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BioWorld - Friday, December 19, 2025
Home » Topics » Regulatory » IND

IND
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Lung cancer illustration
Immuno-oncology

CSPC Pharmaceutical’s antibody-drug conjugate CPO-301 cleared to enter clinic in US for lung cancer

April 3, 2023
CSPC Pharmaceutical Group Ltd. has received FDA clearance of its IND for a phase I trial of its antibody-drug conjugate CPO-301 for the treatment of advanced lung cancer with alterations in the EGFR gene or EGFR over-expression.
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CAR T cell with implanted gene strand
Musculoskeletal

Cabaletta’s IND for CABA-201 for SLE receives FDA clearance

April 3, 2023
Cabaletta Bio Inc.’s IND application for CABA-201, a 4-1BB-containing fully human CD19-chimeric...
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Pregnant woman
Obstetrics

Comanche’s siRNA therapy CBP-4888 cleared by FDA to enter clinic for pre-eclampsia

March 31, 2023
Comanche Biopharma Corp. has received IND clearance from the FDA to conduct a first-in-human study of CBP-4888, its novel, small interfering ribonucleic acid (siRNA) therapy to treat pre-eclampsia.
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Immune

Pathovax receives IND clearance for phase I study of HPV16 RG1-VLP

March 30, 2023
Pathovax LLC is developing a universally preventative human papillomavirus (HPV)...
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Skin, tissue layer illustration
Dermatologic

Eloxx files IND application for ZKN-013 to treat recessive dystrophic epidermolysis bullosa

March 29, 2023
Eloxx Pharmaceuticals Inc. has filed an IND application with the FDA for ZKN-013 for the...
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Immuno-oncology

Cullinan’s cytokine therapy CLN-617 cleared to enter clinic for solid tumors

March 28, 2023
Cullinan Oncology Inc. has received IND clearance from the FDA to conduct a phase I trial of CLN-617 in patients with advanced solid tumors.
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Immuno-oncology

Glenmark’s HPK1 inhibitor GRC-54276 cleared by FDA to enter clinic for advanced solid tumors and lymphomas

March 17, 2023
Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals Ltd., has received FDA...
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Immuno-oncology

Henlius’ agonistic anti-OX40 humanized monoclonal antibody HLX-51 cleared to enter clinic in China

March 16, 2023
Shanghai Henlius Biotech Inc. has received...
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Cancer

Sapience's β-catenin peptide antagonist ST-316 cleared by FDA to enter clinic for solid tumors

March 15, 2023
Sapience Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of ST-316 for the treatment of solid tumors.
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Respiratory

Tetra Bio-Pharma's oral ARDS-003 cleared by Health Canada to enter clinic

March 13, 2023
Tetra Bio-Pharma Inc. has received clearance from Health Canada to proceed with a first-in-human trial in Canada using oral ARDS-003 (onternabez) to treat various immunomodulatory conditions. Oral ARDS-003 is positioned to modulate acute systemic inflammation and prevent sepsis, acute respiratory distress syndrome (ARDS) and organ damage.
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