1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
Insilico Medicine Cayman Topco has obtained IND approval from the FDA for ISM-8969 for the treatment of Parkinson’s disease, enabling initiation of a phase I trial in healthy volunteers.
Alveus Therapeutics Inc. has obtained IND clearance from the FDA for ALV-100, for chronic weight management, enabling initiation of a phase Ib study. Dosing has now commenced in the study.
Avacta Therapeutics (Avacta Group plc) has obtained IND clearance from the FDA for FAP-Exd (AVA-6103), a Precision peptide-drug conjugate based on exatecan.
Neok Bio Inc. has obtained IND clearance from the FDA for NEOK-001, enabling initiation of a phase I trial for solid tumors. Dosing is expected to begin in the coming months, and initial clinical data are anticipated next year.
Boundless Bio Inc. has obtained IND approval from the FDA for its novel kinesin oral degrader program, BBI-940. A first-in-human trial (KOMODO-1) for metastatic breast cancer is expected to begin in the first half of this year.
D3 Bio Inc. has obtained IND clearance from the FDA for D3S‑003, enabling initiation of a first‑in‑human phase I trial in patients with advanced solid tumors harboring KRAS G12D mutations.
GT Biopharma Inc. has filed an IND application with the FDA for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3-expressing solid tumor cancers. Pending approval, the planned phase I basket trial will evaluate GTB-5550 administered subcutaneously in solid tumors.
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