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BioWorld - Friday, June 26, 2026
Home » Topics » Regulatory » IND

IND
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DNA and cancer cells
Cancer

Siren Biotechnology’s glioma program gains IND clearance

Jan. 29, 2026
No Comments
Siren Biotechnology Inc. has obtained IND approval from the FDA enabling the initiation of its first-in-human trial for its lead investigational program SRN-101 in adult patients with recurrent high-grade glioma.
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Korean Won currency symbol made of gray cast iron

1st Biotherapeutics closes $22M series D, preps for IPO

Jan. 27, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Korean Won currency symbol made of gray cast iron

1st Biotherapeutics closes $22M series D, preps for IPO

Jan. 26, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Concept art for "unlocking the secrets of the mind"
Neurology/psychiatric

Insilico Medicine’s ISM-8969 gains IND clearance for Parkinson’s

Jan. 26, 2026
No Comments
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.
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Endocrine/metabolic

Alveus Therapeutics’ ALV-100 gains IND clearance for obesity

Jan. 23, 2026
No Comments
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.
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Drug R&D concept image.
Cancer

Avacta’s AVA-6103 gains IND clearance for solid tumors

Jan. 22, 2026
No Comments
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.
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Art concept for tumor
Immuno-oncology

Neok Bio’s bispecific ADC NEOK-001 gains IND clearance

Jan. 22, 2026
No Comments
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.
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Blue gloved hand holding a syringe
Immuno-oncology

FDA clears IND for Immunomic’s ITI-5000

Jan. 21, 2026
No Comments
Immunomic Therapeutics Inc. has received FDA clearance of its IND application for ITI-5000, enabling initiation of a first-in-human study.
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Scientific illustration of a migrating breast cancer cell
Cancer

Boundless Bio’s kinesin degrader gains IND approval

Jan. 21, 2026
No Comments
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.
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KRAS protein
Cancer

D3 Bio’s KRAS G12D inhibitor D3S‑003 gains IND clearance

Jan. 19, 2026
No Comments
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.
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