A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

The main purpose of this study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease (MRD) negative response

开始日期2024-12-13

申办/合作机构

Wugen, Inc.

NCT05674526 / Recruiting临床1期

A Phase 1b Study of WU-NK-101 in Combination With Cetuximab for Advanced and/or Metastatic Colorectal Cancer (CRC) and Advanced and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This study is a Phase 1b open-label study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 in combination with cetuximab in patients with advanced and/or metastatic CRC (Cohort 1), and in patients with advanced and/or metastatic SCCHN (Cohort 2). The overall study will be comprised of two phases, a Dose Escalation Phase, and a Cohort Expansion Phase.

开始日期2024-05-21

申办/合作机构

Wugen, Inc.

NCT05377827 / Active, not recruiting临床1期IIT

Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies

Effective treatment options for relapsed/refractory acute myeloid leukemia (AML) and T-cell non-Hodgkin lymphoma (T-NHL) represent a significant unmet medical need. CAR T therapy has offered durable remissions and potential cures in some forms of hematologic malignancy, including B-cell acute lymphoblastic leukemia. In AML, however, CAR T approaches have been limited by the lack of suitable antigens, as most myeloid markers are shared with normal hematopoietic stem cells and targeting of these antigens by CAR T therapy leads to undesirable hematologic toxicity. Similarly, T-NHL has not yet benefited from CAR T therapy due to a lack of suitable markers. One potential therapeutic target is CD7, which is expressed normally on mature T-cells and NK-cells but is also aberrantly expressed on
30% of acute myeloid leukemias. CAR T therapy for patients with CD7+ AML and T-NHL will potentially offer a new therapeutic option which has a chance of offering durable benefit.
WU-CART-007 is a CD7-directed, genetically modified, allogeneic, fratricide-resistant chimeric antigen receptor (CAR) T-cell product for the treatment of CD7+ hematologic malignancies. These cells have two key changes from conventional, autologous CAR T-cells. First, because CD7 is present on normal T-cells including conventional CAR T products, CD7 is deleted from WU CART-007. This allows for targeting of CD7 without the risk of fratricide (killing of WU-CART-007 cells by other WU-CART-007 cells). Second, the T cell receptor alpha constant (TRAC) is also deleted. This makes WU CART 007 cells incapable of recognizing antigens other than CD7 and allows for the use of an allogeneic product without causing Graft-versus-Host-Disease (GvHD).

开始日期2023-10-10

申办/合作机构

Washington University School of Medicine

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项与 Wugen, Inc. 相关的文献（医药）

2022-10-28·Science immunology

Antigen-specific depletion of CD4 ⁺ T cells by CAR T cells reveals distinct roles of higher- and lower-affinity TCRs during autoimmunity

Article

作者: Miller, Aidan T. ; Egawa, Takeshi ; Hsieh, Chyi-Song ; Hsu, Yu-Sung ; Bradstreet, Tara R. ; Singh, Nathan ; Zhou, You W. ; Wu, Gregory F. ; Edelson, Brian T. ; Archambault, Angela S. ; Jones, Andrew J. ; Yi, Jaeu ; Fremont, Daved H. ; Bandla, Sravanthi

Both higher- and lower-affinity self-reactive CD4 + T cells are expanded in autoimmunity; however, their individual contribution to disease remains unclear. We addressed this question using peptide-MHCII chimeric antigen receptor (pMHCII-CAR) T cells to specifically deplete peptide-reactive T cells in mice. Integration of improvements in CAR engineering with TCR repertoire analysis was critical for interrogating in vivo the role of TCR affinity in autoimmunity. Our original MOG 35–55 pMHCII-CAR, which targeted only higher-affinity TCRs, could prevent the induction of experimental autoimmune encephalomyelitis (EAE). However, pMHCII-CAR enhancements to pMHCII stability, as well as increased survivability via overexpression of a dominant-negative Fas, were required to target lower-affinity MOG-specific T cells and reverse ongoing clinical EAE. Thus, these data suggest a model in which higher-affinity autoreactive T cells are required to provide the “activation energy” for initiating neuroinflammatory injury, but lower-affinity cells are sufficient to maintain ongoing disease.

2021-09-01·Cancer immunology research1区 · 医学

A Fusion Protein Complex that Combines IL-12, IL-15, and IL-18 Signaling to Induce Memory-Like NK Cells for Cancer Immunotherapy

1区 · 医学

Article

作者: Wong, Hing C. ; Egan, Jack O. ; Fehniger, Todd A. ; Prendes, Caitlin A. ; Spanoudis, Catherine M. ; Muniz, Gabriela J. ; McClain, Ethan ; Marsala, Lynne I. ; Zhu, Xiaoyun ; Foster, Mark ; Gallo, Victor L. ; Wagner, Julia A. ; Sullivan, Ryan P. ; Pence, Patrick ; Rhode, Peter R. ; Becker-Hapak, Michelle K. ; You, Lijing ; Schappe, Timothy ; Echeverri, Christian A. ; Dee, Michael J. ; Leclerc, Gilles M. ; Ramirez, Laritza L. ; Tran, Jennifer ; Jeng, Emily K. ; Chaturvedi, Pallavi ; Jiao, Jin-an ; Shrestha, Niraj ; Desai, Sweta ; Wong, Pamela ; Neal, Carly C. ; Berrien-Elliott, Melissa M. ; Russler-Germain, David A.

Abstract:

Natural killer (NK) cells are a promising cellular therapy for cancer, with challenges in the field including persistence, functional activity, and tumor recognition. Briefly, priming blood NK cells with recombinant human (rh)IL-12, rhIL-15, and rhIL-18 (12/15/18) results in memory-like NK cell differentiation and enhanced responses against cancer. However, the lack of available, scalable Good Manufacturing Process (GMP)–grade reagents required to advance this approach beyond early-phase clinical trials is limiting. To address this challenge, we developed a novel platform centered upon an inert tissue factor scaffold for production of heteromeric fusion protein complexes (HFPC). The first use of this platform combined IL-12, IL-15, and IL-18 receptor engagement (HCW9201), and the second adds CD16 engagement (HCW9207). This unique HFPC expression platform was scalable with equivalent protein quality characteristics in small- and GMP-scale production. HCW9201 and HCW9207 stimulated activation and proliferation signals in NK cells, but HCW9207 had decreased IL-18 receptor signaling. RNA sequencing and multidimensional mass cytometry revealed parallels between HCW9201 and 12/15/18. HCW9201 stimulation improved NK cell metabolic fitness and resulted in the DNA methylation remodeling characteristic of memory-like differentiation. HCW9201 and 12/15/18 primed similar increases in short-term and memory-like NK cell cytotoxicity and IFNγ production against leukemia targets, as well as equivalent control of leukemia in NSG mice. Thus, HFPCs represent a protein engineering approach that solves many problems associated with multisignal receptor engagement on immune cells, and HCW9201-primed NK cells can be advanced as an ideal approach for clinical GMP-grade memory-like NK cell production for cancer therapy.

CANCER IMMUNOLOGY IMMUNOTHERAPY

A “Prime and Expand” strategy using the multifunctional fusion proteins to generate memory-like NK cells for cell therapy

Article

作者: Cooper, Matthew L ; Li, Liying ; McClain, Ethan ; Fehniger, Todd A ; Echeverri, Christian ; Wong, Hing C ; Zhu, Xiaoyun ; Rhode, Peter R ; Foster, Mark ; You, Lijing ; Dee, Michael J ; George, Varghese ; Shrestha, Niraj ; Dufour, Celeste ; Pena, Natalia Valderrama ; Liu, Bai ; Arthur, Laura ; Chaturvedi, Pallavi ; Wang, Meng ; Egan, Jack ; Leclerc, Gilles M ; Kage, Karen ; Kong, Lin ; Berrien-Elliott, Melissa M ; Becker-Hapak, Michelle ; Mathyer, Mary

Abstract:

Adoptive cellular therapy (ACT) using memory-like (ML) natural killer (NK) cells, generated through overnight ex vivo activation with IL-12, IL-15, and IL-18, has shown promise for treating hematologic malignancies. We recently reported that a multifunctional fusion molecule, HCW9201, comprising IL-12, IL-15, and IL-18 domains could replace individual cytokines for priming human ML NK cell programming (“Prime” step). However, this approach does not include ex vivo expansion, thereby limiting the ability to test different doses and schedules. Here, we report the design and generation of a multifunctional fusion molecule, HCW9206, consisting of human IL-7, IL-15, and IL-21 cytokines. We observed > 300-fold expansion for HCW9201-primed human NK cells cultured for 14 days with HCW9206 and HCW9101, an IgG1 antibody, recognizing the scaffold domain of HCW9206 (“Expand” step). This expansion was dependent on both HCW9206 cytokines and interactions of the IgG1 mAb with CD16 receptors on NK cells. The resulting “Prime and Expand” ML NK cells exhibited elevated metabolic capacity, stable epigenetic IFNG promoter demethylation, enhanced antitumor activity in vitro and in vivo, and superior persistence in NSG mice. Thus, the “Prime and Expand” strategy represents a simple feeder cell-free approach to streamline manufacturing of clinical-grade ML NK cells to support multidose and off-the-shelf ACT.

项与 Wugen, Inc. 相关的新闻（医药）

2024-12-05

·GlobeNewswire-Health Care

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

Data Support Start of First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy in Pediatric and Adult PatientsST. LOUIS and SAN DIEGO, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced upcoming scientific presentations, including updates from the company’s Phase 1/2 study of WU-CART-007. Researchers will present Phase 1/2 updates and studies for its investigational cell therapies this week at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 7-10 in San Diego. Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. WU-CART-007 is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy under evaluation for treatment of patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Based on findings to date with WU-CART-007, including this week’s data, Wugen will initiate the first pivotal Phase 2 study for an off-the-shelf CD7-targeted CAR-T cell therapy. “Maturing evidence, including the Phase 1/2 study being presented, suggest WU-CART-007 has the potential to improve current standard of care for patients with these blood cancers. T-ALL/LBL are malignancies associated with high rates of relapse and mortality in patients, many of whom are young,” said Armin Ghobadi, M.D., professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) at the Washington University School of Medicine in St. Louis. “At this year’s ASH meeting, we will present clinical data from adult and adolescent patients that support our soon to open pivotal trial for patients with relapsed or refractory T-ALL/LBL,” said Wugen Chief Medical Officer, Cherry Thomas, M.D. “We are looking forward to working with experienced investigators to provide meaningful clinical benefit to patients with limited treatment options.” The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will involve two groups: a R/R cohort and subsequently an exploratory minimal residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. Wugen Presentations at ASH 3450 WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results Presenter: Armin Ghobadi, M.D., Washington University School of Medicine, St. Louis Presentation type: PosterTime/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II 3461 WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) – Subgroup Analysis of WU-CART-007 1001 Presenter: Shannon L. Maude, M.D., Division of Oncology, Center for Childhood Cancer Research and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia Presentation type: PosterTime/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II Wugen researchers will also present the following abstracts for the company’s investigational memory natural killer cell therapy, WU-NK-101: 916 W-NK1 Choreographs Innate and Adaptive Immune Responses to Provide a Robust and Durable Anti-AML Response Presenter: Tom Leedom, Wugen, Inc., St. Louis Presentation type: Oral Time/location: Monday, Dec. 9, 3:30 p.m. PT; Marriott Grand Ballroom 8-9, Marriott Marquis San Diego MarinaSession: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics Hematology Disease Topics & Pathways: Research, Translational Research 2:45-4:15 p.m. PT 4257 WUN101-01: First in Human (FIH) Phase 1 Study of WU-NK-101 (W-NK1) in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) Presenter: Amanda F. Cashen, M.D., Washington University School of Medicine, St. Louis Presentation type: PosterTime/location: Monday, Dec. 9, 6:00-8:00 p.m. PT; Halls G, HSession: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster IIIHematology Disease Topics & Pathways: Research, Clinical trials, Translational Research, Clinical Research Investigator-initiated research 2066 Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma Presenter: Michael H. Kramer, M.D., Ph.D., Washington University School of Medicine, Saint Louis Presentation type: PosterTime/location: Sat., Dec. 7, 5:30-7:30 p.m. PT; Halls G, HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I; About WU-CART-007 WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794. WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About Wugen Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page. Investor Contact:Mark LewisWugenMlewis@wugen.com314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com215-595-5211

细胞疗法免疫疗法快速通道临床2期ASH会议

2024-11-19

·晨泰医药

【2024 ASH】Wugen 将在2024 ASH汇报通用现货型CD7 CAR-T和NK细胞产品最新数据，5篇研究入选口头报告

新闻速览第66届美国血液学年会（ASH）将于2024年12月7日~10日在美国圣地亚哥召开。ASH作为全球血液学领域规模最大、涵盖最全面的国际学术盛会之一，每年吸引着成千上万名来自世界各地的专家学者，分享最前沿的血液学进展和突破性临床数据。根据ASH最新公布的摘要，Wugen公司有5项研究入选Oral Presentation，将以口头汇报形式报告通用现货型CD7 CAR-T（WU-CART-007)和NK细胞（WU-NK-101）疗法的最新数据。 CD7 CAR-T报告详情如下： 2066 Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I 3450 WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II 3461 WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) Subgroup Analysis of WU-CART-007 1001 Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II WU-CART-007已获FDA授予的孤儿药、快速通道和罕见儿科疾病认定、再生医学先进疗法认定；EMA优先审评药物认定。此次会议上，Wugen将报告通用现货型CD7 CAR-T疗法的最新临床数据,主要亮点包括： CD7 CAR-T治疗（R/R）T-ALL/LBL II期阶段试验结果：截至2024年7月24日，共13名患者接受了RP2D剂量治疗表现出可控的安全性以及抗白血病活性。可评估患者中，ORR和CRc分别为91%（10/11）和73%（8/11；6 CR，2 CRi）。中位DOR尚未达到（95% CI: 0.5，NE；范围0.5-9.1个月）；4名患者目前仍持续CR，时间分别为9.1、8.2、6.7和6.7个月。 MRD阴性CR/CRi患者（n=7）的中位DOR为6.6个月（95% CI：1.8，NE），而MRD阳性CR/CRi患者（n=3）为3.7个月（95% CI: 0.5，NE）。MRD阴性患者总生存期（OS）为11.5个月（95% CI：2.7，NE），MRD阳性患者为6.1个月（95% CI：1.4，NE）。 12-18青少年患者亚组分析中，可评估的患者（4/4）CR/CRi率为75%，1例患者达到PR（CD7阴性残留EMD），ORR为100%。CRc患者中，2/3未检测到MRD。达到CR/CRi的3名患者均转为HSCT，其中两名患者有移植史，所有患者在随访9、8.1和6.1个月时仍处于完全缓解状态。后续关键II期研究NCT06514794计划于2024年末开始招募，包括1岁及以上的儿童患者；在R/R患者队列的安全性得到确认后，可能会启动探索性的MRD阳性队列研究。 CD7 CAR-T治疗CD7+ T-NHL I期剂量递增和剂量扩展研究：： 5名T-NHL患者接受WU-CART-007治疗，无患者出现免疫效应细胞相关神经毒性综合征（ICANS）或GvHD，表现出可控的安全性。疗效方面：2例完全缓解（CR）；2例部分缓解（PR）；1例病情稳定（SD），显示出早期疗效迹象。本研究（NCT05377827）的招募仍在进行，以进一步确定其在CD7阳性T-NHL和AML患者中的安全性和初步疗效。 NK细胞疗法报告详情如下： 916 W-NK1 Choreographs Innate and Adaptive Immune Responses to Provide a Robust and Durable Anti-AML Response Program: Oral and Poster Abstracts Type: Oral Session: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics 4257 WUN101-01: First in Human Human (FIH) Phase 1 Study of WU-NK-101 (W-NK1) in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) Program: Oral and Poster Abstracts Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III WU-NK-101已获得美国食品药品监督管理局（FDA）授予的用于治疗AML的孤儿药认证。此次会议上，Wugen将报告通用现货型NK细胞疗法的最新数据,主要亮点包括： WU-NK-101协调固有和适应性免疫应答，提供强效且持久的抗AML反应：与供体cNK细胞相比，W-NK1在NKG2A、2B4、DNAM-1以及免疫参与受体的表达上更高；W-NK1与未成熟DC共培养可增加DC的激活标志物表达；分泌的趋化因子在跨膜实验中能有效招募T细胞；W-NK1显著增强T细胞激活和增殖（P<0.01）；促肿瘤M2型巨噬细胞表现出选择性细胞毒性，显示其倾向于改善TME的免疫抑制状态。这些结果同样通过AML异种移植NCG小鼠模型（THP-1和HL-60）体内得到验证。 WU-NK-101在复发或难治性（R/R）急性髓性白血病（AML）患者中的I期研究：入组9名患者（每个剂量水平3名），表现出可管理的安全性。未报告免ICANS或GvHD；未观察到无疾病情况下的持续性全血细胞减少，也未报告剂量限制性毒性（DLT）。在DL1水平未观察到缓解，但所有患者外周血母细胞均短暂减少；在DL2及以上水平，除1例外，所有患者骨髓母细胞均减少， ORR为50%（包括2例CRi和1例PR）。摘要原文链接： 1. https://ash.confex.com/ash/2024/webprogram/Paper201520.html 2. https://ash.confex.com/ash/2024/webprogram/Paper201812.html 3. https://ash.confex.com/ash/2024/webprogram/Paper202005.html 4. https://ash.confex.com/ash/2024/webprogram/Paper201998.html 5. https://ash.confex.com/ash/2024/webprogram/Paper200809.html 关于WU-CART-007 WU-CART-007是一种通用现货型CD7靶向CAR-T细胞疗法，旨在克服利用CAR-T细胞治疗CD7+血液系统恶性肿瘤的技术挑战。Wugen利用CRISPR/Cas9基因编辑技术，删除CD7和T细胞受体恒定区（TRAC），防止CAR-T细胞自相残杀，降低移植物抗宿主病（GvHD）的风险。WU-CART-007使用健康供者来源的T细胞制备，消除在自体CAR-T环境中观察到的恶性细胞污染风险。Wugen已与合作伙伴共同开发出稳定且高效扩增的CD7 CAR-T商业化生产工艺，已完成首个I/II 期爬坡及扩展队列研究（NCT04984356）,是目前全球临床进度最快的同类通用现货型细胞产品。关于WU-NK-101 WU-NK-101是一种新型的免疫疗法，利用记忆自然杀伤细胞（NK）治疗血液和实体肿瘤。记忆NK细胞是一种功能性强、持久力高的免疫细胞，具备增强的抗肿瘤活性和细胞因子诱导的记忆样（CIML）表型。这种罕见的细胞群具有优越的表型、增殖能力和代谢适应性，与其他NK细胞疗法相比更适合用于癌症治疗。Wugen正在应用其专有的MonetaTM平台，将WU-NK-101开发为一种商业规模化、现货型的癌症细胞疗法。关于上海晨泰森豪医药科技有限公司晨泰森豪成立于2020年，是一家致力于开发临床急需的通用型细胞治疗药物的创新医疗公司。2021年1月与Wugen达成独家许可和合作协议，共同开发通用现货型记忆NK细胞和CAR-T细胞。用于治疗晚期血液瘤和实体瘤，并积极开发神经退行性疾病和自身免疫疾病的应用。晨泰森豪拥有经验丰富的医学、临床运营、药学开发、注册事务和商业化团队，通过整合肿瘤领域的专业知识，不断寻找创新解决方案，从而改善肿瘤患者的生活。关于Wugen Inc. Wugen是一家临床阶段的生物技术公司，致力于开发下一代用于治疗癌症的“现货型”免疫记忆自然杀伤 (NK) 细胞疗法和CAR-T细胞疗法。Wugen利用其专有的技术平台和深厚的基因组工程专业技术来开创一种新型的免疫记忆NK细胞和CAR-T细胞疗法，以治疗血液和实体恶性肿瘤。文章封面来源：Freepik

免疫疗法细胞疗法临床结果孤儿药优先审批

2024-11-14

·GlobeNewswire-Health Care

HCW Biologics Reports Third Quarter 2024 Financial Results and Business Highlights

MIRAMAR, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2024. Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 2024, the Company expanded our product portfolio and possible disease indications that may be treated with our immunotherapeutic compounds, consisting of compounds constructed using two different platforms. Our expanded portfolio now includes constructs with immune-cell engagers targeting tissue factor and other cell-surface antigens associated with diseased cells and multifunctional immunotherapeutic fusions which improve the performance of immune checkpoint inhibitors.” Business Highlights We filed the IND application to obtain approval from the FDA to evaluate HCW9302 in an autoimmune indication and we are currently progressing through the review process. HCW9302 is a category-defining immunotherapeutic designed to activate and expand regulatory T cells, which deactivate inflammasomes. The novel design results in an immunotherapeutic with the therapeutic advantages of IL-2 but that is well tolerated. We believe that these studies support the clinical development of HCW9302 as a potential therapeutic agent for treatment of a broad range of proinflammatory diseases. Our clinical development focus is autoimmune diseases, including alopecia areata, and neurodegenerative diseases. We launched our financing plan in the third quarter of 2024 with the conclusion of an arbitration that has hampered our ability to raise capital and complete business development transactions. In addition to equity financings, the Company has a strategic focus on business development transactions and establishing commercialization partnerships with innovative leaders in the immunotherapy field. On November 13, 2024, the Company engaged Maxim Group to act as the exclusive placement agent to execute a multi-step equity financing strategy.On September 25, 2024, the Company entered into a nonbinding term sheet with a well-known leader in immunology. Definitive agreements are being finalized with a closing expected in the fourth quarter of 2024. The proposed license agreement includes substantial guaranteed minimum payments which are expected within the first year of the term. The license is for a preclinical molecule created with our novel protein platform, and we consider this a validation of the potential and value of this preclinical molecule for human therapy.The Company has developed a new drug discovery platform with a novel protein-based scaffold. It has already used this novel protein scaffold to construct several immunotherapeutic fusions, for development by HCW Biologics or others. The clinical development plan assumes one or more molecules constructed with this novel platform to be in clinical development in 2026, either through a Company-owned program or through the clinical program of one of the Company's licensees. Third Quarter 2024 Financial Results Revenues: Revenues for the quarter ended September 30, 2023 and 2024 were $853,102 and $426,423, respectively. Revenues for the nine months ended September 30, 2023 and 2024 were $1.5 million and $2.2 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used in manufacturing Wugen’s products.Research and development (R&D) expenses: R&D expenses for the quarter ended September 30, 2023 and 2024 were $1.7 million and $1.2 million, respectively, a decrease of $480,529, or 29%. In the three and nine months ended September 30, 2023, the Company incurred comparatively higher clinical expenses than it did in the comparable period in 2024, due to two ongoing clinical trials to evaluate HCW9218 in cancer. Similarly, in the three and nine months ended September 30, 2023, the Company incurred comparatively higher preclinical expenses that it did in the comparable period in 2024, due to costs incurred for the IND-enabling studies required for the IND application for HCW9302 including setup costs and toxicology studies. Manufacturing costs incurred in the nine months ended September 30, 2024 reflect costs incurred replenishing supply of the high-expressing cell line of HCW9101.General and administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2023 and 2024 were $1.5 million and $1.6 million, respectively, an increase of $129,216, or 9%. G&A expenses for the nine months ended September 30, 2023 and 2024 were $5.1 million and $4.8 million, respectively, a decrease of $307,237, or 6%. Changes in G&A expenses reflect cost cutting measures, offset by increases in professional fees, facilities and office expenses, and financing expenses. Legal Expenses: Legal expenses for the quarter ended September 30, 2023 and 2024 were $2.1 million and $1.0 million, respectively, a decrease of $1.1 million, or 54%. Legal expenses for the nine months ended September 30, 2023 and 2024 were $4.6 million and $15.8 million, respectively, an increase of $11.2 million, or 242%. The increase in legal expenses related to preparation of testimony and evidence for the hearing and the hearing itself in connection to the arbitration with ImmunityBio and its affiliates. There has since been a Settlement Agreement and parties have agreed to a stipulation to have the arbitration dismissed along with mutual general releases. See “Financial Guidance” below.Net loss: Net loss for the quarter ended September 30, 2023 and 2024 was $4.9 million and $3.9 million, respectively, a decrease of $1.0 million, or 21%. Net loss for the nine months ended September 30, 2023 and 2024 was $14.3 million and $26.7 million, respectively, an increase of $12.3 million, or 86%. Financial Guidance ImmunityBio and its affiliates initiated legal proceedings against the Company and Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, on December 31, 2022. Ultimately, legal proceedings against Company and Dr. Wong were consolidated in the arbitration before JAMS (“Arbitration”). As reported in the Company’s Form 8-K filed on July 18, 2024, the parties entered into a confidential Settlement Agreement and Release (the “Settlement Agreement”). The Settlement Agreement includes mutual general releases by and among the parties thereto. No party is required to make any monetary payments to any other party or person under the Settlement Agreement and each party agreed to bear its own expenses incurred in connection with the matter. Remediation activities are substantially complete, and the parties agreed to the stipulation and dismissal of the Arbitration. With the execution of the Settlement Agreement, the Company resolved the attendant uncertainties for the outcome of the arbitration and additional complexities. However, the Company incurred substantial legal fees in its defense and for the defense of Dr. Wong. As of September 30, 2024, the Company reported $14.4 million in obligations for legal fees within accounts payable on its condensed balance sheet. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees. As of September 30, 2024, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the condensed interim financial statements, without additional funding or financial support. The Company launched a multi-faceted financing plan in the third quarter of 2024 to raise the capital required through equity financings and business development transactions to fund the future product development and operations of the Company. A major objective of the financing strategy is to regain compliance with Listing Rules of the Nasdaq Stock Market LLC (“Nasdaq”). We were notified by Nasdaq staff that we are not in compliance with continued listing requirements on the Nasdaq Global Market. The Company was granted a period of 180 calendar days by Nasdaq in which to comply. The first deadline is currently scheduled for December 16, 2024. The Company intends to take all reasonable measures available to regain compliance with the continued listing requirements for the Nasdaq Global Market, and will utilize our right to appeal to Nasdaq to extend our deadline to regain compliance based on a solid financial plan to do so. About HCW Biologics: HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular, diabetes, neurodegenerative, and autoimmune diseases, as well as other inflammatory conditions such as long-haul COVID-19. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop two drug discovery platforms, each with a novel backbone which is used to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The Company’s legacy drug discovery platform is its TOBI™ (Tissue factOr-Based fusIon) discovery platform, has a Tissue-Factor based backbone. It was used to create HCW Biologics’ molecules, HCW9218, HCW9302, HCW9206 and HCW9201. The Company’s second drug discovery platform uses a unique protein-based backbone differentiated from Tissue Factor. Immunotherapeutics created with the Company’s two distinct drug discovery platforms have different characteristics and mechanisms of action, expanding the various pathways for treating senescence-associated disorders. The University of Pittsburgh Medical Center has agreed to include HCW9218 in an Investigator-sponsored Phase 2 clinical trial in patients with metastatic, advanced stage ovarian cancer in combination with neoadjuvant chemotherapy (NCT05145569). Forward Looking Statements: Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to finalize the license of a preclinical molecule; the issuance of the IND for HCW9302; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; that the Company may receive feedback from the FDA on the IND application for HCW9302 which may not be given on a timely basis, or the Company may be required to change the design of the clinical protocol in order to address the feedback, potentially resulting in delays and increased costs; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K/A filed with the United States Securities and Exchange Commission (the “SEC”) on May 15, 2024, the latest Form 10-Q filed with the SEC on August 14, 2024, and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Company Contact:Rebecca ByamCFOHCW Biologics Inc.rebeccabyam@hcwbiologics.com HCW Biologics Inc.Condensed Statements of Operations (Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2023 2024 2023 2024 Revenues: Revenues$853,102 $426,423 $1,517,792 $2,171,988 Cost of revenues (678,325) (341,138) (1,210,077) (1,291,546)Total revenues 174,777 85,285 307,715 880,442 Operating expenses: Research and development 1,667,442 1,186,913 5,539,919 5,339,383 General and administrative 1,509,936 1,639,152 5,106,674 4,799,437 Legal Expenses 2,075,279 949,455 4,610,091 15,761,531 Reserve for credit losses — — — 1,300,000 Total operating expenses 5,252,657 3,775,520 15,256,684 27,200,351 Loss from operations (5,077,880) (3,690,235) (14,948,969) (26,319,909)Interest expense (95,514) (223,363) (284,465) (383,029)Other income, net 234,753 11,310 919,688 52,397 Net loss$(4,938,641) $(3,902,288) $(14,313,746) $(26,650,541) HCW Biologics Inc. Condensed Balance Sheets December 31, September 30, 2023 2024 UnauditedASSETS Current assets: Cash and cash equivalents$3,595,101 $998,221 Accounts receivable, net 1,535,757 651,840 Prepaid expenses 1,042,413 356,156 Other current assets 230,916 88,131 Total current assets 6,404,187 2,094,348 Investments 1,599,751 1,599,751 Property, plant and equipment, net 20,453,184 22,833,904 Other assets 56,538 28,476 Total assets$28,513,660 $26,556,479 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Liabilities Current liabilities: Accounts payable$6,167,223 $22,666,107 Accrued liabilities and other current liabilities 2,580,402 1,182,502 Total current liabilities 8,747,625 23,848,609 Debt, net 6,304,318 12,677,494 Total liabilities 15,051,943 36,526,103 Stockholders’ equity (deficit): Common stock: Common, $0.0001 par value; 250,000,000 shares authorized and 36,025,104 shares issued at December 31, 2023; 250,000,000 shares authorized and 37,823,394 shares issued at September 30, 2024 3,603 3,782 Additional paid-in capital 83,990,437 87,209,457 Accumulated deficit (70,532,323) (97,182,863)Total stockholders’ equity (deficit) 13,461,717 (9,969,624)Total liabilities and stockholders’ equity (deficit)$28,513,660 $26,556,479

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药物(靶点)	适应症	全球最高研发状态

WU-CART-007 ( CD7 )	淋巴母细胞淋巴瘤更多	临床2期
WU-NK-101	急性髓性白血病更多	临床1期
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