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BioWorld - Monday, December 29, 2025
Home » Topics » Regulatory » IND

IND
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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.
Read More
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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Multiple sclerosis, neurons concept art.
Neurology/psychiatric

Tr1x’s TRX-319 cleared for clinical trial in progressive MS

Oct. 15, 2025
No Comments
Tr1x Inc. has obtained IND clearance from the FDA for TRX-319, paving the way for initiation of a phase I/IIa study in progressive multiple sclerosis (MS) early next year. TRX-319 is designed to combine targeted B-cell control with active anti-inflammatory signaling and T-cell regulation, with the goal of restoring immune balance.
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3D heart in chest
Cardiovascular

IND approval for Corventum’s drug for chemo-cardioprotection

Oct. 15, 2025
No Comments
Corventum Inc. has gained IND clearance from the FDA for CVT-130 for the prevention of anthracycline-related cardiotoxicity. In cancer patients, the use of anthracyclines as chemotherapy is effective but limited by cumulative heart damage. Protecting against this chemotherapy-induced cardiac injury could enable retreatment for patients with recurrent cancer.
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Immune

Hinge’s HB-2198 gains IND clearance for SLE and lupus nephritis

Oct. 14, 2025
No Comments
Hinge Bio Inc. has obtained IND approval from the FDA to initiate a phase I study of HB-2198 in patients with the B cell-mediated autoimmune diseases systemic lupus erythematosus (SLE) and lupus nephritis. The trial is expected to open this quarter.
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3D illustration of acute lymphoblastic leukemia in blood.
Immuno-oncology

IND approval for Allterum’s 4A10 for acute lymphoblastic leukemia

Oct. 10, 2025
No Comments
Allterum Therapeutics Inc. has obtained IND clearance from the FDA for 4A10, paving the way for initiation of a first-in-human phase I trial in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). 4A10 is a monoclonal antibody with a human immunoglobulin G subclass 1 (IgG1) backbone that specifically binds to CD127 (IL-7Rα).
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Eye, DNA double helix illustration.
Ocular

Complement Therapeutics’ CTx-001 gains IND clearance

Oct. 8, 2025
No Comments
Complement Therapeutics GmbH has obtained clearance for CTx-001, a gene therapy candidate.
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Colorful illustration of the heart
Cardiovascular

IND clearance for UCLA’s AD-NP1 for heart tissue regeneration

Oct. 7, 2025
No Comments
The FDA has cleared AD-NP1, a drug developed by University of California, Los Angeles (UCLA) for heart tissue regeneration, to enter clinical trials. The monoclonal antibody blocks the production of ENPP1 protein, which was found to interfere with healing after a heart attack.
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