CELL™ are trademarks of Sorrento Therapeutics, Inc. ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc. Seprehvir® is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc. All other trademarks are the property of their respective owners. © 2020 Sorrento Therapeutics, Inc. All Rights Reserved.
圣迭戈,2020年5月26日-索伦托治疗公司。今天宣布,它已收到美国食品药品监督管理局(Food and Drug Administration)的批准,其研究的新药申请 STI-6129,一个 CD38靶向抗体药物共轭物。STI-6129利用 Sorento Therapeutics 正在开发的几个技术平台,包括从其全人 G-MAB ™抗体文库、其专利药物有效载荷 Duosttin 5及其特定位点 C-LOCK 结合技术中识别的 CD38特异性抗体。 Sorento Therapeutics 董事长兼首席执行官 Henry Ji 博士说:“ FDA 批准了我们的 STI-6129 IND 申请进行人体试验,这是 Sorento 的另一个重要里程碑。”“连同我们的 CD38 CAR-T 计划,这有可能为有需要的患者提供额外的治疗选择。我们期待进一步评估 STI-6129在临床试验中的安全性和有效性。” 索伦托计划在晚期复发性和/或难治性系统性淀粉样蛋白链淀粉样变性患者中启动一期多中心、开放标签、剂量递增临床试验,主要目的是根据其安全性、初步疗效和药代动力学特征,确定 STI-6129的2期剂量。 “这是 Sorento 的第一个 ADC ,它利用了我们特定的 C-LOCK 结合技术,正在进入临床评估,” Sorento ADC 业务部门 Levena Biopharma 的负责人 Hui Li 博士说。“与传统的非选择性共轭物相比, STI-6129在动物模型中显示了更好的治疗指数,我们期待着将其应用扩展到更多的 ADC 项目中。” 关于索伦托治疗公司。 索伦托是一个临床阶段,以抗体为中心,生物制药公司开发新的治疗方法,把恶性肿瘤变成可控制和可能治愈的疾病。Sorento 通过其广泛的免疫肿瘤平台,包括诸如全人类抗体(“ G-MAB ™库”)、临床阶段免疫细胞治疗(“ CAR-T ”、“ DAR-T ”)、抗体药物共轭物(“ ADC ”)和临床阶段溶瘤病毒(“ Sebrevir ®”)等关键资产,实现了对抗癌症的多模式多点方法。Sorento 还在开发针对冠状病毒的潜在抗病毒疗法和疫苗,包括 COVIDTRAP ™、 ACE-MAB ™、 COVI-MAB ™、 COVI-GUARD ™、 COVI-SHELD ™和 COVI-KILLER ™。 索伦托致力于为患者提供增强生命的治疗,这也体现在我们努力推进非阿片类药物类疼痛管理小分子、利硝唑毒素( RTX )和利多卡因外用系统(利多卡因外用系统)治疗带状疱疹后神经痛的1.8%。抵抗性毒素正在完成与癌症相关的顽固性疼痛 IB 期试验和骨关节炎患者1B 期试验。ZTlido ®于2018年2月28日获得 FDA 批准。 有关更多信息,请访问 www.sorrentothaputics.com 。 前瞻性陈述 本新闻稿以及在任何陈述或会议期间所作的任何陈述都包含与 Sorento Therapeutics , Inc .有关的前瞻性陈述。根据1995年《私人证券诉讼改革法案》第21E 条的安全港条款,可能导致实际结果与预计结果存在重大差异的风险和不确定性。前瞻性陈述包括关于 STI-6129潜在治疗益处的陈述; STI-6129计划进行的 I 期临床试验及其目标; STI-6129的监管批准; STI-6129的安全性和有效性;以及 STI-6129临床试验的完成。可能导致我们的实际结果与前瞻性声明中表达的结果存在重大不利差异的风险和不确定性,包括但不限于与索伦托及其子公司、附属公司和合作伙伴的技术和前景以及与合作伙伴的合作相关的风险,包括但不限于与 STI-6129临床试验的进行和接收结果相关的风险; STI-6129治疗晚期复发性和/或难治性系统性淀粉样变性的临床和商业成功; STI-6129用于治疗领域的治疗的可行性和成功,包括淀粉样光链淀粉样变性;临床开发风险,包括进展、时机、成本以及临床试验和产品开发计划的结果;在获得监管批准方面存在困难或延误的风险;临床研究结果可能不符合临床研究的任何或所有终点,且此类研究产生的任何数据可能不支持监管机构提交或批准的风险;制造和供应药品产品的风险;与利用其员工、子公司、关联公司和合作伙伴的专业知识协助公司执行其治疗产品候选者战略相关的风险;与索伦托债务义务相关的风险;与 COVID-19全球影响相关的风险;以及索伦托最近向美国证券交易委员会提交的定期报告中描述的其他风险。包括索伦托截止2019年12月31日的10-K 表格年度报告,以及随后向美国证券交易委员会提交的10-Q 表格季度报告,包括这些文件中规定的风险因素。投资者务请勿过度依赖该等前瞻性陈述,该等陈述仅于本公布日期方告之,除法律规定外,我们并无义务更新本新闻稿中任何前瞻性声明。 媒体与投资者关系 联系人: Alexis Nahama , DVM ( SVP Corporate Development ) 电话:1.858.203.4120 电子邮件: medirelations @ sorrent othaputics.com Sorento ®和 Sorento 徽标是 Sorento Therapeutics , Inc .的注册商标。 G-MAB ™、 COVI-GUAARD ™、 COVI-SHELD ™、 COVIDTRAP ™、 ACE-MAB ™、 COVI-KILLER ™和 COVI-CELL ™是 Sorento Therapeutics , Inc .的商标。 ZTlido ®是 Scilex Pharmaceuticals Inc .拥有的商标。 Sebrevir ®是 Virttu Biologics Limited 的注册商标,该公司是 TNK Therapeutics , Inc .的全资子公司,也是 Sorento Therapeutics , Inc .旗下公司集团的一部分。 所有其他商标均为其各自所有者的财产。 ©2020 Sorento Therapeutics , Inc .所有权利保留。

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