2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody(mAb)injection independently developed by Henlius, ...
The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank VinluanA Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize its ...
Stockholm3, a prostate cancer test that analyzes a combination of protein and genetic markers from a blood sample using an algorithm, has been shown to predict the likelihood of clinically significant cancer with greater accuracy than the conventional prostate-specific antigen (PSA) test. Research involving over 90,000 men indicates that Stockholm3 outperforms PSA, helping to avoid unnecessary MRIs and biopsies, and identifying serious cancers even in men with low or normal PSA levels. Historically, these studies primarily involved a predominantly White Scandinavian population, casting doubt on their applicability globally. Now, a new study has confirmed that Stockholm3 is equally effective across diverse ethnic backgrounds and continues to outperform the PSA standard significantly. The study, conducted by researchers at Karolinska Institutet (Stockholm, Sweden) where the Stockholm3 blood test was developed, involved more than 2,000 men from 17 clinics, with ethnic backgrounds including 16% Asian, 24% African-American, 14% Latin American, and 46% White ...
The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank Vinluan A Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize ...
The late 90s marked the beginning of the era of precision oncology, yet recent studies in the U.S. indicate that most cancer patients are not receiving FDA-approved precision therapies. Factors such as high costs, extensive tissue requirements, and lengthy processing times have hampered the broader adoption of precision oncology, often leading to treatments that are not only suboptimal but potentially harmful. A significant barrier is the lack of testing; many cancer patients endure critical delays waiting for standard genomic tests following an initial tumor diagnosis, which can be life-threatening. Now, a groundbreaking advancement has been made with the development of a new generation of artificial intelligence (AI) tools that enable the rapid and cost-effective detection of clinically actionable genomic alterations directly from tumor biopsy slides. This innovation could cut weeks and save thousands of dollars in clinical oncology treatment workflows for diseases like breast and ovarian cancers. The new AI ...
Researchers from Guy’s and St Thomas’ and King’s College London (KCL) have revealed a certain type of bacteria is toxic for head and neck cancer and could potentially lead to better outcomes for patients. Published in Cancer Communications, the research was funded by Guy’s Cancer Charity and Cancer Research UK through the City of London Cancer Centre. Currently the sixth most common cancer globally, head and neck cancers affect around 1,000 people in the UK every month. When analysing head and neck cancer patients, the team found that those who harboured higher levels of Fusobacterium, which is usually associated with the progression of bowel cancer, had a better prognosis than those with lower levels of the bacteria. In total, there was a 70% to 99% reduction in the number of viable cancer cells in head and neck cancer cell cultures after being infected with the bacterium, as it destroys the ...
Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
Bowel cancer, commonly referred to as colorectal cancer, can develop anywhere in the large bowel, including the colon and rectum. It ranks among the most prevalent cancers globally, with 1.9 million new cases recorded in 2020. The current protocols for determining the need for chemotherapy for patients with early-stage bowel cancer are not consistently reliable. As a result, some patients receive chemotherapy unnecessarily, while others who might benefit from it do not receive it and may face cancer recurrence. This decision is particularly challenging for stage II colon cancer, where the risk of recurrence post-surgery is generally lower. Now, a new artificial intelligence (AI) test can predict the risk of recurrence in bowel cancers, potentially helping patients avoid unnecessary chemotherapy. This test employs an AI algorithm to measure the concentration of immune cells known as CD3 in tumors at the early stages of bowel cancer. Previous studies have indicated that ...
By Don Tracy, Associate Editor IDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small cell lung cancer. Daiichi Sankyo and Merck have commenced the IDeate-Lung02 Phase III clinical trial, which aims to compare the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) vs. physician’s choice of chemotherapy in patients with relapsed small cell lung cancer (SCLC) following disease progression with only one prior line of platinum-based chemotherapy. According to both companies, the initiation of the trial was based on results from a subgroup analysis of the IDeate-PanTumor01 Phase I/II trial of ifinatamab deruxtecan, which was presented at the 2023 World Conference on Lung Cancer.1 “Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo, in a press release. “The IDeate-Lung02 trial is an important next step as we ...
By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
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