Drugs / WU-NK-101
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05674526 | May 2024 → Sep 2025 overdue | colorectal cancer, head and neck squamous cell carcinoma | Wugen, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05470140 | Jul 2023 → Oct 2024 | acute myeloid leukemia | Wugen, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2023-08-15 | Wugen, Inc. | Regulatory Wugen Begins First-in-Human Phase 1 Clinical Trial of WU-NK-101, its Lead Allogeneic Memory Natural Killer (NK) Cell Therapy for Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) wugen.com ↗
Additionally, Wugen announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-NK-101 for the treatment of AML. |
| 2023-06-09 | Wugen, Inc. | Results Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress wugen.com ↗
Post-infusion of ML-NK cells, high T-cell infiltration to the tumor site signaled the recruitment of the adaptive immune system and the potential for durable effectiveness in patients with R/R AML. |
| 2023-05-11 | Wugen, Inc. | Results Wugen Announces Multiple Presentations at the European Hematology Association (EHA) 2023 Congress wugen.com ↗
The oral presentation includes clinical data demonstrating the unique ability of memory-like natural killer cells to engage the adaptive immune system, and the potential for durable effectiveness in the relapsed or refractory (R/R) acute myeloid leukemia (AML) setting. |
| 2023-04-19 | Wugen, Inc. | Results Wugen Presents New Preclinical Data Reinforcing Anti-Tumor Functionality of WU-NK-101 at the American Association for Cancer Research (AACR) Annual Meeting 2023 wugen.com ↗
WU-NK-101 demonstrated PD-L1 and MHC-I checkpoint upregulation in solid tumor models |
| 2023-01-30 | Alpha Biopharma (Jiangsu) Co., Ltd. | Results Wugen在ASCO胃肠癌症研讨会上公布WU-NK-101联合西妥昔单抗在晚期结直肠癌(CRC)临床前模型中的数据 alphabiopharma.com ↗
WU-NK-101在体内外联合Ctx后，对结直肠癌(CRC)细胞的抑制作用进一步增强，证实了其抗体依赖性细胞毒性(ADCC)的作用机制。 |
| 2023-01-21 | Wugen, Inc. | Results Wugen Presents Data on WU-NK-101 in Combination with Cetuximab in Preclinical Models of Advanced Colorectal Cancer (CRC) at ASCO Gastrointestinal Cancers Symposium wugen.com ↗
WU-NK-101 demonstrated superior anti-tumor efficacy against colorectal cancer (CRC) tumor cell lines in vivo and in vitro compared to cetuximab (Ctx) monotherapy; efficacy was further augmented when deployed in combination |
| 2022-12-15 | Alpha Biopharma (Jiangsu) Co., Ltd. | Results Wugen在美国血液学会（ASH）第64届年会上展示临床开发数据 支持WU-NK-101治疗复发/难治性急性髓系白血病（AML） alphabiopharma.com ↗
与 cNK 细胞相比， WU-NK-101 具有增强的抗肿瘤活性，可运输至骨髓，并显示出代谢灵活性，可能减轻高度免疫抑制型 AML TME 的不良影响。 |
| 2022-12-11 | Wugen, Inc. | Results Wugen Presents Data Supporting Clinical Development of WU-NK-101 for Relapsed / Refractory AML at the American Society of Hematology’s (ASH) 64th Annual Meeting wugen.com ↗ |
| 2022-11-07 | Wugen, Inc. | Results Wugen to Present Data Characterizing WU-NK-101 at The Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting wugen.com ↗
WU-NK-101 showed elevated expression of distinct cytokine-induced memory-like (CIML) NK markers, including cytotoxic molecules, activating receptors, and nutrient transporters. |
| 2022-11-03 | Wugen, Inc. | Results Wugen to Present Data on WU-NK-101 for Relapsed / Refractory Acute Myelogenous Leukemia at The American Society of Hematology’s (ASH) 64th Annual Meeting wugen.com ↗
Compared to conventional NK cells, WU-NK-101 demonstrated enhanced trafficking to the bone marrow, robust anti-tumor activity, and an adaptive metabolic profile consistent with aerobic glycolysis, which may support resilience in an immunosuppressive tumor microenvironment (TME). |
| 2022-09-10 | Wugen, Inc. | Results Wugen Presents Preclinical Data on WU-NK-101 in Solid Tumor Models at the European Society for Medical Oncology (ESMO) Congress 2022 wugen.com ↗
WU-NK-101 demonstrated robust anti-tumor activity, tumor trafficking, and penetration further augmented by monoclonal antibodies (mAbs) |
| 2022-06-11 | Alpha Biopharma (Jiangsu) Co., Ltd. | Results Wugen在欧洲血液学协会(EHA) 2022年线上结合线下会议上展示最新临床前数据证明WU-NK-101增强的抗肿瘤活性 alphabiopharma.com ↗
Wugen, Inc.，一家正在开发现货型细胞疗法，用于治疗广泛的血液和实体恶性肿瘤的临床阶段生物科技公司公布新的临床前数据，表明其先导记忆自然杀伤(NK)细胞治疗产品WU-NK-101增强了抗肿瘤活性。 |
| 2022-06-10 | Wugen, Inc. | Results Wugen Presents New Preclinical Data Demonstrating Enhanced Anti-Tumor Activity of WU-NK-101 at the European Hematology Association (EHA) 2022 Hybrid Congress wugen.com ↗
The data elucidate the unique cytokine-induced memory-like (CIML) phenotype of WU-NK-101 and further support its clinical development for acute myeloid leukemia (AML) and a range of solid tumor indications. |
| 2022-05-12 | Wugen, Inc. | Results Wugen to Present Preclinical Data on WU-NK-101 at the European Hematology Association (EHA) 2022 Hybrid Congress wugen.com ↗
WU-NK-101 displayed activity against AML cell lines both in vitro and in vivo, and improved homing to the bone marrow. |
| 2021-11-12 | Wugen, Inc. | Results Wugen Presents New Preclinical Data from Novel Memory Natural Killer (NK) Platform at The Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting wugen.com ↗
Lead product candidate WU-NK-101 demonstrated potent anti-tumor activity and long-term persistence in vivo |
| 2021-11-09 | Wugen, Inc. | Results Wugen Announces Data Presentation at The Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting wugen.com ↗
The data highlight Wugen’s proprietary large-scale feeder-cell free manufacturing process and demonstrate WU-NK-101’s robust memory phenotype and enhanced anti-tumor activity. |
All press releases naming this drug 18 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | WU-NK-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05470140 ↗ |
| Modality | Cell therapy | “allogeneic enhanced Memory-like anti-tumor NK cell therapy product.” NCT05470140 ↗ |