Phase 1B Study of APVO436 in Combination With Venetoclax and Azacitidine in Elderly or Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The goal of this Phase IB study is to evaluate the safety and tolerability of APVO436 in naïve elderly unfit patients with newly diagnosed primary AML at the RP2D level when it is used as an adjunct to the standard of care and obtain a preliminary assessment of the anti-leukemia activity of an APVO436-containing combination therapy.
Study Objectives:
- Primary Objective: Evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care (venetoclax and azacitidine).
- Secondary Objectives:
Obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental triple drug combination therapy modalities.
Determine pharmacodynamics (PD) of APVO436, including changes in CD123 antigen density and measures of T cell number and function over time.
Determine correlations between response and MRD level and cytogenetic and molecular genetic profiles.

开始日期2025-01-01

申办/合作机构

Aptevo Therapeutics, Inc.

NCT06634394 / Not yet recruiting临床1期

A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.

开始日期2024-10-01

申办/合作机构

Aptevo Therapeutics, Inc.

NCT03647800 / Unknown status临床1期

Phase 1B Open-Label, Dose-Escalation and Dose-Expansion Study of APVO436 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High-Grade Myelodysplastic Syndrome (MDS)

The primary objective of the Phase 1 part of the study is to determine the recommended dose of APVO436 administered intravenously to patients with AML or MDS. The primary objective of the Phase 1b part of the study is to evaluate the clinical activity of APVO436 in patients with AML or MDS.
APVO436 is being studied in this Phase 1b, open-label, multi-center, two-part dose-escalation/dose expansion study to evaluate the safety, pharmacokinetic/pharmacodynamic (PK/PD), and clinical activity of APVO436 in patients with AML and MDS. The study will be conducted in 2 parts. The first part of this Phase 1B study is an open-label, multiple dose ascending dose escalation phase to determine the recommended dose (RP2D) level of APVO436 for future Phase 2 studies. The goal of the dose expansion phase of the study (Part 2) is to (i) evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care and (ii) obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental monotherapy and combination therapy modalities.
Study Objectives for Dose Escalation Phase
Primary Objectives are to:
Determine the RP2D level of APVO436 administered intravenously (IV) in patients with AML or MDS, and
Evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care and obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental monotherapy and combination therapy modalities.
Secondary Objectives are to:
Define the safety profile and immunogenicity of APVO436; to determine the PK/PD of APVO436; to evaluate the clinical activity of APVO436 in AML and MDS patients.
Further evaluate the safety profile and immunogenicity of APVO436 and the PK/PD of APVO436 and the relationship between PK/PD and clinical response.
Study Objectives for Dose Expansion Phase
Primary Objective is to evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care.
Secondary Objective is to obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental monotherapy and combination therapy modalities.

开始日期2018-12-13

申办/合作机构

Aptevo Research & Development LLC

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项与 Mipletamig 相关的文献（医药）

2021-01-01·Frontiers in Oncology3区 · 医学

Post-hoc Analysis of Pharmacodynamics and Single-Agent Activity of CD3xCD123 Bispecific Antibody APVO436 in Relapsed/Refractory AML and MDS Resistant to HMA or Venetoclax Plus HMA.

3区 · 医学

ArticleOA

作者: Cogle, Christopher R ; Mims, Alice ; Lin, Tara L ; Wang, Eunice ; Shahidzadeh, Anoush ; Shami, Paul ; Patel, Prapti ; Watts, Justin ; Uckun, Fatih M ; Lee, Cynthia ; Cull, Elizabeth

APVO436 is a recombinant bispecific antibody designed to direct host cytotoxic T-cells to CD123-expressing blast cells in patients with hematologic malignancies. APVO436 showed promising tolerability and single-agent activity in relapsed or refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary purpose of this post-hoc analysis was to evaluate the therapeutic and pharmacodynamic effects of APVO436 in 14 R/R AML/MDS patients who had failed treatment with hypomethylating agents (HMA) or venetoclax plus HMA prior to being enrolled in the APVO436 Phase 1 dose-escalation study that was recently completed. Eight of these 14 patients had R/R AML and had failed treatment with HMA (N=2) or venetoclax plus HMA (N=6). The remaining 6 patients had R/R MDS and had also failed treatment with HMA (N=5) or venetoclax plus HMA (N=1). They were treated with APVO436 at submicrogram dose levels >0.08 mcg/kg that were active in preclinical NOD/SCID mouse xenograft models of AML. APVO436 activated patients' T-cells as evidenced by reduced numbers of circulating CD123⁺CD34⁺ and CD33⁺CD34⁺ peripheral blasts. Single-agent activity was observed at dose levels ranging from 0.1 mcg/kg to 0.7 mcg/kg in 4 R/R AML patients (50%), including 3 patients with prolonged stable disease (SD) and one patient with complete remission (CR). Likewise, 3 MDS patients had SD (50%) and 3 additional MDS patients (50%) had a marrow CR at dose levels ranging from 0.1 mcg/kg to 0.8 mcg/kg. The median survival for the combined group of 14 R/R AML/MDS patients was 282 days. This early evidence of single-agent activity of APVO436 in R/R AML/MDS patients who failed HMA with or without venetoclax provides proof of concept supporting its in vivo immunomodulatory and anti-leukemic activity and warrants further investigation of its clinical impact potential.

Cancers2区 · 医学

A Clinical Phase 1B Study of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

2区 · 医学

ArticleOA

作者: Lin, Tara L. ; Shahidzadeh, Anoush ; Mims, Alice S. ; Shami, Paul J. ; Patel, Prapti ; Cogle, Christopher R. ; Lee, Cynthia ; Cull, Elizabeth ; Watts, Justin ; Uckun, Fatih M.

APVO436 is a recombinant T cell-engaging humanized bispecific antibody designed to redirect host T cell cytotoxicity in an MHC-independent manner to CD123-expressing blast cells from patients with hematologic malignancies and has exhibited single-agent anti-leukemia activity in murine xenograft models of acute myeloid leukemia (AML). In this first-in-human (FIH) multicenter phase 1B study, we sought to determine the safety and tolerability of APVO436 in R/R AML/myelodysplastic syndrome (MDS) patients and identify a clinically active recommended phase 2 dose (RP2D) level for its further clinical development. A total of 46 R/R AML/MDS patients who had failed 1–8 prior lines of therapy received APVO436 as weekly intravenous (IV) infusions at 10 different dose levels, ranging from a Minimum Anticipated Biological Effect Level (MABEL) of 0.3 mcg to 60 mcg. APVO436 exhibited a favorable safety profile with acceptable tolerability and manageable drug-related adverse events (AEs), and its maximum tolerated dose (MTD) was not reached at a weekly dose of 60 mcg. The most common APVO436-related AEs were infusion-related reactions (IRR) occurring in 13 (28.3%) patients and cytokine release syndrome (CRS) occurring in 10 (21.7%). The single dose RP2D level was identified as 0.2 mcg/kg. Preliminary efficacy signals were observed in both AML and MDS patients: Prolonged stable disease (SD), partial remissions (PR), and complete remissions (CR) were observed in R/R AML patients as best overall responses to APVO436 at the RP2D level. Three of six evaluable MDS patients had marrow CRs. The safety and preliminary evidence of efficacy of APVO436 in R/R AML and MDS patients warrant further investigation of its clinical impact potential.

Cancers2区 · 医学

Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436

2区 · 医学

ArticleOA

作者: Lin, Tara L. ; Wang, Eunice ; Mims, Alice S. ; Shami, Paul J. ; Patel, Prapti ; Cogle, Christopher R. ; Lee, Cynthia ; Watts, Justin ; Cull, Elizabeth ; Uckun, Fatih M.

We evaluate the risk, characteristics and biomarkers of treatment-emergent cytokine release syndrome (CRS) in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who received APVO436 during the dose-escalation phase of a Phase 1B study (ClinicalTrials.gov, identifier: NCT03647800). Of four patients who developed Grade ≥ 3 CRS, two received steroid prophylaxis. The dose level, gender, race, obesity, or baseline hematologic parameters in peripheral blood did not predict the risk of CRS. Patients with a higher leukemia burden as determined by a higher total WBC, higher percentage of blasts in bone marrow, or higher percentage of blasts in peripheral blood (by hematopathology or immunophenotyping) did not have a higher incidence of CRS. There was an age difference between patients who did versus patients who did not develop CRS (72.9 ± 1.6 years (Median 73.5 years) vs. 63.3 ± 2.3 years (Median: 65.0 years), which was borderline significant (p = 0.04). Premedication with steroids did not eliminate the risk of CRS. Cytokine profiling in patients who developed CRS after APVO436 infusion indicates that the predominant cytokine in this inflammatory cytokine response was IL-6. APVO436-associated CRS was generally manageable with tocilizumab with or without dexamethasone. Notably, the development of CRS after APVO436 therapy did not appear to be associated with a response. The prolonged stabilization of disease, partial remissions and complete remissions were achieved in both patients who experienced CRS, as well as patients who did not experience CRS after APVO436 infusions.

项与 Mipletamig 相关的新闻（医药）

2024-11-24

·药明康德

一次注射有效半年的下一代RNAi疗法；12周减少肝脏脂肪近70%的MASH疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. RNAi疗法nucresiran治疗转甲状腺素蛋白（ATTR）介导淀粉样变性患者的早期临床试验结果亮眼，单次给药后第15天，患者平均血清转甲状腺素蛋白（TTR）水平降低超过90%，并维持至试验第6个月。 2. 抗体偶联药物PYX-201在一项1期临床试验中，在头颈部鳞状细胞癌患者中的疾病控制率（DCR）达100%，客观缓解率（ORR）达50%。 3. 用于治疗代谢功能障碍相关性脂肪性肝炎（MASH）和肥胖症的胰高血糖素样肽-1（GLP-1）/胰高血糖素双重受体激动剂pemvidutide在一项早期临床试验中展现积极疗效，患者用药12周后肝脏脂肪含量（LFC）相对基线减少68.5%。药明康德内容团队整理 Nucresiran（ALN-TTRsc04）：公布1期临床试验的新数据 Alnylam Pharmaceuticals公司公布了其下一代RNAi疗法nucresiran（曾用名ALN-TTRsc04）用于治疗转甲状腺素蛋白介导淀粉样变性患者的1期临床研究的最新数据。Nucresiran通过Alnylam专有IKARIA平台所开发，旨在迅速降低突变型和野生型TTR的水平，从根本上治疗ATTR淀粉样变性。Nucresiran具有实现更深层次和更持久TTR快速降低的潜力，从而能够减少用药频率。此次公布的显示，单次给予300 mg或更高剂量的nucresiran，可在第15天实现患者平均血清TTR水平快速降低超过90%，且这一效果持续至试验第6个月。数据表明，nucresiran具有每半年或每年进行一次皮下注射的潜力。Alnylam计划在2025年第一季度公布3期临床开发方案。 PYX-201：公布1期临床试验数据 Pyxis Oncology公司公布了其候选抗体偶联药物PYX-201治疗多种类型实体瘤的1期剂量递增研究的初步积极数据。PYX-201以微管抑制剂（优化的auristatin）作为有效载荷，能独特地靶向肿瘤细胞外基质（ECM）中的一种非细胞结构成分——纤连蛋白B结构域（Extradomain-B Fibronectin，EDB+FN）。截至2024年10月4日的数据，在6例疗效可评估的头颈部鳞状细胞癌患者中，观察到确认的ORR为50%，包括1例确认的完全缓解（CR）和2例确认的部分缓解（PR），DCR为100%。在所有6种研究者感兴趣的实体瘤（头颈部鳞状细胞癌、卵巢癌、非小细胞肺癌、HR+/HER2-乳腺癌、三阴性乳腺癌和肉瘤）患者（n=31）中，ORR为26%，研究人员还观察到剂量依赖性的缓解。此外，PYX-201通常耐受性良好，具有良好的安全性。 Pemvidutide：公布1b期临床试验数据 Altimmune公司公布了pemvidutide治疗代谢功能障碍相关性脂肪性肝病（MASLD）的1b期试验的最新数据。Pemvidutide是一种GLP-1/胰高血糖素双重受体激动剂，目前正在开发用于治疗MASH和肥胖症。该研究中，94名超重或肥胖且LFC≥10%的受试者按1：1：1：1的比例被分配接受pemvidutide（1.2 mg、1.8 mg和2.4 mg）或安慰剂，每周一次皮下注射，持续12周。数据显示，患者血浆中与心血管不良后果相关的多类炎症脂质有所减少。患者接受pemvidutide治疗12周后，LFC相对基线减少了68.5%，总胆固醇和甘油三酯分别最多降低了12.2%和44.6%。研究结果支持pemvidutide对MASH合并症的潜在益处，包括动脉粥样硬化、心脏病和代谢综合征。 IMA402：公布1期临床试验的初步数据 Immatics公司公布了其下一代半衰期延长的T细胞受体（TCR）双特异性分子IMA402的1期剂量递增试验数据。IMA402靶向由HLA-A*02呈递的黑色素瘤抗原PRAME。PRAME是一种在各种实体瘤中经常表达的蛋白质，因此IMA402具潜力治疗广泛的癌症患者群体。截至2024年11月6日的数据，IMA402在接受治疗的33例患者中表现出良好的耐受性。最常见的治疗相关不良事件多为轻度至中度细胞因子释放综合征（CRS）和短暂的淋巴细胞减少症。早期药代动力学数据表明，IMA402的中位半衰期约为7天，有望支持每两周一次的给药方案。9例PRAME检测阳性或未接受PRAME检测的患者中有7例实现了靶病灶缩小，1例皮肤黑色素瘤患者获得了确认的PR，靶病灶已缩小40.2%。 ▲1期剂量递增试验的初步数据（图片来源：参考资料[6]） Mipletamig：公布1b/2期临床试验的初步数据 Aptevo Therapeutics公司公布了其正在进行的1b/2期临床试验RAINIER中首例患者的治疗情况。该研究针对18岁及以上新确诊为急性髓系白血病且不符合强化诱导化疗条件的成人患者，旨在评估使用mipletamig联用标准治疗维奈托克和阿扎胞苷作为一线疗法的效果。APVO436是一种创新双特异性重组蛋白，它像两个单克隆抗体连接在一起，可以同时靶向肿瘤细胞表面的CD123和T淋巴细胞表面的CD3，从而将宿主免疫系统的T细胞重定向到患者的肿瘤细胞上，以快速和完全摧毁表面表达CD123的肿瘤细胞。此次公布的结果显示，首例患者在治疗的前30天内白血病细胞减少了90%，延续了先前研究中观察到的总体疗效趋势。 ST-503：IND申请获得FDA许可 Sangamo Therapeutics公司宣布，美国FDA批准了其在研表观遗传调节剂ST-503的IND申请，用于治疗特发性小纤维神经病变引起的顽固性疼痛（iSFN），这是一种慢性神经病理性疼痛。大量的证据表明，钠通道在介导神经病理性疼痛的病理生理过程中起着重要作用。开发特异性靶向Nav1.7钠通道的小分子药物具有挑战性，因为不同钠通道之间的结构相似性很高，难以实现选择性并避免脱靶效应。ST-503以腺相关病毒（AAV）为载体，携带工程化的锌指抑制子（ZFR），能够特异性地靶向编码Nav1.7钠通道的人类基因SCN9A，该基因在疼痛信号传导中起关键作用。在动物模型中，通过直接靶向SCN9A基因，ST-503被证明可以特异性地减少感觉神经元中Nav1.7钠通道的表达，并在单次鞘内给药后显著减少对疼痛的高敏感性。临床前研究表明，ST-503在非人灵长类动物中具有良好的耐受性，观察到显著的Nav1.7减少且没有脱靶效应，这显示了ST-503治疗慢性神经病理性疼痛的潜力。Sangamo公司正在准备进行1/2期临床研究，以评估单次剂量ST-503的安全性、耐受性和初步疗效，该药物将通过鞘内给药的方式给予iSFN患者，并计划于2025年中期开始患者招募。 ENS-002：1期临床试验完成首例受试者给药 Concerto Biosciences公司宣布，其用于治疗特应性皮炎的微生物组疗法ENS-002的1期临床试验已完成首例受试者给药。ENS-002是该公司利用一种名为kChip的强大筛选技术，从超过600万个皮肤微生物群落中发现的可缓解湿疹的细菌组合，该组合中包含三种菌株，能够抑制皮肤炎症的关键驱动因素金黄色葡萄球菌（S.aureus）。与类固醇和免疫抑制剂相比，该候选疗法旨在解决特应性皮炎背后的微生物组缺陷，以提供一条缓解更持久且副作用更少的潜在新治疗途径。 ▲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] Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose. Retrieved November 18, 2024 from https://investors.alnylam.com/press-release?id=28541 [2] Altimmune Presents New Data on the Effect of Pemvidutide on Inflammatory Lipids in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) at The Liver Meeting® 2024. Retrieved November 22, 2024 from https://ir.altimmune.com/news-releases/news-release-details/altimmune-presents-new-data-effect-pemvidutide-inflammatory [3] Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain. Retrieved November 22, 2024 from https://www.businesswire.com/news/home/20241119527555/en/Sangamo-Therapeutics-Announces-U.S.-FDA-Clearance-of-IND-Application-for-ST-503-for-the-Treatment-of-Idiopathic-Small-Fiber-Neuropathy-a-Type-of-Chronic-Neuropathic-Pain [4] Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/20/2984764/0/en/Pyxis-Oncology-Announces-Favorable-Preliminary-PYX-201-Clinical-Phase-1-Part-1-Data.html [5] First Patient Dosed in Aptevo's Ongoing RAINIER Trial Achieves 90% Reduction in Leukemic Blasts Within the First 30 Days of Treatment, Continues Overall Efficacy Trend Seen in Prior Mipletamig AML Studies. Retrieved November 22, 2024 from https://aptevotherapeutics.gcs-web.com/news-releases/news-release-details/first-patient-dosed-aptevos-ongoing-rainier-trial-achieves-90 [6] Immatics Announces Third Quarter 2024 Financial Results, Business Update and First Clinical Data on TCER® IMA402 Targeting PRAME. Retrieved November 22, 2024 from https://investors.immatics.com/news-releases/news-release-details/immatics-announces-third-quarter-2024-financial-results-business [7] Celldex Announces First Patient Dosed in Phase 1 Healthy Volunteer Study of CDX-622, a Bispecific Antibody, for the Treatment of Inflammatory Diseases. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/20/2984404/0/en/Celldex-Announces-First-Patient-Dosed-in-Phase-1-Healthy-Volunteer-Study-of-CDX-622-a-Bispecific-Antibody-for-the-Treatment-of-Inflammatory-Diseases.html [8] Insilico Medicine receives IND clearance from FDA for ISM5939, an oral ENPP1 inhibitor treating solid tumors. Retrieved November 20, 2024, from https://www.eurekalert.org/news-releases/1065685 [9] AmacaThera Announces Phase 1 Results of First-in-Human Study with AMT-143, Exceeding Expectations and Paving the Way for a Novel Approach to Post-Operative Pain Relief. Retrieved November 20, 2024, from https://www.prnewswire.com/news-releases/amacathera-announces-phase-1-results-of-first-in-human-study-with-amt-143-exceeding-expectations-and-paving-the-way-for-a-novel-approach-to-post-operative-pain-relief-302310726.html [10] LAPIX Therapeutics Announces Positive Topline Phase 1 Clinical Data Results with LPX-TI641 for the Treatment of Autoimmune Diseases. Retrieved November 20, 2024, from https://www.globenewswire.com/news-release/2024/11/20/2984711/0/en/LAPIX-Therapeutics-Announces-Positive-Topline-Phase-1-Clinical-Data-Results-with-LPX-TI641-for-the-Treatment-of-Autoimmune-Diseases.html [11] Ocugen Announces Compelling Preliminary Data for OCU410—a Single Dose Novel Modifier Gene Therapy to Treat Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. Retrieved November 20, 2024, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-announces-compelling-preliminary-data-ocu410-single-dose [12] Genethon presents positive initial results from a phase 1/2/3 trial of its gene therapy (GNT0004) for Duchenne Muscular Dystrophy at ASGCT Breakthroughs in Muscular Dystrophy in Chicago. Retrieved November 22, 2024, from https://www.eurekalert.org/news-releases/1065424 [13] REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA. Retrieved November 18, 2024, from https://www.prnewswire.com/news-releases/regenxbio-initiates-pivotal-phase-of-affinity-duchenne-trial-of-rgx-202-gene-therapy-and-reports-positive-functional-data-302307989.html [14] Children's Hospital of Philadelphia Researchers Announce Promising Results from First-of-its-Kind, Multicenter, Phase 1 Gene Therapy Trial for Danon Disease. Retrieved November 22, 2024, from https://www.prnewswire.com/news-releases/childrens-hospital-of-philadelphia-researchers-announce-promising-results-from-first-of-its-kind-multicenter-phase-1-gene-therapy-trial-for-danon-disease-302308857.html [15] Spirovant Sciences Doses First Patient in the SAAVe Phase 1/2 Clinical Trial of Its Investigational, Aerosol-Delivered Genetic Medicine for the Treatment of Cystic Fibrosis. Retrieved November 22, 2024, from https://www.prnewswire.com/news-releases/spirovant-sciences-doses-first-patient-in-the-saave-phase-12-clinical-trial-of-its-investigational-aerosol-delivered-genetic-medicine-for-the-treatment-of-cystic-fibrosis-302304959.html [16] Intellia Announces First Clinical Evidence from Ongoing Phase 1 Study that Nexiguran Ziclumeran (nex-z), an In Vivo CRISPR/Cas9-Based Gene Editing Therapy, May Favorably Impact Disease Progression in Transthyretin (ATTR) Amyloidosis. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/16/2982349/0/en/Intellia-Announces-First-Clinical-Evidence-from-Ongoing-Phase-1-Study-that-Nexiguran-Ziclumeran-nex-z-an-In-Vivo-CRISPR-Cas9-Based-Gene-Editing-Therapy-May-Favorably-Impact-Disease.html [17] CERo Therapeutics, Inc. Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Its Lead Compound CER-1236 in Acute Myelogenous Leukemia. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/15/2982017/0/en/CERo-Therapeutics-Inc-Receives-FDA-Clearance-of-Investigational-New-Drug-Application-to-Initiate-Phase-1-Clinical-Trial-of-Its-Lead-Compound-CER-1236-in-Acute-Myelogenous-Leukemia.html [18] Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE1831 in IgG4-Related Disease. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-investigational-new-drug-application-for-ace1831-in-igg4-related-disease-302306506.html [19] Fate Therapeutics Presents 6-Month Follow-up Data on First Patient Treated in Phase 1 Autoimmunity Study with Fludarabine-free Conditioning and FT819 Off-the-shelf, 1XX CAR T-cell Product Candidate at ACR Convergence. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/18/2982757/24675/en/Fate-Therapeutics-Presents-6-Month-Follow-up-Data-on-First-Patient-Treated-in-Phase-1-Autoimmunity-Study-with-Fludarabine-free-Conditioning-and-FT819-Off-the-shelf-1XX-CAR-T-cell-P.html [20] Cabaletta Bio Presents Positive Clinical Safety and Efficacy Data on CABA-201 at ACR Convergence 2024. Retrieved November 22, 2024 from https://www.cabalettabio.com/news-media/press-releases/detail/119/cabaletta-bio-presents-positive-clinical-safety-and [21] Adicet Bio Announces First Lupus Nephritis Patient Dosed in Phase 1 Clinical Trial of ADI-001 in Autoimmune Diseases. Retrieved November 22, 2024 from https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-announces-first-lupus-nephritis-patient-dosed-phase-1 [22] Fate Therapeutics Highlights FT522 Off-the-shelf, ADR-armed CAR NK Cell Product Candidate at 2024 ACR Convergence. Retrieved November 22, 2024 from https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-ft522-shelf-adr-armed-car-nk-cell [23] RESTEM Presents Phase 1 Data of its ULSC Program in Polymyositis/Dermatomyositis at ACR Convergence 2024. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/18/2982728/0/en/RESTEM-Presents-Phase-1-Data-of-its-ULSC-Program-in-Polymyositis-Dermatomyositis-at-ACR-Convergence-2024.html [24] Theolytics Doses First Patient in Phase I/IIa Trial of THEO-260 in Ovarian Cancer. Retrieved November 22, 2024 from https://www.theolytics.com/post/theolytics-doses-first-patient-in-phase-i-iia-trial-of-theo-260-in-ovarian-cancer [25] Virion Therapeutics Reports First-Ever Clinical Responses with VRON-0200, a Novel Checkpoint Modifier for HBV Functional Cure, at AASLD's The Liver Meeting. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/virion-therapeutics-reports-first-ever-clinical-responses-with-vron-0200-a-novel-checkpoint-modifier-for-hbv-functional-cure-at-aaslds-the-liver-meeting-302304358.html [26] GigaGen Doses First Patient in Phase 1 Trial of Recombinant Polyclonal Drug Candidate, GIGA-2339, for Hepatitis B Virus. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/19/2983574/0/en/GigaGen-Doses-First-Patient-in-Phase-1-Trial-of-Recombinant-Polyclonal-Drug-Candidate-GIGA-2339-for-Hepatitis-B-Virus.html [27] Concerto Biosciences Announces First Participant Dosed with Live Biotherapeutic ENS-002 in Phase 1 Trial for Atopic Dermatitis. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/concerto-biosciences-announces-first-participant-dosed-with-live-biotherapeutic-ens-002-in-phase-1-trial-for-atopic-dermatitis-302310102.html [28] Contineum Therapeutics Expands Clinical Development of PIPE-791 With FDA Authorization of Its Investigational New Drug (IND) Application for Chronic Pain. Retrieved November 22, 2024 from https://www.businesswire.com/news/home/20241114778987/en/Contineum-Therapeutics-Expands-Clinical-Development-of-PIPE-791-With-FDA-Authorization-of-Its-Investigational-New-Drug-IND-Application-for-Chronic-Pain/ [29] Karolinska Development’s portfolio company Umecrine Cognition presents positive interim data from Phase 1b/2a clinical study. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/18/2982478/0/en/Karolinska-Development-s-portfolio-company-Umecrine-Cognition-presents-positive-interim-data-from-Phase-1b-2a-clinical-study.html [30] Omega Therapeutics Announces Successful Completion of Phase 1 Trial for Novel Epigenomic Controller, Prioritized Pipeline, Leadership Changes, and Third Quarter 2024 Financial Results. Retrieved November 22, 2024 from https://ir.omegatherapeutics.com/news-releases/news-release-details/omega-therapeutics-announces-successful-completion-phase-1-trial 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

临床结果siRNA临床1期临床2期

2024-07-01

·BioSpace

Aptevo Therapeutics Announces Closing of $2.75 Million Offering

SEATTLE, WA / ACCESSWIRE / July 1, 2024 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced the closing of its previously announced offering of (i) 5,339,806 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 10,679,612 shares of its common stock (the "Common Warrants") at a purchase price of $0.515 per share and associated Common Warrant in a registered direct offering priced at-the-market under Nasdaq rules. Each share of common stock is being offered together with two Common Warrants, each to purchase one share of common stock. The Common Warrants have an exercise price of $0.515 per share, are exercisable upon stockholder approval, and will expire five years following the date stockholder approval. Roth Capital Partners acted as placement agent of the offering, with Dawson James Securities, Inc. acted as co-agent. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, were approximately $2.75 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes. The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-280226), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 28, 2024. The offering was made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained at the SEC's website at or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at rothecm@roth.com. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. All offers were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The Company also amended certain existing warrants that were previously issued in (i) August 2023 to purchase up to 41,239 shares of the Company's common stock and have exercise price of $27.28 per share, (ii) November 2023 to purchase up to 610,334 shares of the Company's common stock and have exercise price of $10.252 per share, and (iii) April 2024 to purchase up to 6,666,668 shares of the Company's common stock and have exercise price of $1.35 per share, whereas effective upon the closing of the offering, such existing warrants have a reduced exercise price of $0.515 per share and shall become exercisable upon stockholder approval. About Aptevo Therapeutics Inc. Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes of cancer patients. For more information, please visit . Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements regarding the use of proceeds of the offering, and any other statements containing the words "may," "continue to," "believes," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; uncertainties related to market conditions, and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the rising conflict in the Middle East, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Aptevo Therapeutics Email: IR@apvo.com or Millerm@apvo.com Phone: 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on accesswire.com

2024-06-28

·BioSpace

Aptevo Therapeutics Announces $2.75 Million Offering Priced At-the-Market Under Nasdaq Rules

SEATTLE, WA / ACCESSWIRE / June 28, 2024 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced that it has entered into securities purchase agreements with certain healthcare-focused and institutional investors to purchase (i) 5,339,806 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 10,679,612 shares of its common stock (the "Common Warrants") at a purchase price of $0.515 per share and associated Common Warrant in a registered direct offering priced at-the-market under Nasdaq rules. Each share of common stock is being offered together with two Common Warrants, each to purchase one share of common stock. The Common Warrants will have an exercise price of $0.515 per share, are exercisable upon stockholder approval, and will expire five years following the date stockholder approval. The offering is expected to close on or about July 1, 2024, subject to customary closing conditions. Roth Capital Partners is acting as placement agent of the offering. Dawson James Securities, Inc. is acting as co-agent. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $2.3 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes. The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-280226), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 28, 2024. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC's website at or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at rothecm@roth.com. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The Company also has agreed to amend certain existing warrants that were previously issued in (i) August 2023 to purchase up to 41,239 shares of the Company's common stock and have exercise price of $27.28 per share, (ii) November 2023 to purchase up to 610,334 shares of the Company's common stock and have exercise price of $10.252 per share, and (iii) April 2024 to purchase up to 6,666,668 shares of the Company's common stock and have exercise price of $1.35 per share, effective upon the closing of the offering, such existing warrants will have a reduced exercise price of $0.515 per share and shall become exercisable upon stockholder approval. About Aptevo Therapeutics Inc. Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes of cancer patients. For more information, please visit . Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements regarding the completion, timing, size and use of proceeds of the offering, the satisfaction of customary closing conditions related to the offering and any other statements containing the words "may," "continue to," "believes," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the rising conflict in the Middle East, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Aptevo Therapeutics Email: IR@apvo.com or Millerm@apvo.com Phone: 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on accesswire.com

100 项与 Mipletamig 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
急性髓性白血病	临床1期	-	Aptevo Therapeutics, Inc.	2024-10-01
骨髓增生异常综合征	临床1期	美国	Aptevo Research & Development LLC	2018-12-13
难治性急性髓细胞白血病	临床1期	美国	Aptevo Research & Development LLC	2018-12-13

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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


EHA2024	临床1/2期	急性髓性白血病	243	Magrolimab	鹹衊糧艱遞夢襯選壓膚(鑰顧襯艱糧憲鹽構獵範) = 憲觸齋築獵簾憲鏇鑰網築衊遞憲鬱顧遞積糧膚 (構鬱襯艱憲遞壓獵願窪, 0.28 ~ 0.54) 更多	-	2024-05-14
EHA2024	临床1/2期	急性髓性白血病	243	Durvalumab	鏇願網鏇艱憲齋製糧製(糧範選鑰壓衊製遞醖網) = 選鹽鏇製壓糧憲夢醖窪醖艱夢蓋獵繭餘製積簾 (網衊壓艱醖遞鹽鹽鏇艱 )	-	2024-05-14
Corporate Publications 人工标引	临床1期	急性髓性白血病一线	11	APVO436+venetoclax+azacitidine	糧艱糧憲蓋襯網壓艱醖(獵積製衊襯憲構夢廠鹹) = 獵顧遞艱鏇艱簾願鹽憲選選願範觸襯齋鑰壓顧 (鑰鹽選餘醖築範襯憲繭 ) 更多	积极	2023-07-18
NCT03647800 (APVO436-5001, ASH2022) 人工标引	临床1期	急性髓性白血病 \| 骨髓增生异常综合征	30	APVO436	鑰積憲齋廠鹹鬱遞築獵(糧窪衊窪蓋築積糧齋夢) = 願鏇艱築夢廠膚繭獵範獵築鹽窪願鏇艱鹽鏇範 (衊窪壓齋繭鹹夢願壓艱 ) 更多	积极	2022-11-15
NCT03647800 (APVO436-5001, ASH2022) 人工标引	临床1期	急性髓性白血病 \| 骨髓增生异常综合征	30	APVO436 (Cohorts 1)	憲網願鹽鑰觸窪選鑰構(繭觸築網膚鹽遞夢築艱) = 遞構壓獵醖鏇範蓋艱範選壓簾淵醖廠遞壓鏇鹹 (壓製獵築餘糧鏇獵醖遞 )	积极	2022-11-15
NCT03647800 (Accesswire) 人工标引	临床1期	急性髓性白血病	11	APVO436	願廠顧網獵選網餘顧製(糧構鑰顧淵鹽鹽蓋蓋範) = 遞衊鏇膚夢齋鏇憲製選憲願齋顧簾遞艱觸願糧 (糧範遞餘獵齋膚廠範壓 )	积极	2022-06-09
NCT03647800 (Pubmed \| Cancers (Basel)) 人工标引	临床1期	急性髓性白血病 \| 骨髓增生异常综合征	46	APVO436	願範膚鹹鏇壓衊顧蓋襯(衊簾襯製鑰齋觸範顧選) = 選糧齋醖鏇艱簾醖膚築積襯餘廠簾鹽範願膚簾 (糧淵積築淵鏇簾鏇憲餘 ) 更多	积极	2021-08-15