Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
Equillium Inc. is forging ahead with regulatory plans for itolizumab in first-line treatment of patients with acute graft-vs.-host disease (GVHD), despite a phase III disappointment. Shares of the La Jolla, Calif.-based firm (NASDAQ:EQ) closed March 27 at 46 cents, down 29 cents, or 39%, on top-line data from the Equator study testing itolizumab, which is designed to target the CD6-ALCAM signaling pathway.
Transplanting an animal organ into a human is now a closer reality following the successful xenotransplantation of a genetically modified pig liver into a patient diagnosed with brain death in China. The operation was intended to evaluate organ function over a 10-day period. This is a complex experimental trial that did not involve removing the patient's liver and still requires further study. However, the positive preclinical results suggest this strategy could save the lives of those waiting for a human organ, at least in certain cases.
Astrazeneca plc is investing heavily in China, signing two R&D deals, worth up to about $8 billion in up-front payments and milestones combined, with Chinese companies Harbour Biomed Ltd. and Syneron Bio, establishing a joint venture with Shenzhen Kangtai Biological Products Co. (Biokangtai) for vaccines, and creating a new R&D center in Beijing through another $2.5 billion investment.
Hillstar Bio came out of stealth mode, announcing a $67 million series A financing round with investors including Droia Ventures, Frazier Life Sciences, Novo Holdings A/S and Lifearc Ventures.
Astrazeneca plc is investing heavily in China, signing two R&D deals, worth up to about $8 billion in up-front payments and milestones combined, with Chinese companies Harbour Biomed Ltd. and Syneron Bio, establishing a joint venture with Shenzhen Kangtai Biological Products Co. (Biokangtai) for vaccines, and creating a new R&D center in Beijing through another $2.5 billion investment.
Taimed Biologics Inc.’s TMB-365/TMB-380 long-acting combination of broadly neutralizing antibodies regimen for HIV maintenance could reshape HIV treatment management, offering a viable alternative to daily combination antiretroviral therapy (cART), the Taipei-based company said after reporting on phase IIa results.
Sanofi SA is getting deeper into oncology and immunology therapy development through buying Dren Bio Inc.’s myeloid cell engager for deep B-cell depletion, DR-0201. The deal could reach as high as $1.9 billion for privately held Dren. Sanofi is paying a hefty $600 million up front, and milestone payments to come could add up to $1.3 billion.
Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
Oxford Biotherapeutics Ltd. is partnering with Roche AG to expand the current field of tumor antigens that can be drugged with antibodies, as part of a potential $1 billion-plus agreement. The agreement will see Oxford Biotherapeutics apply its membrane protein discovery platform to search for novel cancer cell antigens, which will be validated through the research collaboration, with Roche then taking the lead in advancing any resulting antibody programs.
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