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Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

SAN FRANCISCO and SUZHOU, China, June 13, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC (R&D code: IBI343), for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. Previously, IBI343 has already received FDA approval of its IND application for the treatment of PDAC. At the ASCO 2024 Annual Meeting, Innovent reported the preliminary Phase 1 results of IBI343 in advanced PDAC patients who have received at least one prior line of treatment. In the 6 mg/kg dose group, among the 10 evaluable PDAC patients with CLDN18.2 1/2/3+≥60%, the overall response ...
- Source: drugdu
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- June 14, 2024
Novel AI-Powered Method for Tissue Analysis Improves Understanding of Disease Pathology

Scientists at Brown University (Providence, RI, USA) and the University of Michigan (Ann Arbor, MI, USA) have created a groundbreaking computational technique to examine complex tissue data, potentially revolutionizing our understanding of diseases and their treatment. The method, known as Integrative and Reference-Informed tissue Segmentation (IRIS), utilizes machine learning and artificial intelligence to provide biomedical researchers with accurate insights into tissue development, disease pathology, and tumor structuring. IRIS employs spatially resolved transcriptomics (SRT) data and incorporates single-cell RNA sequencing data as a reference. This approach allows for the simultaneous examination of multiple tissue layers and accurately identifies different regions with exceptional computational speed and precision. In contrast to traditional methods that offer averaged data from tissue samples, SRT delivers a much more detailed perspective, locating thousands of specific points within a single tissue section. Handling vast and complex datasets has always posed significant challenges, and IRIS addresses these by using ...
- Source: drugdu
- 135
- June 13, 2024
Proteomics Platform Identifies Proteins in Blood to Give Cancer Warning 7 Years before Diagnosis

To improve cancer survival rates, it’s crucial to understand the disease during its initial stages. Research involving data from thousands of cancer patients has uncovered exciting findings about how blood proteins can influence cancer risk, highlighting the need for further investigation to determine which proteins could be effectively utilized for prevention. Researchers have now employed a cutting-edge proteomics platform to identify blood proteins that could potentially provide a seven-year advance warning for various types of cancer. Their study findings underscore the significant potential of proteomics to transform cancer detection, enabling earlier interventions that could lead to improved treatment success and possibly even prevention. In this groundbreaking study recently published in Nature Communications, the researchers used Olink Holding AB’s (Uppsala, Sweden) next-generation Olink Explore proteomics platform to examine blood samples from over 44,000 individuals. They successfully identified 371 proteins associated with 19 different types of cancer, including 107 proteins that could ...
- Source: drugdu
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- June 13, 2024
FDA Approves Regeneron and Sanofi’s Kevzara to Treat Patients with Active Polyarticular Juvenile Idiopathic Arthritis

Don Tracy, Associate Editor Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics. The FDA has approved Regeneron’s and Sanofi’s approved Kevzara (sarilumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing over 138 lbs. According to a joint press release, the approval was based on results of controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.1 “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, in a press release. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable ...
- Source: drugdu
- 134
- June 13, 2024
Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. By Frank VinluanA rare liver disease that can progress to organ failure now has a new FDA-approved therapy, a drug from Ipsen that brings a novel approach to treating the chronic condition. The Ipsen drug, elafibranor, treats primary biliary cholangitis (PBC). The regulatory decision announced late Monday makes the drug just the third approved therapy for the chronic liver disorder, but competition in this indication is heating up. Paris-based Ipsen will market its new product under the brand name Iqirvo. PBC is an autoimmune condition in which bile and toxins build up in the liver, leading to inflammation and damage to ...
- Source: drugdu
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- June 13, 2024
Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

The Dana-Farber Cancer Institute and OncoHost have partnered to research and identify biomarkers for renal cell carcinoma (RCC), a form of kidney cancer. The collaboration aims to create a proteomic plasma profile by providing OncoHost with materials using Dana-Farber’s repository of patient plasma samples and clinical data. According to Cancer Research UK, kidney cancer is the sixth most common cancer in the UK, accounting for 4% of all new cancer cases. RCC occurs when malignant cells are found in the lining of tubules in the kidney and there is currently no blood test available for these patients to help make personalised treatment recommendations, explained Wenxin Xu, physician, Dana-Farber and assistant professor of medicine at Harvard Medical School. For most RCC patients, immune-checkpoint inhibitor therapy (ICI) has been used to treat the disease. However, ICIs may not benefit all patients and can cause immune-related adverse events (irAEs). The PROPHETIC trial will ...
- Source: drugdu
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- June 13, 2024
New paediatric blood test to prevent sudden death from hereditary heart condition

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK Researchers from University College London (UCL) and Great Ormond Street Hospital have developed a new blood test that could identify children with a potentially fatal, hereditary heart condition. The research, co-funded by LifeArc and Action Medical Research, was published in the journal Circulation: Genomics and Precision Medicine. In the UK, up to 1,000 children are living with hypertrophic cardiomyopathy (HCM), a rare hereditary condition that causes the thickening of the heart muscle. Over time, the heart can no longer take in or pump out enough blood to supply the body’s needs, which can cause sudden death in children and young people. Results from the study showed that the new test successfully acted as a marker for HCM. Juan Pablo Kaski, professor of paediatric inherited cardiovascular medicine, UCL Institute of Cardiovascular Science and consultant cardiologist at ...
- Source: drugdu
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- June 13, 2024
AbbVie’s Telisotuzumab Vedotin (Teliso-V) Included in CDE’s List of Breakthrough Therapeutic Varieties

Recently, the Center for Drug Evaluation (CDE) of the State Drug Administration formally included AbbVie’s clinically developed sterile lyophilized powder for infusion, Telisotuzumab Vedotin (Teliso-V), into the list of breakthrough therapeutic drug varieties for the treatment of advanced/late stage c-Met protein (OE) with high expression of c-Met protein (OE) with disease progression occurring during or after platinum-based drug therapy. metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq) non-small cell lung cancer (NSCLC) patients. About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational first-in-class antibody-coupled drug (ADC) targeting the c-MET protein in patients with tumors overexpressing c-Met, a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. Its efficacy safety as monotherapy in previously treated patients with c-Met overexpressing NSCLC will be further evaluated in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868) For more information on the Teliso-V clinical trial, please visit https://clinicaltrials.gov/. Currently, there ...
- Source: drugdu
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- June 13, 2024
2024 ASCO | Benmelstobart monotherapy research results in gynecologic oncology and other areas updated

The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago from May 31 to June 4, local time. Chiatai Tianqing’s recently launched Class 1 innovative biologic Benmelstobart announced a number of research results at the meeting, covering the fields of digestive and gynecological oncology. Benmelstobart monoclonal antibody is an innovative humanized anti-PD-L1 monoclonal antibody with a new sequence, which was just approved for marketing in May 2024. The first approved indication is for the first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SLC) in combination with amilotinib hydrochloride capsule, carboplatin and etoposide. Endometrial cancer is one of the most common gynecologic malignancies and its incidence is on the rise worldwide. Most patients with endometrial cancer are diagnosed at an early stage and have a good overall prognosis, with a 5-year survival rate of 95%. Once localized spread or distant metastasis occurs, the 5-year survival rate ...
- Source: drugdu
- 116
- June 13, 2024
CMEF

Organiser：Reed Sinopharm Exhibitions Time：October 12 – 15, 2024 address：No. 1 Zhancheng Road, Heping Community, Fuhai Street, Bao’an District, Shenzhen Exhibition hall：Shenzhen World Exhibition & Convention Center (New Hall) Product range: Medical Imaging Area: Radiology products, ultrasound products, nuclear medicine products, molecular imaging, interventional products, etc. Operating Room Area: Hybrid operating rooms, integrated operating room systems, surgical instruments, anesthesia machines, ventilators, monitors, operating room engineering, surgical lights, ceiling-mounted towers, etc. In Vitro Diagnostic Area: Overall laboratory solutions, clinical diagnostic equipment, diagnostic reagents, POCT, home diagnostic equipment, etc. Rehabilitation and Physiotherapy Area: Rehabilitation equipment, assistive devices, traditional Chinese medicine treatments, physical therapy equipment, medical high-frequency equipment, etc. Orthopedics Area: Orthopedic implants, surgical instruments and equipment, bone power tools, and other orthopedic-related products covering three main categories: joints, trauma, and spine. Medical Information Technology Area: System integrators, mobile healthcare, medical management, quality control, clinical hospital information management systems, IT equipment providers for ...
- Source: drugdu
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- June 12, 2024

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