To investigate the efficacy of AMB-05X in patients with CRC with MRD as determined by a ctDNA(+) blood test and no clinically detectable radiographic disease.

开始日期2024-12-04

申办/合作机构-

NCT05349760

/ Withdrawn临床2期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.

开始日期2023-03-01

申办/合作机构

AmMax Bio, Inc.

NCT05349643

/ Completed临床2期

A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

开始日期2023-01-26

申办/合作机构

AmMax Bio, Inc.

100 项与 AMB-051 相关的临床结果

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100 项与 AMB-051 相关的转化医学

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项与 AMB-051 相关的文献（医药）

2025-10-01·EUROPEAN JOURNAL OF CANCER

Pharmacokinetics and pharmacodynamics of an anti-CSF1 receptor antibody in the intra-articular treatment of tenosynovial giant cell tumor

Article

作者: van de Sande, Michiel ; Gelderblom, Hans ; Alani, Laman ; Johnson, Kirk ; Lai, Chinglin ; Nguyen, Dorothy ; Scharschmidt, Thomas ; van Langevelde, Kirsten ; Nguyen, Tiffany

AIM:

CSF1R-targeted pharmacotherapy is a viable treatment approach for TGCT but may be associated with pharmacologic side effects when given systemically. As a first study of its kind, intra-articular (IA) administration of an anti-CSF1R antibody (AMB-05X) into the knee of normal monkeys and TGCT patients was characterized.

METHODS:

Following favorable results of 5 mg/kg IA dosing in monkeys, a multi-center, single-arm, Phase 2a trial was undertaken. IA AMB-05X was administered to the affected knee at 150 mg (N = 8) or 90 mg (N = 3) every 2 weeks for 12-weeks. Safety and tolerability, and efficacy (tumor response assessed on MRI and patient reported outcomes (PROs)), PK, PD, and anti-drug antibody (ADA) were evaluated.

RESULTS:

IA injection to monkeys was well-tolerated and AMB-05X knee synovial fluid levels were greater than that in serum with a similar half-life. In the clinical trial, most common low-grade treatment-emergent adverse events (TEAEs) were edema (55 %), fatigue (46 %), arthralgia (36 %), rash (36 %) and pruritus or hypertension (27 %). These events were lower in the 90 mg cohort compared to the 150 mg cohort. Q2W dosing resulted in accumulation of high synovial vs systemic AMB-05X (PK) and CSF1 (PD) levels. Objective tumor response by RECISTv1.1 was 36 % overall, while Modified RECIST was 45 %. PROs were significantly improved at 10-12 weeks. ADA was 0 %.

CONCLUSION:

Favorable PK, PD, efficacy, and safety/tolerability of intra-articular administration of an anti-CSF1R mAb for TGCT was validated. These results support further development of this novel treatment approach.

项与 AMB-051 相关的新闻（医药）

2025-03-04

·PRNewswire

Ono's ROMVIMZA Approval Shakes Up Tenosynovial Giant Cell Tumors Market, Challenging Daiichi Sankyo's TURALIO Dominance | DelveInsight

On February 14, 2025, Ono Pharmaceuticals secured FDA approval for vimseltinib, a therapy for tenosynovial giant cell tumor (TGCT), which will be marketed as ROMVIMZA. This approval places Ono in direct competition with another Japanese pharmaceutical company, Daiichi Sankyo, in the TGCT market. LAS VEGAS, March 4, 2025 /PRNewswire/ -- Tenosynovial giant cell tumor, also known as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treated through surgical resection. For localized TGCT, the typical approach involves direct removal of the tumor nodule. In contrast, diffused-type TGCT (DTGCT) tends to present as larger tumors affecting major joints, making treatment more complex. Management options for DTGCT often include total synovectomy, joint replacement, or, in extremely rare cases, amputation. Among the 7MM, the United States had the highest prevalence of tenosynovial giant cell tumor, accounting for approximately 45% of total cases. In 2023, localized TGCT in the U.S. was most commonly found in the digits, representing around 75% of cases. Depending on whether the tumor is localized or diffuse, giant cell tumors can also occur in the knee, ankle, hip, and other areas. According to DelveInsight analysts, diffuse TGCT was most frequently observed in the knee, with an estimated 30,000 cases in the US in 2023. The primary approach to treating TGCT is surgery, often supplemented by alternative options like Radiation Therapy, Radiosynovectomy, and Systemic Therapies, including CSF1 inhibitors and Tyrosine Kinase Inhibitors. TURALIO (pexidartinib, previously known as PLX3397) is a targeted therapy developed by Daiichi Sankyo for adult patients with symptomatic tenosynovial giant cell tumor that leads to significant morbidity or functional limitations and cannot be effectively treated with surgery. This orally administered small-molecule tyrosine kinase inhibitor acts on colony-stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) with an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand contributes to excessive cell proliferation and accumulation in the synovium. The US FDA approved TURALIO in August 2019 for the treatment of TGCT in adults with severe symptoms and limited surgical options. Before this, in October 2015, pexidartinib received Breakthrough Therapy Designation (BTD) from the FDA for TGCT treatment. TURALIO carries a risk of serious and potentially life-threatening liver toxicity and is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program. Learn more about the FDA-approved TGCT drugs @ Drugs for Tenosynovial Giant Cell Tumors Treatment Recently, in February 2025, Ono Pharmaceuticals secured FDA approval for vimseltinib for the treatment of tenosynovial giant cell tumor. Marketed under the brand name ROMVIMZA, the drug places Ono in direct competition with fellow Japanese pharmaceutical company Daiichi Sankyo in the TGCT space. Like TURALIO, which became the first FDA-approved TGCT treatment in 2019, ROMVIMZA is a colony-stimulating factor 1 receptor (CSF1R) inhibitor. As a kinase inhibitor, it blocks the CSF1 receptor to slow the growth of cells expressing this protein, potentially limiting tumor progression in TGCT. Ono Pharmaceuticals acquired ROMVIMZA through its $2.4 billion purchase of Deciphera Pharmaceuticals last year, making the U.S.-based firm a subsidiary. At the time, Ono's CEO, Gyo Sagara, described the acquisition as a strategic effort to expand the company's targeted oncology pipeline, strengthen its presence in the U.S. and European markets, and enhance its kinase drug discovery expertise. To compete with TURALIO's early market entry, Ono is positioning ROMVIMZA as a more convenient TGCT treatment. Unlike Daiichi Sankyo's drug, which requires twice-daily dosing, ROMVIMZA is administered only twice a week, with at least 72 hours between doses. Additionally, while TURALIO carries a boxed warning for hepatotoxicity due to the risk of severe liver damage, ROMVIMZA does not have this safety warning. To know more about TGCT treatment options, visit @ New Treatment for Tenosynovial Giant Cell Tumors TGCT that is not amenable to improvement from surgery. Several companies, such as SynOx Therapeutics (Emactuzumab), AmMax Bio (AMB-05X), Merck KGaA (pimicotinib), and others, are involved in developing therapies for TGCT. Discover which therapies are expected to grab major TGCT market share @ Tenosynovial Giant Cell Tumors Market Report Pimicotinib is an investigational, orally administered small-molecule inhibitor designed to selectively and effectively target the colony-stimulating factor-1 receptor. Developed by Abbisko, it remains under clinical evaluation. In December 2023, Abbisko Therapeutics agreed with Merck, granting Merck exclusive rights to commercialize pimicotinib-based products for all indications in mainland China, Hong Kong, Macau, and Taiwan, with the possibility of expanding to global markets, including the US. Pimicotinib has been granted Breakthrough Therapy Designation (BTD) by both the China National Medical Products Administration (NMPA) and the FDA, as well as Priority Medicine (PRIME) designation by the European Medicines Agency (EMA) for the treatment of patients with TGCT who are not candidates for surgery. In November 2024, Merck reported that the Phase III MANEUVER trial, conducted by Abbisko Therapeutics, met its primary endpoint. The study showed a significant improvement in the objective response rate (ORR) for patients with tenosynovial giant cell tumor. By week 25, pimicotinib achieved an ORR of 54.0%, compared to 3.2% in the placebo group (p<0.0001). Emactuzumab is a monoclonal antibody that serves as a potent and selective inhibitor of CSF-1R. By interacting with two key cytokines, CSF-1 and IL-34, the CSF-1 receptor plays a crucial role in regulating macrophages and related cells across various biological processes and organ systems. This makes it a compelling target with wide-ranging therapeutic potential. SynOx Therapeutics is currently assessing emactuzumab in the Phase III TANGENT clinical trial. In April 2024, the company secured a $35 million loan facility from Hercules Capital, bolstering its financial position as it advances the trial. Additionally, SynOx successfully completed a $75 million Series B funding round. Earlier, in August 2022, the European Medicines Agency (EMA) granted orphan medicinal product designation to emactuzumab for both localized and diffuse TGCT. AMB-05X is a powerful monoclonal antibody targeting CSF1R, designed as a therapeutic platform for severe macrophage-driven inflammatory, fibrotic, and neovascular conditions. It has received Fast Track designation from the FDA and PRIME designation from the EMA for TGCT. Currently, it is being evaluated in a Phase II clinical trial to assess its safety, tolerability, efficacy, and pharmacokinetics when administered via intra-articular injection in TGCT patients. Discover more about drugs for TGCT in development @ Tenosynovial Giant Cell Tumors Clinical Trials The anticipated launch of these emerging therapies for TGCT are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the TGCT market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for TGCT is expected to grow from USD 300 million in 2023, with a significant CAGR by 2034. This growth can be attributed to the approval of new therapies with improved safety and tolerability compared to pexidartinib, which will significantly impact the treatment landscape in the coming years. This will lead to increased adoption of these new therapies, with patients transitioning from off-label treatments to these newer options during the forecast period (2023‒2034). DelveInsight's latest published market report, titled as Tenosynovial Giant Cell Tumors Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the TGCT country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The TGCT market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of TGCT Growth Pattern-specific Prevalent Cases of TGCT Gender-specific Prevalent Cases of Localized TGCT Gender-specific Prevalent Cases of Diffuse TGCT Tumor Location-specific of Localized TGCT Tumor Location-specific Cases of Diffuse TGCT Total Treated Cases of TGCT The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM TGCT market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this TGCT market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the TGCT market. Also, stay abreast of the mitigating factors to improve your market position in the TGCT therapeutic space. Related Reports Tenosynovial Giant Cell Tumors Epidemiology Tenosynovial Giant Cell Tumors Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted TGCT epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan. Tenosynovial Giant Cell Tumors Pipeline Tenosynovial Giant Cell Tumors Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TGCT companies, including AmMax Bio, Inc., Deciphera Pharmaceuticals SynOx Therapeutics, Abbisko Therapeutics Co, Ltd., Hutchison Medipharma Limited, Elixiron Immunotherapeutics, among others. Rheumatoid Arthritis Market Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key rheumatoid arthritis companies, including Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec, Genosco, Mesoblast, Pfizer Akros Pharma, Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, among others. Rheumatoid Arthritis Pipeline Rheumatoid Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key rheumatoid arthritis companies, including Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期上市批准快速通道

2023-01-31

·GlobeNewswire-Health Care

AmMax Bio Announces First Patients Dosed in Phase 2b Study of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)

REDWOOD CITY, Calif., Jan. 30, 2023 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including a next-generation antibody-drug conjugate (ADC) and a mAb targeting colony-stimulating factor 1 receptor (CSF1R), today announced that the first patients have been dosed in the Company’s Phase 2b study evaluating AMB-05X for the treatment of tenosynovial giant cell tumor (TGCT). The AmMax phase 2b trial is an open-label, adaptive, dose-ranging study to evaluate the safety, efficacy and pharmacokinetics of intra-articular administration of AMB-05X in patients with TGCT after 24 weeks of treatment and an additional long-term extension period. (ClinicalTrials.gov Identifier: NCT05349643) “The expansion of our TGCT program into this Phase 2b study builds on the strong proof-of-concept safety and efficacy data reported in 2022 which evaluated the treatment of AMB-05X in TGCT patients over a 12-week period,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “Since announcing those results, both FDA Fast Track designation and EMA PRIME designation have been granted to AMB-05X, reflecting its significant potential to address the unmet medical need for this patient population with few treatment options. With six months of treatment, we believe patients will receive greater benefit with AMB-05X than any other pharmacological options, and we plan to use the data from this trial to finalize our Phase 3 study design.” “Encouraged by the treatment experience with AMB-05X from the earlier POC study, our patients are excited to enroll in this Phase 2b trial,” stated the principal investigators, Hans Gelderblom, M.D., Ph.D., Chair of Medical Oncology, and Michiel van de Sande, M.D., Professor of Orthopedic Oncology at the Leiden University Medical Center in the Netherlands. “With AMB-05X already demonstrating positive safety and efficacy over a 12-week treatment period, this larger Phase 2b study, with a broader enrollment scope, will assess the treatment durability of this novel, locally administered therapy over a 24-week treatment period. If successful, AMB-05X would provide TGCT patients with a much-needed alternative to immediate surgical resection and the associated complications, long recovery times, and high rates of recurrence.” About TGCT Tenosynovial Giant Cell Tumor (TGCT), with a worldwide incidence of over 300,000, is a serious and debilitating locally aggressive tumor in which patients can experience severe pain, disability, and diminished quality of life. Surgical resection, the primary standard of care for TGCT, carries significant risk to patients, including complications from infections and prolonged postoperative care, and frequent relapse. A safe and efficacious pharmacologic therapy that can be used as an alternative to surgery remains a significant unmet need. AmMax is uniquely positioned to address this need for patients with TGCT by leveraging the target selectivity and enhanced safety profile of AMB-05X via local intra-articular administration, while creating a sizable commercial opportunity from improved patient care. About AMB-05X A potent monoclonal antibody against CSF1R granted Fast Track designation by the FDA and PRIME designation by EMA for TGCT, AMB-05X represents a therapeutic platform targeting serious macrophage-driven inflammatory, fibrotic and neovascular diseases. CSF1R, via its binding to two regulatory cytokines, CSF1 and IL-34, is critically involved in the regulation of macrophages and related cells in multiple biological processes across many organ systems, making it an attractive target with broad therapeutic applications. About AmMax Bio Inc. AmMax is a private biotechnology company focused on leveraging our core expertise in translational science and drug development to build a clinical portfolio of first-in-class and best-in-class oncology products in areas of significant unmet medical need. The Company’s core portfolio consists of AMB-101, a novel antibody-drug conjugate (ADC) with a proprietary next generation topoisomerase 1 inhibitor-based linker-payload that is expected to enter the clinic in 2023, and AMB-05X from the Company’s CSF1R platform as a potentially best-in-class locally administered treatment for TGCT. AmMax is currently leveraging positive clinical data and an improved safety profile to advance AMB-05X in an actively enrolling Phase 2 study.

临床2期快速通道抗体药物偶联物

2023-01-19

·BioSpace

AmMax Bio’s AMB-05X Receives EMA PRIME Designation for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)

AMB-05X is the First and Only Investigational Drug Candidate to Receive PRIME Designation for the Treatment of TGCT PRIME Designation Validates Unique Therapeutic Potential of AMB-05X as Demonstrated in Prior Phase 2 Study of TGCT Initial Results from Phase 2b Trial Remains on Track for Second Half of 2023 REDWOOD CITY, Calif., Jan. 19, 2023 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including a next-generation antibody-drug conjugate (ADC) and a mAb targeting colony-stimulating factor 1 receptor (CSF1R), today announced that the European Medicine Agency (EMA) has granted AMB-05X Priority Medicines (PRIME) designation for the treatment of tenosynovial giant cell tumor (TGCT). “The positive proof-of-concept data from our prior 12-week Phase 2 study of AMB-05X in TGCT provided the basis for our PRIME application,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “We appreciate EMA’s decision to award AMB-05X its PRIME designation, which validates the high potential therapeutic value of the program and the significant unmet medical need for patients impacted by TGCT.” In November 2022, AmMax presented positive Phase 2 data for the novel local administration of AMB-05X in patients with TGCT at the Connective Tissue Oncology Society (CTOS) meeting. The significant efficacy data across multiple clinical endpoints and a favorable safety pro the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT, regardless of surgical resectability. PRIME designation was launched by the EMA to enhance support for the development of medicines that target an unmet medical need. PRIME fosters the efficient development of medicines by enhancing interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier. Through PRIME, the EMA offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine's benefits and risks and enable accelerated assessment of medicines applications. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.1 In September 2022, AMB-05X was also granted Fast Track designation by the U.S. Food and Drug Administration (FDA). 1 About TGCT Tenosynovial Giant Cell Tumor (TGCT), with a worldwide incidence of over 300,000, is a serious and debilitating locally aggressive tumor in which patients can experience severe pain, disability, and diminished quality of life. Surgical resection, the primary standard of care for TGCT, carries significant risk to patients, including complications from infections and prolonged postoperative care, and frequent relapse. A safe and efficacious pharmacological therapy that can be used alongside surgery remains a significant unmet need. AmMax is uniquely positioned to address this need for patients with TGCT by leveraging the target selectivity and enhanced safety pro AMB-05X via local intra-articular administration, while creating a sizable commercial opportunity from improved patient care. About AMB-05X A potent monoclonal antibody against CSF1R granted Fast Track designation by the FDA and PRIME designation by EMA for TGCT, AMB-05X represents a therapeutic platform targeting serious macrophage-driven inflammatory, fibrotic and neovascular diseases. CSF1R, via its binding to two regulatory cytokines, CSF1 and IL-34, is critically involved in the regulation of macrophages and related cells in multiple biological processes across many organ systems, making it an attractive target with broad therapeutic applications. About AmMax Bio Inc. AmMax is a private biotechnology company focused on leveraging our core expertise in translational science and drug development to build a clinical portfolio of first-in-class and best-in-class oncology products in areas of significant unmet medical need. The Company’s core portfolio is a novel antibody-drug conjugate (ADC) with a proprietary next generation topoisomerase 1 inhibitor-based linker-payload (the TMALIN platform) that is expected to enter the clinic in 2023. Additionally, the Company’s CSF1R platform includes AMB-05X, a potentially best-in-class locally administered treatment for TGCT. AmMax is currently leveraging positive clinical data and an improved safety pro advance AMB-05X in an actively enrolling Phase 2 study. For more information, please visit the company’s website at . Contact AmMax Bio, Inc. Andrew Sauter, CFO Email: andrewsauter@ammaxbio.com Tel: 650-787-3777

临床2期快速通道抗体药物偶联物临床结果临床1期

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适应症	最高研发状态	国家/地区	公司	日期
特发性肺纤维化	临床2期	-	AmMax Bio, Inc.	2023-03-01
色素沉着的绒毛结节性滑膜炎	临床2期	美国	AmMax Bio, Inc.	2021-05-25
色素沉着的绒毛结节性滑膜炎	临床2期	荷兰	AmMax Bio, Inc.	2021-05-25
色素沉着的绒毛结节性滑膜炎	临床2期	波兰	AmMax Bio, Inc.	2021-05-25
色素沉着的绒毛结节性滑膜炎	临床2期	乌克兰	AmMax Bio, Inc.	2021-05-25

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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


NCT04731675 (AMB-051-01, CTgov)	临床2期	色素沉着的绒毛结节性滑膜炎	11	AMB (AMB-05X - High Dose)	鏇憲窪網鏇觸醖壓遞淵 = 築鑰襯鑰構鹹窪齋鏇繭襯窪衊夢廠鏇廠窪構獵 (壓鹽獵憲鏇築齋廠願壓, 憲鏇製遞齋齋衊廠獵鑰 ~ 夢鹹構遞遞鬱願憲構鏇) 更多	-	2024-06-27
NCT04731675 (AMB-051-01, CTgov)	临床2期	色素沉着的绒毛结节性滑膜炎	11	AMB (AMB-05X Low Dose)	鏇憲窪網鏇觸醖壓遞淵 = 窪願鹽觸願鏇齋醖願窪襯窪衊夢廠鏇廠窪構獵 (壓鹽獵憲鏇築齋廠願壓, 餘夢築網顧壓糧鹹製蓋 ~ 鏇衊鹽鏇憲積夢遞窪餘) 更多	-	2024-06-27
NCT04731675 (AMB-051-01, ESMO2022) 人工标引	临床2期	腱鞘巨细胞瘤	8	AMB-05X 150 mg	窪願製廠鑰淵廠艱蓋鹽(鹹網網選範繭顧鏇鑰顧) = 20-fold greater in synovial fluid vs serum 範鹹獵鹽壓鹽餘艱齋選 (獵選製網築憲構觸衊製 )	积极	2022-09-12