Rgenta Therapeutics Inc. has received IND clearance by the FDA for RGT-61159, which is being developed for adenoid cystic carcinoma, colorectal cancer and other solid tumors, as well as acute myeloid leukemia.
Abata Therapeutics Inc. has obtained FDA clearance for its IND application enabling initiation of a first-in-human study of ABA-101 in patients with progressive multiple sclerosis (MS). A phase I study will open later this year.
Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.
Kbio Inc. has obtained IND clearance from the FDA for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis.
Circle Pharma Inc. has submitted an IND application to the FDA for CID-078, a first-in-class cyclin A/B RxL inhibitor. Pending approval, the company plans to initiate a phase I trial in patients with advanced solid tumor malignancies.
SCG Cell Therapy Pte Ltd. has gained FDA clearance of its IND application to initiate a phase I/II trial of SCG-142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T)-cell therapy for patients with HPV-associated solid tumors.
Concerto Bioscience Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial of Ensemble No.2 (ENS-002), an investigational live biotherapeutic product to treat atopic dermatitis.
Adicet Bio Inc. has obtained FDA clearance of its IND application to evaluate ADI-270, an armored allogeneic λδ CAR T-cell therapy candidate targeting CD70-positive cancers, for the treatment of relapsed or refractory renal cell carcinoma (RCC).
4D Molecular Therapeutics Inc. has obtained IND clearance by the FDA for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with geographic atrophy.
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