Aurinia Pharmaceuticals Inc. has added two potential drugs to its pipeline targeting autoimmune and kidney-related diseases through an acquisition and a licensing deal. Victoria, British Columbia-based Aurinia is building on its first ever FDA approval at the beginning of the year, for Lupkynis (voclosporin) for treating active lupus nephritis in adults.
Gentibio Inc. has raised $157 million to develop its engineered regulatory T cells (Tregs), setting itself a target to cure type 1 diabetes and treat other diseases caused by the immune system. Boston-based Gentibio launched in August last year with $20 million seed funding from Orbimed, Novartis Venture Fund and RA Capital. Those investors stayed on into the next round, which was led by Matrix Capital Management with participation by Avidity Partners and JDRF T1D Fund.
LONDON – Mestag Therapeutics Ltd. has closed a hefty $45 million seed round to advance development of antibodies targeting activated fibroblasts, in the treatment of cancer and immune diseases.
After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc. The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy.
LONDON – Topas Therapeutics GmbH announced the close of a series B round at €40 million (US$47.5 million), to take forward its two lead immune tolerizing programs. The first, TPM-203, is in clinical development for the treatment of the rare, severe autoimmune skin disorder pemphigus vulgaris, while the second, TPM-502, is due to enter the clinic in celiac disease before the end of the year.
Six weeks ahead of its PDUFA date, Kadmon Holdings Inc.’s NDA for Rezurock (belumosudil) has been approved to treat chronic graft-vs.-host disease. The selective oral inhibitor of Rho-associated coiled-coil kinase 2, a daily treatment for patients 12 and older after failure of at least two prior lines of systemic therapy, is the New York-based company’s first approved therapy.
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
Keymed Biosciences Inc. debuted on the Hong Kong Stock Exchange (HKSE) on July 8, raising HK$2.94 billion (US$378.48 million) in the process. The company will use the funds raised for the R&D and commercialization of key pipeline candidates.
Multiple companies are pursuing CD47-blockade as a tumor immunotherapy approach. Sana Biotechnology Inc., too, is interested in the therapeutic potential of CD47 – but from a very different angle. By overexpressing CD47 on stem cells, researchers at Sana want to make transplanted cells invisible to the immune system.