Phase I/II Clinical Study on the Safety and Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen as Neoadjuvant Therapy for Children and Adolescents With Intermediate/High-Risk Rhabdomyosarcoma

This study comprises both Phase I and Phase II research. This phase focuses on safety, tolerability, and pharmacokinetics using a "3+3" dose escalation design with three dose groups: 1 mg/kg, 3 mg/kg, and 6 mg/kg. The drug will be administered in combination with the standard regimen for intermediate/high-risk rhabdomyosarcoma once every three weeks (Q3W). In phase II study, all subjects will receive Pucotenlimab combined with the standard regimen for intermediate/high-risk rhabdomyosarcoma for 2-4 cycles of neoadjuvant therapy every 3 weeks (Q3W), followed by surgery.

Start Date06 Jun 2024

Sponsor / Collaborator

Sun Yat-Sen University

NCT06192797 / RecruitingPhase 2IIT

A Phase 2, Open-label, Single Arm Study of Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.

Start Date04 Jun 2024

Sponsor / Collaborator

GenePlus Co. Ltd.

NCT06192784 / RecruitingPhase 2IIT

A Phase 2, Open-label, Single Arm Study of Combined Drug-eluting Beads-TACE, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of drug eluting beads-transcatheter arterial chemoembolization combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.

Start Date09 Dec 2023

Sponsor / Collaborator

Shanghai Tongji Hospital

[+1]

100 Clinical Results associated with Pucotenlimab

100 Translational Medicine associated with Pucotenlimab

100 Patents (Medical) associated with Pucotenlimab

Literatures (Medical) associated with Pucotenlimab

01 Dec 2023·Cell reports. Medicine

Pucotenlimab in patients with advanced mismatch repair-deficient or microsatellite instability-high solid tumors: A multicenter phase 2 study

Article

Author: Yin, Xianli ; Yu, Junyan ; Liang, Xinjun ; Li, Shengmian ; Liu, Zhihui ; Wang, Ke ; Zeng, Shan ; Liu, Yunpeng ; Luo, Suxia ; Dou, Yiwei ; Fan, Qingxia ; Wang, Fen ; Zhuang, Zhixiang ; Li, Enxiao ; Zhang, Shu ; Liu, Qian ; Zhang, Jingdong ; Huang, Jing ; Xu, Nong ; Kou, Xiaoge ; Zhu, Xiaodong ; Wang, Hui ; Song, Yan ; Bai, Yuxian ; Ma, Taiyang ; Shu, Yongqian ; Zhang, Bo ; Zhong, Haijun ; He, Yifu

We report a multicenter, phase 2 study evaluating the efficacy of pucotenlimab, an anti-PD-1 antibody, in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, and potential biomarkers for response. Overall, 100 patients with previously treated, advanced solid tumors centrally confirmed as dMMR or MSI-H received pucotenlimab at 200 mg every 3 weeks. The most common cancer type is colorectal cancer (n = 71). With a median follow-up of 22.5 months, the objective response rate is 49.0% (95% confidence interval 38.86%-59.20%) as assessed by the independent review committee, while the median progression-free survival and overall survival have not been reached. Grade ≥3 treatment-related adverse events were observed in 18 patients. For the biomarker analysis, responders are enriched in patients with mutations in the KMT2D gene. Pucotenlimab is an effective treatment option for previously treated advanced dMMR/MSI-H solid tumors, and the predictive value of KMT2D mutation warrants further research. This study is registered with ClinicalTrials.gov: NCT03704246.

01 Sep 2023·Cancer communications (London, England)

Low level of ARID1A contributes to adaptive immune resistance and sensitizes triple-negative breast cancer to immune checkpoint inhibitors.

Article

Author: Ni, Ting ; Li, Bin ; Shao, Zhi-Ming ; Yang, Meng-Di ; Tao, Zhong-Hua ; Wang, Bi-Yun ; Yang, Yu ; Zhang, Jian ; Wang, Ye ; Huang, Sheng-Lin ; Huang, Lei-Huan ; Hu, Xi-Chun ; Jin, Juan ; Chen, Xin-Yu

BACKGROUND:

Immune checkpoint inhibitors (ICIs) shed new light on triple-negative breast cancer (TNBC), but only a minority of patients demonstrate response. Therefore, adaptive immune resistance (AIR) needs to be further defined to guide the development of ICI regimens.

METHODS:

Databases, including The Cancer Genome Atlas, Gene Ontology Resource, University of California Santa Cruz Genome Browser, and Pubmed, were used to screen epigenetic modulators, regulators for CD8⁺ T cells, and transcriptional regulators of programmed cell death-ligand 1 (PD-L1). Human peripheral blood mononuclear cell (Hu-PBMC) reconstruction mice were adopted for xenograft transplantation. Tumor specimens from a TNBC cohort and the clinical trial CTR20191353 were retrospectively analyzed. RNA-sequencing, Western blotting, qPCR and immunohistochemistry were used to assess gene expression. Coculture assays were performed to evaluate the regulation of TNBC cells on T cells. Chromatin immunoprecipitation and transposase-accessible chromatin sequencing were used to determine chromatin-binding and accessibility.

RESULTS:

The epigenetic modulator AT-rich interaction domain 1A (ARID1A) gene demonstrated the highest expression association with AIR relative to other epigenetic modulators in TNBC patients. Low ARID1A expression in TNBC, causing an immunosuppressive microenvironment, promoted AIR and inhibited CD8⁺ T cell infiltration and activity through upregulating PD-L1. However, ARID1A did not directly regulate PD-L1 expression. We found that ARID1A directly bound the promoter of nucleophosmin 1 (NPM1) and that low ARID1A expression increased NPM1 chromatin accessibility as well as gene expression, further activating PD-L1 transcription. In Hu-PBMC mice, atezolizumab demonstrated the potential to reverse ARID1A deficiency-induced AIR in TNBC by reducing tumor malignancy and activating anti-tumor immunity. In CTR20191353, ARID1A-low patients derived more benefit from pucotenlimab compared to ARID1A-high patients.

CONCLUSIONS:

In AIR epigenetics, low ARID1A expression in TNBC contributed to AIR via the ARID1A/NPM1/PD-L1 axis, leading to poor outcome but sensitivity to ICI treatment.

03 Apr 2023·Scientific reports

HX009, a novel BsAb dual targeting PD1 x CD47, demonstrates potent anti-lymphoma activity in preclinical models.

Article

Author: Xiong, Lingxin ; He, Xiangfei ; Ke, Hang ; Sun, Ruilin ; Zhang, Faming ; Ju, Cunxiang ; Zhang, Lei ; Chen, Cen ; O'Connor, Owen A. ; Wang, Jingjing ; Mao, Binchen ; Guo, Sheng ; Li, Qi-Xiang ; An, Xiaoyu ; Wang, Yueying ; Tu, Xiaolong

Both PD1/PD-L1 and CD47 blockades have demonstrated limited activity in most subtypes of NHL save NK/T-cell lymphoma. The hemotoxicity with anti-CD47 agents in the clinic has been speculated to account for their limitations. Herein we describe a first-in-class and rationally designed bispecific antibody (BsAb), HX009, targeting PD1 and CD47 but with weakened CD47 binding, which selectively hones the BsAb for tumor microenvironment through PD1 interaction, potentially reducing toxicity. In vitro characterization confirmed: (1) Both receptor binding/ligand blockade, with lowered CD47 affinity; (2) functional PD1/CD47 blockades by reporter assays; (3) T-cell activation in Staphylococcal-enterotoxin-B-pretreated PBMC and mixed-lymphocyte-reaction. In vivo modeling demonstrated antitumor activity in Raji-B and Karpass-229-T xenograft lymphomas. In the humanized mouse syngeneic A20 B-lymphoma (huCD47-A20) HuGEMM model, which has quadruple knocked-in hPD1xhPD-L1xhCD47xhSIRPα genes and an intact autologous immune-system, a contribution of effect is demonstrated for each targeted biologic (HX008 targeting PD1 and SIRPα-Fc targeting CD47), which is clearly augmented by the dual targeting with HX009. Lastly, the expression of the immune-checkpoints PD-L1/L2 and CD47 seemed co-regulated among a panel of lymphoma-derived-xenografts, where HX009 maybe more effective in those with upregulated CD47. Our data warrants HX009's further clinical development for treating NHLs.

News (Medical) associated with Pucotenlimab

22 Aug 2023

·www.biospace.com

Crown Bioscience Enables HanX Biopharmaceutical to Progress HX009 to Clinical Trials

SAN DIEGO--(BUSINESS WIRE)-- Crown Biosciences Inc., a global contract research organization (CRO) and JSR Life Sciences company, has announced that its collaborative work with HanX Biopharmaceuticals, Inc. (“HanX”), employing a unique and broad portfolio of preclinical modeling in support of HanX’s successful FDA Investigational New Drug (IND) application, has been published in Scientific Reports, a journal within the Nature portfolio. The study demonstrated that HX009, an investigational “first-in-class” PD-1 x CD47 bispecific antibody, binds differentially to both PD-1 and CD47 with strong affinity to PD-1 but weakened affinity to CD47. This feature enables better targeting to the tumor microenvironment (TME) and minimizes potential hematological toxicity. In addition, HX009 exhibited enhanced T-cell activating capability over HX008, an approved and marketed anti-PD-1 monoclonal antibody in China. Specifically, this new study showed that HX009 exerted robust anti-lymphoma activity in two cell-derived xenograft (CDX) models (Raji B-lymphoma and Karpas-299 T-lymphoma) with high CD47 expression. Additionally, custom patient-derived xenograft (PDX) models established by Crown Bioscience, further confirmed the efficacy of CD47 targeting by HX009. In addition, an A20-hCD47 mouse B-lymphoma model developed in hSIRPα/hCD47/PD-1/PD-L1 quadruple knock-in genetically engineered mouse models (HuGEMMTM) mice, HX009 exhibited superior anti-lymphoma efficacy compared to CD47 or PD-1 targeting alone. These results imply a synergy between CD47 and PD-1 dual targeting. These Crown Bioscience studies played an important role in supporting the application of HX009 for the treatment of lymphoma in clinical trials. They also played an instrumental role in supporting the clearance of HanX’s FDA Investigational New Drug (IND) application, which has paved the way for a U.S.-based Phase I/II clinical study that will assess HX009 in the treatment of relapsed/refractory lymphoma. This exciting result exemplifies the value that Crown Bioscience brings to its partners as they seek better solutions for advancing their oncology research. Specifically, the collaboration between scientists from both organizations, utilizing an integrated solution approach, leveraged a comprehensive collection of preclinical and translational studies to investigate the anti-lymphoma activity of HX009. While HX009 has been studied in Phase I clinical studies in Australia and China in both solid tumor and lymphoma indications, HanX is now expanding the next phase of clinical development globally in a variety of clinical indications. Henry Li, PhD, Cofounder, Chief Executive Officer and Chief Scientific Officer of HanX, stated: “We are delighted with the exceptional outcomes of our partnership with Crown Bioscience. By leveraging a wide breadth of in vivo solutions such as cell-derived xenograft (CDX), patient-derived xenograft (PDX), and genetically engineered mouse models, together with translational applications, we were able to conduct a comprehensive evaluation of HX009’s anti-lymphoma activity prior to clinical trials.” Ludovic Bourre, PhD, VP, Research and Innovation at Crown Bioscience, added: “Our commitment goes beyond identifying the right candidate drug or drug combination. Crown Bioscience consistently invests in expanding the number and diversity of models for drug development, ensuring that our models accurately represent the relevant clinical disease biology and provide a solid foundation for making informed decisions about novel therapeutics such as HanX's HX009.” This work has laid a robust foundation for the advancement of HX009 as a highly promising therapeutic agent in the treatment of relapsed/refractory lymphoma. To learn more, Crown Bioscience and HanX are hosting an exclusive webinar on Tuesday August 29, 2023, where a team of scientists will discuss the implications of the study. The webinar will provide a unique opportunity to engage with the experts. ### About Crown Bioscience Crown Bioscience, a JSR Life Sciences company, is a global CRO that provides preclinical and translational platforms to help our customers advance their research and development in oncology, immuno-oncology, and immune-mediated inflammatory diseases. We are the exclusive preclinical CRO to offer tumor organoid services with the well-established Hubrecht Organoid Technology. In addition, we have developed the largest commercially available PDX collection in the world. We focus on helping our customers develop novel therapies to maximize the chances that patients receive the right treatment at the right time. Founded in 2006, Crown Bioscience has 14 facilities across the United States, Europe, and Asia. For more information or to get in touch, please visit About HanX HanX is a global biopharmaceutical company that develops innovative immuno-oncology antibody-based drugs, such as novel BsAb antibodies to address significant unmet medical needs. HanX brings together experts from both China and the U.S., to aid in activities ranging from early discovery, process development, business development, and clinical research. The company aims to accomplish its ambitious goals by relying on in-house research and development in combination with external global collaborations.

Phase 1Immunotherapy

23 Aug 2022

·www.prnewswire.com

Bladder Cancer Clinical Trial Pipeline Insights Featuring 100+ Companies | DelveInsight

DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. LAS VEGAS, Aug. 23, 2022 /PRNewswire/ -- DelveInsight's ' Bladder Cancer Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline bladder cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the bladder cancer pipeline domain. Key Takeaways from the Bladder Cancer Pipeline Report DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. Leading bladder cancer companies such as CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co., Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others are evaluating novel bladder cancer drugs candidate to improve the treatment landscape. Key bladder cancer pipeline therapies in various stages of development include CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. In July 2022, The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023. In June 2022, CG Oncology announced the interim data on two ongoing clinical studies to be presented at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.The first poster presentation reports on efficacy and safety data from a global Phase 2 study (CORE1) of CG0070 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The second poster presentation centers on a Phase 1b/2 study (CORE2) of CG0070 in combination with OPDIVO®(nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. In May 2022, Asieris Pharmaceuticals announced that the ANTICIPATE Study will be presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting on June 3-7, 2022, in Chicago. This is a study of taking oral APL-1202 in combination with BeiGene's tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC). In March 2022, Protara Therapeutics, Inc. announced that the Company had dosed the first patient in ADVANCED-1, its Phase 1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC). In January 2022, Vaxiion Therapeutics, announced the U.S. Food and Drug Administration had cleared the company's Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy. In December 2021, LintonPharm Co., Ltd., announced that the first patient had been dosed in the Company's Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Request a sample and discover the recent advances in bladder cancer treatment @ Bladder Cancer Pipeline Report The bladder cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage bladder cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the bladder cancer pipeline landscape. Bladder Cancer Overview Bladder cancer usually starts in the cells that line the inside of the bladder. It typically affects adults over the age of 70 and is more common in men. Bladder cancer is the fifth most prevalent type of cancer in the general population and the fourth most common in males. When detected early, bladder cancer usually responds well to bladder cancer treatment. Smoking is among the most common bladder cancer causes. Blood in the urine is usually the first sign of bladder cancer. Other bladder cancer symptoms may include urine pain or burning, as well as a change in urinary habits. This can include frequent urination or the need to urinate but being unable to do so. The tests used for bladder cancer diagnosis include biopsy, cystoscopy, urine cytology, imaging tests, and others. Find out more about bladder cancer drugs in development @ Bladder Cancer Drugs A snapshot of the Bladder Cancer Pipeline Drugs mentioned in the report: Learn more about the novel and emerging bladder cancer pipeline therapies @ Bladder Cancer Clinical Trials Bladder Cancer Therapeutics Assessment The bladder cancer pipeline report proffers an integral view of the bladder cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Bladder Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Parenteral, Oral, Intravenous, Subcutaneous, Intramuscular Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem cell, Vaccine Therapeutics Assessment By Mechanism of Action: Cell death stimulants, Granulocyte macrophage colony stimulating factor agonists, Interleukin-15 receptor agonists, DNA synthesis inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Gene transference, IFNA2B expression stimulants, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants Key Bladder Cancer Companies: CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co.,Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others Key Bladder Cancer Pipeline Therapies: CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. Dive deep into rich insights for bladder cancer drugs, visit @ Bladder Cancer Treatment Table of Contents For further information on the bladder cancer pipeline therapeutics, reach out @ New Drug for Bladder Cancer Treatment Related Reports Bladder Cancer Market Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 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 bladder cancer companies including RemeGen Co., Ltd., Taiho Oncology, Inc., Xennials Therapeutics, Flame Biosciences, among others. Bladder Cancer Epidemiology Forecast Bladder Cancer Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted bladder cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Muscle Invasive Bladder Cancer Pipeline Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key muscle invasive bladder cancer companies, including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Muscle Invasive Bladder Cancer Market Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 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 muscle invasive bladder cancer companies including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Non Muscle Invasive Bladder Cancer Pipeline Non Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non muscle invasive bladder cancer companies, including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Non Muscle Invasive Bladder Cancer Market Non Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 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 non muscle invasive bladder cancer companies including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Other Trending Reports Persistent Depressive Disorder Market | Gene Therapy for Ocular Rare Disease Market | Congestive Heart Failure Market | CRISPR Therapies Pipeline | Desmoplastic Small Round Cell Tumors Market | India Healthcare Outlook Report | Psychosis Market | Dental Lasers Market | Primary Immune Deficiency Market I Dyslipidemia Market | Lateral Epicondylitis Disease Market | Castration-Resistant Prostate Cancer Market | Metrorrhagia Market | Global Messenger RNA-based Vaccines and Therapeutics Market | Negative Pressure Wound Therapy Systems Market | US Healthcare Outlook Report | Mucinous Cystic Neoplasms Market | Hot Flashes Market | Varicose Veins - Market | Hemostats Market | Injectable Drug Delivery Devices Market | Breast Pumps Market | Physiotherapy Equipment Market | Trastuzumab Biosimilars Insight | Deep Brain Stimulation Devices Market | Retinoblastoma Market | Venous Stenosis Market | Tumor Ablation Market | Substance Abuse Market | Insulin Glargine Biosimilar Insight | Interspinous Spacers Market | Anti-hypertension Market Related Healthcare Blogs Bladder Cancer Highlights From ASCO GU 2022 Non Small Cell Lung Cancer Market Outlook Rare Cancers Market Domain About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

CollaborateAntibodyGene TherapyBiosimilarFirst in Class

25 Jul 2022

·www.prnewswire.com

Anti-PD-1 monoclonal antibody Puyouheng™ (HX-008, Pucotenlimab injection) Co-developed by LEPU BIOPHARMA and HANX BIOPHARMACEUTICALS was approved for marketing in China by NMPA

HANGZHOU, China, July 25, 2022 /PRNewswire/ -- Anti-PD-1 monoclonal antibody – PuyouhengTM (HX-008, pucotenlimab injection), was conditionally approved by the National Medical Products Administration (NMPA) for marketing in China to treat patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, specifically: Patients with advanced colorectal cancers have progressed following previous treatment with a fluoropyrimidine, oxaliplatin and irinotecan; Patients with other advanced solid tumors that have progressed following at least previous first-line therapy with no satisfactory alternative treatment options. The approval is based on a multi-center, open-label, phase II clinical study with a primary study endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST1.1. As of December 4, 2021, a total of 100 patients with histologically confirmed advanced solid tumors that are identified as having MSI-H/dMMR by the central Laboratory were enrolled in the study. They were given 200 mg of pucotenlimab by intravenous drip every 3 weeks (Q3W). The median follow-up duration for the ITT population was 22.5 months. And the ORR for the ITT population was 49.0% (95% CI: 38.86%, 59.20%), with 9 cases of complete response (CR) and 40 cases of partial response (PR). In the subgroup of patients with colorectal cancers who had failed previous triplet therapy (a fluoropyrimidine, oxaliplatin, and irinotecan), the ORR was 50.0% (95% CI: 31.30%, 68.70%). The results of the study showed that pucotenlimab monotherapy was safe and effective in patients with unresectable or metastatic MSI-H/dMMR advanced solid tumors who have failed previous standard therapy. The expected clinical endpoints were achieved, indicating that patients can benefit significantly from the therapy. The results of the clinical study were first published at the 2021 American Society of Clinical Oncology (ASCO) annual meeting. "We are thrilled to see the approval of pucotenlimab, which validates our years of collaboration with Lepu Biopharma", said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals, Inc., "I'm very glad to see the first indication of pucotenlimab was approved in China. The clinical research data of pucotenlimab for MSI-H/ dMMR solid tumors is outstanding and the approval brings new hope to better meet the demands of clinical treatment. Pucotenlimab is the first product launched by Lepu Biopharma as well as a significant milestone in the company's evolution towards Biopharma", commended by Dr. Sui Ziye, CEO of Lepu Biopharma. About Puyouheng (HX-008, pucotenlimab injection) Puyouheng (pucotenlimab injection) is a humanized IgG4 monoclonal antibody against human PD-1 discovered by HanX Biopharmaceuticals, It can bind to PD-1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2. Puyouheng (pucotenlimab injection) adopts an innovative molecular design to prolong its half-life, showing strong clinical anti-tumor activity and good safety. The innovative use of antibody engineering technology to introduce triple mutations in the Fc region improves the binding affinity of FcRn, thereby prolonging the drug's half-life significantly, showing its promising clinical efficacy and drug compliance in patients [5]. Compared with all rival anti-PD-1 antibodies that have been marketed or entered phase III clinical trials, the mean half-life of Puyouheng (pucotenlimab injection) is 21.8 days (single dosing) and 38.2 days (steady-state). In addition, the prolonged half-life does not cause additional adverse events, indicating the excellent clinical efficacy of the drug. About HANX BIOPHARMACEUTICALS Hanx Biopharmaceutical Co., Ltd. is a global biopharmaceutical company that develops innovative immune-oncology antibody drugs. It brings together well-known experts, from both China and United States, from early discovery, process development, business development, to clinical research. The company leverages expertise to develop patented high-affinity long half-life antibody screening and tumor-immune cell specific tumor-targeting antibody GPSmAb technology platforms. The company develops innovative treatments to address significant unmet medical needs, and to help patients around the world. The company aims to accomplish goal through in-house research development as well as external global collaborations. About LEPU BIOPHARMA (2157.HK) LEPU BIOPHARMA is committed to innovation, focusing on the discovery, development and commercialization of first-in-class and best-in-class drug candidates in targeted anti-tumor therapy and immunotherapy drugs in China and the US. The company's mission is to develop the safest, most effective, and most accessible drugs for patients to improve their quality of life and fill the huge demand gap in the medical system. The company attaches great importance to the continuous construction of its commercialization capabilities, and strives to achieve a strong transformation from core technologies to finished drugs as well as the goal of industrialization. At present, the product pipeline of LEPU BIOPHARMA covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including 1 commercially marketing drug and 7 drug candidates at the clinical stage (5 of which are ADC drugs) and the combination therapies of multiple major drug candidates at the clinical stage. The company houses the leading ADC drug candidate pipeline in China. SOURCE Hanx Biopharmaceutical Co., Ltd.

100 Deals associated with Pucotenlimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Melanoma	CN	Lepu Biopharma Co., Ltd.	20 Sep 2022
Microsatellite instability-high cancer	CN	Lepu Biopharma Co., Ltd.	19 Jul 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Microsatellite instability-high colorectal cancer	Phase 3	CN	Xikang(Wuhan)Biopharmaceutical Co., Ltd.	28 Feb 2023
Microsatellite instability-high colorectal cancer	Phase 3	CN	Lepu Biopharma Co., Ltd.	28 Feb 2023
Embolism	Phase 3	CN	Xikang(Wuhan)Biopharmaceutical Co., Ltd.	03 Feb 2023
Embolism	Phase 3	CN	Lepu Biopharma Co., Ltd.	03 Feb 2023
Metastatic melanoma	Phase 3	CN	Taizhou Hanzhong Biomedical Co., Ltd.	31 Dec 2022
Metastatic Colorectal Carcinoma	Phase 3	CN	Taizhou Hanzhong Biomedical Co., Ltd.	20 Dec 2022
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 3	CN	Taizhou Hanzhong Biomedical Co., Ltd.	20 Dec 2022
Gastroesophageal junction adenocarcinoma	Phase 3	CN	Lepu Biopharma Co., Ltd.	25 Mar 2022
stomach adenocarcinoma	Phase 3	CN	Lepu Biopharma Co., Ltd.	25 Mar 2022
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Taizhou Hanzhong Biomedical Co., Ltd.	25 Sep 2020

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04508803 (CHANGEABLE, ASCO2024) Manual	Phase 2	Metastatic breast cancer BRCA2 Mutation (Germline) \| BRCA1 Mutation (Germline)	37	Niraparib+ HX008	zoqdjtcnla(qybtevzlgh) = lclruiznsg yaraabkplu (toabbdvrah ) View more	Positive	24 May 2024
NCT04508803 (CHANGEABLE, ASCO2024) Manual	Phase 2		37	HX008+niraparib+pyrotinib	zoqdjtcnla(qybtevzlgh) = vqrsaonlsn yaraabkplu (toabbdvrah ) View more	Positive	24 May 2024
NCT05688605 (Phase I/II study, ASCO2024) Manual	Phase 1/2	EGFR mutation Solid Tumors EGFR-positive	33	Pucotenlimab(HX008) + MRG003	fudphdhsfe(fgevalhriq) = pverblcxbc ahoylkuerv (lzwydmowaj ) View more	Positive	24 May 2024
NCT04750083 (ESMO2023) Manual	Phase 2	Non-squamous non-small cell lung cancer First line EGFR mutation \| ALK mutation	43	Pucotenlimab 200mg+pemetrexed+platinum	gkvkpmfrtt(szfhdnampr) = faoxdagfow wqpbpwlzuu (mjjdgljbyn, 38.9, 59.2) View more	Positive	23 Oct 2023
NCT05068453 (ASCO2023) Manual	Phase 1	Liver metastases	10	Pucotenlimab+OH2	vuisnargro(nfygqndloq) = qbpsjamrjb lthaqmjkxd (mpfjswxgiu ) View more	Positive	31 May 2023
NCT04741165 (ASCO2023) Manual	Phase 2	Advanced Hepatocellular Carcinoma First line	75	Bevacizumab+Pucotenlimab (C1)	mucuvdbnen(drmiufskbt) = uvfegjutbq oxlsbvuifh (ubrcezmoho ) View more	Positive	26 May 2023
NCT04741165 (ASCO2023) Manual	Phase 2	Advanced Hepatocellular Carcinoma First line	75	lenvatinib+Pucotenlimab (C2)	mucuvdbnen(drmiufskbt) = jeriduuuwp oxlsbvuifh (ubrcezmoho ) View more	Positive	26 May 2023
SABCS2023	Phase 1	Metastatic Triple-Negative Breast Carcinoma First line	31	Pucotenlimab (HX008) + gemcitabine + cisplatin	gswvveplsu(uubrxovcqt) = vmbwsnelfp lptqqkjgyc (tpjtgrpyxk, 55.4% - 88.1%) View more	Positive	24 Apr 2023
NCT04749485 (Pubmed)	Phase 2	Locally Advanced Melanoma	119	Pucotenlimab 3 mg/kg	nocbekxblx(uieriajnoy) = kgytwfqnzi eqqeidfoir (nbebxqbrdm, 13.370% - 28.506%) View more	-	06 Feb 2023
NCT03704246 (ASCO_GI2023) Manual	Phase 2	Mismatch repair-deficient Solid Tumors \| Microsatellite Instability-high Solid Tumors Second line MSI-H \| dMMR	100	200mg pucotenlimab	kbuggyqecf(mtemjlwcgl) = lmbsugvtfo lyrusrfzli (dkymdcycut, 38.86 - 59.20) View more	Positive	24 Jan 2023
CTR20191353 (Pubmed) Manual	Phase 1	Triple Negative Breast Cancer First line triple-negative	31	Gemcitabine+Cisplatin+Pucotenlimab	ecfywpoaeg(fwqpxjvowf) = neutropenia (74.1%), anemia (35.5%), thrombocytopenia (32.3%), hypocalcemia (9.7%), hypokalemia (9.7%), and alanine aminotransferase increased (6.5%). cbdcwotfvg (kthyjfdjpg )	Positive	02 Aug 2022
HX008 (CSCO2021)	Phase 2	Advanced gastric carcinoma \| Gastrooesophageal junction cancer	35	HX008	egzhcsaato(dgjuytamgc) = 所有受试者均发生治疗相关不良事件(TRAEs)，常见(>10%)的≥3级TRAEs有：贫血(25.7%)、中性粒细胞计数降低(20.0%)、血小板计数降低(20.0%)、白细胞计数降低(17.1%)、乏力(17.1%)和手足综合征(11.4%) acvdrlxdgh (kdxawdunno )	Positive	25 Sep 2021

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