Mission Therapeutics Ltd. has reported clinical trial authorization (CTA) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for a first-in-human phase I study of MTX-325 for the treatment of Parkinson’s disease. Dosing is expected to commence in the first quarter of next year, with preliminary data to follow later in the year.
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.
CSPC Pharmaceutical Group Ltd.’s SYH-2053 injection has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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).
Sernova Corp. has announced that its hemophilia A program, combining the Sernova Cell Pouch with a patient’s own cells corrected for the production of factor VIII (FVIII), has been awarded U.S. orphan drug and rare pediatric disease designations.
Ethris GmbH has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with a first-in-human trial of its inhaled mRNA program, ETH-47, in healthy participants for the treatment and prophylaxis of respiratory viral infections.
CSPC Pharmaceutical Group Ltd.’s selective son of sevenless homolog 1 (SOS-1) inhibitor SYH-2038 has received clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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