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).
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.
Neurogene Inc. has received FDA clearance of its IND application for NGN-401 for the treatment of Rett syndrome. The company plans to initiate a phase I/II trial in female pediatric patients with Rett syndrome this year.
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