XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. There were a range of therapies under discussion, from targeted therapies to advanced antibody-drug conjugates (ADCs) and cell and gene therapies,” he says.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

pharmaphorum

NOVEMBER 6, 2022

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. Naturally, the pharma industry has seen an explosion of mAbs in the pipeline, which has led to the evolution of new methods for improving and refining the antibody pipeline. AI for accelerated antibody discovery.

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Antibody Drugs Protein Life Science 123

XTalks

DECEMBER 4, 2024

The company’s lead candidate, ENV105, is an antibody targeting CD105, which is implicated in cancer cell resistance to various treatments. Dr. Yu has also led numerous clinical trials. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Drugs 59

Drugs Life Science Clinical Trials Clinical Trials 59

XTalks

MAY 4, 2023

A blood test can detect antibodies to gluten, but a definitive diagnosis requires a biopsy of the small intestine. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments. How does Beyond Celiac spread awareness about research and clinical trials for celiac disease?

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Clinical Trials Clinical Trials Trials Immune Response 98

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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Clinical Trials Clinical Trials Trials Antibody 98

XTalks

NOVEMBER 21, 2024

The test, the first of its kind approved for over-the-counter (OTC) use in the US, detects antibodies for Treponema pallidum , the bacterium responsible for syphilis. Using a single drop of blood, it delivers highly accurate results, with clinical trials showing a 99.5 percent accuracy rate for negative cases and 93.4

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Bacterium Antibody Manufacturing Pharmacy 104

XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. COVID-19: The Pandemic and the Vaccines.

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Life Science Vaccination Vaccine Trials 98

BioSpace

MAY 14, 2024

Armed with a $300 million commitment from Blackstone Life Sciences and a former Merck monoclonal antibody, Uniquity Bio is starting Phase II clinical trials in asthma and chronic obstructive pulmonary disease.

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Life Science Clinical Trials Clinical Trials Antibody 79

XTalks

MARCH 10, 2025

Omalizumab is an anti-IgE antibody that works by blocking the effects of IgE, a key driver in many allergic reactions. In a global Phase III clinical trial, 619 adult patients were enrolled and received either 150 mg or 300 mg of omalizumab-igec every four weeks.

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Allergies FDA Approval Antibody Trials 66

XTalks

JANUARY 29, 2021

Data from Eli Lilly and Company’s (NYSE: LLY) Phase III clinical trial evaluating its monoclonal antibody drugs bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) show that combining the two significantly reduced the risk of COVID-19 hospitalizations and death by 70 percent. percent) compared with 36 events (7.0

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Antibody Clinical Trials Clinical Trials Trials 96

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. percent show less reliability). Optimal methods for bioinformatic analysis are still needed.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

DECEMBER 31, 2024

Imlifidase is an enzyme that works by cleaving immunoglobulin G (IgG) antibodies, thereby halting the immune-mediated damage that characterizes GBS. The first-in-class IgG cleaving enzyme has shown promise in other applications, including kidney transplantation and antibody-mediated rejection.

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Life Science Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 9, 2023

Co-led by Venrock Healthcare Capital Partners (Venrock) and Enavate Sciences, the financing round has seen participation from new investors Wellington Management and Bain Capital Life Sciences. It is also preparing for a swift transition to Phase III development.

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Clinical Development Development Life Science Clinical Trials 147

XTalks

FEBRUARY 12, 2025

XTALKS WEBINAR: Overcoming Challenges in Clinical Trial Completion Live and On-Demand: Wednesday, March 19, 2025, at 10:30am EDT (3:30pm CET/EU-Central) Register for this free webinar to transform challenges into opportunities and optimize the crucial final stages of clinical trials.

Clinical Trials 66

Clinical Trials Clinical Trials Trials FDA Approval 66

BioTech 365

JANUARY 4, 2021

Tiziana Life Sciences plc (“Tiziana” or the “Company”) – Tiziana announces completion of the clinical trial with nasally administered Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19 patients in Brazil Tiziana Life Sciences plc (“Tiziana” … Continue reading (..)

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Life Science Clinical Trials Clinical Trials Antibody 40

XTalks

MARCH 15, 2021

Eli Lilly (NASDAQ: LLY ) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo. The study is part of Lilly’s ongoing Phase III BLAZE-1 trial evaluating the antibody duo.

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Antibody Trials Protein Regulation 92

XTalks

APRIL 1, 2025

In hemophilia patients, inhibitors are antibodies that interfere with the effectiveness of clotting factor replacement therapies. Clinical Trials Backing Qfitlias Approval Two Phase III studies involving adult and pediatric male patients with hemophilia A or B supported Qfitlias FDA approval.

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FDA Approval RNA Clinical Trials Clinical Trials 59

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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Antibody Immune Response Trials Clinical Trials 75

BioSpace

OCTOBER 14, 2021

Read about TFF Pharmaceuticals and Augmenta Bioworks' dry powder COVID-19 antibody formula, the world's first gene editing clinical trial for PKU, Bayer's COVID-19 vaccine and other key developments in life sciences research.

Gene Editing 66

Gene Editing Life Science Clinical Trials Clinical Trials 66

XTalks

APRIL 1, 2025

Related: Niktimvo (Axatilimab) Approved as First-in-Class Therapy for Chronic GVHD More on Itolizumabs Clinical Data Itolizumab is a humanized anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway involved in T cell activation and trafficking. The risk limits the number and type of patients who receive HSCT.

Immune Response 94

Immune Response Trials Licensing Licensing 94

XTalks

APRIL 2, 2025

Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fordyce discuss new innovations in therapies for autoimmune diseases like IgA nephropathy and the work he is leading at Vera Therapeutics.

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Life Science Clinical Development Development Trials 59

The Pharma Data

MARCH 15, 2022

Global Head of Research and Development for Sanofi “ The collaboration with Blackstone will accelerate our ability to offer patients a subcutaneous anti-CD38 antibody therapy that we believe will be innovative and more convenient. Sarclisa ® is a monoclonal antibody that targets a specific epitope on the CD38 receptor on MM cells.

Life Science 52

Life Science Antibody Medicine Clinical Trials 52

XTalks

DECEMBER 10, 2024

Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 This aligns with previous studies, reinforcing its potential as a well-tolerated treatment option. percent platelet response in a study published in The New England Journal of Medicine.

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Trials Protein Clinical Development Drugs 104

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%

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Immune Response Vaccination Vaccine Trials 59

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

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Antibody Trials Clinical Trials Clinical Trials 52

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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Antibody Clinical Trials Clinical Trials Medicine 52

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

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials 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

The Pharma Data

JANUARY 3, 2021

Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated: “We are delighted to receive positive feedback from patients treated in the clinical trial. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.

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Life Science Clinical Trials Clinical Trials Antibody 40

XTalks

AUGUST 10, 2022

Ayesha also talked about the FDA approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science FDA Approval Drugs Licensing 52

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

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Trials Clinical Trials Clinical Trials Antibody 97

XTalks

AUGUST 8, 2022

Medicxi is a prominent international life sciences investment firm that invested in over 60 portfolio companies such as Versanis Bio, Rivus Pharmaceuticals, Capella Bioscience and more. One of Medicxi’s portfolio companies called MiroBio is set to be acquired by Gilead Sciences for approximately $405 million in cash.

Immune Response 98

Immune Response Antibody Life Science Engineer 98

XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

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Drug Delivery Systems Dermatology Drug Delivery Antibody 111

pharmaphorum

JANUARY 13, 2021

The Series B fundraiser follows the FDA’s decision to grant Breakthrough Therapy designation last month for a combination of its lead immune-oncology therapies IO102 and IO103, with anti-PD-1 monoclonal antibodies for patients with metastatic melanoma.

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Vaccination Vaccine Development In-Vivo 95

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. . Phase1b/2 clinical study to be conducted in the United States and several European countries. and Europe.

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Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

NOVEMBER 30, 2020

Shailubhai will provide updates on the Company’s proposed move from AIM to the Standard Segment of the Main Market of the London Stock Exchange, ongoing clinical trials, as well as other recent developments in Tiziana Life Sciences. About Tiziana Life Sciences. NEW YORK and LONDON, Dec.

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