Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-564 for the treatment of solid tumors.
Nextpoint Therapeutics Inc. has received FDA clearance of its IND application for NPX-887, a fully human monoclonal antibody targeting HHLA2 (B7-H7), a novel immune checkpoint and tumor target antigen highly expressed in many cancers independently of PD-L1.
Vittoria Biotherapeutics Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial with VIPER-101, a gene-edited, autologous, chimeric antigen receptor (CAR) T-cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma.
Simcere Pharmaceutical Group Ltd.’s subsidiary Simcere Zaiming Pharmaceutical Co. Ltd. has received FDA clearance of an IND application for SIM-0501, an oral small-molecule inhibitor of ubiquitin-specific peptidase 1 (USP1), for advanced solid tumors.
KSQ Therapeutics Inc., in collaboration with The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), have announced FDA clearance of an IND application for a phase I/II study of KSQ-001EX, KSQ’s lead engineered tumor-infiltrating lymphocyte (eTIL) program.
Pasithea Therapeutics Corp. has received written responses from the FDA to questions submitted for a type 2 pre-IND meeting regarding the clinical development plan for PAS-004 (CIP-137401).
Carisma Therapeutics Inc. has received FDA clearance of its IND application for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor (CAR)-monocyte cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics.
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