This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q). The study will assess safety and efficacy of Orca-Q in pediatric patients with hematologic malignancies.

开始日期2022-08-16

申办/合作机构

University of Florida

[+2]

NCT03802695 / Recruiting临床1期

A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

开始日期2019-04-08

申办/合作机构

Orca Biosystems, Inc.初创企业

100 项与 Orca Q 相关的临床结果

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100 项与 Orca Q 相关的转化医学

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100 项与 Orca Q 相关的专利（医药）

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项与 Orca Q 相关的文献（医药）

2020-09-01·Clinical Oral Investigations2区 · 医学

How to intervene in the caries process in adults: proximal and secondary caries? An EFCD-ORCA-DGZ expert Delphi consensus statement

2区 · 医学

Article

作者: Manton, David ; Haak, Rainer ; Banerjee, Avijit ; Ekstrand, Kim ; Zero, Domenick ; Campus, Guglielmo ; Zimmer, Stefan ; Hannig, Matthias ; Giacaman, Rodrigo A ; Machiulskiene, Vita ; Jablonski-Momeni, Anahita ; Opdam, Niek ; Juric, Hrvoje ; Tassery, Hervé ; Doméjean, Sophie ; Bottenberg, Peter ; Hickel, Reinhard ; Zandona, Andrea ; Lussi, Adrian ; Paris, Sebastian ; Breschi, Lorenzo ; Schwendicke, Falk ; Santamaria, Ruth ; Splieth, Christian H

AbstractObjectivesTo provide consensus recommendations on how to intervene in the caries process in adults, specifically proximal and secondary carious lesions.MethodsBased on two systematic reviews, a consensus conference and followed by an e-Delphi consensus process were held with EFCD/ORCA/DGZ delegates.ResultsManaging an individual’s caries risk using non-invasive means (oral hygiene measures including flossing/interdental brushes, fluoride application) is recommended, as both proximal and secondary carious lesions may be prevented or their activity reduced. For proximal lesions, only cavitated lesions (confirmed by visual-tactile, or radiographically extending into the middle/inner dentine third) should be treated invasively/restoratively. Non-cavitated lesions may be successfully arrested using non-invasive measures in low-risk individuals or if radiographically confined to the enamel. In high-risk individuals or if radiographically extended into dentine, for these lesions, additional micro-invasive (lesion sealing and infiltration) treatment should be considered. For restoring proximal lesions, adhesive direct restorations allow minimally invasive, tooth-preserving preparations. Amalgams come with a lower risk of secondary lesions and may be preferable in more clinically complex scenarios, dependent on specific national guidelines. In structurally compromised (especially endodontically treated) teeth, indirect cuspal coverage restorations may be indicated. Detection methods for secondary lesions should be tailored according to the individual’s caries risk. Avoiding false positive detection and over-treatment is a priority. Bitewing radiographs should be combined with visual-tactile assessment to confirm secondary caries detections. Review/refurbishing/resealing/repairing instead of replacing partially defective restorations should be considered for managing secondary caries, if possible.ConclusionsAn individualized and lesion-specific approach is recommended for intervening in the caries process in adults.Clinical significanceDental clinicians have an increasing number of interventions available for the management of dental caries. Many of them are grounded in the growing understanding of the disease. The best evidence, patients’ expectations, clinicians’ expertise, and the individual clinical scenario all need to be considered during the decision-making process.

2020-05-01·iScience2区 · 综合性期刊

ORCA/LRWD1 Regulates Homologous Recombination at ALT-Telomeres by Modulating Heterochromatin Organization

2区 · 综合性期刊

ArticleOA

作者: Jaba Mitra ; Yo Chuen Lin ; Mirit I. Aladjem ; Vasudha Aggarwal ; Branden Moriarity ; Kannanganattu V. Prasanth ; Rosaline Y.C. Hsu ; Deepak K. Singh ; Supriya G. Prasanth ; Taekjip Ha ; Abhijith Matur ; Qinyu Sun ; Christophe Redon ; Yating Wang

Telomeres are maintained by telomerase or in a subset of cancer cells by a homologous recombination (HR)-based mechanism, Alternative Lengthening of Telomeres (ALT). The mechanisms regulating telomere-homeostasis in ALT cells remain unclear. We report that a replication initiator protein, Origin Recognition Complex-Associated (ORCA/LRWD1), by localizing at the ALT-telomeres, modulates HR activity. ORCA's localization to the ALT-telomeres is facilitated by its interaction to SUMOylated shelterin components. The loss of ORCA in ALT-positive cells elevates the levels of two mediators of HR, RPA and RAD51, and consistent with this, we observe increased ALT-associated promyelocytic leukemia body formation and telomere sister chromatid exchange. ORCA binds to RPA and modulates the association of RPA to telomeres. Finally, the loss of ORCA causes global chromatin decondensation, including at the telomeres. Our results demonstrate that ORCA acts as an inhibitor of HR by modulating RPA binding to ssDNA and inducing chromatin compaction.

2020-01-01·Caries Research

How to Intervene in the Caries Process: Dentin Caries in Primary Teeth

Review

作者: Zandona, Andrea G Ferreira ; Gomez, Grace Felix ; Mourad, Mhd Said ; Gül, Gülsün ; Abudrya, Mohamed Hassan ; Santamaría, Ruth M

For an ORCA/EFCD consensus, this review systematically assessed available evidence regarding interventions performed and materials used to manage dentin carious lesions in primary teeth. A search for systematic reviews (SRs) and randomized clinical trials (RCTs) with a follow-up of at least 12 months after intervention was performed in PubMed, LILACS, BBO, and the Cochrane Library. The risk of bias tool from the Cochrane Collaboration and the PRISMA Statement were used for assessment of the included studies. From 101 screened articles, 2 SRs and 5 RCTs, which assessed the effectiveness of interventions in terms of pulp vitality and success of restoration, and 10 SRs and 1 RCT assessing the success of restorative materials were included. For treatments involving no carious tissue removal, the Hall technique showed lower treatment failure for approximal carious lesions compared to complete caries removal (CCR) and filling. For the treatment of deep carious lesions, techniques involving selective caries removal (SCR) showed a reduction in the incidence of pulp exposure. However, the benefit of SCR over CCR in terms of pulp symptoms or restoration success/failure was not confirmed. Regarding restorative materials, preformed metal crowns (PMCs) used to restore multisurface lesions showed the highest success rates compared to other restorative materials (amalgam, composite resin, glass ionomer cement, and compomer), and in the long term (12–48 months) these were also less likely to fail. There is limited evidence supporting the use of PMCs to restore carious lesions with single cavities. Among nonrestorative options, silver diammine fluoride was significantly more effective in arresting caries than other treatments for treating active carious lesions of different depths. Considerable heterogeneity and bias risk were observed in the included studies. Although heterogeneity observed among the studies was substantial, the trends were similar. In conclusion, less invasive caries approaches involving selective or no caries removal seem advantageous in comparison to CCR for patients presenting with vital, symptomless, carious dentin lesions in primary teeth. There is evidence in favor of PMCs for restoring multisurface carious lesions in primary molars.

项与 Orca Q 相关的新闻（医药）

2024-11-05

·Business Wire

Orca Bio to Present Clinical Data on Its High-Precision Cell Therapies at the 66th American Society of Hematology Annual Meeting

MENLO PARK, Calif.--( BUSINESS WIRE )--Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that new clinical data will be presented in three oral sessions at the American Society of Hematology (ASH) Annual Meeting from December 7-10 in San Diego, CA. Three-year survival data with Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, will be presented from the multicenter Phase 1b clinical trial of patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Additionally, initial feasibility, safety and efficacy data from an investigator-sponsored trial evaluating the combination of Orca-T with allogeneic CD19/CD22-CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) will be shared. In a third oral session, data from a multicenter Phase 1 clinical trial will be presented from patients treated with Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, Orca-Q, in patients with hematologic malignancies without the use of any post-treatment graft versus host disease (GvHD) prophylaxis. “We are pleased to present exciting new data from our lead clinical programs for patients with blood cancers, including three-year follow-up with Orca-T, our lead cell therapy candidate currently being evaluated in a pivotal Phase 3 clinical trial,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. "We also look forward to debuting the results of patients treated with Orca-Q without the use of any GvHD prophylaxis. Overall, these findings represent important progress toward our goal of delivering our high-precision approach to more patients who could potentially benefit." The ASH abstracts are now available at www.hematology.org . Details of the Orca Bio oral presentations follow: Oral Session : 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Finding the Ideal Donor and Graft: Going Beyond HLA Title : Observational Comparison of Overall Survival between Phase 1b Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients Abstract Number : 694 Date and Time : Sunday, December 8, 2024 at 5:15 PM PT Location : San Diego Convention Center, Room 6A Oral Session : 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: B Cell-directed CAR T Cell Therapies for ALL and for Autoimmunity Title : Safe and Effective Combination of Donor-Derived, Allogeneic CD19/CD22-CAR T Cells with Myeloablative Graft-Engineered Allo-HCT for High-Risk B-ALL Abstract Number : 679 Date and Time : Sunday, December 8, 2024 at 4:30 PM PT Location : Marriott Marquis San Diego Marina, Marriott Grand Ballroom 2-4 Oral Session : 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Monitoring, Understanding and Optimizing GVHD Interventions Title : Preliminary Safety and Efficacy of Myeloablative Orca-Q with No GvHD Prophylaxis for Treatment of Advanced Hematologic Malignancies Abstract Number : 382 Date and Time : Saturday, December 7, 2024 at 4:45 PM PT Location : San Diego Convention Center, Room 6CF About Orca-T Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T is comprised of highly purified regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial which has completed enrollment at leading transplant centers across the U.S. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. About Orca-Q Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform. About Orca Bio Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. Our investigational products are designed to replace a patient’s diseased blood and immune system with a healthy one, with the goal of improving outcomes with fewer risks than the standard of care. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to transform allogeneic cell therapy. At Orca Bio, our mission is to make curative cell therapies both more effective and safer, and in doing so, push past the field’s current boundaries and redefine its future. For more information, visit www.orcabio.com .

细胞疗法免疫疗法临床3期临床1期ASH会议

2024-05-26

·药明康德

不用吃药，自身免疫疾病患者实现长期缓解；总生存率100%的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. Dyne Therapeutics公司治疗杜氏肌营养不良（DMD）等肌肉疾病的潜在“first-in-class”抗体偶联反义寡核苷酸（ASO）疗法的早期临床试验数据积极，可改善患者的肌肉功能。2. 在Orca Bio公司的在研同种异体T细胞免疫疗法Orca-T治疗急性髓系白血病（AML）的1期研究中，患者的一年总生存率达100%。3. iCell Gene Therapeutics公司的BCMA与CD19靶向复合嵌合抗原受体-T（BCMA-CD19 cCAR-T）细胞免疫疗法在早期临床试验中使系统性红斑狼疮（SLE）患者实现了长期无药物缓解。药明康德内容团队整理DYNE-101、DYNE-251：公布1/2期临床试验数据Dyne Therapeutics公司公布了分别用于治疗强直性肌营养不良1型（DM1）和DMD的抗体偶联ASO疗法DYNE-101和DYNE-251的积极1/2期临床试验结果。DYNE-101由与片段抗体（Fab）偶联的反义寡核苷酸组成，Fab与肌肉上高表达的转铁蛋白受体1（TfR1）结合。它旨在实现靶向肌肉组织递送，目的是减少细胞核中的有毒DMPK RNA、释放剪接蛋白、允许正常mRNA处理和正常蛋白翻译，并有可能阻止或逆转疾病进展。在1/2期临床试验ACHIEVE中，DYNE-101（5.4 mg/kg）在第3个月时表现出剂量依赖性剪接校正，剪接校正比例达到27%。此外，DYNE-101改善了患者的肌肉强直、肌肉力量以及多种患者报告的功能性和疲惫指标。DYNE-251由Fab偶联的磷酸二酰胺吗啉寡聚物（PMO）组成。它旨在实现靶向肌肉组织递送，促进外显子51跳跃，使肌肉细胞产生截短、功能性的抗肌萎缩蛋白（dystrophin），目标是停止或逆转疾病进展。在1/2期临床试验DELIVER中，DYNE-251（10 mg/kg）在6个月时将抗肌萎缩蛋白的表达水平提高到接受标准治疗患者的10倍。多种功能性检测也显示出接受DYNE-251治疗患者的功能改善。Orca-T：公布1b期临床试验数据 Orca Bio公司公布了其在研同种异体T细胞免疫疗法Orca-T用于治疗AML患者的1b期临床试验的积极结果。这款细胞疗法由富集的CD34+干细胞，以及通过高精度平台纯化、取材自单倍体匹配供体的特定T细胞亚群组合而成。Orca-Q有潜力改善患者的预后和降低移植物抗宿主疾病（GvHD）风险，并且无需对无法找到人类白细胞抗原（HLA）匹配的患者进行移植后环磷酰胺（PTCy）治疗。此次公布的结果显示，接受Orca-T治疗的37例AML患者中，12个月的无复发生存率和总生存率分别为82.5%和100%，12个月的非复发死亡率为0%。Orca-T在该亚组中的安全性与更大范围的1b期人群一致，没有发现新的安全性信号。Orca-T目前正在美国各大治疗中心进行关键性的3期临床试验评估。BCMA-CD19 cCAR-T：公布1期临床试验数据 iCell Gene Therapeutics宣布其BCMA-CD19 cCAR-T细胞免疫疗法的研究者发起临床试验（IIT）的积极结果。这款由iCell所设计的cCAR-T细胞免疫疗法，在单一结构中表达两种不同且功能齐全的CAR分子，一种靶向B细胞上的CD19分子，另一种靶向浆细胞上的BCMA。鉴于B细胞和长寿浆细胞具有独立的记忆，因此需要同时靶向B细胞和长寿浆细胞以消除所有升高的自身抗体。分析显示，所有接受足量初始剂量cCAR-T治疗的SLE/狼疮性肾炎（LN）患者，在治疗3个月后体内自身抗体呈现阴性，并在随访46个月时，均达到无症状和无药物缓解。ARO-RAGE：公布1/2期临床试验数据Arrowhead Pharmaceuticals公司公布了其用于治疗哮喘等肺部炎症性疾病的RNA干扰（RNAi）疗法ARO-RAGE的最新中期临床数据。高级糖化终产物受体（RAGE）是2型和非2型炎症级联的上游介质，与哮喘和多种炎症疾病的发病机制有关。ARO-RAGE通过RNAi抑制RAGE表达，旨在减少肺上皮细胞中RAGE蛋白的表达，从而有望减少RAGE依赖性炎症通路，以达到降低哮喘患者病情恶化的频率并改善其通气的目的。此次公布的中期结果表明，使用ARO-RAGE治疗后，正常健康受试者（NHV）和轻中度哮喘患者支气管肺泡灌洗液（BALF）和血清中的可溶性RAGE浓度呈剂量依赖性降低。轻度至中度哮喘患者使用两剂ARO-RAGE后，血清中的可溶性RAGE降低了88%，平均最大降幅达77%。此外，该候选疗法的安全性良好，药效学效应持续时间长，有望支持每两个月一次的给药频率。FG-3246：公布1期临床试验的新数据 FibroGen公布了其与Fortis Therapeutics联合开发的潜在“first-in-class”抗体偶联药物（ADC）FG-3246的1期临床试验的新数据。FG-3246旨在治疗转移性去势抵抗性前列腺癌和其他肿瘤类型，其靶向的CD46是一种细胞受体靶点，在前列腺癌和其他肿瘤类型中高度表达，并在大多数正常组织中表达非常有限。FG-3246由抗CD46抗体与抗有丝分裂剂MMAE连接而成，MMAE是一种已经过临床验证的ADC有效载荷。此次公布的结果显示，FG-3246联用恩杂鲁胺使未经生物标志物筛选的患者的中位放射学无进展生存期（PFS）达到10.2个月。此外，FG-3246具有可接受的安全性，不良事件与其他包含细胞毒性药物MMAE作为载荷的ADC一致。TTX-080：公布1b期临床试验数据 Tizona Therapeutics公司公布了其HLA-G靶向抗体TTX-080在转移性结直肠癌（mCRC）和局部晚期/转移性头颈部鳞状细胞癌（mHNSCC）患者中的1b期临床试验数据。TTX-080联用西妥昔单抗对野生型RAS、BRAF、HER2阴性mCRC患者具有抗肿瘤活性，这些患者之前接受过的中位治疗线数为2线（范围为1-5）。患者的中位PFS为24.4周，36周时的无进展生存率为47%。在14例可评估的患者中，4例患者（29%）获得部分缓解（PR），6例患者（43%）保持疾病稳定（SD），这10例（71%）患者的疾病控制了超过90天。TTX-080联用西妥昔单抗可在人乳头瘤病毒（HPV）阴性mHNSCC患者中产生抗肿瘤活性。这些患者之前接受过的中位治疗线数为1线（范围为1-2），所有患者之前都接受过免疫疗法。患者的中位PFS为23.9周，24周时的无进展生存率为43%。在7例可评估的患者中，1例（14%）患者达到了完全缓解（CR），3例（43%）患者达到了PR，1例（14%）患者达到了SD，这5例（71%）患者的疾病控制了超过90天。SON-1010：公布两项1期临床试验的新数据 Sonnet BioTherapeutics公司公布了其在研免疫调节重组蛋白SON-1010的两项1期临床试验的新数据。SON-1010为一重组蛋白，由单链人类IL-12蛋白与和白蛋白结合的抗体单链片段组合而成，具潜力通过刺激产生干扰素γ将像是非小细胞肺癌、黑色素瘤等肿瘤微环境由“冷”转“热”，活化先天免疫与适应性免疫细胞。这些肿瘤的肿瘤微环境中表达SPARC与GP60蛋白。目前，SON-1010研究共招募了61名受试者，患者已接受了25个周期的SON-1010单药治疗或10个周期的SON-1010联用Tecentriq治疗，在任何剂量水平上都未出现剂量限制性毒性。细胞因子数据显示，与重组人IL-12相比，SON-1010的半衰期延长了约10倍，可诱导长时间和可控的干扰素γ反应，且任何剂量下均未发现细胞因子释放综合征的证据。可评估的晚期实体瘤患者中有35%（8/23）在开始给药后的第四个月出现临床获益。Azenosertib：公布1期临床试验数据Zentalis Pharmaceuticals公司公布了新型、选择性口服生物可利用的WEE1抑制剂azenosertib联用吉西他滨治疗复发性或难治性骨肉瘤1期试验的最终结果。WEE1是G1-S和G2-M细胞周期检查点的主调控因子，通过对CDK1和CDK2的负调控来阻止DNA受损细胞的复制。通过抑制WEE1，azenosertib可使细胞周期在存在高水平DNA损伤的情况下继续进行，从而使癌细胞积累DNA损伤并最终死亡。此次公布的结果显示，azenosertib联用吉西他滨的耐受性良好，与过去类似患者人群的队列相比，接受该组合疗法的患者的无事件生存率（EFS）的提高具有临床意义。前者16周的EFS大约为12%，后者18周时的EFS为39%（11/28）。NDI-101150：公布1/2期临床试验数据 Nimbus Therapeutics公司公布了其小分子HPK1抑制剂NDI-101150的早期临床试验的新数据。临床前研究发现，NDI-101150对HPK1的选择性是MAP4K家族相关蛋白的300多倍，这有望减少脱靶效应。此次公布的结果显示，NDI-101150的单药治疗为30例可评估患者中的5例（16.7%）带来了临床获益，包括1例CR（肾细胞癌）、1例PR（肾细胞癌）和3例SD。3名患有胰腺癌、肾细胞癌或子宫内膜癌的患者表现出了长时间（>6个月）的SD，肾细胞癌患者已保持疾病稳定21个月。此外，NDI-101150的耐受性良好，整体安全性可接受。KN-002：公布1b期临床试验数据 Kinaset Therapeutic公司公布了其口腔吸入式泛JAK抑制剂KN-002的1b期研究的积极结果。KN-002是一种对所有JAK亚型（即JAK1、JAK2、JAK3和TYK2）均有效的均衡抑制剂，目前正作为一种非侵入性抗炎治疗药物进行开发，适用于所有接受中高剂量吸入型糖皮质激素（ICS）或长效β2受体激动剂（LABA）维持治疗但病情控制不佳的嗜酸性粒细胞性和非嗜酸性粒细胞性哮喘患者以及慢性阻塞性肺病患者。KN-002配制成干粉，具有出色的递送效率和化学/物理稳定性。通过吸入进行局部给药，KN-002能够在肺部炎症部位达到治疗浓度，同时最大限度地降低全身暴露水平。这项随机、双盲、安慰剂对照研究报告称，在为未接受过吸入皮质类固醇治疗的轻度哮喘患者进行为期10天、每天剂量≤16 mg的治疗后，未发现安全性或耐受性问题。此外，每天使用一次和两次KN-002可在临床上显著降低部分呼出一氧化氮（FeNO）水平。▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Approval. 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Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887728/33333/en/Coherus-Presents-Preliminary-Results-from-Phase-I-Dose-Escalation-Study-of-its-Anti-chemokine-receptor-8-CCR8-Antibody-CHS-114-at-the-2024-American-Society-of-Clinical-Oncology-ASC.html[26] AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523653892/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

细胞疗法免疫疗法临床结果临床1期信使RNA

2024-05-25

·药明康德

使肉瘤患者肿瘤完全消失超过6年的CAR-T疗法；使白血病患者一年总生存率达100%的T细胞疗法…… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。Atara Biotherapeutics公司的突破性现货型T细胞疗法tabelecleucel（tab-cel）已向FDA递交了上市申请。在Orca Bio公司的在研同种异体T细胞免疫疗法Orca-T治疗急性髓系白血病（AML）的1期研究中，患者的一年总生存率达100%。一款HER2靶向的嵌合抗原受体（CAR）T细胞疗法在临床试验中使1名肉瘤患者保持完全缓解已超过6年。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF———✦研发进展✦———◇ Atara Biotherapeutics宣布已向美国FDA提交了tabelecleucel（tab-cel）的生物制品许可申请（BLA），以申请tab-cel作为单药疗法，用于治疗爱泼斯坦-巴尔病毒（EBV）阳性的移植后淋巴增殖性疾病（PTLD）。患者群体包括至少接受过一次治疗的成人以及两岁以上儿科患者。新闻稿指出，如果获批，tab-cel将成为FDA批准的首款同种异体T细胞疗法，以及治疗EBV阳性PTLD的首款疗法。Tab-cel是一种同种异体的EBV特异性T细胞免疫疗法，旨在靶向并消除EBV感染的细胞。在关键性临床试验ALLELE中，tab-cel的客观缓解率（ORR）达48.8%。此前，tab-cel（商品名：Ebvallo）已被欧盟委员会以及英国和瑞士的监管机构批准上市。在这三个地区，Ebvallo被批准作为单药疗法，治疗至少接受过一次治疗的复发/难治性EBV阳性PTLD成人患者，以及两岁以上儿科患者。去年11月，Pierre Fabre Laboratories和Atara Biotherapeutics达成合作协议，Pierre Fabre Laboratories囊获tab-cel的全球开发和商业化权益。◇ NKGen Biotech公司宣布，安全审查委员会已批准其在研NK细胞疗法SNK01进入阿尔茨海默病（AD）的2期临床试验，预计在2024年第二季度启动。SNK01是一款自体、非基因工程改造的NK细胞产品。它具有增强的细胞毒性和激活性受体的表达。此前公布的1期试验结果显示，SNK01除了先前披露的对淀粉样蛋白β（Aβ）和神经炎症生物标志物的积极影响外，对晚期AD患者的认知功能也具有临床疗效。在10名可评估的AD患者中，90%患者的阿尔茨海默病综合评分（ADCOMS）较基线时有改善或保持稳定。◇ Orca Bio公司公布了其在研同种异体T细胞免疫疗法Orca-T用于治疗AML患者的1b期临床试验的积极结果。接受Orca-T治疗的37例AML患者中，12个月的无复发生存率和总生存率分别为82.5%和100%，12个月的非复发死亡率为0%。Orca-T在该患者亚组中的安全性与更大范围的1b期人群一致，没有发现新的安全性信号。Orca-T目前正在美国各大治疗中心进行关键性的3期临床试验评估。Orca-T由富集的CD34+干细胞，以及通过高精度平台纯化、取材自单倍体匹配供体的特定T细胞亚群组合而成。Orca-Q有潜力改善患者的预后和降低移植物抗宿主疾病（GvHD）风险，并且无需对无法找到人类白细胞抗原（HLA）匹配的患者进行移植后环磷酰胺（PTCy）治疗。◇ iCell Gene Therapeutics公布了其BCMA与CD19靶向复合嵌合抗原受体-T（BCMA-CD19 cCAR-T）细胞免疫疗法的研究者发起临床试验（IIT）的积极结果。分析显示，所有接受足量初始剂量cCAR-T治疗的系统性红斑狼疮（SLE）/狼疮性肾炎（LN）患者，在治疗3个月后体内自身抗体呈现阴性，并在随访46个月时，均达到无症状和无药物缓解（MFR）。▲iCell的BCMA-CD19 cCAR-T疗法作用机制（图片来源：参考资料[12]）这款由iCell所设计的cCAR-T细胞免疫疗法，在单一结构中表达两种不同且功能齐全的CAR分子，一种靶向B细胞上的CD19，另一种靶向浆细胞上的BCMA。鉴于B细胞和长寿浆细胞具有独立的记忆，因此需要同时靶向B细胞和长寿浆细胞以消除所有升高的自身抗体。◇ AffyImmune Therapeutics公司公布了细胞间粘附分子-1（ICAM-1）靶向CAR-T细胞疗法AIC100治疗晚期甲状腺癌的1期临床试验数据。结果显示，在6例可评估的患者中，ORR为33%，其中一名患者获得了持久的部分缓解（PR），一名患有侵袭性甲状腺未分化癌的患者获得了持久的代谢完全缓解（mCR），该患者可以停止所有化疗。该研究中的疾病控制率（DCR）为67%。◇ Anixa Biosciences公司宣布其新型CAR-T细胞疗法治疗卵巢癌的1期临床试验已开始第5位患者的治疗。Anixa公司的CAR-T疗法是一种自体细胞疗法，由针对促卵泡激素受体（FSHR）的工程T细胞组成。FSHR在免疫学上只存在于卵巢的颗粒细胞中。由于靶点是一种嵌合内分泌（CE）受体，而靶点结合域来自其天然配体，因此这种技术被称为CER-T（嵌合内分泌受体T）细胞疗法，是一种新型CAR-T细胞疗法。◇ 美国得克萨斯儿童医院和贝勒医学院的研究团队近期在Nature Cancer杂志上领衔发表了一篇论文，内容是关于一种HER2特异性CAR-T细胞疗法治疗晚期肉瘤患者的1期临床试验结果。在接受治疗的14名患者中，有7名（50%）患者的病情得到稳定或缓解。中位随访时间为8.2个月时，患者的1年生存率为46%。一名患者在接受多次CAR-T细胞输注后达到完全缓解，并持续缓解超过6年。安全性方面，大多数患者出现了细胞因子释放综合征（CRS），但均可通过支持性治疗得到控制。没有观察到与HER2 CAR-T细胞相关的严重神经毒性或心脏毒性。▲患者的生存曲线和无进展生存曲线（图片来源：参考资料[4]）◇ NKGen Biotech公司公布了其非基因修饰的异体NK细胞SNK02治疗晚期实体瘤患者的1期临床试验的中期结果。结果显示，100%的患者（n=4）在完成8个周期的SNK02治疗后实现了疾病稳定（SD）的最佳客观缓解。此外，SNK02作为单一疗法的耐受性良好。SNK02有望成为潜在“first-in-class”的低温保存的异体NK细胞疗法，用于治疗实体瘤。这种疗法在给药前不需要进行淋巴清除，这可能会使其在未来与免疫检查点抑制剂联用时产生更好的整体协同作用。◇ Antion Biosciences公司宣布将开发新一代CD19靶向CAR-T细胞疗法，用于治疗B细胞驱动的自身免疫性疾病。Antion公司基于微RNA（miRNA）的miCAR技术平台能够将单个基因载体中多个基因的共同表达和沉默无缝地整合在一起。与其他基因工程技术相比，这种方法只需一个基因递送步骤就能安全高效地制造出多重工程细胞。▲miCAR技术平台图示（图片来源：Antion Biosciences公司官网）Antion公司的多重工程细胞旨在解决现有细胞疗法产品的关键限制。例如，其细胞产品经过基因工程改造提升了安全性，能够规避传统细胞疗法使用前的化疗预处理，并进一步减轻炎症风险。作为一种同种异体现货型细胞疗法，它能够规模化生产，满足全球患者的需求。———✦融资、合作、M&A✦———图片来源：123RF◇ Captain T Cell公司宣布完成了850万欧元的种子轮融资，该资金将用于进一步推动其潜在“first-in-class”主打产品进入临床，以及用于开发针对实体瘤的新型现货型同种异体细胞疗法平台。i&i Biotech Fund I、Brandenburg Kapital和HIL-INVENT等经验丰富的生命科学投资者参与了本轮融资。利用新一代技术，Captain T Cell公司生产的T细胞受体（TCR）T细胞具有更强的持久性，能够应对难治性实体瘤的恶劣肿瘤微环境。在临床前的体内模型中，这些功效增强的T细胞能够彻底根除侵袭性的肿瘤。◇ Indapta Therapeutics公司宣布获得了得克萨斯州癌症预防与研究所（CPRIT）授予的450万美元的资助，该资金将支持Indapta公司用于治疗晚期非霍奇金淋巴瘤和多发性骨髓瘤患者的主打NK细胞疗法IDP-023的临床开发。Indapta Therapeutics的NK细胞疗法基于NK细胞的特定亚群。这一名为g-NK的细胞亚群能够在不需要基因工程改造的情况下，显著增强单克隆抗体的肿瘤杀伤能力。G-NK细胞的产生源于NK细胞接触巨细胞病毒（CMV）后产生的表观遗传学变化。Indapta的技术平台可以从健康供体中倾向性扩增g-NK细胞，从而生产IDP-023。这一现货型细胞疗法的差异化特征在于它是一种可以冷冻保存的细胞疗法，并且与传统NK细胞相比，能够释放更多免疫激活细胞因子和肿瘤杀伤化合物。Indapta Therapeutics公司的首席执行官Mark Frohlich博士在接受药明康德内容团队采访时表示，在目前获批的疗法中，每一种细胞疗法只能针对一种癌症抗原。然而癌症抗原表达有着固有异质性，尤其是在面临选择性压力时，这促成了肿瘤的难治性或复发。该公司相信g-NK细胞有望成为一种“best-in-class”的NK细胞疗法，特别是当它与单克隆抗体或先天免疫双特异性衔接分子等靶向疗法联合使用，可以靶向多种癌症抗原并解决肿瘤异质性问题。相关阅读：单一疗法便能覆盖多种癌症抗原，“全能型”肿瘤NK细胞疗法是如何诞生的 | 迅猛新分子▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA. Retrieved May 20, 2024, from https://www.businesswire.com/news/home/20240520985176/en[2] NKGen Biotech’s SNK01 NK Cell Therapy Cleared to Start Phase 2 Clinical Trial in Alzheimer’s Disease. Retrieved May 23, 2024, from https://nkgenbiotech.com/nkgen-biotechs-snk01-nk-cell-therapy-cleared-to-start-phase-2-clinical-trial-in-alzheimers-disease/[3] Anixa Biosciences Commences Treatment of Fifth Patient in Ovarian Cancer CAR-T Clinical Trial. Retrieved May 23, 2024, from https://www.prnewswire.com/news-releases/anixa-biosciences-commences-treatment-of-fifth-patient-in-ovarian-cancer-car-t-clinical-trial-302150758.html[4] Hegde M, Navai S, DeRenzo C, Joseph SK, Sanber K, Wu M, Gad AZ, Janeway KA, Campbell M, Mullikin D, Nawas Z, Robertson C, Mathew PR, Zhang H, Mehta B, Bhat RR, Major A, Shree A, Gerken C, Kalra M, Chakraborty R, Thakkar SG, Dakhova O, Salsman VS, Grilley B, Lapteva N, Gee A, Dotti G, Bao R, Salem AH, Wang T, Brenner MK, Heslop HE, Wels WS, Hicks MJ, Gottschalk S, Ahmed N. Autologous HER2-specific CAR T cells after lymphodepletion for advanced sarcoma: a phase 1 trial. Nat Cancer. 2024 Apr 24. doi: 10.1038/s43018-024-00749-6. Epub ahead of print. PMID: 38658775.[5] Antion Biosciences announces development of safety-enhanced and off-the-shelf CAR T-cells for autoimmune disease. Retrieved May 23, 2024, from https://www.globenewswire.com/news-release/2024/05/22/2886347/0/en/Antion-Biosciences-announces-development-of-safety-enhanced-and-off-the-shelf-CAR-T-cells-for-autoimmune-disease.html[6] Captain T Cell Secures Seed Financing Round Totaling € 8.5 Million. Retrieved May 23, 2024, from https://www.globenewswire.com/news-release/2024/05/22/2886221/0/en/Captain-T-Cell-Secures-Seed-Financing-Round-Totaling-8-5-Million.html[7] Indapta Therapeutics Awarded $4.5 Million by CPRIT to Advance Clinical Development of its Allogenic Natural Killer Cell Therapy. Retrieved May 23, 2024, from https://www.businesswire.com/news/home/20240521592452/en/[8] NKGen Biotech Publishes Phase 1 Interim Analysis Results of SNK02 Allogeneic NK Cell Therapy in Advanced Solid Tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887701/0/en/NKGen-Biotech-Publishes-Phase-1-Interim-Analysis-Results-of-SNK02-Allogeneic-NK-Cell-Therapy-in-Advanced-Solid-Tumors-at-the-2024-American-Society-of-Clinical-Oncology-ASCO-Annual-.html[9] Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523266449/en/[10] AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523653892/en[11] iCell Gene Therapeutics Announces Positive Clinical Data from Investigator Initiated Phase 1 Trial Evaluating BCMA-CD19 Compound CAR in Patients with Systemic Lupus Erythematosus/Lupus Nephritis Published in Annals of the Rheumatic Diseases. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523089601/en[12] Our Pipeline. Retrieved May 23, 2024 from https://www.icellgene.com/our-pipeline免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

免疫疗法细胞疗法基因疗法临床2期临床1期

100 项与 Orca Q 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
急性淋巴细胞白血病	临床2期	美国	Orca Biosystems, Inc.初创企业	2022-08-16
急性髓性白血病	临床2期	美国	Orca Biosystems, Inc.初创企业	2022-08-16
加速期慢性骨髄性白血病	临床2期	美国	Orca Biosystems, Inc.初创企业	2022-08-16
急性转化期慢性粒细胞性白血病	临床2期	美国	Orca Biosystems, Inc.初创企业	2022-08-16
混合表型急性白血病	临床2期	美国	Orca Biosystems, Inc.初创企业	2022-08-16
骨髓增生异常综合征	临床1期	美国	Orca Biosystems, Inc.初创企业	2019-04-08
费城染色体阳性慢性粒细胞白血病	临床1期	美国	Orca Biosystems, Inc.初创企业	2019-04-08
原发性骨髓纤维化	临床1期	美国	Orca Biosystems, Inc.初创企业	2019-04-08
多发性硬化症	临床申请	美国	Orca Biosystems, Inc.初创企业	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03802695 (ASH2023) 人工标引	临床1期	血液肿瘤	33	Orca-Q	(鹹鑰壓齋齋鬱遞獵獵艱) = 鬱鑰網壓鏇鹽糧襯築鏇餘壓顧選襯構觸構鹽觸 (艱遞遞製網艱廠範鹽鏇 ) 更多	积极	2023-12-11