Search Results for “immune” – Page 25 – media

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
- 131
- 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
- 154
- June 13, 2024
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
- 104
- June 12, 2024
Qilu Pharmaceutical’s Three Clinical Studies on Cancer Immunotherapy Presented at ASCO 2024

JINAN, China, June 6, 2024 /PRNewswire/ — The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting convened from May 31 to June 4, 2024 in Chicago, USA, adopting a hybrid format. Among the presented works, three clinical studies from Qilu Pharmaceutical were selected for poster sessions. These studies introduced novel immunotherapeutic agents, specifically QLF31907, a bispecific antibody targeting PD-L1/4-1BB; iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research involved treatments for advanced solid tumors and lymphoma, nasopharyngeal carcinoma, as well as solid tumors characterized by either DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H). QLF31907, developed by Qilu Pharmaceutical, combines two mechanisms: blockade of PD-L1 to restore T-cell receptor (TCR) signaling, while binding to 4-1BB to provide costimulatory signals essential for T-cell activation. This dual-action mechanism fosters T-cell proliferation and activation, enhancing the anti-tumor immune response. The study, led ...
- Source: drugdu
- 88
- June 12, 2024
Kangpu Biopharmaceuticals to Present Results from Phase 2a of KPG-818 in SLE at EULAR 2024

HEFEI, China, June 10, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals today announced that a poster tour presentation highlighting the Phase 2a clinical data of KPG-818 in patients with Systemic Lupus Erythematosus (SLE) will be presented at the upcoming Annual European Congress of Rheumatology EULAR 2024, taking place in Vienna, Austria, June 12-15, 2024. Poster tour presentation details: Abstract Title: KPG-818, a Novel Cereblon Modulator in Patients with Systemic Lupus Erythematosus: Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study Abstract number: POS0057 Abstract authors: Robert Levin, et al. Poster tour title: Clinical Poster Tours: Systemic lupus – Of old and new therapies Poster tour date and time: Wednesday, June 12, 2024, 15:30 – 16:30 CEST Poster tour location: Hall C The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled study, to assess the safety and tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in patients with SLE, and to select dosing ...
- Source: drugdu
- 92
- June 12, 2024
AI Tool Predicts Cancer Patients’ Response to Immunotherapy

Immune checkpoint inhibitors are a form of immunotherapy drug that enables immune cells to target and destroy cancer cells. At present, the Food and Drug Administration has approved two predictive biomarkers for identifying patients who might benefit from immune checkpoint inhibitors. The first biomarker is tumor mutational burden, which measures the number of mutations in the DNA of cancer cells. The second biomarker is PD-L1, a protein found on tumor cells that inhibits the immune response and is targeted by some immune checkpoint inhibitors. However, these biomarkers are not always reliable in predicting a patient’s response to immune checkpoint inhibitors. Recent machine-learning models utilizing molecular sequencing data have demonstrated potential in predicting responses, but this data is costly and not routinely collected. Researchers have now created an artificial intelligence (AI) tool that uses standard clinical data, such as results from a basic blood test, to predict if a patient’s cancer ...
- Source: drugdu
- 87
- June 7, 2024
FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex

California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex. According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews. A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration. The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing ...
- Source: drugdu
- 71
- June 6, 2024
invoX Pharma’s FS222 delivers encouraging solid tumour treatment results

invoX Pharma Limited has presented updated findings from its phase 1 study of FS222, showcasing significant anti-tumour activity in patients with advanced solid tumours. The data, revealed at the 2024 American Society of Clinical Oncology Annual Meeting, highlights FS222’s potential as a ground-breaking treatment option. FS222, a CD137/PD-L1 bispecific antibody, is part of invoX’s innovative product pipeline. The phase 1 trial involved 100 subjects and aimed to establish the drug’s safety and maximum tolerated dose. The study also assessed FS222’s anti-tumour activity, pharmacokinetics, and pharmacodynamics. The treatment, administered every four weeks, led to increased T cell proliferation and CD8+ T cell infiltration within tumours. While treatment-related adverse events were dose-dependent, they remained manageable and reversible. Dr Elena Garralda, Director of Early Drug Development at Vall d’Hebron University Hospital, commented on the drug’s potential: “While there have been great advances in immuno-oncology research, existing treatments continue to face challenges with response ...
- Source: drugdu
- 62
- June 6, 2024
New UCL-developed immunotherapy shows promising results in treating bone cancer

Bone cancer affects more than 150,000 people in the UK and is often resistant to chemotherapy A new type of immunotherapy developed by researchers from University College London (UCL) has demonstrated promising preclinical results in treating bone cancer. Published in Science Translational Medicine, the OPS-gdT treatment platform outperformed conventional immunotherapy when controlling the growth of osteosarcoma, a form of bone cancer. Affecting more than 150,000 people in the UK, cancer that begins or spreads to the bones is hard to treat as it is frequently resistant to chemotherapy and is the leading cause of cancer-related death. Researchers used a small subset of immune cells known as gamma-delta T (gdT) cells, a type of immune cell that can be made from healthy donor immune cells, to provide an efficient and cost-effective solution for treating this condition. gdT cells work to kill antibody-labelled targets safely from person to person without risking graft-versus-host ...
- Source: drugdu
- 72
- June 5, 2024
BIO-THERA Receives Positive CHMP Opinion for Bevacizumab Avzivi® in Europe

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that it recently received notification from the European Medicines Agency (EMA) that Avzivi® (BAT1706), a biosimilar developed with reference to Anvitin® (bevacizumab), has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended to the European Commission (EC) that it grant marketing authorization for Avzivi® for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and metastatic cervical cancer. The CHMP’s opinion on ...
- Source: drugdu
- 64
- June 5, 2024

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