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Home » Topics » Regulatory » IND

IND
IND RSS Feed RSS

Apimeds prices $11.5M IPO for bee venom-based therapy

Sep. 30, 2024
By Marian (YoonJee) Chu
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
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Immuno-oncology art concept
Immuno-oncology

KSQ Therapeutics’ TIL therapy cleared to enter clinic for solid tumors

Sep. 25, 2024
The FDA has cleared an IND application for a phase I/II study of KSQ-004EX, KSQ Therapeutics Inc.’s second engineered tumor-infiltrating lymphocyte (eTIL) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing.
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Art concept for tumor
Immuno-oncology

FDA clears Chengdian (Suzhou) Biopharmaceutical’s IND for CD-001

Sep. 24, 2024
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
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3D illustration of tumor
Immuno-oncology

Innate’s Nectin-4-targeting ADC obtains IND clearance for solid tumors

Sep. 23, 2024
Innate Pharma SA has obtained IND clearance from the FDA for IPH-4502, its novel and differentiated topoisomerase I inhibitor antibody-drug conjugate (ADC) conjugated to exatecan targeting Nectin-4 in solid tumors. In nonclinical models, IPH-45 was well tolerated and showed antitumor efficacy in vitro and in vivo.
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Art concept for tumor
Immuno-oncology

FDA clears Chengdian (Suzhou) Biopharmaceutical’s IND for CD-001

Sep. 20, 2024
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
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Illustration of lymphocytes
Immune

Cullinan Therapeutics files IND application for CLN-978 to treat SLE

Sep. 16, 2024
Cullinan Therapeutics Inc. has submitted an IND application to the FDA to evaluate its CD19 x CD3 bispecific T-cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE).
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Cancer cell, dropper, test tubes
Immuno-oncology

Medigene’s TCR T therapy MDG-1015 gets green light for clinic in US

Sep. 6, 2024
Medigene AG has obtained FDA clearance of its IND application for lead program MDG-1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma.
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Immuno-oncology

Adaptin Bio’s APTN-101 cleared to enter clinic for glioblastoma

Sep. 5, 2024
Adaptin Bio has obtained IND clearance from the FDA for APTN-101 in glioblastoma, enabling initiation of a first-in-human phase I trial in patients diagnosed with WHO grade IV malignant glioma.
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Alpha-galactosidase enzyme
Endocrine/metabolic

GC Biopharma and Hanmi’s once-monthly subcutaneous treatment for Fabry disease gains US IND clearance

Sep. 3, 2024
The FDA has cleared an IND for a phase I/II trial of LA-GLA (GC-1134A, HM-15421), an innovative enzyme replacement therapy for Fabry disease being co-developed by GC Biopharma Corp. and Hanmi Pharmaceutical Co. Ltd.
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Illustration of head with maze that is missing parts
Neurology/psychiatric

Suven gains IND clearance for muscarinic M1 receptor PAM

Aug. 29, 2024
Suven Life Sciences Ltd. has received IND approval from the FDA allowing it to initiate a first-in-human phase I study of SUVN-I6107, a muscarinic M1 receptor positive allosteric modulator (PAM) as a potential new treatment to address the dementia market.
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