- Use of the Neurgain PDI system could support later-stage trials of OPC1 in cervical injury patients- OPC1 Investor & Analyst Day planned for February 22, 2021

-使用Neurgain PDI系统可以支持OPC1在颈椎损伤患者中的后期试验- OPC1投资者和分析师日计划于2021年2月22日举行

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it has entered into an exclusive option and license agreement with Neurgain Technologies, Inc. ("Neurgain"), a medical device company that is commercializing technology developed by neurosurgeons at the University of California San Diego ("UC San Diego"). Under the terms of the agreement, Lineage and Neurgain will collaborate on the clinical testing of Neurgain’s novel Parenchymal Delivery Injection ("PDI") system, which is designed to allow for the administration of cells to the spinal cord without stopping the patient’s respiration. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. Lineage also will be hosting an OPC1 Investor and Analyst Day on February 22, 2021 to provide details on recent OPC1 milestones and plans for 2021.

谱系细胞疗法,Inc .(纽交所美国和家常便饭:LCTX),临床分期生物科技公司发展中同种异体细胞治疗未满足的医疗需求,今天宣布它已经进入排他性选择和Neurgain技术许可协议,Inc .(“Neurgain”),一个医疗设备公司,是商业化的技术开发的神经外科医生加州大学圣地亚哥分校(加州大学圣地亚哥分校)。根据协议条款，Lineage和neurogain将合作进行neurogain新型实质注射(PDI)系统的临床测试，该系统的设计目的是在不停止患者呼吸的情况下将细胞注入脊髓。在手术过程中不需要停止呼吸，预计可以降低将细胞送入损伤区域的复杂性、风险和可变性。天堂还将于2021年2月22日举办OPC1投资者和分析师日，提供OPC1近期里程碑和2021年计划的细节。

Lineage will evaluate the Neurgain PDI system’s ability to safely and effectively deliver OPC1, Lineage’s allogeneic oligodendrocyte progenitor cell (OPC) transplant, to the spinal cord in both preclinical and clinical studies beginning this year. If results from the PDI system are positive, then Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the PDI system into a later-stage clinical trial and if approved, commercial use of OPC1 for the treatment of patients with a cervical spinal cord injury. There currently are no U.S. Food and Drug Administration ("FDA") approved treatments for spinal cord injury.

在今年开始的临床前和临床研究中，Lineage将评估neurogain PDI系统安全有效地将OPC1植入脊髓的能力，OPC是Lineage的异体少树突细胞祖细胞(OPC)移植。如果PDI系统的结果是阳性的，那么Lineage就可以行使自己的选择权，与Neurgain达成事先协商好的许可和商业化协议。根据该协议，Lineage可能将PDI系统整合到后期临床试验中，如果获得批准，将OPC1用于治疗颈脊髓损伤患者的商业应用。目前还没有美国食品和药物管理局(FDA)批准的治疗脊髓损伤的方法。

Brian M. Culley, Lineage CEO stated, "Several months ago, we announced we had significantly improved the process for manufacturing OPC1, leading to large increases in purity and scale. More recently, we successfully developed a new 'thaw-and-inject' formulation, eliminating the commercially undesirable steps of handling and preparing cells one day prior to their use. Today, we are announcing another valuable improvement to the OPC1 program: access to a novel and convenient delivery system, which reduces a significant technical hurdle of conducting a larger-scale clinical trial. The Neurgain PDI offers an easier, potentially safer, and commercially more attractive option to treat SCI patients and is preferable to the complicated gantry utilized in an earlier study. It also will allow us to incorporate our new 'thaw-and-inject' formulation of OPC1, thereby enabling faster patient enrollment via access to a larger number of clinical trial sites. Most importantly, the PDI can eliminate the need for a patient’s respirator to be turned off during the procedure, facilitating a measured and targeted transplantation of cells to the affected area."

Lineage首席执行官Brian M. Culley表示:“几个月前，我们宣布已经显著改进了OPC1的制造工艺，从而大幅提高了纯度和规模。最近，我们成功地开发了一种新的“解冻-注射”配方，消除了在使用电池前一天处理和准备电池的商业上不需要的步骤。今天，我们宣布OPC1项目的另一项有价值的改进:使用一种新颖和方便的交付系统，这减少了进行大规模临床试验的重大技术障碍。neurogain PDI提供了一种更容易、潜在更安全、在商业上更有吸引力的脊髓损伤患者治疗选择，优于早期研究中使用的复杂的机架。这也将允许我们纳入我们新的OPC1“解冻-注射”配方，从而通过访问更多的临床试验站点，使患者更快地登记。最重要的是，PDI可以避免在手术过程中关闭患者的呼吸器，从而促进对受影响区域的细胞进行测量和定向移植。”

"We look forward to collaborating with Lineage on their novel OPC1 program and demonstrating the value that Neurgain’s PDI system can provide for the effective delivery of cell therapies in general and for the treatment of spinal cord injury in particular," stated Michael Krupp, Neurgain CEO.

Neurgain首席执行官Michael Krupp表示:“我们期待着与Lineage在他们新颖的OPC1项目上进行合作，并证明Neurgain的PDI系统可以提供有效的细胞疗法，特别是治疗脊髓损伤的价值。”

Brian Culley added, "Similar to our alliance with Gyroscope Therapeutics for the Orbit Subretinal Delivery System, this new partnership with Neurgain delivers on our stated commitment to identifying and deploying optimal combinations of allogeneic cell therapies, modern manufacturing techniques, and superior delivery solutions in pursuit of our goal of becoming the pre-eminent allogeneic cell transplant company."

布莱恩Culley补充道,“类似于我们的联盟与陀螺仪疗法对于轨道视网膜下交付系统,这个新的伙伴关系Neurgain提供明确承诺我们要识别和部署同种异体细胞疗法的最优组合,现代制造技术,在追求我们的目标和上级交付解决方案成为杰出的同种异体细胞移植公司。”

The Neurgain PDI System has been designed to provide specific, on-target delivery of cells with accurate dosing. The PDI system is more compact than existing devices and it is attached directly to the patient during the procedure. It is comprised of a platform and manipulator with a disposable magnetic needle assembly. This novel delivery system is expected to provide a significant improvement in usability and precision when compared to the methods and tools utilized to deliver OPC1 cells in the completed phase 1/2a SCiStar study of OPC1 for the treatment of acute cervical SCI.

neurogain PDI系统被设计用来提供精确剂量的特定的、靶向的细胞输送。PDI系统比现有设备更紧凑，在手术过程中直接连接到患者身上。它由平台和机械手组成，机械手带有一次性磁针组件。与已完成的1/2a期SCiStar关于OPC1治疗急性颈椎损伤的研究中用于输送OPC1细胞的方法和工具相比，这种新型输送系统有望在可用性和精确度方面有显著提高。

About Spinal Cord Injuries

关于脊髓损伤

A spinal cord injury (SCI) occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. There are no FDA-approved drugs specifically for the treatment of SCI. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.

脊髓损伤(SCI)发生在脊髓受到严重挤压或挫伤时，经常导致严重的功能损害，包括肢体瘫痪、异常疼痛信号、膀胱控制和其他身体功能丧失。在美国，每年大约有18000例新的脊髓损伤。目前还没有fda批准的专门用于脊髓损伤治疗的药物。严重脊髓损伤的终身护理费用可高达500万美元。

About OPC1

关于OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM). OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the FDA.

OPC1是一种少突胶质细胞祖细胞(OPC)移植疗法，旨在为急性脊髓损伤(SCI)患者的运动恢复提供有临床意义的改善。OPCs是自然产生的细胞前体，以髓鞘的形式为神经轴突提供电绝缘。OPC1项目的部分资金来自加州再生医学研究所(CIRM) 1430万美元的拨款。OPC1已经获得了美国FDA授予的再生医学高级治疗(RMAT)和孤儿药称号。

About the OPC1 Clinical Study

关于OPC1临床研究

The "SCiStar" Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 administered 21 to 42 days post-injury in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). Patient enrollment in this study is complete; 96% of patients reported one level of improved motor function and 33% of patients reported two levels of improved motor function. Patients continue to be evaluated on a long-term basis. Patients enrolled in the study had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the study was safety. Secondary outcome measures included neurological function measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment.

关于OPC1的“SCiStar”研究是一项开放标签的、有25名患者的单臂试验，测试了亚急性运动完全性(AIS-A或AIS-B)颈(C-4至C-7)急性脊髓损伤(SCI)患者受伤后21至42天三种顺序递增剂量的OPC1。本研究的患者登记已完成;96%的患者报告了一个水平的运动功能改善，33%的患者报告了两个水平的运动功能改善。患者继续接受长期评估。参与研究的患者都经历过严重的上肢和下肢瘫痪。该研究的主要终点是安全性。次要指标包括治疗后365天的上肢运动评分(UEMS)和国际脊髓损伤神经分类标准(ISNCSCI)检查中的运动水平。

About Neurgain Technologies, Inc.

关于Neurgain科技公司