Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that the latest results from three preclinical studies of the company’s novel drug candidates olverembatinib, MDM2-p53 inhibitor alrizomadlin, FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and EED inhibitor APG-5918, have been selected for presentations at the 2024 American Association of Cancer Research Annual Meeting (AACR 2024). These abstracts are now available on the AACR’s official website. The AACR annual meeting is one of the world’s largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year’s AACR annual meeting will be held from April 5-10 2024, in San Diego, California, USA. These three preclinical abstracts from Ascentage Pharma include: ...
Researchers from Johns Hopkins Kimmel Cancer Center and the Johns Hopkins University School of Medicine have developed an algorithm to identify high-risk precancerous lesions that lead to ovarian high-grade serous carcinoma (HGSC). Published in Clinical Cancer Research, researchers aimed to develop a tool that could detect and stratify serous tubal intraepithelial carcinomas (STICs) based on key genetic alterations and mutations. STICs are lesions that are presumed to be the main precursors of HGSC, the most common form of ovarian cancer in women. Using a technique called Repetitive Element AneupLoidy Sequencing System (RealSeqS), researchers sequenced 150 DNA samples and analysed the level of aneuploidy, missing or extra DNA chromosomes, in STIC versus HGSC and normal-appearing samples. Results showed that STIC samples had more non-random genetic alterations, including whole and partial deletions of chromosome 17 in the tumour suppressor p53 proteins, while normal-appearing samples had low levels of aneuploidy. The team suggests ...
Ovarian high-grade serous carcinoma (HGSC) is the predominant form of ovarian cancer affecting women. Serous tubal intraepithelial carcinomas (STICs), which are precancerous lesions on the fallopian tubes, are considered the main precursors of HGSC. Women undergoing salpingectomy, the surgical removal of fallopian tubes, often do so without a detailed examination of these precancerous lesions. The challenge lies in the molecular diversity of STICs and the difficulty in detecting aggressive forms early, owing to their small size. In response to this urgent diagnostic need, researchers have developed an algorithm to identify STICs before they can progress to cancer. This pioneering algorithm, named “REAL-FAST” (RealSeqS-based algorithm for fallopian tube aneuploidy pattern in STIC), was developed by a team at Johns Hopkins Medicine (Baltimore, MD, USA). In a pilot study, REAL-FAST distinguished five unique types of precancerous lesions in fallopian tubes, with two identified as particularly aggressive and often linked to recurrent HGSC. ...
Davy James Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus cisplatin and gemcitabine in the frontline treatment of adults with unresectable or metastatic urothelial carcinoma (UC).1 The regulatory action adds to an array of approved indications for Opdivo, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic UC; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.2 “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients ...
The agreement outlines the potential for Merus to earn up to $1.5bn payments from Gilead. Merus will head the early-stage research works for two programmes, with the option to expand to a third asset. Credit: aslysun / Shutterstock.com. Gilead Sciences has entered a research partnership, option and licence agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies. The partnership will leverage Merus’ Triclonics technology and Gilead’s capabilities in the oncology field. The aim is to advance multiple preclinical research programmes that could potentially transform cancer treatment. Merus focuses on the development of full-length, multispecific antibodies named Biclonics and Triclonics, referred to collectively as Multiclonics. These antibodies are created by a common light chain technology. The Triclonics trispecific platform creates antibodies that can target three different antigens simultaneously. Merus will spearhead the early-stage research works for two programmes, with the option to expand to a third asset. ...
BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
TMR-CT will help doctors select treatment and predict the spread of lung cancer in patients Imperial College London (ICL) researchers have used artificial intelligence (AI) to identify information about the chemical makeup of lung tumours from medical scans of lung cancer. Published in npj Precision Oncology, the study demonstrates, for the first time, how medical imaging in combination with AI can be used to provide ‘virtual biopsies’ for cancer patients. Responsible for around 35,000 deaths each year, lung cancer is the most common cause of cancer death in the UK. Supported with funding from the National Institute for Health and Care Research’s Imperial Biomedical Research Centre, the non-invasive method works to classify the type of lung cancer patients have. Researchers used data from 48 lung cancer patients recruited from University Hospital Reina Sofia in Spain to develop an AI-powered, deep learning assessment tool called tissue-metabolomic-radiomic-CT (TMR-CT). Using the data, researchers ...
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