Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia

A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are:
* Does visugromab help participants put weight back on and have a better appetite?
* Does visugromab help participants move more and better?
* What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug).
Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.

开始日期2026-04-16

申办/合作机构

CatalYm GmbH

NCT07219459

/ Recruiting临床2期

A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)

This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.

开始日期2026-03-19

申办/合作机构

CatalYm GmbH

NCT07246863

/ Recruiting临床2期

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).
The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

开始日期2025-10-07

申办/合作机构

CatalYm GmbH

100 项与维苏格罗单抗相关的临床结果

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100 项与维苏格罗单抗相关的转化医学

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100 项与维苏格罗单抗相关的专利（医药）

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项与维苏格罗单抗相关的文献（医药）

2026-01-20·CHINESE MEDICAL JOURNAL

Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications

Review

作者: Huang, Weichao ; Yang, Lu ; Li, Yifan ; Zhu, Weizhen ; Wei, Qiang ; Xiong, Xingyu ; Feng, Dechao ; Xu, Hang

Abstract:

Prostate cancer (PCa) presents a significant global health challenge, and cachexia in end-stage PCa further reduces survival time and deteriorates patient quality of life. This necessitates nuanced approaches to prevention, diagnosis, and treatment. This review analyzes the complex role of growth differentiation factor 15 (GDF15) in various aspects of PCa, including metabolism, chemoresistance, metastasis, and clinical implications. Mechanically, the interactions of GDF15 with PCa lipid metabolism and stromal activation are hypothesized to drive PCa progression and promote cachexia. GDF15’s role in PCa bone metastasis is mediated through interactions with osteoblasts and osteoclasts. Furthermore, GDF15’s role in chemoresistance emphasizes its impact on drug responses and suggests a potential therapeutic target. Clinically, GDF15 has shown potential as a biomarker, offering diagnostic precision and prognostic value, particularly when combined with established markers such as prostate-specific antigen. The review concludes with a discussion on several monoclonal antibodies targeting GDF15 in clinical trials, such as AV-380, NGM120, Visugromab, and AZD8853, highlighting promising strategies for novel therapies and precision medicine.

2025-01-30·Nature

Neutralizing GDF-15 can overcome anti-PD-1 and anti-PD-L1 resistance in solid tumours

Article

作者: Trojan, Jörg ; Vilalta-Lacarra, Anna ; Fettes, Petra ; Richly, Heike ; Akdemir, Julia ; Chun, Felix Kyoung Hwan ; Gajewski, Thomas F ; Hackl, Hubert ; Racca, Fabricio ; Esteban-Villarrubia, Jorge ; Rössler, Bernhard ; Reis, Henning ; Torres-Jiménez, Javier ; Bargou, Ralf ; Lloyd, Peter ; Wild, Peter ; Trajanoski, Zlatko ; Alonso, Guzman ; Landa-Magdalena, Ana ; Auckenthaler, Alexandra ; Hermann, Frank ; Schuler, Martin ; Schuberth-Wagner, Christine ; Gjorgjioska, Ana ; Rodriguez Ruiz, Maria-Esperanza ; König, David ; Koster, Kira-Lee ; Foerster, Friedrich ; Melero, Ignacio ; Goebeler, Maria-Elisabeth ; Auer, Marlene ; Saavedra, Omar ; Koll, Florestan J ; Machacek, Matthias ; Dutta, Aradhana ; Gromke, Tanja ; Fridman, Wolf H ; Galle, Peter R ; de Miguel Luken, Maria ; Eggenschwiler, Corinne ; Soto-Castillo, Juan José ; Liebig, Mara ; Sanduzzi-Zamparelli, Marco ; Dummer, Reinhard ; Garralda, Elena ; Hess, Dagmar ; Läubli, Heinz ; Rüschoff, Josef ; da Silva, Antonio ; Tereshchenko, Anastasiia ; Eggermont, Alexander M M ; Rüdiger, Manfred ; Calvo, Emiliano ; L'Huillier, Phil ; Haake, Markus ; Fortuny, Marta ; Koch, Christine ; Klar, Kathrin ; Gogolla, Falk ; Moreno, Irene ; Sayehli, Cyrus ; Joerger, Markus ; Sabat, Paula ; Oberoi, Arjun ; Hernando-Calvo, Alberto ; Schmitt, Andreas M ; Reichhardt, Daniela ; Schöniger, Sandra ; Lichtenegger, Felix S ; Ramelyte, Egle ; Zink, Carina ; de Velasco, Guillermo ; Martín-Liberal, Juan ; Reig, Maria ; Wischhusen, Jörg ; Leo, Eugen

Cancer immunotherapies with antibodies blocking immune checkpoint molecules are clinically active across multiple cancer entities and have markedly improved cancer treatment¹. Yet, response rates are still limited, and tumour progression commonly occurs². Soluble and cell-bound factors in the tumour microenvironment negatively affect cancer immunity. Recently, growth differentiation factor 15 (GDF-15), a cytokine that is abundantly produced by many cancer types, was shown to interfere with antitumour immune response. In preclinical cancer models, GDF-15 blockade synergistically enhanced the efficacy of anti-PD-1-mediated checkpoint inhibition³. In a first-in-human phase 1-2a study (GDFATHER-1/2a trial, NCT04725474 ), patients with advanced cancers refractory to anti-PD-1 or anti-PD-L1 therapy (termed generally as anti-PD-1/PD-L1 refractoriness) were treated with the neutralizing anti-GDF-15 antibody visugromab (CTL-002) in combination with the anti-PD-1 antibody nivolumab. Here we show that durable and deep responses were achieved in some patients with non-squamous non-small cell lung cancer and urothelial cancer, two cancer entities identified as frequently immunosuppressed by GDF-15 in an in silico screening of approximately 10,000 tumour samples in The Cancer Genome Atlas database. Increased levels of tumour infiltration, proliferation, interferon-γ-related signalling and granzyme B expression by cytotoxic T cells were observed in response to treatment. Neutralizing GDF-15 holds promise in overcoming resistance to immune checkpoint inhibition in cancer.

2015-07-01·Arteriosclerosis, thrombosis, and vascular biology1区 · 医学

Choline Transporter-Like Protein-2

1区 · 医学

Article

作者: Ulrich J. Sachs ; Yudy Tjahjono ; Hans Deckmyn ; Heike Berghöfer ; Silke Werth ; Behnaz Bayat ; Sentot Santoso ; Simon F. De Meyer

Objective—:

In contrast to other antibodies involved in transfusion-related acute lung injury, anti–HNA-3a antibodies are incapable of inducing direct neutrophil activation and seem to interact with endothelial cells (ECs) primarily. In animal studies, anti–HNA-3a-mediated transfusion-related acute lung injury could be precipitated in the absence of neutrophils, but was stronger when neutrophils were present. In a different context the target protein of these antibodies, choline transporter-like protein-2 (CTL-2), was reported to interact with a protein of the inner ear carrying 2 von Willebrand factor (VWF) A-domains. These observations prompted us to investigate whether VWF might be involved in anti–HNA-3a-mediated neutrophil activation, and whether signaling via CD11b/CD18 is involved, as in various other experimental settings.

Approach and Results—:

Cell adhesion demonstrated specific binding of CTL-2 to VWF. Immunoprecipitation analysis of CTL-2/CD11b/CD18 coexpressing cells indicated that anti–HNA-3a colocalizes CTL-2 and CD11b/CD18 when VWF is present. Functional studies revealed that anti–HNA-3a-mediated neutrophil agglutination is an active, protein kinase C-dependent and partially Fc-dependent process. Agglutination and the production of reactive oxygen species seem to require the formation of a trimolecular complex between the target antigen (CTL-2), CD11b/CD18 and VWF. In line with these observations, anti–HNA-3a induced less severe transfusion-related acute lung injury and less neutrophil recruitment to the alveolar space in VWF knockout mice.

Conclusions—:

We introduce CTL-2 as a new binding partner for VWF. Interaction of neutrophils with VWF via CTL-2 allows anti–HNA-3a to induce signal transduction via CD11b/CD18, which leads to neutrophil activation and agglutination. In transfusion-related acute lung injury, this mechanism may further aggravate endothelial leakage.

项与维苏格罗单抗相关的新闻（医药）

2026-06-12

·Business Wire

CatalYm Appoints Peter Garcia as Chief Financial Officer

MUNICH & SAN FRANCISCO--(BUSINESS WIRE)--CatalYm today announced the appointment of Peter Garcia as Chief Financial Officer (CFO). Mr. Garcia brings more than three decades of biotechnology and oncology financial leadership experience, with a proven track record of leading transformative financings, strategic transactions, and scaling finance organizations to support global clinical development and commercialization. “Pete joins CatalYm at an important stage of growth for our company, with multiple late-stage clinical studies of our lead anti-GDF-15 antibody, visugromab, underway and continued global expansion across the organization,” said Scott Clarke, Chief Executive Officer at CatalYm. “He is an accomplished biotechnology executive with deep expertise in capital formation, strategic planning, and operational execution. Pete has consistently helped innovative biotech companies navigate periods of growth and major value inflection points. His addition to our leadership team positions CatalYm well to execute on our robust clinical development and operational goals in 2026 and beyond.” “The growing body of clinical data of visugromab continues to highlight the therapeutic potential of targeting GDF-15 to restore anti-tumor immune response while addressing the significant burden of cancer cachexia. CatalYm’s broad late-stage clinical development with four ongoing trials provides significant opportunity to improve patient outcomes and is entering an important phase of value creation. I am honored to join CatalYm and help ensure the company is strategically and financially positioned to maximize these opportunities for patients and stakeholders alike,” said Peter Garcia, CFO of CatalYm. Most recently, Mr. Garcia served as CFO of Bluejay Therapeutics where he led financing initiatives and initial public offering (IPO) readiness prior to its acquisition by Mirum Pharmaceuticals. Prior to Bluejay, he served as CFO of ALX Oncology Holdings Inc. where he led the Company’s IPO. Before that, he was CFO at PDL BioPharma, Inc., a profitable royalty management and specialty pharma holding company. He has also held CFO roles at other life science companies and began his biopharma career at Amgen Inc. in senior finance and controller roles. During his career, Mr. Garcia has raised more than $2.5 billion in debt and equity capital, including two IPOs and numerous follow-on equity offerings, private placements, convertible debt financings, and structured credit facilities. He previously served as a member of the Board of Directors of DURECT Corporation (acquired by Bausch Health Companies Inc), Noden Pharma DAC and LENSAR, Inc. Mr. Garcia holds an MBA in Finance and Accounting from the UCLA Anderson School of Management and a B.A. in Economics and Sociology with honors from Stanford University. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated deep and durable anti-tumor efficacy with long-lasting objective responses in relapsed and checkpoint refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC (NCT07098988), second-line metastatic non-squamous NSCLC (NCT07246863), second-line hepatocellular carcinoma (NCT07219459) and cachexia (NCT07112196). Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion.

高管变更临床2期临床1期IPO临床结果

2026-06-06

·今日头条

云南白药首个治疗用生物创新药INB301注射液拟用于治疗肿瘤恶病质

一、药物基本信息与研发进展 INB301注射液是云南白药集团中央研究院自主研发的首个治疗用生物创新药，编号为IND 180081，剂型为注射剂，规格为100mg（1mL）/瓶-3。该药拟开发适应症为肿瘤恶病质，已获得中美两国药监机构的临床试验许可，标志着云南白药成功实现"中美双报"的里程碑突破。从研发时间线来看，项目推进效率较高： 2025年上半年：完成毒理批和临床批的生产与放行检验，启动临床前研究和IND申报资料撰写工作-28； 2026年2月24日：IND正式获得国家药品监督管理局受理，并被纳入创新药审评审批30日快速通道-3-44； 2026年3月30日：获得中国NMPA的临床试验批准-1； 2026年4月27日：向美国FDA递交IND申请； 2026年6月2日：获得美国FDA临床试验许可，用时仅一个多月即通过美方的全面安全性审评-3。截至目前，该项目累计已投入研发费用约人民币 5066.5万元 -1。在国内，该药已于2026年4月启动了针对恶性实体瘤伴恶病质的I/IIa期临床试验-21。二、作用机制与临床优势 INB301的研发思路聚焦于肿瘤恶病质的发病本质。根据已披露信息，INB301作为靶向干预药物，通过调控肿瘤相关代谢通路、抑制异常炎症反应、改善骨骼肌代谢失衡，阻断恶病质的进展进程，同时依托精准靶向设计，减少对正常组织的影响，兼顾疗效与安全性，区别于传统对症支持治疗，具备显著的临床差异化优势。 FDA对INB301注射液的临床许可，意味着其作用机制（MoA）、药学研究、毒理学数据及临床试验方案等关键内容均获得权威认可，这显著降低了后续临床研发的不确定性-12。三、肿瘤恶病质的市场空白与竞争格局肿瘤恶病质是由恶性肿瘤引发的复杂代谢紊乱综合征，以持续性骨骼肌消耗为核心特征，常规营养支持难以逆转。临床数据显示，约80%至90%的晚期肿瘤患者会出现体重减轻、肌肉萎缩等相关症状，严重影响其生存质量及治疗耐受性，约20%的晚期肿瘤患者直接死因为恶病质。目前中美两国尚无获批上市的针对性治疗药物，临床需求极为迫切从市场规模来看，2025年全球癌症恶病质治疗市场规模约1.15亿元，预计至2032年将达到8.16亿元，年复合增长率达 32.3% ，市场增长潜力显著。竞争格局方面，该领域当前处于早期阶段，国内外有多家企业正在积极布局：企业/机构药物名称靶点/机制研发阶段特点云南白药 INB301 靶向干预（具体靶点未公开） I/IIa期（中美双报获批）国内首家进入临床阶段的生物创新药辉瑞 ponsegromab GDF-15 II/III期 2025年8月率先进入该阶段 - CatalYm visugromab GDF-15 II/III期计划2026年启动与PD-1抑制剂联用数据良好 - 阳光诺和 STC008 GHSR激动剂临床试验阶段国内首款进入临床的同类产品，靶点差异化 - 小野药品工业阿拉莫林 Ghrelin受体激动剂已在日本获批全球唯一获批的相关药物，但尚未在中国上市 - 该领域当前以 GDF-15靶点竞争最为激烈，德国CatalYm与辉瑞均已进入II/III期临床阶段-。此外，还有多家企业在开发Y5R激动剂等其他靶点的药物-。INB301的具体靶点尚未对外披露，若其作用机制与GDF-15靶点形成差异化，则有望在该赛道中获得独特竞争优势。四、云南白药的创新药管线布局 INB301并非云南白药的单一产品，而是其多层次创新药管线中的重要一环。公司坚持"打好中药、创新药两张牌"的发展战略，以核药发展为中心，同时在生物药、创新中药等领域系统布局-28。当前云南白药在研的创新药管线主要包括：（一）核药领域（诊断+治疗一体化布局） INR101 ：诊断核药，用于前列腺癌PSMA阳性病灶的PET成像，已启动Ⅲ期临床试验。值得一提的是，该产品仅用6个月即完成I/IIa期临床试验，展现出优异的稳定性和安全性-22-28。 INR102 ：治疗核药，用于PSMA阳性的转移性去势抵抗性前列腺癌，已同步推进I/IIa期临床研究-22。（二）创新中药领域全三七片（1.1类中药新药）：由中国工程院院士朱兆云领衔，具有"止血不留瘀，化瘀不伤正"的独特药理特点，已完成Ⅱ期临床试验全部704例受试者出组-24-45。附杞固本膏：推进Ⅲ期临床研究，完成17家研究中心启动，入组486例受试者，已取得阶段性突破（三）生物药领域 INB301 ：目前已获中美双临床许可，是云南白药在生物药领域的首个1类新药，若最终顺利获批，将为公司打开 2500亿生物药市场大门 -21。在研发投入方面，云南白药持续加码创新。2025年公司研发投入4.23亿元，同比增长21.5%，研发投入占工业收入比重为2.64%；2026年第一季度，研发费用同比大幅增长 27.72% -22-24。公司专门设立了中央研究院，下设昆明、天津、北京、无锡4个研发中心，覆盖中药、化药、核药、高端制剂等多个方向的研发-。五、综合评析（一）战略意义重大，转型路径清晰 INB301注射液获得中美双临床许可，对云南白药而言具有多重战略意义：首先，从"中药龙头"向"创新药企"转型的实质性突破。云南白药长期以中成药和健康品为主要业务，药品制剂超过300个，中成药占比超过七成，暂无生物药获批-21。INB301是该公司的首个治疗用生物创新药，其IND获批标志着公司正式进入全球创新生物药研发赛道，实现了从传统中药企业向创新型医药健康企业跨越的关键一步-3-45。其次，"中美双报"能力的体现。 INB301注射液在短期内相继获得NMPA与FDA的临床试验许可，充分验证了其药学（CMC）质量的国际符合性、临床前研究数据的完整性以及临床试验方案的科学合理性，开创了集团创新管线"中美双报"的先例，为后续产品的全球研发布局积累了宝贵经验-12。第三，填补肿瘤恶病质临床空白的潜力。该领域全球尚无FDA批准的有效治疗药物，属于典型的高壁垒、高价值赛道。INB301若能在临床试验中验证其安全性和有效性，有望成为全球首批针对该适应症的干预性治疗药物之一，具有显著的临床价值和广阔的市场前景-12。（二）面临的挑战与需要关注的要点同时，也需清醒地认识到当前面临的挑战：一是INB301仍处于早期临床阶段，研发风险不容忽视。创新药从IND获批到最终上市，通常需要经过I、II、III期临床试验，成功率较低且耗时漫长。此外，全球范围内已有辉瑞、CatalYm等竞争对手进入更成熟的II/III期临床阶段，云南白药在进度上并不占优势-。二是研发投入规模相对有限。虽然研发费用增速可观，但2025年4.23亿元的研发投入绝对值与跨国药企乃至国内头部创新药企相比仍有较大差距，研发投入占工业收入比重仅2.64%，创新能力的持续积累仍需时日-22。三是商业化能力尚待验证。云南白药在中药和健康品领域拥有强大的渠道优势和品牌影响力，但在生物药这一新兴领域的商业化能力——包括专业化的学术推广、医保准入、定价策略等方面——仍需在后续产品上市过程中接受检验。总体来看，INB301的获批是云南白药向创新药企转型的一个重要信号，体现了公司从资源依赖向科技驱动转变的决心。若后续临床数据积极且顺利上市，不仅能为公司开辟全新的增长曲线，也可能为中国中药企业转型创新药提供一条值得借鉴的路径。但投资者和行业观察者也需理性看待——创新药研发之路道阻且长，INB301距离真正造福患者还有很长的路要走，未来仍需持续关注其临床数据的披露和研发进展的推进。

2026-04-28

·BioSpace

CatalYm Appoints Christian S. Schade as Chairman of the Board of Directors

MUNICH & SAN FRANCISCO--(BUSINESS WIRE)-- CatalYm today announced the appointment of seasoned biotech executive Christian S. Schade as Chairman of the Board of Directors. With over 30 years of executive leadership experience across private and public biopharma companies, Mr. Schade will provide board leadership at a crucial stage for the company, following the initiation of four late-stage clinical studies of its lead candidate, the GDF-15 inhibitor visugromab. “With recent positive clinical data, multiple ongoing clinical studies, and a strong leadership team with deep biotechnology and drug development expertise, CatalYm is well positioned for continued clinical and corporate success,” said Christian S. Schade, Chairman of the Board at CatalYm . “The company’s differentiated approach, targeting GDF-15 to address both checkpoint-refractory tumors and cancer cachexia, has shown encouraging anti-tumor activity in multiple solid tumor indications. I look forward to working with the Board of Directors and the CatalYm team at this pivotal inflection point in the company’s development.” “Chris’ extensive industry experience and track record of supporting the growth of biotech organizations strengthens our Board and adds further strategic depth,” said Scott Clarke, Chief Executive Officer at CatalYm . “His insights and board leadership will be invaluable as we advance visugromab through late-stage clinical development and continue to broaden its potential impact for patients.” Mr. Schade most recently served as President and Chief Executive Officer of Halda Therapeutics, a company developing a novel class of cancer therapeutics, until its $3.05 billion acquisition by Johnson & Johnson in December 2025. Prior to Halda, Chris was a Growth Partner at Flagship Pioneering. His leadership experience includes serving as President, Chief Executive Officer and Board Member of Aprea Therapeutics (Nasdaq: APRE) from 2016 to 2022, and as Chairman from 2020 to 2023. Under his leadership, Aprea advanced its pipeline of oncology therapeutics and completed its IPO in 2019. Before joining Aprea, he held several executive roles at biotechnology companies, including: Chief Executive Officer of Novira, a privately held antiviral drug discovery company until its acquisition by Johnson & Johnson, Chief Financial Officer of Omthera Pharmaceuticals, Inc., a Nasdaq-listed specialty pharmaceuticals company until its acquisition by AstraZeneca Plc, and Senior Vice President of Administration and Chief Financial Officer at Medarex, Inc., a biopharmaceutical company focused on antibody-based therapeutics until its acquisition by Bristol Myers Squibb. Earlier in his career, Mr. Schade was Managing Director at Merrill Lynch in London, following nearly 20 years in corporate finance and capital markets roles at Merrill Lynch and J.P. Morgan in New York and London. Chris received his A.B. degree from Princeton University and an M.B.A. from the Wharton School at the University of Pennsylvania. He currently serves as Senior Advisor to Frazier Life Sciences and is on the Board of Integra LifeSciences. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated deep and durable anti-tumor efficacy with long-lasting objective responses in relapsed and checkpoint refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC ( NCT07098988 ), second-line metastatic non-squamous NSCLC ( NCT07246863 ), second-line hepatocellular carcinoma ( NCT07219459 ) and cachexia ( NCT07112196 ). Founded in 2016 and based in Munich, Germany, and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion. Contacts CatalYm GmbH Clinton Musil, CFO and CBO info@catalym.com Media Inquiries Trophic Communications Dr. Stephanie May or Anja Heuer Phone: +49 171 185 56 82 or +49 151 106 199 05 catalym@trophic.eu

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适应症	最高研发状态	国家/地区	公司	日期
恶病质	临床3期	美国	CatalYm GmbH	2026-04-16
恶病质	临床3期	保加利亚	CatalYm GmbH	2026-04-16
恶病质	临床3期	捷克	CatalYm GmbH	2026-04-16
恶病质	临床3期	法国	CatalYm GmbH	2026-04-16
恶病质	临床3期	德国	CatalYm GmbH	2026-04-16
恶病质	临床3期	意大利	CatalYm GmbH	2026-04-16
恶病质	临床3期	挪威	CatalYm GmbH	2026-04-16
恶病质	临床3期	波兰	CatalYm GmbH	2026-04-16
恶病质	临床3期	罗马尼亚	CatalYm GmbH	2026-04-16
恶病质	临床3期	西班牙	CatalYm GmbH	2026-04-16

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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


NCT04725474 (GDFATHER-01, SITC2025)	临床1/2期	肝细胞癌 \| 局部晚期非鳞状非小细胞肺癌	77	Visugromab (10mg/kg) + Nivolumab (240mg)	鑰獵鑰齋築積製醖衊繭(鏇願壓繭築襯糧鬱蓋顧) = reported in 10/77 (13.0%) pts 淵襯鑰築夢廠積遞壓顧 (觸製鑰鹽鏇製選淵選鏇 )	积极	2025-11-05
NCT04725474 (GDFATHER-01, ESMO2025)	临床1/2期	肝细胞癌 \| 非小细胞肺癌 \| 尿路上皮癌	77	Visugromab (V) + Nivolumab (N) (non-squamous NSCLC + urothelial cancer + hepatocellular cancer + anti-PD1/-L1 relapsed/refractory)	糧夢餘壓觸糧鏇壓艱膚(獵壓鬱鏇膚艱憲簾蓋簾) = 繭蓋網衊廠廠願蓋淵遞壓窪餘窪築鏇願廠鹹廠 (餘齋鹽繭鏇範壓簾簾窪 ) 更多	积极	2025-10-17
NCT06059547 (GDFather-NEO, ESMO2025)	临床2期	肌层浸润性膀胱癌新辅助	31	Nivolumab+Visugromab	鏇網遞鑰繭築鏇襯範廠(鹽窪願築選範願糧艱顧) = 遞獵鏇糧選糧醖製廠製齋鬱夢壓鏇夢遞壓廠醖 (艱鏇壓顧壓廠鑰願鬱鑰 ) 更多	积极	2025-10-17
NCT06059547 (GDFather-NEO, ESMO2025)	临床2期	肌层浸润性膀胱癌新辅助	31	Nivolumab+Placebo	鏇網遞鑰繭築鏇襯範廠(鹽窪願築選範願糧艱顧) = 淵遞醖觸淵鑰願鑰簾構齋鬱夢壓鏇夢遞壓廠醖 (艱鏇壓顧壓廠鑰願鬱鑰 ) 更多	积极	2025-10-17
NCT04725474 (GDFATHER, BusinessWire) 人工标引	临床1/2期	肝细胞癌 \| 实体瘤 \| 非鳞状非小细胞肺癌 ... 更多	-	visugromab (non-squamous NSCLC)	遞淵艱獵夢遞製糧艱憲(構齋製壓艱蓋簾築獵壓) = 衊獵餘蓋艱襯選積簾製窪顧簾網觸範鹹艱鹽膚 (餘選窪齋鏇繭顧襯廠醖 ) 更多	积极	2024-12-11
NCT04725474 (GDFATHER, BusinessWire) 人工标引	临床1/2期	肝细胞癌 \| 实体瘤 \| 非鳞状非小细胞肺癌 ... 更多	-	visugromab (UC)	遞淵艱獵夢遞製糧艱憲(構齋製壓艱蓋簾築獵壓) = 廠憲膚構繭鹽廠餘齋鑰窪顧簾網觸範鹹艱鹽膚 (餘選窪齋鏇繭顧襯廠醖 ) 更多	积极	2024-12-11
NCT04725474 (GDFATHER, Biospace) 人工标引	临床1/2期	肝细胞癌 \| 非小细胞肺癌 \| 尿路上皮癌	-	Visugromab + Nivolumab	積網顧憲範餘選壓顧鹹(築淵觸壓遞積夢鑰壓糧) = 鏇鏇膚繭網襯衊築顧選鹽築醖襯範廠壓選範醖 (簾夢製糧簾鏇淵艱製鬱 )	积极	2024-06-02
NCT04725474 (GDFATHER, Biospace) 人工标引	临床1/2期	肝细胞癌 \| 非小细胞肺癌 \| 尿路上皮癌	-	Visugromab + Nivolumab (NSCLC)	遞糧鬱夢夢廠簾選鹽簾(簾鏇簾艱簾選糧遞艱鬱) = 壓築窪蓋鹹鹽遞鹽蓋積衊齋餘窪淵糧蓋衊夢壓 (積廠窪鏇膚壓顧壓憲衊 )	积极	2024-06-02
NCT04725474 (GDFather, ASCO2024) 人工标引	临床2期	肝细胞癌 \| 鳞状非小细胞肺癌 \| 尿路上皮癌	87	Visugromab 10 mg/kg + Nivolumab 240 mg Q2W	鑰襯積構餘艱醖鏇窪鑰(鏇積鑰醖範餘網夢醖網) = 淵鏇鏇觸憲積築窪窪餘膚壓鹹選艱壓製遞觸選 (窪齋繭醖壓齋艱鏇觸鹹 ) 更多	积极	2024-05-24
NCT04725474 (GDFather, ASCO2024) 人工标引	临床2期	肝细胞癌 \| 鳞状非小细胞肺癌 \| 尿路上皮癌	87	Visugromab 10 mg/kg + Nivolumab 240 mg Q2W (NSCLC)	-	积极	2024-05-24
NCT04725474 (GDFATHER-2, Biospace) 人工标引	临床2期	晚期非小细胞肺癌 \| 尿路上皮癌 PD-L1 Positive	27	Visugromab+nivolumab (NSCLC)	鹹憲獵製醖製蓋糧鬱範(餘積築衊鏇網獵鑰獵齋) = 鏇構襯繭鏇鹹醖窪範選繭糧簾築憲鹽鏇鬱鹽積 (艱構願觸襯鹹鏇蓋網膚 )	积极	2023-12-06
NCT04725474 (ESMO_IO2023)	临床2期	实体瘤 \| 非小细胞肺癌 \| 膀胱癌 PD-L1+	114	Visugromab 10 mg/kg + Nivolumab 240 mg	遞積齋製蓋獵鏇網遞鹹(積鬱壓顧襯壓網顧鹹網) = 鏇壓襯鹹範壓獵糧繭繭顧顧築齋觸鬱獵鏇鹹壓 (窪鏇糧窪願衊襯艱繭繭 )	积极	2023-12-06
NCT04725474 (GDFATHER, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	实体瘤	79	Nivolumab 240 mg+visugromab 10 mg/kg	鑰鑰憲窪鹹鹽獵網襯鬱(願選壓獵憲夢蓋鏇繭淵) = 鹹鑰齋鬱觸願築簾鹽鑰築壓繭鏇願襯觸鏇餘醖 (獵醖餘網簾廠廠繭憲觸 ) 更多	积极	2023-05-31
NCT04725474 (GDFATHER-1, ESMO2022) 人工标引	临床1期	复发性实体肿瘤	25	CTL-002 0.3-20 mg/kg+Nivolumab	壓壓簾餘廠範窪衊壓齋(醖鬱窪襯壓衊鏇製願鬱) = 齋鹹夢夢簾糧衊鏇鹹製鬱顧簾選膚蓋糧構觸簾 (鬱範鑰築選糧遞遞築積 ) 更多	积极	2022-09-10