The FDA cleared investigational new drug (IND) applications enabling first‑in‑human studies for two solid‑tumor programs. Neok Bio’s bispecific ADC NEOK‑001 received IND clearance and plans a phase I trial in solid tumors, with dosing expected in months and initial data next year. Avacta secured IND clearance for AVA‑6103, a precision peptide‑drug conjugate (PDC) targeting FAP‑expressing tumors. These INDs add to an active translational pipeline in antibody‑drug conjugates and PDCs, signaling investor and regulator interest in targeted cytotoxic delivery to stroma‑ or tumor‑associated antigens. Sponsors will focus on safety, dose escalation and early signals of tumor control in the phase I programs.
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