Cullinan Therapeutics Inc. has submitted an IND application to the FDA to evaluate its CD19 x CD3 bispecific T-cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE).
Medigene AG has obtained FDA clearance of its IND application for lead program MDG-1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma.
Adaptin Bio has obtained IND clearance from the FDA for APTN-101 in glioblastoma, enabling initiation of a first-in-human phase I trial in patients diagnosed with WHO grade IV malignant glioma.
The FDA has cleared an IND for a phase I/II trial of LA-GLA (GC-1134A, HM-15421), an innovative enzyme replacement therapy for Fabry disease being co-developed by GC Biopharma Corp. and Hanmi Pharmaceutical Co. Ltd.
Suven Life Sciences Ltd. has received IND approval from the FDA allowing it to initiate a first-in-human phase I study of SUVN-I6107, a muscarinic M1 receptor positive allosteric modulator (PAM) as a potential new treatment to address the dementia market.
Find Therapeutics Inc. has obtained FDA clearance of its IND application for FTX-101, a first-in-class remyelinating agent that aims to restore vision in people with chronic optic neuropathy.
Azitra Inc. has obtained IND clearance from the FDA for a first-in-human phase I/II study of ATR-04 for moderate to severe EGFR inhibitor-associated dermal toxicity. The study is expected to begin by year-end.
Immpact Bio USA Inc. has obtained IND clearance from the FDA for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with multiple sclerosis (MS). A phase I trial will focus on patients who have suboptimal disease control despite prior treatment with high efficacy disease-modifying therapies in all forms of MS.
Innovec Pharmaceutical Technology Co. Ltd. (Innovec Biotherapeutics) has received FDA clearance for its IND application for IVB-103, an AAV-based gene therapy for neovascular age-related macular degeneration (AMD).
Cidara Therapeutics Inc. announced in its Q2 filing that it received IND clearance for its drug-Fc conjugate (DFC) immunotherapy CBO-421 in July of 2024.
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