KYV-101 designed as a CD19 CAR T-cell therapy. Image Credit: Adobe Stock Images/Trsakaoe Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). “We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” said Peter Maag, PhD, CEO, Kyverna Therapeutics. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their ...
Genes may be responsible for third of complex regional pain syndrome cases. But the condition is less common in men, even though they are more likely to have the 4 genetic variations implicated in heightened risk, suggesting that there may be sex specific causes, say the researchers. Most cases of CRPS are usually triggered by an injury, with the skin of the affected body part hypersensitive to the slightest touch or temperature change. CRPS is difficult to treat, and while it often improves with time, some people experience intense pain for many years. But why some people develop CRPS yet others don’t after the same injury, isn’t clear. A heritable component to CRPS has been suggested, sparking the theory that some people might be genetically predisposed to the condition. To explore this further, the researchers looked for variations in genes, formally known as single nucleotide polymorphisms, or SNPs for short, ...
The study will offer new insights into the immune system’s response to iGAS Spencer Dayman Meningitis Research has announced that scientists at the University of Bristol have begun a research project to aid in the development of a vaccine against invasive group A streptococcus (iGAS). The study will offer new and unique insights into the adaptive immune response to iGAS. iGAS is a severe infection caused by bacteria invading parts of the body, including the blood, deep muscle, fat tissues or lungs, which can lead to diseases such as meningitis and sepsis. Since April 2023, there have been 3,287 cases of iGAS in the UK, 761 of which occurred in children aged 18 years and under. There is currently no vaccine to protect individuals from group A streptococcus, which can also cause rheumatic fever and scarlet fever. Funded by Spencer Dayman Meningitis Research, scientists Dr Ana Goenka, Dr Alice Halliday ...
Swedish company Salipro Biotech has entered into a multi-target antibody research agreement with biotech company Icosagen. The agreement leverages Salipro’s proprietary platform technology for membrane proteins to identify drugs that target specific G protein-coupled receptors (GPCRs) and solute carrier (SLC) transporters, as per a 10 October announcement. These membrane proteins play a role in different areas such as oncology and autoimmune diseases. Estonian company Icosagen has CRO [contract research organisation] and CDMO [contract development and manufacturing organisation] capabilities, with expertise in protein production and analytics, which contributes to the drug development of monoclonal antibodies. Icosagen will utilise its QMCF technology to advance the project, based on the 10 October press release. The company’s QMCF technology is based on a proprietary mammalian expression system for producing recombinant proteins. Monoclonal antibodies have been identified by GlobalData as a key innovation area for cancer therapy, with Johnson & Johnson being the leading patent ...
Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage trial of its anti-PD-1 therapy Keytruda (pembrolizumab) in certain bladder cancer patients. The phase 3 AMBASSADOR trial has been evaluating Keytruda versus observation as an adjuvant treatment for patients with localised muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma. At a pre-specified interim analysis, Keytruda demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of disease-free survival versus observation in these patients after surgery. The safety profile of Keytruda was consistent with that observed in previously reported studies, Merck said, adding that the National Cancer Institute-sponsored study will continue to evaluate its second dual primary endpoint of overall survival. More than 82,000 people in the US are expected to be diagnosed with bladder cancer this year, and approximately 7% of bladder cancer cases are locally advanced ...
How can the propagation of influenza viruses be stopped? For a new approach in the therapy of influenza infections, Prof. Hiroki Kato from the Institute of Cardiovascular Immunology at the University Hospital Bonn (UKB) and the Cluster of Excellence ImmunoSensation2 of the University of Bonn receives an Open Philanthropy grant of 2.2 million US dollars. Together with his team, he found a compound that inhibits the body’s own methyltransferase MTr1 and thus prevents the replication of influenza viruses. The funded project now aims to identify further MTr1 inhibitors with influenza-inhibiting activity that could be considered for clinical trials in the near future. When a virus enters our body, it binds to the host cell and introduces its genetic information in form of ribonucleic acid (RNA). Using these blueprints, the host cell is now forced to produce numerous new viruses. “This is because viruses have evolved various mechanisms, including modifications of ...
Nanobiotix has shared positive new data from an early-stage study evaluating a drug designed to enhance the efficacy of radiotherapy in patients with locally advanced pancreatic cancer. Results from the phase 1 study of NBTXR3, which is being conducted as part of an ongoing collaboration between Nanobiotix and the University of Texas MD Anderson Cancer Center, were presented at this year’s American Association for Cancer Research Special Conference on Pancreatic Cancer. Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis and remains one of the leading causes of cancer-related death worldwide. For more than 90% of patients with locally advanced disease who are not eligible for surgery, there are few treatment options with curative intent, and the five-year overall survival rate for patients with unresectable PDAC remains less than 5%. Radiotherapy is one of the most common treatment modalities for cancer, with approximately 50% of patients undergoing it at ...
Emergex Vaccines has signed a Memorandum of Understanding (MoU) with the Vaccine Industrial Company (VIC) to develop and commercialise T cell-priming immune set-point candidates against infectious disease therapies. The territories included in the agreement were Saudi Arabia and other specified territories, such as GCC member states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE), other Middle Eastern territories and specified regions. As per the deal, VIC will have an equity share in Emergex, contingent on the Saudi Arabian government’s support for Phase II/III clinical trials of Emergex’s T cell-priming candidates. These are beings studied for dengue, Covid-19, and others, including the add-on therapies related to these indications. In June, Emergex reported positive data from the Phase I trial of its T cell-priming immune set-point candidate, DengueTcP, for treating dengue. The results showed that the therapy was well tolerated in healthy volunteers. The company also reported positive data for CoronaTcP, a ...
A Novavax Covid-19 vaccine developed for the fall vaccination season now has the FDA green light, bringing an alternative to the messenger RNA shots that are already rolling out to pharmacies, doctor’s offices, and other locations throughout the country. The FDA decision announced Tuesday afternoon is not an approval. Last year’s emergency authorization for the Novavax vaccine is now amended to include an updated formula, which reflects currently circulating variants. The initial Novavax vaccine was authorized for those 18 and older. For the updated shot, the FDA expanded the age range to 12 and older. The regulatory decision for the latest version of the Novavax vaccine means the company’s initial vaccine, developed for the original SARS-CoV-2 strain, is no longer authorized for use in the U.S. Gaithersburg, Maryland-based Novavax makes its protein-based vaccines with nanoparticle technology that engineers proteins that mimic antigens found on natural pathogens. For its Covid-19 vaccine, ...
by John Pinching The treatment targets extensive stage small cell lung cancer and aims to boost therapeutic impact Ariceum Therapeutics, a company developing products for the treatment of specific cancers, has announced that the first patient has been dosed with its satoreotide therapy. The treatment targets extensive stage small cell lung cancer (ES-SCLC), while the research is taking place at the Murdoch University Health Center in Australia. Ariceum’s broader open label phase 1b trial will analyse the tolerability and safety of the ‘theranostic pair’ of somatostatin receptor antagonists, ga-satoreotide trizoxetan and lu-satoreotide tetraxetan, among patients with ES-SCLC. The central aim of the research is to establish a recommended phase 2 dose and schedule in due course. ‘Theranostics’ is the system of incorporating two paired drugs: the first, a diagnostic agent to identify cells that exhibit a particular biomarker, and the second, a therapeutic drug which subsequently acts on those cells. ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.