CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6016, the company’s mRNA respiratory syncytial virus (RSV) vaccine.
Autoimmune disease specialist Scirhom GmbH has raised €63 million (US$68 million) in a series A to take an antibody against iRhom2, an enzyme that regulates TNF-alpha secretion, into the clinic. The company has approval for a phase I trial in healthy volunteers that will start later this year, with plans for proof-of-concept trials in rheumatoid arthritis and inflammatory bowel disease to follow.
A new methodology based on the regulation of genetic enhancers has made it possible to develop a cellular map that reveals new types of helper T cells related to immunological disorders that could be explored for the development of new therapies. “I am very interested in the function of rare T cells, and I am trying to analyze their function by eliminating certain rare T cells with antibodies with ADCC [antibody-dependent cell-mediated cytotoxicity] activity or by disrupting genes that characterize rare T cells in animal models,” senior author Yasuhiro Murakawa told BioWorld.
At the Congress of the European Academy of Neurology, researchers from Dianthus Therapeutics Inc. presented preclinical data on DNTH-103, a monoclonal antibody engineered to selectively target the active form of complement C1s.
Cartesian Therapeutics Inc.’s phase IIb study of its lead candidate, Descartes-08, in treating generalized myasthenia gravis (gMG) hit its primary endpoint while the company also notched a $130 million private placement equity financing.
Pharma Foods International Co. Ltd. (PFI) has announced the achievement of a milestone under its licensing agreement with Mitsubishi Tanabe Pharma Corp. for a new investigational therapeutic antibody for autoimmune diseases.
MTX-101 (Mozart Therapeutics Inc.) is a bispecific CD8 Treg modulator that targets CD8 and the KIR2DL family, including KIR2DL1, KIR2DL2 and KIR2DL3, and is being developed for the treatment of CD4-driven autoimmunity and restoring immune balance.
Alumis Inc. began trading (NASDAQ:ALMS) earlier this morning, with the company’s IPO debuting at $16 per share to raise $210 million, with another $40 million coming through a concurrent private placement at the same price. That was the lower end of its previously announced price range, which had stretched as high as $18 per share.
Two days before the PDUFA date, the U.S. FDA handed down a complete response letter (CRL) for Rocket Pharmaceuticals Inc.’s Kresladi (marnetegragene autotemcel), delaying potential approval of the lentiviral-based gene therapy as the first therapeutic option for leukocyte adhesion deficiency type I, a rare, inherited immune disorder. But the Cranbury, N.J.-based company has suggested that delay won’t be long, as the CRL requests only “limited” chemistry manufacturing and controls (CMC) information – additional CMC data were also cited as the reason for the three-month review extension earlier this year.
Researchers at The Scripps Research Institute and the IAVI Neutralizing Antibody Center are developing a novel experimental vaccine targeting the germline to stimulate precursor B cells and produce broadly neutralizing antibodies (bnAbs) against the membrane-proximal external region (MPER) of the gp41 protein found in the HIV-1 envelope.
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