XTalks

JUNE 11, 2024

Askanase shares her insights on the crucial role of patient voices in shaping research, offering hope for new, more effective lupus treatments. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

JULY 25, 2022

Later lines of treatment can include monoclonal antibodies, tyrosine kinase inhibitors and antibody-drug conjugates (ADCs). XTALKS WEBINAR: Discussing the Concerns within Clinical Research in Oncology and In-Home Healthcare. ADCs consist of an antibody attached to a cytotoxin that is delivered to targeted cells.

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Antibody Drugs Clinical Trials Clinical Trials 59

pharmaphorum

APRIL 7, 2021

billion DKK ($672 million) from AbbVie after the companies struck an R&D deal to research epcoritamab, a bispecific antibody targeting CD3 and CD20 that the biotech developed in-house. Genmab has four technology platforms to draw from, with the most established being bispecific antibodies which target two receptors at once.

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Antibody Life Science Development Drugs 91

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Phase1b/2 clinical study to be conducted in the United States and several European countries. P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

XTalks

FEBRUARY 12, 2025

Similarly, Mediar Therapeutics entered a global licensing agreement with Eli Lilly to advance MTX-463, a first-in-class human IgG1 antibody that neutralizes WISP1-mediated fibrotic signaling, into a Phase II trial.

Clinical Trials 66

Clinical Trials Clinical Trials Trials FDA Approval 66

XTalks

DECEMBER 13, 2024

Blenrep is an antibody-drug conjugate (ADC) created by linking a B-cell maturation antigen (BCMA)-targeting monoclonal antibody to a potent cytotoxic agent, auristatin F, using a stable, non-cleavable linker technology. A day before GSKs announcement, Johnson & Johnson also released two promising clinical trial results.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.

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Trials Clinical Trials Clinical Trials Antibody 101

XTalks

DECEMBER 28, 2023

BillionToOne will provide its UNITY Fetal Antigen Non-invasive Prenatal Test Clinical Trial Assay (UNITY Fetal Antigen CTA) as a critical screening tool to determine the eligibility of pregnant participants. Nipocalimab is an investigational monoclonal antibody that targets the neonatal Fc receptor.

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Trials Clinical Trials Clinical Trials Antibody 97

XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

DECEMBER 5, 2024

Unlike the reigning blockbuster GLP-1 drugs on the market namely Novo Nordisks Wegovy (semaglutide) and Eli Lillys Zepbound (tirzepatide), the latter of which is a dual agonist of the GLP-1 and GIP receptors Amgens MariTide is an antibody-peptide conjugate that combines a GLP-1 receptor agonist (consisting of two peptides that mimic the GLP-1 hormone) (..)

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

XTalks

JULY 26, 2024

Merck recently announced encouraging topline results from its Phase IIb/III trial ( MALRI ) of clesrovimab (MK-1654), an investigational monoclonal antibody aimed at preventing respiratory syncytial virus (RSV) in infants. However, advancements in monoclonal antibody technology have opened new avenues for RSV prevention and treatment.

Antibody 59

Antibody Vaccination Vaccine Trials 59

XTalks

JULY 14, 2022

Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies. This is why methotrexate was paired with it, as methotrexate is used to treat inflammatory conditions like arthritis.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

XTalks

DECEMBER 5, 2024

Unlike the reigning blockbuster GLP-1 drugs on the market — namely Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide), the latter of which is a dual agonist of the GLP-1 and GIP receptors — Amgen’s MariTide is an antibody-peptide conjugate that combines a GLP-1 receptor agonist (consisting of two peptides that mimic the GLP-1 (..)

Trials 96

Trials Drugs Clinical Trials Clinical Trials 96

The Pharma Data

NOVEMBER 1, 2020

Clinical Data Expected by End of Year. Tiziana Life Sciences plc. (“Tiziana” or the “Company”). This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil.

Clinical Trials 40

Clinical Trials Clinical Trials Antibody Life Science 40

XTalks

JUNE 4, 2024

In the past, the majority of drugs evaluated in the clinical pharmacology space were small molecules. Today, there’s been a shift towards more complex, large molecules or biologics like monoclonal antibodies, antibody-drug conjugates (ADCs) and advanced therapies like RNA-based treatments and cell and gene therapies.

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Clinical Development Development Clinical Trials Clinical Trials 110

Crucial Data Soutions

NOVEMBER 9, 2021

CDS), a provider of innovative software to advance clinical research, announced today a new functionality on their mobile app, TrialKit, that enables people to self-enroll in global patient registries and participate in research directly from their smartphone or tablet. “We’re

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Antibody Clinical Trials Clinical Trials Life Science 40

XTalks

MARCH 20, 2024

When it comes to leadership in clinical trials today, what qualities are necessary to navigate the evolving landscape of clinical research effectively? Xtalks recently had the opportunity to discuss Enciso’s journey in the clinical research industry and her decision to join Regeneron.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JULY 3, 2024

Previously approved for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive, Vyvgart Hytrulo is now available for CIDP patients as weekly 30-to-90 second subcutaneous injections.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Antibody 52

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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Trials Drug Delivery Drugs Gene 83

The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Martin Carter Professor in Clinical Investigation and Head of the Laboratory of Investigative Dermatology at The Rockefeller University and Weinblatt is the co-director of Clinical Rheumatology at the Brigham and Women’s Hospital.

Development 52

Development Gene Therapy Engineer Life Science 52

XTalks

JUNE 4, 2024

Borie explains how Kyverna Therapeutics’ research and development efforts are grounded in leveraging the immune system to target the pathogenesis of autoimmune diseases such as lupus nephritis and myasthenia gravis.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

XTalks

AUGUST 2, 2024

Nemolizumab is a monoclonal antibody that targets IL-31, a cytokine responsible for many atopic dermatitis symptoms. These trials reveal nemolizumab’s potential to significantly improve key aspects of atopic dermatitis, including skin lesions, itch and sleep disturbance, in both adolescent and adult patients with moderate-to-severe cases.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

XTalks

OCTOBER 7, 2024

In addition, recent clinical research and new therapeutic approvals bring promising advances in managing rheumatic and musculoskeletal diseases (RMDs). DC-9476 also showed no toxicity, making it a potential candidate as a novel oral monotherapy.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

XTalks

SEPTEMBER 17, 2020

While clinical researchers occasionally need to identify and validate a new surrogate endpoint for a given trial, choosing endpoints that have been previously used as the basis of NDAs and BLAs can clear the path to eventual approval. Primary Hyperoxaluria Type 1 (PH1). Prevalence: 1 to 3 in 1 million.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

DECEMBER 4, 2020

Since CKD is a broad diagnosis that can have a variety of underlying causes, a beneficial focus of current research strategies has been to identify biomarkers and develop diagnostics that can help stratify patients into clinically relevant categories and help guide their management. Study Design for Chronic Kidney Disease Trials.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

NOVEMBER 5, 2020

Prior to Lonza, she led External Science and Partnering across the globe for Sanofi R&D. Previously, he was an associate director at Navigant Life Science Consulting. O’Day has been a principal investigator for more than 200 clinical trials. Schollmeier is managing director of a consulting and investment firm. .

Genome 40

Genome Genomics Medicine Life Science 40

XTalks

MAY 17, 2024

XTALKS CLINICAL EDGE: Issue 2 — Calliditas interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 13, 2023

Radiopharmaceutical therapy (RPT) uses isotopes that are conjugated to tumor-targeting agents (such as peptides, antibodies and novel small molecules). Radionuclide-ligand conjugates, including radionuclides that are conjugated to antibodies or peptides, have been studied extensively.

Clinical Trials 52

Clinical Trials Clinical Trials Trials DNA 52

XTalks

DECEMBER 6, 2024

Namilumab, a monoclonal antibody targeting granulocyte macrophage colony-stimulating factor (GM-CSF), was investigated for its potential to reduce lung inflammation and granuloma formation in sarcoidosis.

Trials 105

Trials Drugs Antibody Clinical Trials 105

XTalks

DECEMBER 30, 2024

Quality assurance (QA) plays a vital role across industries like life sciences, food, medical devices and healthcare. From life-saving drugs to ensuring the food we consume is safe, QAs impact is far-reaching. Background, Skills and Know-How A bachelors degree in law, life sciences or business is common.

Compliance 52

Compliance Engineer Life Science Manufacturing 52

XTalks

JANUARY 10, 2025

Its design incorporates monoclonal antibodies (mAbs) to ensure specificity and batch-to-batch consistency. Each test delivers rapid results in just 48 minutes, with platforms capable of processing up to 60 samples per hour making it a powerhouse for busy labs.

Hormones 105

Hormones Antibody Clinical Trials Clinical Trials 105

XTalks

SEPTEMBER 14, 2020

Moderna, for one, recently reported positive results in older adults between 56 and 71, as well as those 71 years of age and older, who reportedly mounted levels of neutralizing antibodies against the SARS-CoV-2 virus after two doses of its vaccine that were comparable to those seen in younger adults. Johnson & Johnson’s COVID-19 Vaccine.

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Vaccine Vaccination Antibody Life Science 92