Escient Pharmaceuticals Inc. has obtained FDA clearance of its IND application for EP-262, a first-in-class, potent, highly selective small-molecule antagonist of Mas-related G-protein coupled receptor member X2 (MRGPRX2) for mast cell-mediated disorders.
Centessa Pharmaceuticals plc has received clearance of its IND application from the FDA to initiate a first-in-human phase I/IIa trial of LB-101 for the treatment of solid tumors.
Sana Biotechnology Inc. has received FDA clearance of its IND application to initiate a first-in-human study of SC-291 in patients with various B-cell malignancies. Initial clinical data from the study are expected later this year. SC-291 is a CD19-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy developed using Sana's hypoimmune platform.
Exegi Pharma LLC has received FDA clearance of its IND application for EXE-346, allowing the company to initiate a clinical trial to evaluate EXE-346 in the management of excessive stool frequency in patients with an ileal pouch-anal anastomosis (IPAA, J-Pouch).
Lapix Therapeutics Inc. has announced the successful outcome of its pre-IND meeting request with the FDA to achieve alignment on the company's IND-enabling plan for LPX-TI641, being developed for neuro-autoimmune indications such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myelin oligodendrocyte glycoprotein antibody disease (MOGAD).
The FDA has cleared Tango Therapeutics Inc.'s IND application for TNG-462, a next-generation methylthioadenosine-cooperative (MTA) inhibitor of protein arginine methyl transferase 5 (PRMT5) for the treatment of cancers with methylthioadenosine phosphorylase (MTAP) deletion.
Immpact Bio USA Inc. has announced clearance of its IND application by the FDA for IMPT-314, a bispecific OR-Gate autologous chimeric antigen receptor (CAR) T-cell therapy targeting the B-cell antigens CD19 and CD20.
The FDA has cleared Cullinan Oncology Inc.'s IND application for CLN-978, a CD19/CD3 T-cell engaging antibody construct with a human serum albumin (HSA) binding domain to increase serum half-life.
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