Search Results for “antibody” – Page 28 – media

Fluid Biomarker Test Detects Neurodegenerative Diseases Before Symptoms Appear

Amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease) and frontotemporal dementia (FTD) are two progressively neurodegenerative conditions that damage essential nerve cells. ALS compromises nerve cells in the brain and spinal cord, leading to movement impairment, while FTD damages brain areas responsible for personality, behavior, and language. Studies indicate that in ALS or FTD patients, TAR DNA-binding protein 43 (TDP-43) malfunctions. This disruption prevents the correct splicing of ribonucleic acid (RNA), essential for generating proteins necessary for nerve growth and function. Instead, RNA strands become riddled with erroneous code sequences, known as “cryptic exons,” which are linked to an elevated risk of developing ALS and FTD. The timing of this anomaly in the disease progression of ALS and FTD was previously unknown. Now, researchers from Johns Hopkins Medicine (Baltimore, MD, USA) have developed a method for identifying a specific protein, hepatoma-derived growth factor-like 2 [HDGFL2], linked to TDP-43 ...
- Source: drugdu
- 87
- March 28, 2024
BIO-THERA’s Phase II Clinical Trial Application for BAT8006 (ADC- FRα) for Injection Approved by US FDA

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
- Source: drugdu
- 130
- March 28, 2024
The Results of Phase II Clinical Study of KN046 Plus Chemotherapy as First-line Treatment for Metastatic NSCLC were Published in Cell Reports Medicine

SUZHOU, China, March 22, 2024 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) announced that the phase II clinical research results of anti- PD-L1/CTLA-4 bispecific antibody KN046 plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) were published online in the renowned journal Cell Reports Medicine (IF: 14.3). Professor Li Zhang from Sun Yat-Sen University Cancer Center is the corresponding author of this paper, and Professor Yuanyuan Zhao is the first author. Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 1.06 million new cases of lung cancer, with a total death toll of 0.73 million in year 2022, far exceeding other tumor types. NSCLC accounts for about 80% – 90% of all lung cancers, and ...
- Source: drugdu
- 131
- March 26, 2024
FDA Fast Tracks ImmVira’s Oncolytic Herpes Simplex Virus Therapy for Head and Neck Squamous Cell Cancer

Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
- Source: drugdu
- 85
- March 25, 2024
Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year. By FRANK VINLUAN Nearly a year ago, Merck struck a $10.8 billion deal to acquire Prometheus Biosciences, a clinical-stage company whose technology platform analyzed genetics and biology data to discover new drugs. The executive who led Prometheus to that buyout is now back with a new immunology startup supported by $400 million. Mirador Therapeutics launched Thursday, aiming to take the precision medicine approaches that have led to advances in cancer drugs and apply them to the research of new therapies for immunology and inflammation. It’s a similar strategy to the one taken by Prometheus under the helm of Mark McKenna, now the CEO of San Diego-based Mirador. There’s a plethora of immunology drugs on the ...
- Source: drugdu
- 117
- March 25, 2024
Groundbreaking pTau217 Blood Test as Accurate as Brain Imaging or CSF Testing in Diagnosing Alzheimer’s

Alzheimer’s disease (AD) is a neurodegenerative condition that causes the brain to deteriorate over time, marked by the buildup of certain harmful proteins that eventually lead to a decline in brain function and cell death. These changes can happen long before any symptoms show up. Scientists have found certain proteins in the cerebrospinal fluid that are good indicators of AD. One of the most promising markers for early and more precise detection of AD in the blood is phosphorylated tau at position 217 (pTau217). It’s seen as a game-changer for diagnosing AD sooner, categorizing patients for research studies, and improving how patients are cared for and treated. Now, an innovative and novel blood test can be used in the screening, diagnosis, and monitoring of AD based on the circulating level of this promising biomarker pTau217. ALZpath Dx (Carlsbad, CA, USA) has developed a robust and scalable plasma-based ultra-sensitive assay, branded ...
- Source: drugdu
- 154
- March 23, 2024
Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein. By FRANK VINLUANCancer immunotherapy comes in several forms, and one area of growing research interest is a type of drug called a T cell engager. These drugs bind to a cancer cell and a T cell simultaneously, bringing both of them together to spark a therapeutic effect. Robert Ross, CEO of Clasp Therapeutics, likens T cell engagers to the chaperone at a middle school dance who grabs a boy and a girl in each hand, getting them to dance together. But in cancer drugs, just as in school dances, sometimes the pairing just isn’t right. The wrong pairing in cancer happens when a drug that’s targeted to a tumor also hits healthy cells, causing toxic effects. Clasp is developing ...
- Source: drugdu
- 90
- March 22, 2024
BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
- Source: drugdu
- 125
- March 20, 2024
A Startup’s Flexibility With ADC Cancer Drugs Attracts €128M for Clinical Trials

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting. By FRANK VINLUAN The concept of an antibody drug conjugate, or ADC, is straightforward: a cancer-killing drug is chemically linked to an antibody that targets the delivery of the therapy to a tumor. This drug class has made progress with several approved products and many more on their heels in clinical development. But there’s still plenty of room to improve on this type of targeted cancer therapy, contends Dominik Schumacher, CEO of Tubulis. When an ADC releases its drug payload too early, it hits healthy tissue and sparks toxic effects, Schumacher said. Also, current ADC designs are restricted in their ability to match the biology of cancer ...
- Source: drugdu
- 153
- March 19, 2024
ImmVira’s oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment

SHENZHEN, China, March 15, 2024 /PRNewswire/ — ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC. HNSCC has become a growing public health concern, with increases in incidence ...
- Source: drugdu
- 90
- March 19, 2024

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