Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Patients with Recurrent Platinum-resistant Ovarian Cancer: Phase II Study

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

开始日期2023-03-30

申办/合作机构

University of Pittsburgh

[+2]

NCT05868226

/ Recruiting临床1期

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

开始日期2023-02-15

申办/合作机构

Quantumleap Healthcare Collaborative

NCT05524545

/ Active, not recruiting临床1期

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.

开始日期2022-11-02

申办/合作机构

ALX Oncology, Inc.

100 项与 Evorpacept 相关的临床结果

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100 项与 Evorpacept 相关的转化医学

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100 项与 Evorpacept 相关的专利（医药）

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项与 Evorpacept 相关的文献（医药）

2024-07-01·CURRENT OPINION IN ONCOLOGY

State of the art and upcoming trends in HER2-directed therapies in gastrointestinal malignancies

Review

作者: Lee, Jaeyop ; Ku, Geoffrey

Purpose of review:

This review critically evaluates the evolution and current status of human epidermal growth factor receptor 2 (HER2)-directed therapies in upper gastrointestinal (GI) malignancies, a timely and relevant inquiry given the dynamic shifts in therapeutic strategies over the past decade. Initial enthusiasm following the Trastuzumab for Gastric Cancer (ToGA) study's demonstration of trastuzumab's efficacy, however, encountered hurdles due to subsequent trials showing limited progress, underscoring the necessity for a reevaluation of therapeutic approaches and the exploration of novel agents.

Recent findings:

The review highlights significant breakthroughs in the form of immune checkpoint inhibitors and innovative therapeutic technologies, which have redefined treatment paradigms and shown promising efficacy in HER2-positive cases. Emerging treatments such as trastuzumab deruxtecan (T-DXd), zanidatamab and evorpacept further illustrate the ongoing efforts to leverage unique mechanisms of action for improved HER2-positive antitumor activity.

Summary:

The advancements in HER2-directed therapies underscore a pivotal era in the management of upper GI malignancies. These developments not only reflect the profound impact of integrating novel therapeutic combinations but also highlight the critical role of ongoing research in overcoming resistance mechanisms and tailoring treatment to individual disease profiles.

2024-01-01·TRANSFUSION MEDICINE AND HEMOTHERAPY

Evorpacept-Induced Interference and Application of a Novel Mitigation Agent, Evo-NR, in Pretransfusion Testing

Article

作者: Yoon, Eungjun ; Kim, Tae Yeul ; Kim, Hyungsuk ; Cho, Duck

Introduction: Evorpacept is a CD47-blocking agent currently being developed for the treatment of various cancers. Interference by evorpacept in pretransfusion compatibility testing has been reported at limited plasma concentrations. Although various mitigation strategies have been proposed, none are practical. This in vitro study assessed evorpacept-induced interference at extended concentrations and investigated the capability of a novel mitigation agent, Evo-NR. Methods: Antibody screening tests were performed on evorpacept-spiked plasma with (anti-E and anti-Jk^a) or without alloantibodies at evorpacept concentrations up to 2,000 μg/mL using manual gel cards and automated analyzers. Evorpacept-coated red blood cells (RBCs) (rr [ce/ce], Fy[a+b−], S−s+) were tested by direct antiglobulin testing (DAT) and antigen typing using anti-Fy^b and anti-S reagents at indirect antiglobulin testing (IAT) phase. Evo-NR was used to resolve the interference in plasma and RBC samples. Flow cytometry was used to assess the mitigation effects. Results: Evorpacept-spiked plasma showed panreactive interference in antibody screening tests using manual gel cards (2+ to 3+) and automated analyzers (4+). A carryover effect was also observed in the automated analyzers. The use of a 3- to 6-fold molar excess of Evo-NR effectively resolved the interference in the plasma and enabled accurate alloantibody identification. Although the reduction in evorpacept binding to RBCs was identified via flow cytometry, Evo-NR was incapable of resolving the serologic interference observed in DAT and antigen typing at IAT phase. Discussion: Evorpacept showed constant panreactivity and a carryover effect at high concentrations. Evo-NR successfully resolved the interference in the plasma samples and could be considered a practical and efficient mitigation solution. Implementation of Evo-NR has the potential to support RBC transfusion for patients undergoing evorpacept treatment.

2021-12-01·The Lancet. Oncology1区 · 医学

Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study

1区 · 医学

Article

作者: Patricia LoRusso ; Hyun Cheol Chung ; Keun-Wook Lee ; Hong I Wan ; Nehal J Lakhani ; Pierre Squifflet ; Wells A Messersmith ; Justin F Gainor ; Yung-Jue Bang ; Jaume Pons ; Frank Stephen Hodi ; Won Seog Kim ; Laura Q M Chow ; Jeeyun Lee ; Sophia S Randolph ; Philip Fanning ; Feng Jin ; Tracy C Kuo ; Rafael Santana-Davila

BACKGROUND:

Both innate and adaptive immune responses are important components of anticancer immunity. The CD47-SIRPα interaction could represent an important pathway used by tumour cells to evade immune surveillance. We aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and anticancer activity of evorpacept (also known as ALX148), a high-affinity CD47-blocking protein with an inactive IgG Fc region in patients with solid tumours.

METHODS:

We did a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study at nine hospitals and one clinic in the USA and Korea. Eligible patients for the dose-escalation and safety lead-in phases were aged 18 years or older with histological or cytological diagnosis of advanced or metastatic solid tumours with no available standard therapy, measurable or unmeasurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status score of 0 or 1. In the dose-escalation phase, which used a 3 + 3 design, patients received intravenous evorpacept at either 0·3, 1, 3, or 10 mg/kg once per week in 21-day cycles, or 30 mg/kg once every other week in 28-day cycles. In the safety lead-in phase, patients were given the maximum tolerable dose of evorpacept from the dose-escalation phase plus either intravenous pembrolizumab (200 mg administered once every 3 weeks) or intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks). In the dose-expansion phase, additional patients aged 18 years or older with second-line or later-line advanced malignancies were enrolled into three parallel cohorts: those with head and neck squamous cell carcinoma (HNSCC) and those with non-small-cell lung cancer (NSCLC) were given the maximum tolerated dose of evorpacept plus intravenous pembrolizumab (200 mg administered once every 3 weeks), and patients with HER2-positive gastric or gastroesophageal junction cancer were given the maximum tolerated dose of evorpacept plus intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks) until disease progression, voluntary withdrawal from the study, or unacceptable toxicity. The primary endpoint was the maximum tolerated dose of evorpacept administered as a single agent and in combination with pembrolizumab or trastuzumab, measured by the occurrence of dose-limiting toxicities during the first cycle, and was assessed in all patients who had received at least one dose of evorpacept. Secondary outcomes included the safety, tolerability, and antitumour activity of evorpacept, alone or in combination with pembrolizumab or trastuzumab. The primary outcome, safety, and tolerability were assessed in all patients who had received at least one dose of evorpacept, and antitumour activity was assessed in those who recieved at least one dose of study treatment and underwent at least one post-baseline tumor assessment. This trial is registered with ClinicalTrials.gov, NCT03013218.

FINDINGS:

Between March 6, 2017, and Feb 21, 2019, 110 patients received single-agent evorpacept (n=28), evorpacept plus pembrolizumab (n=52), or evorpacept plus trastuzumab (n=30), and were included in the safety analysis. Median follow-up was 29·1 months (95% CI not calculable [NC]-NC) in the single-agent cohort, 27·0 months (25·1-28·8) in the evorpacept plus pembrolizumab cohort, and 32·7 months (27·0-32·7) in the evorpacept plus trastuzumab cohort. Two (7%) dose-limiting toxicities in the first cycle were reported in patients who received single-agent evorpacept; neutropenia with an associated infection in one patient with gastroesophageal junction cancer who received 3 mg/kg once per week, and thrombocytopenia with associated bleeding in one patient with pancreatic cancer who received 30 mg/kg once every other week. No maximum tolerated dose was reached; the maximum administered doses were 10 mg/kg once per week or 30 mg/kg once every other week. The 10 mg/kg once per week dose was used in the expansion cohorts in combination with pembrolizumab or trastuzumab. The most common grade 3 or worse treatment-related adverse events were thrombocytopenia with single-agent evorpacept (two [7%] patients) and evorpacept plus pembrolizumab (two [4%]), and thrombocytopenia (two [7%]) and neutropenia (two [7%]) with evorpacept plus trastuzumab. In patients who received single-agent evorpacept, four treatment-related serious adverse events were reported. Five serious treatment-related adverse events related to evorpacept plus pembrolizumab were reported, and one serious adverse event related to evorpacept plus trastuzumab was reported. In response-evaluable patients in the dose-escalation phase (n=15) receiving single-agent evorpacept once per week, four (27%) had a best overall response of stable disease (two received 0·3 mg/kg, one received 3 mg/kg, and one received 10 mg/kg); in the 11 patients who received single-agent evorpacept at the highest dose of 30 mg/kg once every other week, two (18%) had stable disease. In the dose-expansion cohort, overall responses were recorded in four (20·0%; 95% CI 5·7-43·7) of 20 patients with HNSCC who received evorpacept plus pembrolizumab, in one (5·0%; 0·1-24·9) of 20 patients with NSCLC who received evorpacept plus pembrolizumab, and in four (21·1%; 6·1-45·6) of 19 patients with gastric or gastroesophageal junction cancer who received evorpacept plus trastuzumab.

INTERPRETATION:

The safety findings support the use of evorpacept in combination with pembrolizumab or trastuzumab for patients with advanced solid tumours. Preliminary antitumour activity results support future investigation of evorpacept combined with pembrolizumab or trastuzumab in patients with HNSCC, gastric or gastroesophageal junction cancer, and NSCLC.

FUNDING:

ALX Oncology.

163

项与 Evorpacept 相关的新闻（医药）

2025-05-20

·ir.alxoncology.com

ALX Oncology Highlights Differentiated Design, Preclinical Data and Development Plans for EGFR-Targeted ADC, ALX2004, in R&D Webcast Event

- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window by reducing toxicity - Following recent IND clearance from U.S. FDA, ALX2004 will enter clinical studies mid-year 2025 with initial safety data anticipated in 1H 2026 - Trials evaluating the Company’s lead investigational therapy, CD47-blocker evorpacept, in breast and colorectal cancers planned to initiate in mid-2025 with multiple key inflection points from evorpacept and ALX2004 development programs anticipated in 2026 SOUTH SAN FRANCISCO, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, provides an overview of the clinical development program for its highly-differentiated antibody-drug conjugate (ADC), ALX2004, at the Company’s R&D webcast event today. ALX Oncology leadership will discuss the unique design profile, preclinical data and clinical development plans for ALX2004, a potential best- and first-in-class ADC for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, that is planned to enter Phase 1 studies in mid-year 2025. "ALX Oncology is driving a new, highly differentiated approach to the treatment of EGFR-expressing tumors, harnessing our proprietary linker-payload platform to bring forward an ADC candidate that we believe may be able to overcome challenges seen with EGFR-ADCs in the past and drive a best-in-class molecule forward," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "As we advance ALX2004 into the clinic, we are excited to share the development program and highlight how we rigorously designed all components of this ADC with an optimized, validated payload and antibody to maximize its potential for success across a variety of tumor types." The Company’s ALX2004 R&D webcast event will include presentations on: ALX2004 Unique Design: Optimized for Anti-Tumor Activity and Improved Outcomes Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor payload and linker-payload platform, ALX2004 has been rigorously designed to maximize the therapeutic window and overcome toxicity challenges observed in this class. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary linker-Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. Initiation of Phase 1 Clinical Development Program The U.S. Food and Drug Administration (FDA) cleared ALX Oncology’s Investigational New Drug (IND) application for ALX2004 in April 2025. ALX Oncology will provide an overview of its Phase 1 clinical trial design for ALX2004 planned to initiate mid-2025. The Company anticipates initiating a Phase 1 dose escalation trial in EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and esophageal squamous cell carcinoma, targeting patients with relapsed/refractory cancers. The Company anticipates initial safety data in the first half of 2026. ALX2004 Webcast Information The virtual event will be webcast live and a replay will be available after the event by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations." Date & Time: Tuesday, May 20, 2025, 8:00 a.m. PT/11:00 a.m. ET Webcast Access: https://edge.media-server.com/mmc/p/ohnn53h5 About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown Healthcare Communications audrafriis@sambrown.com (917) 519-9577

临床申请抗体药物偶联物临床1期

2025-05-15

·Business Wire

Innate Pharma Highlights ANKET ® Abstracts Selected for the EHA 2025 Congress

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that an abstract regarding IPH6501, its ANKET® targeting CD20 B cells currently developed in relapsed and/or refractory Non-Hodgkin Lymphoma, has been selected for the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy. Abstract details Antitumor characterization of IPH6501, a novel il2v-armed tetraspecific NK cell engager targeting CD20 B cells, in DLBCL and FL patient samples, and in preclinical combination with R-CHOP Abstract Code: PS2004 Session: Poster session 2 Session Date/Time: Saturday, June 14, 2025, 18:30 – 19:30 CEST More information can be found on the EHA website. In addition, an abstract related to SAR’514/IPH6401 (developed by Sanofi) was accepted for online publication. The BCMA NK Cell Engager SAR'514 Induces Macrophage-Mediated Phagocytosis which is improved by combination with Evorpacept, a CD47 Blocker, in Multiple Myeloma Abstract Code: PB2850 About ANKET® ANKET® (Antibody-based NK cell Engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. About IPH6501 IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not the alpha subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023, Carrette, SITC 2024, Demaria et al, Science Immunology 2024). IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with relapsed and/or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com. Follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

免疫疗法临床研究

2025-05-10

·生物制药小编

被要求与DS8201对照，公司放弃寻求批准

近日，ALX Oncology公布了第一季度的财报，并提供了公司的业务更新。根据公司这份公告披露，公司寻求其CD47抑制剂Evorpacept在“HER2阳性胃癌”这个适应症的上市批准可能没戏了。根据FDA的反馈，由于标准护理的改变，其SPEN-06临床试验已不符合加速批准的条件，基于此，ALX Oncology选择不在美国寻求监管批准。此外，ALX Oncology还宣布缉将对公司进行精简（具体未公布），以将现金跑道延长至2026年第四季度。需要与DS8201 PKEvorpacept是一款SIRPα-Fc融合蛋白，旨在阻断CD47与其受体SIRPα结合，促使巨噬细胞攻击肿瘤细胞。HER2阳性胃癌是ALX Oncology寄托批准希望的适应症，这一厚望主要来自于名为ASPEN-06 Ⅱ期临床试验的激励。2023年10月，ALX Oncology公布发ASPEN-06的中期分析结果显示，相较于对照组，Evorpacept联用组在客观缓解率 (ORR) 显著提升（52% vs 22%）。这一临床数据令市场大受鼓舞，公司股价开盘大涨了70%。虽然在之后公布的顶线数据中（2024年7月），Evorpacept联用组的ORR相比对照组有所下降（40.3% VS 26.6%），但并未动摇公司的信心，ALX Oncology还称Evorpacept为首个在前瞻性随机临床试验中显示出持久临床益处且耐受性良好的CD47阻断剂。在今年3月的研发日活动中，公司便表示，将基于ASPEN-06临床数据与FDA讨论Evorpacept在该适应症中的监管路径，具体结果会在今年第二季度对外公布。但是，SPEN-06并未能得到FDA的认可，FDA认为SPEN-06不符合其获得加速批准的条件，因为Enhetu现在是HER2阳性胃癌的标准治疗方案，FDA指出，Evorpacept想要获得监管批准，需要开展与Enhetu对照的Ⅲ期临床试验。而ALX Oncology现在不打算按照FDA的要求来，放弃在美国开展Ⅲ期临床试验，那这也意味着公司现在放弃寻求该适应症在美国的上市批准。多次临床失败作为少数能挺到现在的CD47抑制剂，Evorpacept已经遭受了不少打击。最初，ALX Oncology的开发重点和吉利德、天境生物等一样，首推的适应症主要是MDS（骨髓增生异常综合征）和AML（急性髓细胞性白血病）。不过，结局也吉利德一样，ALX Oncology在这个两个适应症上也失败了，2023年8月，ALX Oncology终止了Evorpacept分别针对MDS和AML的两项临床试验ASPEN-02和ASPEN-05，原因是在ASPEN-02试验中，对比Azacitidine单药历史疗效，Evorpacept+Azacitidine联用并没有取得显著改善，同时基于Azacitidine在MDS和AML中的作用机制类似，AML也因此被一同放弃开发。实体瘤也不例外。今年4月，ALX Oncology宣布Evorpacept与K药联用的两项Ⅱ期临床试验ASPEN-03和ASPEN-04皆未达到主要终点目标，结果显示，相比Keytruda单药，Evorpacept+Keytruda联用未能提高晚期头颈部鳞状细胞癌(HNSCC)患者的ORR。基于此，ALX Oncology便宣布放弃Evorpacept+K药在该适应症中的开发。失败的还有尿路上皮癌（UC)，在这次的财报中，公司还宣布决定停止Evorpacept联合Padcev（Nectin-4 -ADC）临床试验，因为对SPEN-07临床试验进行最终分析后发现，加入Evorpacept并未能提高Padcev的疗效。下一步打算几大适应症的接连失败，基本上把ALX Oncology打回原地。现在公司把希望放在了新的临床试验上，根据公司披露的开发计划，公司将在今年年中启动两项新的临床试验，包括联合trastuzumab治疗HER2阳性乳腺癌的Ⅱ期临床试验ASPEN-Breast，以及联合cetuximab用于治疗结直肠癌（CRC）的Ⅰ期临床试验ASPEN-CRC 。另外，现在公司还在重点推进的管线为其EGFR ADC管线ALX2004，此前已经获得FDA的IND批准，公司计划今年年中启动临床试验。总结作为目前少数还在坚持开发CD47抑制剂的Biotech，ALX Oncology一路走来实属不易，经历了MDS和AML、HNSCC、UC等多个适应症失败，现在几乎是从头再来，只是公司的资金经得起消耗么？参考出处https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-reports-first-quarter-2025-financial-results-andhttps://endpts.com/alx-oncology-wont-seek-approval-for-cd47-drug-in-gastric-cancer-korro-bios-layoffs/

财报临床2期临床3期加速审批临床失败

100 项与 Evorpacept 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12193	-	-	-

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适应症	最高研发状态	国家/地区	公司	日期
HER2表达胃腺癌	临床3期	美国	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	美国	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	日本	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	日本	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	澳大利亚	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	比利时	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	比利时	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	ALX Oncology, Inc.	2022-01-15

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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


NCT05025800 (AACR2025) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept + lenalidomide + rituximab	蓋淵夢繭鹹製壓觸製選(鑰膚願鹹顧網選淵淵糧) = 觸餘餘鹹鏇遞積蓋蓋鹹鏇糧蓋鏇築鏇窪構簾艱 (襯鬱窪構糧築範膚廠簾 ) 更多	积极	2025-04-29
NCT04675294 (ASPEN-03, Company_Website) 人工标引	临床2期	晚期头颈部鳞状细胞癌一线 PD-L1 Positive	-	Evorpacept + pembrolizumab	醖壓繭襯顧簾製簾襯鹹(範觸鬱淵積積鑰獵顧淵) = Not Meet Primary Endpoints 製壓餘鏇衊築簾製窪製 (淵蓋獵廠醖繭襯壓鑰觸 ) 未达到	不佳	2025-04-25
				pembrolizumab
NCT04675333 (ASPEN-04, Company_Website) 人工标引	临床2期	晚期头颈部鳞状细胞癌	-	evorpacept + pembrolizumab + chemotherapy	鏇壓壓獵壓壓遞鬱夢艱(膚艱願觸艱艱夢鑰衊遞) = Not Meet Primary Endpoints. 廠選築繭選築製鹹窪繭 (廠鹽衊夢淵淵構積選願 ) 未达到	不佳	2025-04-25
				pembrolizumab + chemotherapy
NCT05002127 (ASPEN-06, Corporate Publications) 人工标引	临床2/3期	HER2阳性胃食管交界处癌 \| HER2阳性胃癌 HER2 Positive	127	Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel	衊積網襯鬱顧獵範鏇艱(遞鑰鹽餘夢鑰鬱夢遞鏇) = 鏇鬱積憲積艱鹹膚淵願簾簾廠顧襯範壓襯顧選 (簾觸夢鏇積窪製鹹襯齋, 29.0 ~ 54.4) 更多	积极	2025-01-23
				Trastuzumab + Ramucirumab + Paclitaxel	衊積網襯鬱顧獵範鏇艱(遞鑰鹽餘夢鑰鬱夢遞鏇) = 衊遞壓鹽構鹹廠鬱繭積簾簾廠顧襯範壓襯顧選 (簾觸夢鏇積窪製鹹襯齋, 16.3 ~ 39.1) 更多
NCT05002127 (ASPEN-06, ASCO_GI2025) 人工标引	临床2/3期	HER2阳性胃食管腺癌 \| HER2阳性胃癌 HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	蓋壓鹽鏇顧築構鑰鏇網(遞鏇廠構顧繭顧繭壓遞) = 製鹹糧窪齋鹽構醖鬱繭鹹憲繭淵製艱繭醖遞鏇 (餘積醖蓋願簾繭選鬱壓 ) 更多	积极	2025-01-23
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	蓋壓鹽鏇顧築構鑰鏇網(遞鏇廠構顧繭顧繭壓遞) = 鹹壓積遞製壓醖衊蓋網鹹憲繭淵製艱繭醖遞鏇 (餘積醖蓋願簾繭選鬱壓 ) 更多
NCT05002127 (ASPEN-06, Company_Website) 人工标引	临床2/3期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌 HER2 Positive	127	Evorpacept + trastuzumab + CYRAMZA + paclitaxel	築齋構構餘廠餘壓膚獵(蓋遞餘襯構廠齋窪鏇積) = 簾夢衊鏇淵積淵製獵糧鹽襯廠繭衊積窪積範鏇 (廠簾蓋繭壓製積艱顧壓 ) 更多	积极	2024-07-31
				Trastuzumab + CYRAMZA + paclitaxel	築齋構構餘廠餘壓膚獵(蓋遞餘襯構廠齋窪鏇積) = 夢顧衊築憲顧襯鏇襯糧鹽襯廠繭衊積窪積範鏇 (廠簾蓋繭壓製積艱顧壓 ) 更多
NCT05167409 (ASCO2024) 人工标引	临床2期	转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	16	Evorpacept (E) 15 mg/kgcetuximabpembrolizumab	鹽蓋餘衊憲鏇齋艱願願(淵顧觸窪窪膚網遞蓋製) = 顧構繭積築衊簾遞遞範廠襯壓範鏇餘廠廠糧顧 (糧構遞顧網積製選遞構 ) 更多	不佳	2024-05-24
NCT05524545 (ASCO2024) 人工标引	临床1期	局部晚期尿路上皮癌 \| 转移性尿路上皮癌	20	Evorpacept 20 mg/kgenfortumab vedotin	襯繭願觸鏇膚簾繭選憲(繭膚積壓獵積鑰鑰鑰構) = Not observed. 網獵願淵蓋選襯積艱艱 (顧築餘積範蓋觸顧襯鹽 ) 更多	积极	2024-05-24
NCT05025800 (AACR2024) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept+rituximab+lenalidomide	憲鬱製築淵鹹鬱簾鑰積(觸範膚膚廠糧窪鹽鹹願) = 糧齋鹹醖鹹襯窪鬱製繭簾鏇鬱獵壓衊蓋衊遞艱 (壓夢窪餘顧衊觸願齋遞 ) 更多	积极	2024-04-05
NCT05002127 (ASPEN-06, NEWS) 人工标引	临床2期	转移性 HER2 阳性胃食管结合部癌 \| HER2阳性胃癌二线 HER2 Positive	54	Evorpacept 30 mg/kg+trastuzumab + CYRAMZA + paclitaxel	鑰襯糧襯廠獵膚齋餘築(範願醖積選鑰鹽構鏇廠) = 鏇獵範醖鏇淵遞憲廠獵夢製範壓顧遞壓廠齋繭 (鬱積淵衊壓膚鹽觸獵顧 ) 更多	积极	2023-10-03
				trastuzumab + CYRAMZA + paclitaxel	鑰襯糧襯廠獵膚齋餘築(範願醖積選鑰鹽構鏇廠) = 鏇膚襯襯獵觸鹽醖糧積夢製範壓顧遞壓廠齋繭 (鬱積淵衊壓膚鹽觸獵顧 ) 更多