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BioWorld - Monday, January 12, 2026
Home » Topics » Regulatory » IND

IND
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Non-Hodgkin lymphoma cells in the blood flow
Immuno-oncology

Verismo submits IND application for Synkir-310 for relapsed or refractory B-cell NHL

April 4, 2024
Verismo Therapeutics Inc. has submitted an IND application to the FDA seeking to initiate a phase I trial this year of Synkir-310 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma.
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Bispecific antibodies with heavy chain in green and pink, light chain in blue and yellow
Immuno-oncology

Context Therapeutics files IND application for CTIM-76 for CLDN6-positive gynecologic and testicular cancers

April 2, 2024
Context Therapeutics Inc. has submitted an IND application to the FDA to begin a first-in-human phase I study of CTIM-76 in patients with claudin 6 (CLDN6)-positive gynecologic and testicular cancers.
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Cancer

Nested’s RAF/MEK molecular glue NST-628 cleared to enter clinic for solid tumors

March 28, 2024
Nested Therapeutics Inc. has obtained FDA clearance of its IND application for NST-628 for the treatment of patients with advanced solid tumors harboring genetic alterations in the RAS-MAPK pathway.
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Endocrine/Metabolic

Cinfina Pharma obtains IND clearance for PYY3-36 analogue CIN-110 for obesity

March 27, 2024
Cinfina Pharma Inc. has obtained FDA clearance of its IND application for CIN-110, a PYY3-36 analogue, allowing it to initiate a first in-human study in otherwise healthy subjects with obesity. CIN-110 is a stable and long-acting analogue of PYY3-36 being developed both as a monotherapy and for co-administration for obesity.
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3D rendering of CAR T therapy in cell
Newco news

US-China company Triarm on a mission to democratize CAR Ts

March 26, 2024
By Tamra Sami
Triarm Therapeutics Ltd. is on a mission to democratize CAR T therapies to make them more accessible and affordable, Triarm CEO Jay Zhang told BioWorld. “Nearly half of the patients eligible for CAR T therapies still cannot get treated, and the main reason is the expense, and the second is they cannot afford to wait.
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Illustration of polycystic kidney
Nephrology

US IND clearance for VX-407 for autosomal dominant polycystic kidney disease

March 22, 2024
Vertex Pharmaceuticals Inc. has obtained IND clearance from the FDA for VX-407, an investigational first-in-class small-molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
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3D rendering of CAR T therapy in cell
Newco news

US-China company Triarm on a mission to democratize CAR Ts

March 21, 2024
By Tamra Sami
Triarm Therapeutics Ltd. is on a mission to democratize CAR T therapies to make them more accessible and affordable, Triarm CEO Jay Zhang told BioWorld. “Nearly half of the patients eligible for CAR T therapies still cannot get treated, and the main reason is the expense, and the second is they cannot afford to wait.
Read More
Brain and DNA
Neurology/Psychiatric

Depymed’s DPM-1003 receives IND clearance for Rett syndrome evaluation

March 20, 2024
Depymed Inc. has received FDA clearance to initiate a phase I trial for DPM-1003 for the treatment of Rett syndrome.
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Immune

Imunon files IND application for COVID-19 booster

March 14, 2024
Imunon Inc. has filed an IND application with the FDA seeking clearance to begin a phase I study of IMNN-101 as a seasonal COVID-19 booster vaccine.
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Multiple myeloma cells in the bone marrow.
Immuno-oncology

Trispecific antibody SIM-0500 approved for trials in the US and China for multiple myeloma

March 12, 2024
Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd., has received approval from the FDA and China’s National Medical Products Administration (NMPA) to conduct clinical trials with SIM-0500 in patients with relapsed or refractory multiple myeloma.
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