High-grade serous ovarian carcinoma is the most lethal type of ovarian cancer, and it poses significant detection challenges. Typically, patients initially respond to surgery and chemotherapy, but the cancer often returns. Now, researchers have used spatial analysis of tissue samples to uncover patterns that could indicate whether patients with this form of ovarian cancer are likely to experience early recurrence following treatment, potentially guiding future therapeutic strategies. Researchers at Cedars-Sinai (Los Angeles, CA, USA) conducted spatial protein analyses on ovarian cancer tissue samples to identify patterns correlated with early cancer relapse soon after treatment. The study involved 42 patients and examined both primary and recurrent tumors using imaging mass cytometry, which allows for the detailed spatial examination of protein presence within tissues. Their key findings highlighted the role of plasma cells in the tumor’s immune response. The study found that the location of plasma cells and their relationship with nearby ...
Autoimmune diseases such as multiple sclerosis (MS) are thought to occur partly due to unusual immune responses to common infections. Early MS symptoms, including dizziness, spasms, and fatigue, often resemble other conditions, complicating diagnosis, which heavily relies on detailed brain MRI evaluations. MS can severely impair motor control, but advancements in treatment can slow down its progression and help maintain functions such as walking. Notably, around 10% of MS patients begin producing a distinctive set of antibodies against their own proteins years before symptoms appear. These autoantibodies have been found to bind to both human cells and common pathogens, possibly explaining why immune attacks on the brain and spinal cord occur in MS. Now, researchers have identified a unique autoantibody signature in about 10% of MS patients that appears years before the onset of clinical symptoms, raising hopes for early detection via a simple blood test and earlier treatment initiation. ...
ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce ...
On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
Shanghai, China, April 23, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). Currently, no product targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial ...
Both will develop cancer vaccine candidates in selected haematological and solid tumour indications CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs. Solid tumour cancer, such as sarcoma, carcinoma and lymphoma, is characterised by an abnormal mass of tissue that usually does not contain cysts or liquid areas. Haematologic cancer, otherwise known as blood cancer, including leukaemia, lymphoma and multiple myeloma, begins in blood-forming tissues such as the bone marrow or in the cells of the immune system. Under the terms of the agreement, MD Anderson will be responsible for conducting phase 1/2 studies of the selected promising validated cancer vaccine candidates and the completion of investigational new ...
Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate-to-severe acute pain. The company announced its plans to submit an NDA following positive Phase III results from two clinical trials investigating the drug in patients who had undergone bunionectomy (NCT05553366) or abdominoplasty (NCT05558410) surgery. Both trials met the primary endpoints, and suzetrigine demonstrated a favourable safety profile with no serious adverse events reported. Vertex has started the rolling submission process and aims to finish by Q2 2024. With FDA fast track and breakthrough therapy designations already secured for the drug to treat acute pain, Vertex is now focusing on neuropathic pain, where positive Phase II results have been achieved. Following a successful end-of-Phase II meeting with the FDA, Vertex is planning a Phase III pivotal programme for patients with diabetic peripheral neuropathy (DPN) later ...
Don Tracy, Associate Editor With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis. GSK announced that the FDA has accepted for review an application for its five-in-one meningococcal vaccine MenABCWY. MenABCWY is a combination of GSK’s two existing vaccines, Bexsero and Menveo, and targets the five primary serogroups (A, B, C, W, and Y) of Neisseria meningitidis. These serogroups are credited with causing the majority of meningococcal disease (IMD) cases around the world. According to the company, a final decision is expected on February 14, 2025.1 “In the Phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the ...
Clinical-stage biotech Chemomab Therapeutics has announced the publication of a study highlighting that high serum CCL24 levels are linked to more severe forms of systemic sclerosis (SSc). SSc is a chronic autoimmune disease characterised by excessive collagen production, leading to thickening and hardening of the skin and various internal organs. Affecting the skin, blood vessels, muscles, and internal organs, the condition causes symptoms like joint pain, skin tightening, and organ dysfunction. The study, published in the Arthritis Care and Research journal and conducted at the University of Leeds in the UK, looked at 200 patients with SSc. It found that a quarter of them had high levels of CCL24 in their blood, even though they were receiving standard treatment. Higher CCL24 levels were linked to more severe forms of the condition, including worse skin problems and lung issues. Scientists identified that high CCL24 levels were predictive of lung problems worsening ...
Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
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