Be The Match BioTherapies® Announces Strategic Collaboration with Kiadis Pharma to Accelerate Patient Access to Haploidentical Stem Cell Therapies

Be Match BioTherapies与 Kiadis开展战略合作,以支持ATIR101 III期临床试验

2019-05-23 22:30:00 BioSpace


Under the terms of the collaboration agreement, Be The Match BioTherapies will provide logistical and technological solutions to support Kiadis’ Phase III clinical trial for ATIR101, an adjunctive immunotherapeutic designed to address key risks and limitations of HSCT in the treatment of blood cancers. Kiadis’ multinational Phase III clinical trial is evaluating the safety and efficacy of ATIR101 as an adjunctive treatment to HSCT from a half-matched (haploidentical) family donor compared to post-transplant cyclophosphamide (PTCy or “Baltimore” protocol) in adult patients with blood cancers. The Phase III study is currently enrolling patients in the EU, Canada, Israel and the U.S. The collaboration will leverage Be The Match BioTherapies’ industry-leading expertise in cell delivery logistics and supply chain case management, including the company’s MatchSource® end-to-end supply chain management software, to manage the transport and processing of cellular products for use at Kiadis’ clinical trial sites in the U.S. and Canada. “Kiadis’ quest to provide better treatment outcomes for patients receiving stem cell transplants is one we deeply share, given the foundational role that our parent company, the National Marrow Donor Program®/Be The Match®, has played in improving stem cell transplantation for more than three decades,” said Chris McClain, vice president of Sales and New Business Development, Be The Match BioTherapies. “We look forward to utilizing our cell therapy expertise to advance Kiadis’ important work.” “We’re pleased to partner with Be The Match BioTherapies to progress our clinical investigation of ATIR101 and to expedite its availability to patients,” said Andrew Sandler, chief medical officer of Kiadis Pharma. “We believe this therapeutic approach could allow family members to serve as stem cell donors for those patients who would otherwise not find a matching donor in time, ultimately saving lives.” About Kiadis Founded in 1997, Kiadis Pharma is a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with late-stage blood cancers. With headquarters in Amsterdam, the Netherlands, Kiadis Pharma is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life. Kiadis Pharma is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at About ATIR101 ATIR101TM is an investigational allodepleted T-cell immunotherapy product candidate, which is designed to be given after a haploidentical (genetically half-matched) hematopoietic stem cell transplantation (HSCT). Administered as an adjunctive immunotherapeutic on top of HSCT, ATIR101 provides a single dose donor lymphocyte infusion (DLI) with functional, mature immune cells from a haploidentical family member. The T-cells in ATIR101 will help fight infections and remaining tumor cells, until the immune system has fully re-grown from stem cells in the transplanted graft. In ATIR101, T-cells that would cause GVHD are depleted from the donor lymphocytes, using our photodepletion technology. At the same time, ATIR101 contains potential cancer-killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease. About Be The Match BioTherapies® Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program®/Be The Match®, and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance cell and gene therapies in any stage of development. Be The Match BioTherapies is dedicated to providing high-quality cellular starting material consented for research, clinical and commercial use, developing and managing expansive cell collection networks, and navigating cell therapy regulatory compliance. Using proven infrastructure to successfully manage cell therapy supply chains, including MatchSource® Supply Chain Software, dedicated cell therapy supply chain case managers and logistics experts, the organization has a history of compliance managing the chain of identity. The collaboration with CIBMTR extends services to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies. For more information, follow Be The Match BioTherapies on LinkedIn or Twitter at @BTMBioTherapies. Kiadis Forward-Looking Statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.   View source version on Be The Match BioTherapies: Stephanie Simon Ten Bridge Communications +1 (617) 581-9333 Kiadis Pharma: Maryann Cimino, Manager, Corporate Affairs +1 (617) 710-7305   Source: Be The Match BioTherapies® View this news release online at:
根据合作协议的条款, Be The Match BioTherapies 将提供后勤和技术解决方案,以支持 Kiadis 针对 ATIR101的 III 期临床试验。 ATIR101是一种辅助免疫治疗,旨在解决 HSCT 在治疗血癌方面的主要风险和局限性。 Kiadis 的多国 III 期临床试验正在评估 ATIR101作为半配对(单倍体)家庭供体对 HSCT 的辅助治疗的安全性和有效性,与成人血癌患者移植后的环磷酰胺( PTCy 或 Baltimore )方案相比。第三阶段研究目前正在欧盟、加拿大、以色列和美国招募患者。 此次合作将利用 Match BioTherapies 在细胞交付物流和供应链案例管理方面的行业领先专业知识,包括该公司的 Matrix Source ®端到端供应链管理软件,管理用于美国和加拿大 Kiadis 临床试验场地的细胞产品的运输和处理。 “ Kiadis 寻求为接受干细胞移植的患者提供更好的治疗结果,这是我们深入分享的一个问题,因为我们的母公司国家骨髓捐赠计划®/ Be The Match ®,在改善干细胞移植方面发挥了30多年的基础作用,” Chris McClain 说。销售和新业务开发副总裁,配对生物治疗。“我们期待利用我们的细胞治疗专家来推进 Kiadis 的重要工作。” Kiadis Pharma 首席医疗官 Andrew Sandler 表示:“我们很高兴与 Be The Match BioTherapies 合作,以推进我们对 ATIR101的临床研究,并加快向患者提供这种药物。”“我们相信,这种治疗方法可以让家庭成员为那些不能及时找到匹配供体的患者充当干细胞供体,最终挽救生命。” 关于 Kiadis Kiadis Pharma 成立于1997年,是一家完全整合的生物制药公司,致力于开发针对晚期血癌患者的创新疗法。总部设在荷兰阿姆斯特丹的 Kiadis 制药公司正在通过利用人类的自然力量和我们的集体免疫系统来寻找生命中最好的细胞来重新培育药物。 Kiadis Pharma 自2015年7月2日起在 Euronext Amsterdam 和 Euronext Brussels 的监管市场上市,代码为 KDS 。在 kiadis 学习更多信息。com 。 关于 ATIR101 ATIR101TM 是研究同种异体 T 细胞免疫治疗产品的候选者,设计用于单倍体(基因半匹配)造血干细胞移植( HSCT )后给予。 ATIR101作为 HSCT 上的一种辅助免疫治疗,提供一种单剂量供者淋巴细胞输注( DLI ),具有单倍体家族成员的功能成熟免疫细胞。ATIR101中的 T 细胞将帮助对抗感染和剩余的肿瘤细胞,直到免疫系统从移植移植物中的干细胞完全重新生长。 在 ATIR101中,使用我们的光衰技术,导致 GVHD 的 T 细胞从供体淋巴细胞中耗尽。同时, ATIR101含有潜在的致癌性 T 细胞从捐赠者,可以消除残余癌细胞和帮助防止疾病复发。 关于配对生物治疗® 成为 Match BioTherapies 是唯一的细胞和基因治疗解决方案提供商,提供可定制的服务,以支持端到端细胞治疗供应链。在国家骨髓捐赠计划®/ Be The Match ®的行业领先经验以及与 CIBMTR ®(国际血液和骨髓移植研究中心®)的研究伙伴关系的支持下,该组织设计了在任何发展阶段推进细胞和基因治疗的解决方案。 Be Match BioTherapies 致力于为研究、临床和商业用途提供高质量的细胞起始材料,开发和管理可扩展的细胞收集网络,并引导细胞治疗法规遵从性。使用经过验证的基础架构成功管理细胞治疗供应链,包括 Matrix Source ®供应链软件、专业的细胞治疗供应链案例管理人员和物流专家,本组织拥有管理身份链的法规遵从性历史。与 CIBMTR 的合作扩展了服务,包括对 FDA 批准的头两种 CAR-T 疗法的长期跟踪。 有关更多信息,请参见 LinkedIn 或@ BTMBioTherapies 的 Twitter 上的配对生物疗法。 Kiadi 的前瞻性陈述 本新闻稿中的某些陈述、信念和意见是前瞻性的,反映了 Kiadis Pharma 或酌情反映了 Kiadis Pharma 董事目前对未来事件的预期和预测。根据其性质,前瞻性陈述涉及若干风险、不确定性和假设,可能导致实际结果或事件与前瞻性陈述所表达或暗示的结果或事件存在重大差异。这些风险、不确定性和假设可能对本文所述计划和事件的结果和财务影响产生不利影响。许多因素,包括但不限于需求、规章、竞争和技术的变化,可能导致实际事件、业绩或结果与任何预期发展有很大差异。本新闻稿中所载关于过去趋势或活动的前瞻性陈述不应被视为未来此类趋势或活动将持续的代表。因此, Kiadis Pharma 明确放弃任何义务或承诺,不会因预期的任何变化或这些前瞻性陈述所依据的事件、条件、假设或情况的任何变化而对本新闻稿中的任何前瞻性陈述进行任何更新或修订。Kiadis Pharma 及其顾问或代表、其任何附属公司或任何该等人士的高级职员或雇员均不保证该等前瞻性陈述所依据的假设不存在任何错误,亦不会就本新闻稿所载前瞻性陈述的未来准确性或预测发展的实际发生承担任何责任。你不应过分依赖前瞻性陈述,这些陈述仅在本新闻稿发布之日发表。 查看 businesswire 上的源代码。网站: 成为匹配的生物治疗: Stephanie Simon 十桥通讯 stehanie @ +1(617)581-9333 Kiadis Pharma : Maryann Ciino ,企业事务经理 m 。cimino @ +1(617)710-7305 资料来源:是匹配生物治疗® 在线查看本新闻稿,网址为: en