A Phase 1 Trial of Naptumomab Estafenatox (NAP) in Combination With Pembrolizumab (Pembro) Preceded by Obinutuzumab (Obi) in Patients With Urothelial Cancers

The main purpose of this study is to test the safety and tolerability of naptumomab estafenatox (NAP), the planned experimental (investigational) drug, in combination with pembrolizumab following a single pretreatment with Obinutuzumab (Obi), and determine its side effects and effects on urothelial cancer. It is hypothesized that adding NAP will make pembrolizumab more effective. Participants will receive 2 infusions of Obi prior to the treatment of NAP in combination with pembrolizumab. This treatment is given in 21-day cycles for 6 cycles with NAP administered daily for 4 consecutive days, Days 1-4, + pembrolizumab given on day 2 of each cycle. After these six cycles of therapy, participants will continue to receive pembrolizumab every 3 weeks, without NAP, for a total number of up to 34 pembrolizumab administrations since cycle 1. After the treatment of Obi is completed, participants will start NAP in combination with pembrolizumab and continue that treatment in a 28 day cycle period. NAP will be given for a total of 6 cycles and pembrolizumab will be given every 21 days for a total of up to 2 years. After stopping treatment, participants have follow-up visits or phone calls about every 12 weeks until the study is closed.

Start Date01 Nov 2023

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

NCT04880863 / CompletedPhase 2

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.

Start Date26 Oct 2021

Sponsor / Collaborator

NeoTX Therapeutics Ltd.Startup

[+1]

EUCTR2006-004956-19-BG / Not yet recruitingNot Applicable

A randomized, open-label, multi-center, phase II/III study on treatment with ABR-217620 combined with IFN-a vs. IFN-a alone in patients with advanced renal cell carcinoma

Start Date09 Mar 2007

Sponsor / Collaborator

Active Biotech AB

100 Clinical Results associated with Naptumomab estafenatox

100 Translational Medicine associated with Naptumomab estafenatox

100 Patents (Medical) associated with Naptumomab estafenatox

930

Literatures (Medical) associated with Naptumomab estafenatox

01 Feb 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A simple eco-friendly spectrofluorimetric resolution approach for the simultaneous determination of Naproxen and Domperidone in pharmaceutical formulation and human plasma; assessment of method greenness

Article

Author: Abdel Rahman, Mona A. ; Mostafa, Noha S ; Mostafa, Noha S. ; Ayish, Nada S ; Abdel Rahman, Mona A ; Ayish, Nada S.

Designing new verified methods for the determination of pharmaceutical compounds in their specified formulation without prior separation and with high sensitivity taking in consideration analytical performance and simplicity has become a major concern of pharmaceutical quality control units. In the present work, a new simple and eco-friendly spectrofluorimetric method was developed and validated for the determination of Naproxen (NAP) and Domperidone (DOM) in their binary mixture, pharmaceutical formulation in addition to human plasma without prior separation. The proposed method is based on measuring the second derivative fluorescence intensity for NAP at 345 nm and for DOM at 292 after excitation at 235 nm without any interference from each other. All the variables affecting fluorescence intensity were studied and optimized. The proposed method showed excellent sensitivity with limit of detection (LOD) 12.286 ng/mL and 3.240 ng/mL for NAP and DOM respectively. In compliance with the ICH requirements, the optimized method was validated and was successfully utilized for the determination of both drugs in their pharmaceutical formulation and human plasma. Finally, the greenness of the proposed method was assessed using different assessment tools.

01 Dec 2024·SLEEP MEDICINE REVIEWS

To nap or not? Evidence from a meta-analysis of cohort studies of habitual daytime napping and health outcomes

Review

Author: Li, Ming-Zhe ; Yuan, Kai ; Deng, Jia-Hui ; Yang, Ying-Bo ; Bao, Yan-Ping ; Wen, Xin ; Li, Jiao ; Zheng, Yong-Bo ; Chen, Yu ; Gong, Yi-Miao ; Zhang, Zhao-Hui ; Yu, Zhou-Long ; Yang, Lu-Lu ; Sun, Jie ; Shi, Jie ; Wang, Yu-Mei ; Shi, Le ; Yu, Gui-Hua ; Shi, Pei-Pei ; Zhao, Hao-Yun ; Yang, Yong-Feng ; Lu, Lin ; Vitiello, Michael V ; Li, Su-Xia

Habitual daytime napping is a common behavioral and lifestyle practice in particular countries and is often considered part of a normal daily routine. However, recent evidence suggests that the health effects of habitual daytime napping are controversial. We systematically searched PubMed, Web of Science, Embase, and Cochrane Library databases from inception to March 9, 2024, to synthesize cohort studies of napping and health outcome risk. A total of 44 cohort studies with 1,864,274 subjects aged 20-86 years (mean age 56.4 years) were included. Overall, habitual napping increased the risk of several adverse health outcomes, including all-cause mortality, cardiovascular disease, metabolic disease, and cancer, and decreased the risk of cognitive impairment and sarcopenia. Individuals with a napping duration of 30 min or longer exhibited a higher risk of all-cause mortality, cardiovascular disease, and metabolic disease, whereas those with napping durations less than 30 min had no significant risks. No significant differences in napping and health risks were observed for napping frequency, percentage of nappers, sample size, sex, age, body mass index, follow-up years, or comorbidity status. These findings indicate that individuals with a long napping duration should consider shortening their daily nap duration to 30 min or less.

01 Nov 2024·EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Characterization of naproxen salts with amino acid esters and their application in topical skin preparations

Article

Author: Duchnik, Wiktoria ; Lendzion-Bieluń, Zofia ; Kucharski, Łukasz ; Ossowicz-Rupniewska, Paula ; Adamiak-Giera, Urszula ; Janus, Ewa ; Nowak, Anna ; Świątek, Ewelina ; Kopciuch, Ewelina

In the study, the modification of naproxen (NAP) with esters of four amino acids (AAs): glycine (GlyOiPr), L-proline (ProOiPr), L-leucine (LeuOiPr), and L-serine (SerOiPr) isopropyl ester was performed to improve water solubility and enhance the permeation of the drug through the skin in comparison to the parent NAP. The NAP derivatives were prepared using the equimolar ratio of the components. In-depth NMR and FTIR analysis revealed that the salts formed with the proton transfer from the carboxylic group of NAP to the amine group of the appropriate AA ester. The NAP salts exhibited improved solubility in water and PBS solution (pH 7.4) when compared to parent NAP. The values of the partition coefficient (log P_O/W) for prepared salts were lower than for NAP, however, the salts maintained hydrophobic character determined by the positive values of log P. The In vitro permeation through the pig skin performed in Franz diffusion cells showed that all NAP salts exhibited a higher cumulative mass of permeated NAP (Q_24h) than the parent acid. The highest permeation value was noted for [ProOiPr][NAP], with a pseudo-steady state flux (J_ss) 32.5 µg NAP cm^-2h^-1, and Q_24h = 246.4 µg NAP cm^-2, it was 2.5 % of the applied dose. Moreover, topical preparations with [ProOiPr][NAP] and NAP were prepared based on two vehicles - Celugel® and Pentravan®- approved in pharmacy recipes. The permeation experiments through the Strat-M® showed, that both the J_ss and Q_24h of permeated drug from preparations containing [ProOiPr][NAP], were statistically several times greater than from the respective preparations with the unmodified acid. Additionally, preparations with [ProOiPr][NAP] provided significantly improved permeation of NAP than two commercial preparations, one of which contained naproxen as the acid and the other - as the sodium salt.

News (Medical) associated with Naptumomab estafenatox

30 May 2024

·www.biospace.com

Sarah Cannon Research Institute to Present Latest Cancer Research Insights at 2024 ASCO® Annual Meeting

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, announced today that it will highlight its latest research insights through more than 145 presentations at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from Friday, May 31 – Tuesday, June 4 in Chicago, Ill. Over 100 investigators from across SCRI’s network are co-authors on clinical trial updates that will be showcased at the Annual Meeting, including data from more than 65 early-phase clinical trials. “We look forward to connecting with colleagues from around the world at ASCO’s Annual Meeting to discuss the latest developments in advancing therapies for cancer patients,” says Howard A. “Skip” Burris, III, MD, President, SCRI. “The depth and breadth of clinical research being presented by SCRI experts signifies our commitment to accelerating drug development and providing greater access to cutting-edge therapies closer to home.” For a comprehensive list of abstracts and presentations, visit SCRI’s ASCO Site. To learn more about our research experts, visit our Leadership Page. Noteworthy Presentations Breast Cancer Erika Hamilton, MD, SCRI, will present “H3B-6545 in Women with Locally Advanced/Metastatic Estrogen Receptor-Positive, HER2 Negative Breast Cancer” in an oral presentation during the Breast Cancer – Metastatic Rapid Oral Abstract Session on Monday, June 3 from 11:30 a.m. - 1:00 p.m. CDT in Hall D1. Joyce O'Shaughnessy, MD, SCRI at Texas Oncology I The US Oncology Network, will deliver “Association of MammaPrint Index and 3-Year Outcome of Patients with HR+HER2- Early-Stage Breast Cancer Treated with Chemotherapy with or without Anthracycline” in an oral presentation during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. - 4:15 p.m. CDT in E451. Denise Yardley, MD, SCRI, will give the oral presentation, “Baseline Characteristics and Efficacy Endpoints for Patients with Node-Negative HR+/HER2− Early Breast Cancer: NATALEE Trial” during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. - 4:15 p.m. CDT in E451. Lung Cancer David Spigel, MD, SCRI, will discuss “ADRIATIC: Durvalumab as Consolidation Treatment for Patients with Limited-Stage Small-Cell Lung Cancer” in an oral presentation during the Plenary Session on Sunday, June 2 from 1:00 p.m. - 4:00 p.m. CDT in Hall B1. Clinical Trial Access Ishwaria Subbiah, MD, MS, SCRI, will present “5-Year Multicenter Analysis of Clinical Trial Participation and Total Cost of Care for Older Adults with Cancer” in an oral presentation during the Quality Care/Health Services Research Rapid Oral Abstract Session on Monday, June 3 from 1:15 p.m. - 2:45 p.m. CDT in S102. In addition to scientific presentations, SCRI leadership will participate in and lead ASCO sessions, including: Meredith McKean, MD, MPH, SCRI, is a discussant in the Oral Abstract Session, Melanoma/Skin Cancers, on Friday, May 31 from 2:45 p.m. - 5:45 p.m. CDT in Hall D1, where she will present “PD-1–Refractory Advanced Melanoma: How Do We Get to the Finish Line?” Dr. Burris will deliver the “Presentation and Recognition of Conquer Cancer Top Donors” in the Opening Session on Saturday, June 1 from 9:30 a.m. - 12:00 p.m. CDT in Hall B1. Dr. Hamilton will chair the Clinical Science Symposium, Next-Generation Antibody-Drug Conjugates: The Revolution Continues, and present “The ABCs of ADCs: What Does the Future Hold?” on Sunday, June 2 from 9:45 a.m. - 11:15 a.m. CDT in Hall D1. Abdul Naqash, MD, SCRI at OU Health - Stephenson Cancer Center, will chair the Oral Abstract Session, Developmental Therapeutics—Immunotherapy, on Monday, June 3 from 11:30 a.m. - 2:30 p.m. CDT in Hall D2. Andrew McKenzie, PhD, SCRI & Genospace, and Vivek Subbiah, MD, SCRI, will serve as panelists in the Case-Based Panel, Beyond Tumor Types: Advancing Tumor-Agnostic Drug Development and the Role of the Tumor Microenvironment, on Monday, June 3 from 3:00 p.m. - 4:00 p.m. CDT in Hall D2. Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute, will present “Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma,” during the Breaking Ground in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Novel Therapies Beyond PD-L1 Immunotherapy Education Session on Tuesday, June 4 from 8:00 a.m. - 9:15 a.m. CDT in S100a. Additional Poster Presentations with SCRI First Authors Saturday, June 1 “Validation of PD-L1 as a Predictive Biomarker of Response in Operable Gastroesophageal Adenocarcinoma: A Meta-Analysis and Meta-Regression of Neoadjuvant Chemoimmunotherapy Trials,” Antonella Cammarota, MD, SCRI at HCA Healthcare UK, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Phase 1 Trial Safety and Efficacy of Ragistomig, a Bispecific Antibody Targeting PD-L1 and 4-1BB, in Advanced Solid Tumors,” Gerald Falchook, MD, SCRI at HealthONE, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “NALIRIFOX versus Nab-Paclitaxel and Gemcitabine in Treatment-Naïve Patients with Metastatic Pancreatic Ductal Adenocarcinoma: Updated Overall Survival Analysis with 29-Month Follow-Up of NAPOLI 3,” Maen Hussein, MD, SCRI at Florida Cancer Specialists & Research Institute, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Safety and Preliminary Efficacy of EIK1001 in Combination with Atezolizumab in Participants with Advanced Solid Tumors,” & “Preliminary Results from a Phase 1 Study of AC699, an Orally Bioavailable Chimeric Estrogen Receptor Degrader, in Patients with Advanced or Metastatic Breast Cancer,” Manish Patel, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Results from Phase 1a/1b Analyses of TTX-080, a First in Class HLA-G Antagonist, in Combination with Cetuximab in Patients with Metastatic Colorectal Cancer and Head and Neck Squamous Cell Carcinoma,” Susanna Ulahannan, MD, MMEd, SCRI at OU Health - Stephenson Cancer Center, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Phase 1/2 Study of NGM707, an ILT2/ILT4 Dual Antagonist Antibody, in Advanced Solid Tumors: Interim Results from Dose-Escalation,” Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. - 12:00 p.m. CDT, Hall A Sunday, June 2 “Trastuzumab Deruxtecan vs Trastuzumab Emtansine in Patients with HER2+ Metastatic Breast Cancer: Updated Survival Results of DESTINY-Breast03,” Dr. Hamilton, 9:00 a.m. - 12:00 p.m. CDT, Hall A. Monday, June 3 “Subcutaneous Epcoritamab Administered Outpatient for Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma: Results from Phase 2 EPCORE NHL-6," David Andorsky, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9 a.m. - 12 p.m. CDT, Hall A “MYTX-011 in Patients with Previously Treated Locally Advanced or Metastatic NSCLC: Initial Dose Escalation Results in The Phase 1 KisMET-01 Study,” Melissa Johnson, MD, SCRI, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Clinical Activity and Safety of Naptumomab Estafenatox and Docetaxel in Patients with Checkpoint Inhibitor –Pretreated Advanced/Metastatic Non-Small Cell Lung Cancer: Preliminary Results of a P2 Trial,” Tim Larson, MD, SCRI at Minnesota Oncology I The US Oncology Network, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Treatment of Acute Myeloid Leukemia with Orca-T,” Jeremy Pantin, MD, SCRI at TriStar Centennial, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Safety and Tolerability of Durvalumab + Carboplatin/Paclitaxel Followed by Durvalumab ± Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer in the DUO-E/GOG-3041/ENGOT-EN10 Trial,” Jessica Thomes Pepin, MD, SCRI at Minnesota Oncology I The US Oncology Network, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “OPTec: A Phase 2 Study to Evaluate Outpatient Step-Up Administration of Teclistamab, a BCMA-Targeting Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma,” Robert Rifkin, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Clinical Trial Participation and End-of-Life Care Among Older Adults: A Multi-Center Longitudinal Observational Cohort Analysis of 121,717 Patients with Cancer,” Dr. I. Subbiah, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Performance of Comprehensive Genomic Profiling versus Single Gene Testing in Guideline-Recommended Biomarker Selection in Non-Small Cell Lung Cancer,” Dr. V. Subbiah, 1:30 p.m. - 4:30 p.m. CDT, Hall A. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI joined with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Learn more about our research offerings. View source version on businesswire.com: Contacts Becca Gelman Becca.Gelman@scri.com Source: Sarah Cannon Research Institute View this news release online at:

ASCOPhase 1Phase 2Clinical ResultImmunotherapy

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

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03 Jun 2022

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Clinical Catch-Up: NIH's COVID-19 Trial and All About ASCO

With the American Society of Clinical Oncology (ASCO) Annual Meeting being held over the weekend, it was a hectic week for clinical trial news and updates. Here’s a look at just some of them. COVID-19-Related The National Institutes of Health (NIH) reported results from part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trial, specifically its ACTIVE-1 Immune Modulators clinical trial. The study found that both Bristol Myers Squibb’s Orencia (abatacept) and Johnson & Johnson's Remicade (infliximab) demonstrated a strong but not statistically significant improvement in time to recovery by the day of discharge from the hospital. This was the primary endpoint of the study. There were also substantial improvements in the trial’s key secondary endpoints of mortality and clinical status at 28 days. Non-COVID-19-Related Immutep presented new interim data from Part A of its Phase II TACTI-002 in first-line non-small cell lung cancer (NSCLC). The study is evaluating eftilagimod alpha in combination with Merck’s anti-PD-L1 checkpoint inhibitor Keytruda (pembrolizumab). Eftilagimod is a soluble LAG-3 protein. The drug combination demonstrated an improved overall response rate (ORR) of 37.3% in its intent to treat population and compared to 36.1% presented at last year’s ASCO meeting. Responses were seen in all PD-L1 subgroups with 32% ORR in patients with no or low PD-L1 levels, and the combination demonstrated an improved disease control rate of 73.3% compared to 66.7% at last year’s meeting. The company is also presenting an abstract for the design of its ongoing Phase IIb TACTI-003 trial at the meeting. That trial is evaluating the same drug combination as first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma. InxMed presented data from its Phase Ib trial of IN10018 in platinum-resistant recurrent ovarian cancer. The drug is an oral inhibitor of focal adhesion kinase. It was dosed with pegylated liposomal doxorubicin. Denali Therapeutics and Biogen initiated dosing on the Phase IIb LUMA trial of BIIB122 in early-stage Parkinson’s disease. BIIB122 is an investigational small molecule inhibitor of LRRK2 discovered and developed by Denali. Secarna Pharmaceuticals announced its partner Lipigon Pharmaceutical dosed the first patient in its Phase I trial of Lipisense. Lipisense is an antisense oligonucleotide for rare lipid-related diseases. PDS Biotechnology announced the expansion of its VERSATILE-002 trial of PDS0101 in combination with Merck’s Keytruda. PDS0101 is based on the company’s Versamune system and Infectimune T-cell activating technology platforms. Celltrion Healthcare presented post-hoc analysis of pivotal Phase III studies showing that the subcutaneous formulation of Remsima (infliximab) was associated with significantly greater clinical outcomes than IV formulation of the drug at week 30 in patients with rheumatoid arthritis. The drug is biosimilar to infliximab. Attgeno completed its Phase I trial of Supernitro for acute pulmonary hypertension. Supernitro is a potent substance that works by releasing NO in the pulmonary blood vessels. Attgeno also received the go-ahead in Sweden to initiate a Phase II trial of Supernitro for acute pulmonary hypertension after cardiac surgery. RhoVac AB reported that its RV001 (onilcamotide) failed to demonstrate its superiority over placebo in the Phase IIb BRaVac trial in prostate cancer and biochemical recurrence after curative therapy. RV001 stimulates the T-cells to spot and destroy cells that carry the RhoC protein. BioMarin Pharmaceutical announced updated results from its ongoing Phase I/II trial of valoctocogene roxaparvovec in severe hemophilia A. The drug is investigational gene therapy. Eureka Therapeutics and City of Hope treated the first patient with GPC3-positive advanced hepatocellular carcinoma (HCC) with ECT204, an experimental T cell therapy. The therapy targets ARTEMIS T cells. Horizon Therapeutics announced data from the Phase III trial of Uplizna in neuromyelitis optica spectrum disorder (NMOSD) patients with genetic variations. Uplizna is a highly specific CD19 B-cell depleting agent that targets an extended range of B cells. TScan Therapeutics received the go-ahead from the FDA to evaluate TSC-101 for hematologic malignancy patients undergoing allogeneic hematopoietic cell transplantation. TSC-101 targets the minor histocompatibility antigen HA-2. PolyPid completed enrollment in the Phase III SHIELD I study of D-PLEX100 for the prevention of surgical site infections in abdominal surgery. D-PLEX100 leverages Polymer-Lipid Encapsulation matrix (PLEX) technology with Active Pharmaceutical Ingredients for a prolonged and continuous release of the broad-spectrum antibiotic doxycycline. AffaMed Therapeutics dosed the first patient in its Phase I trial of AM712 for retinal diseases. The drug is a bispecific biologic molecule blocking both VEGF and Ang-2. BlueRock Therapeutics completed enrollment of its Phase I trial of pluripotent stem cell-derived dopaminergic neurons in Parkinson’s disease. The goal is to evaluate the safety, tolerability and preliminary efficacy of BRT-DA01. Antengene Corporation dosed the first patient in the Phase I STAMINA-001 trial of ATG-037 for patients with locally advanced or metastatic solid tumors. It is being tested alone and in combination with Merck’s Keytruda. ATG-037 is an oral small molecule CD73 inhibitor. Eledon Pharmaceuticals announced positive topline data from its Phase IIa trial of Tegoprubart for amyotrophic lateral sclerosis (ALS). The drug is a humanized monoclonal antibody that inhibits CD40 Ligand (CD40L). PAI Life Sciences dosed the first patient in a trial of SchistoShield, the company’s preventive vaccine against schistosomiasis. Schistosomiasis is caused by parasitic flatworms. Memo Therapeutics initiated a Phase I trial of MTX-005 against BK polyomavirus infection in renal transplant patients. The drug is a therapeutic antibody that neutralizes all strains of BKV at extremely low concentrations. Axsome Therapeutics published results from the pivotal Phase III GEMINI trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). It was published in The Journal of Clinical Psychiatry. The study demonstrated rapid, substantial and statistically significant improvement in depressive symptoms and induction of remission. The drug is an NMDA receptor antagonist, using a proprietary formulation and dose of dextromethorphan and bupropion. Sage Therapeutics and Biogen reported their Phase III SKYLARD study demonstrated promising results for women with severe postpartum depression. The trial evaluated zuranolone, an oral GAMA signaling pathway modulator. NeuroSense Therapeutics enrolled the first patient in its Phase IIB PARADIGM trial of PrimeC for amyotrophic lateral sclerosis (ALS). The drug is a novel, patented formulation of specific doses of two FDA-approved drugs, ciprofloxacin and celecoxib. ReAlta Life Sciences dosed the first patient in its Phase Ib inhaled lipopolysaccharide (LPS) challenge trial in support of RLS-0071 for severe asthma. RLS-0071 is a dual-action complement inhibitor and innate anti-inflammatory peptide in development for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases. NeoTX completed the first stage of a Simon 2 stage Phase IIa trial of naptumomab estafenatox (NAP) in combination with docetaxel in advanced non-small cell lung cancer (NSCLC) patients previously treated with chemotherapy and checkpoint inhibitors. NAP is a Tumor Targeted Superantigen (TTS) molecule; TTS binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating an expanding tumor specific immune cells that are redirected from the periphery to the tumor. Indivior enrolled the first patient in the Phase IIb trial of AEF0117 for moderate to severe cannabis use disorder. The drug is a first-in-class synthetic Signaling Specific Inhibitor. TauRx Pharmaceuticals announced unblinding of initial data from the completion of the randomized part of their Phase III LUCIDITY trial of HMTM for Alzheimer’s disease. Participants receiving the drug showed a substantially slower rate of decline. AbbVie presented full results from two studies from the Phase III SELECT-AXIS 2 program of Rinvoq (upadacitinib) in active non-radiographic axial spondylarthritis and patients with treatment-refractory active ankylosing spondylitis with an inadequate response to biologic disease-modifying antirheumatic drugs. Both studies hit the primary endpoints. AlgoTx received clearance from the FDA for a Phase II trial of ATX01 for chemotherapy-induced peripheral neuropathy. The trial will be in the pain of CIPN in adult cancer survivors. SynDevRx opened a Phase Ib/II trial of evexomostat in triple-negative breast cancer and baseline insulin resistance. The drug will be tested in combination with standard-of-care treatment Halaven (eribulin). Evexomostat binds irreversibly to MetAP2, triggering downstream improvements in the metabolic hormones insulin, leptin and adiponectin, regulation of key lipids, and inhibiting of the bFGF and VEGF-C. Dyve Biosciences presented data from the Phase II TARGETS study of DYV702 for pain associated with acute gout flares. DYV702 is a patented transdermal cream formulation of sodium bicarbonate. Trethera announced that the independent safety review committee unanimously recommends further trial advancement after reviewing favorable data from the Phase Ia dose escalation trial of TRE-515. The drug is a first-in-class deoxycytidine kinase inhibitor to treat solid tumors. Abivax published results from its Phase IIa trial of obefazimod for moderate to severe active rheumatoid arthritis. The drug has a novel mechanism of action based on the upregulation of a single, specific micro-RNA with anti-inflammatory properties called miR-124. Bristol Myers Squibb announced results from the primary analysis of the Phase II PILOT trial of Breyanzi (lisocabtagene maraleucel) in r/r large B-cell lymphoma after first-line therapy in patients who were not deemed candidates for high-dose chemotherapy and hematopoietic stem cell transplant. Breyanzi is a CAR-T therapy. Alterity Therapeutics initiated enrollment in its Phase II trial of ATH434 for Multiple System Atrophy. MSA is a rare neurodegenerative disease similar to Parkinson’s. ATH434 is engineered to decrease the toxic accumulation of alpha-synuclein and preserve nerve cells by restoring normal iron balance in the brain. Viracta Therapeutics announced that the Safety Monitoring Committee for its ongoing Phase Ib/II trial of Nana-val in patients with EBV+ solid tumors has approved advancing to the next dose level. Nana-val (nanatinostat and valganciclovir): nanatinostat is an oral histone deacetylase (HDAC) inhibitor being developed by Viracta. Valganciclovir is an antiviral agent. InVivo Therapeutics completed enrollment in the INSPIRE 2.0 Study for acute spinal cord injury patients. The trial is to evaluate the Neuro-Spinal Scaffold. MaaT Pharma announced the completion of its Phase Ib CIMON trial of MaaT033 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HRMS) having received intensive chemotherapy. The drug is a high-richness, high-diversity Microbiome Ecosystem Therapy (MET). VecctivBio dosed the first two patients in the Phase II STARGAZE trial of apraglutide in steroid-refractory gastrointestinal acute Graft-versus-Host Disease. The drug is a next-generation, long-acting GLP-2 analog. Vaxart reported positive preliminary data from its recently completed Phase Ib trial of its oral norovirus vaccine candidate in elderly adults. The data demonstrated a robust immune response across all doses. Braxia Scientific Corp. presented positive preliminary data from a Phase II trial of psilocybin-assisted therapy for treatment resistant depression. The data supported the feasibility of the company’s proprietary psilocybin-assisted therapy protocol with clinically meaningful improvements in depression severity. Cullinan Oncology presented updated data from its Phase I/IIa trial of CLN-081 in EGFR Exon 20 insertion mutation positive NSCLC. The drug is an orally available small molecule, next-generation, irreversible EGFR inhibitor. Biogen and Ionis Pharmaceuticals announced the Phase III VALOR trial results and an open-label extension (OLE) trial of tofersen for amyotrophic lateral sclerosis (ALS). Toferson is an antisense drug that binds to SOD1 messenger RNA (mRNA), helping it degrade by RNase-H, which decreases the synthesis of SOD1 protein production. Novo Nordisk announced results from two Phase IIIa trials of icodec, the company’s once-weekly insulin. It was non-inferior to Sanofi’s insulin glargine, Lantus. Acelyrin, Affibody and Inmagene Biopharmaceuticals reported positive Phase II data of izokibep in psoriatic arthritis. The drug appears to have better efficacy than current standard of care. Izokibep is an antibody mimetic, IL-17A inhibitor. Legend Biotech received clearance from the FDA for a Phase I trial of LB1908. The drug is an autologous CAR T-cell therapy targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with r/r gastric, esophageal or pancreatic cancers. Daiichi Sankyo presented data from a Phase I/II trial demonstrating patritumab deruxtecan demonstrated clinically meaningful and durable responses in two early-stage trials in previously treated patients with HER3 expressing metastatic breast cancer or advanced NSCLC without EGFR-activating mutations. The drug is a potential first-in-class HER3 directed antibody drug conjugate. Novocure and Zai Lab announced that their Phase II pilot study of Tumor Treating Fields (TTF) with standard-of-care as first-line treatment in gastric adenocarcinoma hit its primary endpoint of objective response rate with supportive signals across secondary endpoints. TTF is an investigational device for the treatment of gastric cancer, using electric fields that disrupt cancer cell division. OliX Pharmaceuticals completed patient enrollment in the Phase IIa trial of OLX101A. OLX101A is an investigational therapy for the treatment of hypertrophic scars. Incannex Healthcare announced positive data from the Phase II trial of IHL-42X for obstructive sleep apnea. The drug is a form of unique medical cannabis. Biogen and Bio-Thera Solutions presented positive Phase III data for BIIB800. The drug is a biosimilar candidate referencing Genentech’s Actemra/Roactemra (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. OncXerna Therapeutics presented new clinical data from an investigator-sponsored Phase II trial of bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients. Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor. Kazia presented positive final data from a Phase II trial of paxalisib in newly diagnosed GBM. The drug is a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway. PTC Therapeutics announced encouraging preliminary safety and efficacy data from its Phase Ib trial of unesbulin in advanced leiomyosarcoma (LMS) patients. The drug is an oral tubulin binding agent that arrests tumor cells in the G2/M phase, including cancer stem cells. The Janssen Pharmaceutical Companies of Johnson & Johnson announced primary data from the Phase III SHINE trial. It demonstrated that the combination of once-daily oral Umbruvica (ibrutinib) plus bendamustine-rituximab (BR) and rituximab maintenance significantly decreased the risk of disease progression or death by 25% in patients 65 years or older with newly diagnosed mantle cell lymphoma (MCL).

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100 Deals associated with Naptumomab estafenatox

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KEGG	Wiki	ATC	Drug Bank
-	Naptumomab estafenatox	-	DB12807

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Renal Cell Carcinoma	Phase 3	BG	Active Biotech AB	01 Jan 2007
Advanced Renal Cell Carcinoma	Phase 3	RO	Active Biotech AB	01 Jan 2007
Advanced Renal Cell Carcinoma	Phase 3	RU	Active Biotech AB	01 Jan 2007
Advanced Renal Cell Carcinoma	Phase 3	UA	Active Biotech AB	01 Jan 2007
Advanced Renal Cell Carcinoma	Phase 3	GB	Active Biotech AB	01 Jan 2007
Renal Cell Carcinoma	Phase 3	BG	Active Biotech AB	01 Jan 2007
Renal Cell Carcinoma	Phase 3	RO	Active Biotech AB	01 Jan 2007
Renal Cell Carcinoma	Phase 3	RU	Active Biotech AB	01 Jan 2007
Renal Cell Carcinoma	Phase 3	UA	Active Biotech AB	01 Jan 2007
Kidney Neoplasms	Phase 3	GB	Active Biotech AB	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04880863 (ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer	32	Naptumomab estafenatox + Docetaxel	zvihcxxjek(qwkfxvsbpy) = xpxnikxsat givyjbmdeb (gxwvhcsdch, 1.3 - 20.8) View more	Positive	24 May 2024
NCT00420888 (Pubmed \| Clin Cancer Res) Manual	Phase 2/3	Renal Cell Carcinoma	513	IFNα+Naptumomab Estafenatox	sovgrhwhlp(buscttmrmm) = wepgtswmpa xmysuvtthh (kbsbnsjzai ) View more	Negative	01 Jul 2016
NCT00420888 (Pubmed \| Clin Cancer Res) Manual	Phase 2/3	Renal Cell Carcinoma	513	IFNα	sovgrhwhlp(buscttmrmm) = yvrnifcfbz xmysuvtthh (kbsbnsjzai ) View more	Negative	01 Jul 2016

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