PHILADELPHIA--(BUSINESS WIRE)--Medeor Therapeutics today announced positive interim data from its multicenter, international Phase III clinical trial. Kidney transplant recipients who received a living donor kidney from an HLA-matched relative achieved functional tolerance and were free from the regimen of immunosuppressive drugs.

费城-（商业线）-Medeor Therapeutics今天宣布其多中心国际III期临床试验的积极中期数据。从HLA匹配的亲戚那里接受活体供体肾脏的肾脏移植受者获得了功能耐受性，并且没有免疫抑制药物的治疗方案。

Typically, these drugs are required to prevent rejection and failure of the kidney transplant. Study results will be presented during a late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week 2023 Annual Meeting..

通常，需要这些药物来防止肾移植的排斥和失败。研究结果将在美国肾脏病学会（ASN）肾脏周2023年会上的最新口头报告中提出。。

Following a kidney transplant, patients today are required to take daily immunosuppression medications for the rest of their lives to prevent rejection of the transplanted kidney. Stopping or skipping medication may cause a rejection to occur. Kidney rejection is hard to diagnose in its early stages and is often not reversible once it starts and can result in the loss of the transplanted kidney.

肾移植后，今天的患者需要在其余生中每天服用免疫抑制药物，以防止移植肾的排斥反应。停止或跳过药物可能会导致拒绝发生。肾脏排斥在其早期阶段难以诊断，并且一旦开始就通常是不可逆的并且可能导致移植肾脏的损失。

However, a lifetime of immunosuppression drugs increases the risk of cancer, diabetes, infection and other medical problems. The litany of side effects and toxicities ultimately impact graft and patient survival such that 30% to 50% of all kidney transplants fail by 10 years post-transplant1. Last year saw a record number of kidney transplants with more than 25,000 patients undergoing the procedure, a 3.4% increase from 2021, according to the United Network for Organ Sharing..

然而，一生的免疫抑制药物会增加患癌症，糖尿病，感染和其他医疗问题的风险。一系列副作用和毒性最终影响移植物和患者的存活率，使得所有肾移植的30%至50%在移植后10年失败1。根据器官共享联合网络的数据，去年有超过25000名患者接受了肾脏移植手术，比2021年增加了3.4%。。

Medeor’s lead product candidate, MDR-101, is a single-dose cellular therapy derived from a living kidney donor’s blood. The therapy is designed to establish mixed chimerism, which occurs when a low level of donor blood cells remains in the blood of the kidney recipient after infusion of donor stem cells.

Medeor的主要候选产品MDR-101是一种来自活体肾脏供体血液的单剂量细胞疗法。该疗法旨在建立混合嵌合体，其在输注供体干细胞后当低水平的供体血细胞保留在肾受体的血液中时发生。

The study was designed to see whether kidney transplant recipients who received a living donor kidney from an HLA-matched relative with the same transplant genes, could taper immunosuppression to tacrolimus monotherapy by six weeks, followed by complete withdrawal by one year and remain off them for at least 2 years after withdrawal without graft loss, death, acute kidney rejection or graft versus host disease..

这项研究的目的是观察肾移植受者是否接受了来自HLA的活体供肾，并与相同的移植基因相匹配，可以在6周内减少对他克莫司单一疗法的免疫抑制，然后完全停用一年，停药后至少2年内没有移植物丢失、死亡、，急性肾排斥反应或移植物抗宿主病。。

The study protocol was originally designed by the late Dr. Samuel Strober, M.D., professor of immunology and rheumatology at Stanford University and one of the founders of Medeor, who was dedicated to finding a way to free transplant recipients from the burden of immunosuppressant drugs. Twenty patients received MDR-101 and were compared to 10 similar patients who had standard of care.

该研究方案最初由已故的斯坦福大学免疫学和风湿病学教授Samuel Strober博士和Medeor的创始人之一设计，Medeor致力于寻找一种方法使移植受者免于免疫抑制药物的负担。20名患者接受了MDR-101，并与10名具有标准护理的类似患者进行了比较。

Results include:.

结果包括：。

The study’s primary efficacy endpoint was met and exceeded. To date, 12 patients, or 63% of the study participants (compared to the protocol anticipated success rate of 48%), completed the trial and have been off immunosuppression therapy for two years.

该研究的主要疗效终点已达到并超过。迄今为止，12名患者或63%的研究参与者（与方案预期的成功率48%相比）完成了试验并且已经停止免疫抑制治疗两年。

4 additional patients have less than six months to complete the trial and currently remain free of immunosuppression therapy.

另外4名患者完成试验的时间不到6个月，目前仍然没有免疫抑制治疗。

3 patients resumed immunosuppression therapy during the trial and one patient withdrew from the study at six months.

3名患者在试验期间恢复了免疫抑制治疗，1名患者在6个月时退出研究。

Moreover, the Kidney Disease Quality of Life (KDQOL-36) survey demonstrated statistically significant improvements in the Treated group vs Control group at two- and three-years post-transplant. These include Burden of Kidney Disease, which is defined by interference with daily life, or the patient feeling like a burden, and Mental Health, which includes depression, anxiety, etc..

此外，肾脏疾病生活质量（KDQOL-36）调查显示，在移植后2年和3年，治疗组与对照组相比有统计学显着改善。这些包括肾脏疾病的负担，其定义为干扰日常生活，或患者感觉像负担，以及心理健康，包括抑郁，焦虑等。。

“The results of this study have the potential to truly change the trajectory of the treatment for kidney transplants,” said Giovanni Ferrara, President and CEO, at Medeor Therapeutics. “By combining donor and recipient cells to create mixed chimerism and immune tolerance within the transplant recipient, we are working to alleviate the stress and burden of daily immunosuppressants, thereby improving quality of life and prolonged graft survival.

Medeor Therapeutics的总裁兼首席执行官乔瓦尼·费拉拉（Giovanni Ferrara）说：“这项研究的结果有可能真正改变肾脏移植治疗的轨迹。“通过结合供体和受体细胞在移植受者体内产生混合嵌合和免疫耐受，我们正在努力减轻日常免疫抑制剂的压力和负担，从而改善生活质量和延长移植物存活时间。

We are buoyed by the study results presented today and look forward to the completion of our study and making MDR-101 the new treatment standard for donor matched kidney transplants.”.

我们对今天提出的研究结果感到鼓舞，并期待完成我们的研究，并使MDR-101成为供体匹配肾移植的新治疗标准“。

'The results from this study are extremely promising. This innovative trial provides direction toward reducing the need for life-long anti-rejection medications in transplant recipients,” said Dr. Dixon Kaufman, Medical Director, UW Health Transplant Center at the University of Wisconsin. “With the achievement of mixed chimerism in this trial, we are on course to provide a safer and more effective treatment approach for many patients in need of a kidney transplant.”.

'这项研究的结果非常有希望。威斯康星大学威斯康星大学健康移植中心医学主任Dixon Kaufman博士说，这项创新性试验为减少移植受者终身抗排斥药物的需求提供了方向。“随着这项试验中混合嵌合体的实现，我们当然要为许多需要肾移植的患者提供更安全，更有效的治疗方法。”。

Regulatory Status

监管状况

MDR-101 is being studied under an IND in the U.S. and a CTA in Canada and has been granted Orphan Drug Designation in both the U.S. and EU. MDR-101 is also designated as a Regenerative Medicine Advance Therapy (RMAT) by the FDA. The clinical trial is being conducted under an FDA Special Protocol Assessment (SPA)..

MDR-101正在美国的IND和加拿大的CTA下进行研究，并已在美国和欧盟获得孤儿药名称。MDR-101也被FDA指定为再生医学高级疗法（RMAT）。临床试验正在FDA特殊方案评估（SPA）下进行。。

About MDR-101

关于MDR-101

MDR-101 is a cellular therapy manufactured from a living kidney donor’s blood and peripheral stem cells. MDR-101 is intended to induce donor specific immune tolerance in order to avert transplant kidney rejection, eliminate the cumulative and serious side effects associated with immunosuppressive drugs and thereby preserve transplant kidney function and survival.

MDR-101是由活体肾脏供体的血液和外周干细胞制造的细胞疗法。MDR-101旨在诱导供体特异性免疫耐受，以避免移植肾排斥，消除与免疫抑制药物相关的累积和严重副作用，从而保持移植肾功能和存活。

The study was supported by the California Institute of Regenerative Medicine (CIRM). For more information on Medeor’s phase 3 trial, please visit www.clinicaltrials.gov, (NCT03363945)..

该研究得到了加利福尼亚再生医学研究所（CIRM）的支持。有关Medeor 3期临床试验的更多信息，请访问www.clinicaltrials.gov，（NCT03363945）。。

About Medeor Therapeutics

关于Medeor Therapeutics

Medeor Therapeutics is working to improve the lives of transplant patients by eliminating or reducing the need for a life-long regimen of immunosuppressant medications and their potential life-threatening side effects. Medeor’s Phase 3 clinical study demonstrates the significant opportunities of this one-time therapy.

Medeor Therapeutics正在努力通过消除或减少对终身免疫抑制药物治疗方案及其潜在危及生命的副作用的需求来改善移植患者的生活。Medeor的3期临床研究证明了这种一次性治疗的重要机会。

For more information, visit www.medeortx.com..

欲了解更多信息，请访问www.medeortx.com。。

1 Poggio ED, Augustine JJ, Arrigain S, Brennan DC, Schold JD. Long-term kidney transplant graft survival-Making progress when most needed. Am J Transplant. 2021 Aug;21(8):2824-2832. doi: 10.1111/ajt.16463. Epub 2021 Feb 8. PMID: 33346917.

1 Poggio ED，Augustine JJ，Arrigain S，Brennan DC，Schold JD。长期肾移植移植物存活在最需要时取得进展。我J移植。2021年8月；21（8）：2824-2832。doi:10.1111/ajt.16463。Epub 2021年2月8日。结论：33346917。