An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects

To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.

Start Date01 Nov 2014

Sponsor / Collaborator

UCB Biopharma SRL

[+5]

NCT02167711

/ CompletedPhase 2IIT

Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study

The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.

Start Date17 Sep 2014

Sponsor / Collaborator

The Chinese University of Hong Kong

NCT01802814

/ CompletedPhase 3IIT

International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

Start Date01 May 2014

Sponsor / Collaborator

Charité - Universitätsmedizin Berlin

[+11]

100 Clinical Results associated with Epratuzumab

100 Translational Medicine associated with Epratuzumab

100 Patents (Medical) associated with Epratuzumab

199

Literatures (Medical) associated with Epratuzumab

01 Jul 2024·PEDIATRIC DRUGS

Inotuzumab Ozogamicin: First Pediatric Approval

Review

Author: Dhillon, Sohita

Inotuzumab ozogamicin (BESPONSA™) is a CD22-targeted monoclonal antibody drug conjugate (ADC) developed by Pfizer for the treatment of CD22-postive B-cell precursor acute lymphoblastic leukaemia (ALL). Inotuzumab ozogamicin comprises a humanized IgG4 anti-CD22 monoclonal antibody covalently linked to the potent DNA-binding cytotoxic agent N-acetyl-gamma-calicheamicin dimethylhydrazide (CalichDMH) via a linker. Inotuzumab ozogamicin binds to CD22-expressing tumour cells, facilitating the delivery of conjugated CalichDMH, which after intracellular activation induces double strand DNA breaks, ultimately leading to cell cycle arrest and apoptotic cell death. Inotuzumab ozogamicin is approved in the USA, Europe and several countries worldwide for the treatment of relapsed or refractory CD22-positive B-cell precursor ALL in adults. On 6 March 2024, inotuzumab ozogamicin received its first pediatric approval in the USA for this indication in patients aged ≥ 1 years. Inotuzumab ozogamicin has since been approved in Japan in March 2024 for the same indication in pediatric patients. This article summarizes the milestones in the development of inotuzumab ozogamicin leading to this first approval for the treatment of relapsed or refractory CD22-positive B-cell precursor ALL in pediatric patients.

01 Feb 2024·CPT: pharmacometrics & systems pharmacology

Model‐based meta‐analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus

Article

Author: Roy, Sanjeev ; Mateo, Cristina Vazquez ; Goteti, Kosalaram ; Klopp-Schulze, Lena ; Venkatakrishnan, Karthik ; Gillespie, William R ; French, Jonathan ; Garcia, Ramon ; Guenther, Oliver ; Li, Ying ; Benincosa, Lisa

Abstract:

Several investigational agents are under evaluation in systemic lupus erythematosus (SLE) clinical trials but quantitative frameworks to enable comparison of their efficacy to reference benchmark treatments are lacking. To benchmark SLE treatment effects and identify clinically important covariates, we developed a model‐based meta‐analysis (MBMA) within a latent variable model framework for efficacy end points and SLE composite end point scores (BILAG‐based Composite Lupus Assessment and Systemic Lupus Erythematosus Responder Index) using aggregate‐level data on approved and investigational therapeutics. SLE trials were searched using PubMed and www.clinicaltrials.gov for treatment name, SLE and clinical trial as search criteria that resulted in four data structures: (1) study and investigational agent, (2) dose and regimen, (3) baseline descriptors, and (4) outcomes. The final dataset consisted of 25 studies and 81 treatment arms evaluating 16 different agents. A previously developed (K Goteti et al. 2022) SLE latent variable model of data from placebo arms (placebo + standard of care treatments) was used to describe aggregate SLE end points over time for the various SLE placebo and treatment arms in a Bayesian MBMA framework. Continuous dose‐effect relationships using a maximum effect model were included for anifrolumab, belimumab, CC‐220 (iberdomide), epratuzumab, lulizumab pegol, and sifalimumab, whereas the remaining treatments were modeled as discrete dose effects. The final MBMA model was then used to benchmark these compounds with respect to the maximal efficacy on the latent variable compared to the placebo. This MBMA illustrates the application of latent variable models in understanding the trajectories of composite end points in chronic diseases and should enable model‐informed development of new investigational agents in SLE.

01 Feb 2023·Annals of the rheumatic diseases

Clinical trials in systemic lupus erythematosus: the dilemma—Why have phase III trials failed to confirm the promising results of phase II trials?

Review

Author: Lorenzo-Vizcaya, Ana ; Isenberg, David Alan

Systemic lupus erythematosus (SLE) is an autoimmune rheumatic disease of unknown aetiology, characterised by the production of auto-antibodies and formation of immune complexes against self-antigens and complement activation. This inflammatory response can lead to tissue infiltration and eventually, to organ damage.Patients with SLE invariably have periods of relapse and remission. Flares can occur even when the patient is on seemingly adequate treatment, which suggests that more effective therapies are necessary for the management of SLE. Thus, trials with many drugs against different targets, such as CD22, IL-12 and IL-23 or tyrosine kinases, have been carried out in recent years.A frustrating feature of some of the biologic drugs used to treat SLE has been the reporting of successful phase II trials followed by failures of the phase III trials.In this review, we will focus on phase II and III trials carried out with epratuzumab (anti CD22), baricitinib (Janus kinases inhibitor), rigerimod (P140 peptide) and ustekinumab (IL-12 and IL-23 inhibitor) and consider the reasons for their ultimate failure to ‘make the grade’. Likewise, we will try to explain the possible reasons that can influence why good results may be obtained in phase II trials and lead to undue optimism.

News (Medical) associated with Epratuzumab

06 Nov 2023

·www.prnewswire.com

LRA Highlights Groundbreaking Lupus Research at ACR Convergence 2023

This information is brought to you by the Lupus Research Alliance and Lupus Therapeutics and is not sponsored by, nor a part of, the American College of Rheumatology. 30+ presentations of studies funded by the LRA spanning a broad spectrum of research areas Positive results from Phase 2/3 clinical studies supported by LRA affiliate Lupus Therapeutics point to potential new treatments Lupus Therapeutics' PALS Program helps overcome challenges of diverse lupus patient trial participation SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- The Lupus Research Alliance (LRA), the largest non-governmental non-profit funder of lupus research worldwide, is pleased to announce results from more than 30 studies supported by the LRA and its clinical research affiliate Lupus Therapeutics will be presented at ACR Convergence 2023, the annual meeting of the American College of Rheumatology. Studies will represent the full continuum of research that the LRA and Lupus Therapeutics support, from innovative foundational research to lupus clinical trials evaluating potential new treatments. "The LRA and Lupus Therapeutics are extremely proud of the tremendous work we have supported that will contribute to the dynamic scientific dialogue at this important rheumatology meeting,' commented LRA President and CEO Albert T. Roy. "We also look forward to many presentations of exciting clinical research, including results from CAR-T cell therapy studies that built on pioneering work funded by the LRA and have the potential to shift the lupus treatment paradigm." FOUNDATIONAL RESEARCH FUNDED BY THE LRA LRA-funded investigators will be presenting their recent breakthroughs across a broad spectrum of lupus research, including the impact of lupus on various organs such as the skin, kidney, and brain, the contribution of the gut microbiome to lupus, dysregulation of a variety of immune cell types underlying lupus, and more. ORAL PRESENTATIONS Sunday, Nov. 12 APOL1 High Risk Genotype in SLE: A Genes in Context Story Abstract # NA, 12:00 PM – Room 11A-B ROCK1 Orchestrates B-cell Differentiation Under Stress Abstract #0729, 2:30 PM – Room 30D-E Lupus Nephritis Flares Linked to Platelet Activation During Gut Pathobiont Blooms Abstract #0851, 5:00 PM, Exhibit Hall A-B Monday, Nov. 13 CXCL13+ T cell differentiation in systemic lupus erythematosus is controlled by opposing effects of aryl hydrocarbon receptor and type I interferon Abstract #1580, 11:15 AM – Exhibit Hall A-B Metabolic Mechanisms that Control Inflammation and Immune-related Disorders Plenary Session II, 12:00 PM – Room 30D-E Keratinocyte VISTA Suppresses Skin IFN-I Production by Regulating DNA Damage Repair and Cytosolic DNA Sensing Abstract #1586, 2:15 PM – Room 32A-B Single-Cell RNA Sequencing Reveals Cellular Drivers of UV-mediated Skin Injury in Cutaneous Lupus Abstract #1599, 2:30 PM – Room 6F/6C Identifying Potential Neuroimaging Biomarkers of Neuropsychiatric Lupus in Children Using Deep Learning Abstract #1625, 3:00 PM – Room 7A-B Tuesday, Nov. 14 Longitudinal Gut Microbiome Analyses and Blooms of Pathogenic Strains during Lupus Disease Flares Abstract #NA, 8:20 AM – Room 6F/6C Development of Engineered Smith-Specific Regulatory T Cells to Treat Lupus Nephritis Abstract #2444, 2:15 PM – Room 26A-B Targeting of Endothelial Dysfunction in Lupus Nephritis: Effect on Human Renal Endothelial Cell Gene Expression and Outcomes in Murine Lupus Nephritis Abstract #2445, 2:30 PM – Room 26A-B UV Light Exposure Induces a Type I Interferon Dependent Activation and Migration of Inflammatory Dendritic Cells to Local Lymph Nodes Abstract #2448, 3:15 PM – Room 26A-B Wednesday, Nov. 15 In Situ Adaptive Immunity in Human Lupus Nephritis Abstract # N/A, 8:30 AM – Room 29A-D POSTER PRESENTATIONS – Poster Hall Sunday, Nov. 12 Elevated Serum Levels of S100A8/A9 Discriminate Systemic Lupus Erythematosus Patients with Cognitive Impairment from Patients Without Impairment Abstract #0558, 9:00 AM Comparison of Plasma Protein Profiles and Endothelial Function in Patients with Pediatric-Onset Systemic Lupus Erythematosus and Healthy Controls Abstract #0568, 9:00 AM Monday, Nov. 13 Specificity of Brain-Intrinsic and Hematopoietic-Derived Mechanisms in Mediating Neuropsychiatric Symptoms of Systemic Lupus Erythematosus Abstract #0890, 9:00 AM Adverse Childhood Experiences in a Paediatric Systemic Lupus Erythematosus Cohort Abstract #1241, 9:00 AM Agreement Between Parent- and Self-Report of Executive Function in Adolescents with Childhood-Onset Systemic Lupus Erythematosus Abstract #1242, 9:00 AM Proinflammatory Neutrophils and NETs Mediate Skin and Kidney Inflammation During Lupus Flare in Asymptomatic Lupus-prone Mice Triggered by UVB Abstract #0920, 9:00 AM IL-4 Acts Through Aryl Hydrocarbon Receptor to Antagonize TLR7-induced Double Negative 2 B Cells in Lupus Abstract #0925, 9:00 AM Examining the Relationship Between Socioenvironmental Factors and Cognitive Functioning in Youth with Childhood-Onset Systemic Lupus Erythematosus Abstract #1226, 9:00 AM Longitudinal Assessment of Self-reported Executive Function in Youth with Childhood-Onset Lupus Abstract #1229, 9:00 AM Complement Deposition on Extracellular Mitochondria Induces Platelet Activation in Vitro Abstract #0900, 9:00 AM The Cellular and Spatial Type I Interferon Response Following Skin Exposure to Ultraviolet Light Abstract #0894, 9:00 AM Tuesday, Nov. 14 Brain Activity Patterns and Behavioural Performance in SLE Patients During a Spatial Working Memory and Sustained Attention Task Abstract #2258, 9:00 AM The Effects of Systematic Lupus Erythematosus Related Cognitive Impairments on Activities of Daily Living and Life Role Participation: A Qualitative Framework Study Abstract #2259, 9:00 AM Association of Mycophenolate and Azathioprine Use with Cognitive Function in Systemic Lupus Using a Bayesian Longitudinal Item-response Theory Model Abstract #2290, 9:00 AM CLINICAL TRIALS SUPPORTED BY LUPUS THERAPEUTICS As the clinical research affiliate of the LRA, Lupus Therapeutics collaborates with biotechnology and pharmaceutical companies, as well as lupus experts from their Lupus Clinical Investigators Network (LuCIN) to help design and conduct high-quality, patient-centric, and diverse lupus studies, including several with results being presented at ACR Convergence 2023. ORAL PRESENTATIONS Tuesday, Nov. 14 Efficacy and Safety of ABBV-599 High Dose (Elsubrutinib 60 mg and Upadacitinib 30 mg) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: A Phase 2, Double-blind, Placebo-controlled Trial Abstract #2488, 2:00 PM – Ballroom 20D Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients Abstract #2487, 2:00 PM – Ballroom 20D POSTER PRESENTATIONS – Poster Hall Monday, Nov. 13 Treatment with Upadacitinib in Patients with Systemic Lupus Erythematosus Results in the Inhibition of B-Cell–related Biomarkers: Analysis of the M19-130 (SLEek) Phase 2 Study Abstract #1489, 9:00 AM Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE: A Post Hoc Analysis of Dapirolizumab Pegol and Epratuzumab Clinical Trial Data Abstract #1503, 9:00 AM Steroid-sparing Effects of Afimetoran (BMS-986256), an Equipotent Toll-like Receptor (TLR)7 and TLR8 Antagonist, in a Lupus Mouse Model Abstract #0897, 9:00 AM Transcriptomic Analysis of the Impact of Iberdomide on Patients with SLE Abstract #1694, 4:00 PM Tuesday, Nov. 14 Dapirolizumab Pegol Impacts Important Immunologic Pathways in SLE: Pharmacodynamic Analysis of B Cell and Type I Interferon Pathways from a Phase 2b Trial Abstract #2333, 9:00 AM Modulation of B Cell and Interferon Pathways by Ianalumab in Patients with Systemic Lupus Erythematosus: Findings from a Phase 2 Clinical Trial Abstract #2342, 9:00 AM WORK CONDUCTED THROUGH THE LUPUS THERAPEUTICS PALS PROGRAM Patient Advocates for Lupus Studies (PALS) is a peer support program that aims to improve participation in lupus clinical trials through increased education and availability of information about clinical trials. Individuals living with lupus who have clinical research act as peer educators, or PALs, to deliver educational sessions to others living with lupus. The PALS program was piloted from 2019-2021 and demonstrated significant increases in knowledge about, attitudes toward, and intentions to participate in lupus clinical trials among program participants. POSTER PRESENTATION – Poster Hall Sunday, Nov. 12 Barriers and Facilitators to Recruiting Underrepresented Participants for Clinical Trials: Insights from the Lupus Clinical Investigators Network (LuCIN) Abstract #0183, 9:00 AM WORK CONDUCTED BY THE ACCELERATING MEDICINES PARTNERSHIP The LRA is a partner in Accelerating Medicines Partnership® Autoimmune Mediated Disease (AMP® AIM), which brings together 20 organizations from the public, private, and nonprofit sectors to accelerate the identification and validation of new therapeutic targets by reconstructing shared immune response pathways through spatial and multi-omics technologies. The project is managed by the FNIH and builds on the success of AMP RA/SLE in which LRA was also a partner. The presentation of results from an AMP® AIM lupus study is noted below. ORAL PRESENTATION Monday, Nov. 13 Single Cell Transcriptomics in Kidney Tissue from African American Patients Enrolled in the Accelerating Medicines Partnership (AMP) Implicates Tubular Cells in the Pathogenesis of APOL1 Associated Lupus Nephritis Abstract #1695, 4:30 PM – Room 6F/6C About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women, often striking during the childbearing years of 15-45. Blacks/African Americans, Hispanics, Asians, and Native Americans are at two to three times greater risk than Caucasians for developing lupus. In lupus, the immune system, meant to defend against infections, produces antibodies that mistakenly recognize the body's own cells as foreign, prompting other immune cells to attack and potentially damage organs such as the kidneys, brain, heart, lungs, blood, skin, and joints. About Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately, cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. About Lupus Therapeutics Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with academic institutions, biotechnology, and pharmaceutical partners through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in the treatment of lupus patients. The organization elevates the patient voice, engages community stakeholders, and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit lupustherapeutics.org for more information. SOURCE Lupus Research Alliance

Phase 2Clinical Result

19 Oct 2015

·www.biospace.com

FDA Designates Pfizer’s Acute Lymphoblastic Leukemia Drug Breakthrough Status

Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL) Pfizer Inc. today announced that investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL). The Breakthrough Therapy designation was based on the results of the Phase 3 INO-VATE ALL trial, which enrolled 326 adult patients with relapsed or refractory CD22-positive ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. Topline results from the trial were announced in April 2015 and also presented at the 20th Congress of the European Hematology Association (EHA). “Inotuzumab ozogamicin is the third Pfizer oncology medicine to be granted Breakthrough Therapy designation by the FDA, underscoring our commitment to innovative research and development that addresses significant unmet needs. Breakthrough Therapy designation will allow us to work more closely with the FDA to bring this important therapy to patients as rapidly as possible,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “Advancing therapies for patients with adult acute lymphoblastic leukemia is crucial as only 10 percent of adults with ALL who relapse after first-line therapy survive five years or more with current treatment options."1 Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is “intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies."2 The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.3 About Acute Lymphoblastic Leukemia (ALL) Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with high unmet need and a poor prognosis in adults.4The current standard treatment is intensive, long-term chemotherapy.5 In 2015, it is estimated that 6,250 cases of ALL will be diagnosed in the United States6, with about 1 in 3 cases in adults. Only approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.7 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.8 About Inotuzumab Ozogamicin Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22,9 a cell surface antigen expressed on approximately 90 percent of B-cell malignancies,10 linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.11 Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing, clinical development and commercialization activities for this molecule. About Pfizer Oncology Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information, please visit . DISCLOSURE NOTICE: The information contained in this release is as of October 19, 2015. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a potential indication for inotuzumab ozogamicin, an investigational oncology therapy, for the treatment of patients with acute lymphoblastic leukemia (ALL), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data and uncertainties regarding whether the overall survival (OS) endpoint of the INO-VATE ALL study will be met; whether and when new drug applications may be filed in any jurisdictions for inotuzumab ozogamicin; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk pro by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of inotuzumab ozogamicin; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at (link is external) and . 1 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950. 2 U.S. Food and Drug Administration Safety and Innovation Act. Available at: (link is external) .Accessed July 11, 2015. 3 U.S. Food and Drug Administration Frequently Asked Questions: Breakthrough Therapies. Available at: (link is external) . Accessed July 11, 2015. 4 National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) – General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at: (link is external) . Accessed July 11, 2015. 5 American Cancer Society: Typical treatment of acute lymphocytic leukemia. Available at: (link is external) . Accessed July 11, 2015. 6 American Cancer Society: What are the key statistics about acute lymphocytic leukemia? Available at: (link is external) . Accessed February 18, 2015. 7 Manal Basyouni A. et al. Prognostic significance of survivin and tumor necrosis factor-alpha in adult acute lymphoblastic leukemia. doi:10.1016/j.clinbiochem.2011.08.1147. 8 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950. 9 Clinicaltrials.gov. A Study of Inotuzumab Ozogamicin versus Investigator’s Choice of Chemotherapy in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia. Available at: (link is external) . Accessed July 11, 2015. 10 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334. 11 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250. Contact: Media: Sally Beatty, +1 (347) 330-7867 sally.beatty@pfizer.com(link sends e-mail) or Investor: Ryan Crowe, +1 (212) 733-8160 ryan.crowe@pfizer.com Help employers find you! Check out all the jobs and post your resume .

Clinical ResultBreakthrough TherapyPhase 3Priority ReviewADC

02 Jun 2015

·www.biospace.com

Immunomedics, Inc. Announces Durable Responses In Metastatic Lung Cancer Patients Treated With Sacituzumab Govitecan

CHICAGO, June 2, 2015 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today announced that sacituzumab govitecan, the Company's lead investigational antibody-drug conjugate (ADC), demonstrated in a mid-stage clinical study promising anti-tumor activity in patients with metastatic lung cancer. These patients had either failed to respond to their last cancer therapies or their cancer had returned or progressed. Lung cancer kills more patients than any other cancers in both men and women, and is the second most commonly diagnosed cancer in the U.S. The disease is classified as small cell (SCLC) or non-small cell (NSCLC) for the purposes of treatment. NSCLC is the most common type of lung cancer, accounting for more than 85% of new diagnoses. Patients with advanced-stage NSCLC are usually treated with chemotherapy, targeted drugs, or some combination of the two. Forty-seven patients with metastatic lung cancer (25 NSCLC, 22 SCLC) have been enrolled into this multicenter study. Treatment response from these patients was assessed by computed tomography using the rules set by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1). In this study, treatment with sacituzumab govitecan produced tumor shrinkage of 30% or more in 6 of 19 patients with advanced NSCLC, or 32%. The disease control rate, which includes patients with treatment response within the range of 30% tumor shrinkage and 20% tumor growth, was 74%. An interim analysis of the length of time patients were living without their cancer progressing showed a median of 5.4 months, with 44% of patients still enjoying this survival benefit. SCLC, which accounts for 13% of new cases of lung cancer, is the more aggressive form. Treatment options for SCLC are more limited, usually involve chemotherapy alone or combined with radiation. According to the National Cancer Institute, from 1999-2006, only 2.7% of patients diagnosed with metastatic SCLC survived for more than 5 years, which was lower than the survival rate of 3.7% for patients with metastatic NSCLC. Despite the aggressive nature of the disease, 30% of 20 patients with advanced SCLC responded to sacituzumab govitecan treatments with 30% or more tumor reduction. The disease control rate in this group of lung cancer patients was 55%. With 70% of patients having had their disease progressed, the interim progression-free survival is currently at 2.4 months. Commenting on these results presented in an Oral Abstract Session at the 2015 Annual meeting of the American Society of Clinical Oncology, Dr. Michael J. Guarino of the Helen F. Graham Cancer Center & Research Institute, Newark, DE, remarked, "These efficacy results are very promising in a challenging disease, such as advanced lung cancer, with duration of response particularly worth noting." For the 25 patients who responded to sacituzumab govitecan, all 11 SCLC patients and 12 of 14 NSCLC patients, or 86%, had a time to progression that was longer than their last therapy. These patients had previously failed a median of 2.5 (range 1-7) and 3 (range 1-8) cancer treatments, respectively. Sacituzumab govitecan has a tolerable safety pro these heavily-pretreated lung cancer patients at the optimal doses of 8 and 10 mg/kg, as has been reported by the Company in triple-negative breast and gastrointestinal cancers, with 18% Grades 3 and 4 neutropenia as the major toxicity and minimal Grade 3 diarrhea (7%). "We believe these findings are compelling enough for us to consider lung cancer as another oncology indication, in addition to triple-negative breast cancer (TNBC), for further development and commercialization of sacituzumab govitecan," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "This agent has Fast Track status from FDA for treating patients with advanced, refractory TNBC, NSCLC, and SCLC," she added. Sacituzumab govitecan is a first-in-class antibody-drug conjugate (ADC) developed by the Company by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers, particularly metastatic colorectal cancers, as a part of combination therapies, so its pharmacology and properties are well-known. Dr. Gregory A. Masters, a colleague of Dr. Guarino at Helen F. Graham Cancer Center & Research Institute also participated in this multicenter study. Other Principal Investigators include Dr. Alexander N. Starodub, Indiana University Health Center for Cancer Care, Goshen, IN; Drs. Rebecca Heist and Aditya Bardia, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Dr. Wells A. Messersmith, University of Colorado Cancer Center, Aurora, CO; Dr. Allyson J. Ocean, Weill Cornell Medical College, New York, NY; and Dr. Sajeve S. Thomas, UF Health Cancer Center, Orlando, FL. About Immunomedics Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics' advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of nine clinical-stage product candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB), to whom the Company licensed epratuzumab for the treatment of all non-cancer indications worldwide. UCB expects Phase 3 data in systemic lupus erythematosus in the first half of 2015. Immunomedics is exploring epratuzumab in oncology in collaboration with independent cancer study groups. Immunomedics' most advanced candidate to which it retains worldwide rights for all indications is 90Y-clivatuzumab tetraxetan. The Company initiated a Phase 3 registration trial in January 2014 in patients with advanced pancreatic cancer and expects patient enrollment to be completed in calendar year 2016. Immunomedics' portfolio of wholly owned product candidates also includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics' most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and pre-clinical development. These include bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 267 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. Immunomedics' strength in intellectual property has resulted in a top-8 ranking in the Biotechnology industry by the Patent Board for the 2014 fiscal year. For additional information on the Company, please visit its website at . The information on its website does not, however, form a part of this press release. This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, outcomes, timing or associated costs), out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on UCB for the further development of epratuzumab for non-cancer indications, risks associated with the outcome of pending litigation and competitive risks to marketed products, and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. CONTACT: For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Corporate Secretary (973) 605-8200, extension 123 ccheng@immunomedics.com Help employers find you! 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100 Deals associated with Epratuzumab

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KEGG	Wiki	ATC	Drug Bank
D04036	Epratuzumab	-	DB04958

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	United States	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Belgium	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Brazil	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Canada	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Czechia	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	France	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Germany	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Italy	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Netherlands	UCB Pharma GmbH	01 May 2005
Systemic Lupus Erythematosus	Phase 3	Spain	UCB Pharma GmbH	01 May 2005

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00553501 \| NCT01145495 \| NCT00117975 (CALGB, Pubmed \| Cancer Med) Manual	Phase 2	Follicular Lymphoma First line	174	rituximab+R-galiximab+R-epratuzumab+R-lenalidomide (early POD)	dphxfmksrd(hrlgjxhikp) = wtvbhbmlod kdwowvtkqr (shdeqfasrk ) View more	Positive	01 Jan 2019
	Phase 2	Follicular Lymphoma First line	174	rituximab+R-galiximab+R-epratuzumab+R-lenalidomide (nonearly POD)	dphxfmksrd(hrlgjxhikp) = wtldrzxlle kdwowvtkqr (shdeqfasrk ) View more	Positive	01 Jan 2019
NCT00660881 (SL0008, Pubmed \| Arthritis Care Res (Hoboken)) Manual	Phase 2	Systemic Lupus Erythematosus	113	SoC+Epratuzumab	hjiznftior(iqieppdxft) = vzyswifhvu tcuhsjagtl (rgkujiygnt ) View more	Positive	01 Apr 2016
NCT01449071 (Pubmed \| Isr Med Assoc J \| Mod Rheumatol) Manual	Phase 1/2	Systemic Lupus Erythematosus	19	epratuzumab	wvfwyqoyfm(ntfgjtrcoo) = qincssfylr hmguxtavjo (oqkvemjuto ) View more	Positive	01 Jan 2016
	Phase 1/2	Systemic Lupus Erythematosus	19	Placebo	nnypbsppnk(jftnastbrr) = scefagokno nomtsvmmhy (bdkxaupouz )	Positive	01 Jan 2016
ACR2015	Not Applicable	-	-	Epratuzumab	zclazkwkwi(tenwmshtha) = Epratuzumab significantly inhibited CD38 expression and the generation of pre-plasma cells without significantly affecting cell survival ekpnmckbkf (yjxmqufyzr ) View more	-	09 Nov 2015
NCT00624351 (EMBLEM™, EULAR2015)	Phase 2	Systemic Lupus Erythematosus CD22 \| CD19 \| CD27 ... View more	-	Epratuzumab	wekirtwogc(wyroamzyqw) = treatment at all dose levels induced a partial but dose-independent decrease in B cell counts ajbfexjkox (dkhttwlmli ) View more	Positive	10 Jun 2015
NCT00098839 (CTgov)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia \| CD22 positive Acute Lymphoblastic Leukemia \| Recurrent Childhood Acute Lymphoblastic Leukemia	134	L-asparaginase+etoposide+doxorubicin hydrochloride+methotrexate+cytarabine+dexrazoxane hydrochloride+epratuzumab+cyclophosphamide+prednisone+leucovorin calcium+Filgrastim+therapeutic hydrocortisone+vincristine sulfate (Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly)	iyhbdrijyi = axsdxmybqf lqhfxnkgnn (jdzcjkvwzt, cpnqjdvpxq - xpavekuyju) View more	-	26 Mar 2015
NCT00098839 (CTgov)	Phase 1/2		134	L-asparaginase+etoposide+doxorubicin hydrochloride+methotrexate+cytarabine+dexrazoxane hydrochloride+epratuzumab+cyclophosphamide+prednisone+leucovorin calcium+Filgrastim+therapeutic hydrocortisone+vincristine sulfate (Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly)	iyhbdrijyi = xarexcrxkj lqhfxnkgnn (jdzcjkvwzt, juerpyqjtn - bbjzaorwms) View more	-	26 Mar 2015
NCT00301821 (CTgov)	Phase 2	Diffuse Large B-Cell Lymphoma	107	epratuzumab+cyclophosphamide+prednisone+doxorubicin hydrochloride+vincristine sulfate+Rituximab	rkkxebuiay = ltdwiaddib ehiuotgvpg (unlfdxrrxc, wsisrzyoib - jrlkcrprlh) View more	-	24 Mar 2015
NCT00553501 (CALGB 50701, CTgov)	Phase 2	Follicular Lymphoma \| CD20 positive Follicular Lymphoma	60	epratuzumab+Rituximab	amzgqqeziw = pftaynrpgd qdgazrlkxn (aheutosddi, criajzbbnp - tcmznaupas) View more	-	24 Jul 2014
EULAR2014	Phase 3	CD22	-	Epratuzumab	utuonwzvsz(bcuzmemcca) = dgjwwigynz imldtihuya (gusikjwnlo )	-	11 Jun 2014
NCT00660881 (EMBLEM, EULAR2014)	Phase 2	Systemic Lupus Erythematosus CD22 \| CD19+ \| CD3+ ... View more	203	Epratuzumab	onprxygleu(xqrtmkdeka) = udelbefhck cctdyagqlq (srphwbmksw )	Positive	11 Jun 2014

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