Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event. The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference. In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer. Pfizer will also be presenting ...
Until now, researchers and clinicians have lacked diagnostic tools to easily differentiate between past infections with different flaviviruses—a family of mostly mosquito- and tick-borne viruses that include Zika and dengue. This challenge has hindered clinical-epidemiologic studies, viral diagnostics, and vaccine development. Antibodies for Zika virus, a mosquito-borne virus that spread to the Americas in 2015 and continues to cause sporadic outbreaks, can often be mistaken for dengue virus antibodies in many diagnostic tests. This confusion makes it difficult to determine if a person who tests positive had dengue, Zika, or both. For reproductive-age women, it is particularly crucial to know if they have had Zika and likely have immunity since infection during pregnancy can lead to birth defects. Knowing their immunity status can guide their efforts to avoid mosquito bites in endemic areas during pregnancy. Now, a newly discovered Zika virus-specific synthetic molecule can distinguish Zika-immune patient samples from those ...
Recently, Hengrui Pharmaceuticals’ subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, approving SHR-2173 Injection, a Class 1 new drug, to carry out clinical trials for IgA nephropathy. At present, there is no similar drug to SHR-2173 on the market or in the clinical development stage at home and abroad. IgA nephropathy is a group of autoimmune glomerulonephritis characterized by IgA deposition in the glomerular mesangial area. Typical clinical manifestations can be seen in microscopic hematuria, and patients have a history of mucosal (e.g., upper respiratory tract, gastrointestinal tract) infections, which is the most common primary glomerulopathies worldwide, and also a major cause of chronic kidney disease (CKD) and renal failure. In China, IgA nephropathy accounts for 45% of primary glomerular diseases in China. There are geographical differences in the incidence of the disease, and the peak ...
Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a nationwide Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQB2223 Injection in combination with Paanoprilumab in subjects with advanced malignant tumors. The study has been approved by the State Drug Administration (Notification No. 2023LP00274) and passed the center’s ethics, and is now recruiting nationwide. Trial drug profile TQB2223 injection is a lymphocyte activation gene-3 monoclonal antibody (LAG-3), registered as therapeutic biological product class 1. LAG-3, as an immune checkpoint, is expressed in activated T cells, NK cells, B cells and plasmacytoid dendritic cells, etc., and can negatively regulate T cells, which plays an important role in the maintenance of homeostasis of the body’s immune system and the promotion of tumor immune escape. LAG-3 monoclonal antibody can block the LAG-3 ligand on the cell surface, enhance the secretion of cytokines and exert anti-tumor immunity. Pavelizumab is a PD-1 monoclonal ...
BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approves the clinical trial application of the Company’s investigational drug BAT1308 in combination with BAT8006 for the treatment of advanced solid tumors. BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA. Its active ingredient is an antibody targeting human programmed cell death protein 1 (PD-1) expressed by Chinese hamster ovary cells, which belongs to the immunoglobulin IgG4κ subtype, and is capable of binding specifically to human PD-1 with high affinity, thus blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. BAT1308 is able to bind to PD-1 on the surface of T-cells and release the inhibitory effect of ...
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 its partner, Bojian (NASDAQ: BIIB), has recently begun marketing and selling TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar in the United States. TOFIDENCE™, a biosimilar developed by BIO-THERA with reference to Amero® (tocilizumab), was approved by the U.S. FDA in September 2023 for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.TOFIDENCE™ is currently available in the U.S. as an intravenous infusion of 80 mg/4 ml, and is sold as an intravenous injection of 80 mg/4 ml. sales, 80 mg/4 mL, 200 ...
Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1. By Frank Vinluan Amgen aims to challenge the Novo Nordisk and Eli Lilly duopoly in the market for injectable obesity medications, and the company is now preparing for Phase 3 testing of an injectable drug candidate that would introduce new competition. While executives are not yet sharing specific details of the clinical data that support these plans, Amgen’s drug candidate could have dosing and manufacturing advantages. The update for the drug, maridebart cafraglutide or MariTide (known in earlier stages of development as AMG 133), came with Amgen’s report of financial results for the first quarter of 2024. CEO Robert Bradway said the company ...
Strategic collaboration to leverage BigHat’s AI/ML (Artificial Intelligence / Machine Learning) guided Milliner platform to design high-quality next-generation protein therapeutics BigHat Biosciences, a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform announced a collaboration with Janssen Biotech Inc., a Johnson & Johnson company. This strategic collaboration combines the drug discovery, clinical development and data science expertise from Johnson & Johnson with BigHat’s Milliner platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high-quality antibodies for multiple Neuroscience therapeutic targets. The agreement was facilitated by Johnson & Johnson Innovation. BigHat’s antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with machine learning technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins ...
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