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BioWorld - Wednesday, April 8, 2026
Home » Topics » Regulatory » IND

IND
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Degradation of motor neurons
Neurology/psychiatric

Vectory’s VTX-002 gains IND clearance for ALS

Dec. 3, 2025
No Comments
Vectory Therapeutics BV has obtained IND clearance from the FDA for a phase I/II trial (PIONEER-ALS) of VTX-002, a first-in-class vectorized antibody targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS). VTX-002 delivers an engineered antibody designed to selectively target toxic species of TDP-43.
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Art concept for gene therapy research
Neurology/psychiatric

FDA clears Latus Bio’s LTS-101 to enter clinic for CLN2 disease

Dec. 3, 2025
No Comments
Latus Bio Inc. has reported IND clearance by the FDA for LTS-101, a gene therapy candidate to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease. The FDA has also granted orphan drug, rare pediatric disease and fast track designations to LTS-101.
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Concept art for targeting cancer
Cancer

Ideaya’s IDE-034 gains IND clearance for solid tumors

Dec. 1, 2025
No Comments
Ideaya Biosciences Inc. has received IND clearance from the FDA for the initiation of a phase I trial to evaluate IDE-034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate.
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Red and blue bispecific antibodies

Phrontline raises $60M in pre-A+ round for bispecific ADCs

Nov. 25, 2025
By Marian (YoonJee) Chu
No Comments
Phrontline Biopharma Suzhou Co. Ltd. closed a $60 million pre-A+ financing round led by Lapam Investment, with participation from nine other investors. The funds raised will support Phrontline’s development of next-generation antibody-drug conjugate (ADC) candidates.
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Cancer

Peptidream files INDs for [225Ac]PD-32766 and [64Cu]PD-32766

Nov. 25, 2025
No Comments
Peptidream Inc. has submitted IND applications to the FDA to initiate phase I studies of [225Ac]PD-32766, as a potential radiotherapeutic, and [64Cu]PD-32766, as the radiodiagnostic pair, for patients with clear cell renal cell carcinoma (ccRCC).
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Concept of business partnership
Drug design, drug delivery & technologies

Evotec and BMS partnership yields IND approval

Nov. 12, 2025
No Comments
Evotec SE has received a $5 million milestone payment from Bristol Myers Squibb Co. (BMS), following the acceptance of an IND application by the FDA in the companies’ strategic protein degradation partnership.
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Handshake with charts, maps, data

Qyuns and Roche partner in $1B+ bispecific antibody deal

Nov. 4, 2025
By Marian (YoonJee) Chu
No Comments
Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.
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Handshake with charts, maps, data

Qyuns and Roche partner in $1B+ bispecific antibody deal

Oct. 29, 2025
By Marian (YoonJee) Chu
No Comments
Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.
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Drug R&D concept image.
Cancer

IND open for Dewpoint’s condensate modulator DPTX-3186

Oct. 22, 2025
No Comments
Dewpoint Therapeutics Inc. has announced an IND in the U.S. for DPTX-3186, a first-in-class oral condensate modulator designed to selectively disrupt oncogenic Wnt/β-catenin signaling in tumors. Dosing is set to begin before year-end in a phase I/II trial conducted in partnership with cancer centers and opinion leaders in gastric and other Wnt-driven cancers.
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Immune

Moonlight’s MOON-101 for peanut allergy gains IND approval

Oct. 20, 2025
No Comments
Moonlight Therapeutics Inc.’s IND application for MOON-101 has been cleared by the FDA, paving the way for a first clinical trial in adults and children with peanut allergy.
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