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Home » Topics » Regulatory » IND

IND
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Cancer immunotherapy illustration
Immuno-oncology

Adcencdo’s ADCE-D01 receives US IND clearance for soft tissue sarcoma

Oct. 8, 2024
Adcencdo ApS has obtained FDA clearance of its IND application for ADCE-D01 in patients with metastatic and/or unresectable soft tissue sarcoma (STS). A first-in-human phase I/II study in patients with metastatic and/or unresectable STS will recruit in the U.S. and Europe.
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Cancer and blood cells
Cancer

FDA clears Recursion’s IND for RBM39 degrader

Oct. 3, 2024
Recursion Pharmaceuticals Inc. has gained IND clearance from the FDA for a phase I/II trial of REC-1245 in a biomarker-enriched patient population, including patients with solid tumors and lymphoma. The trial is expected to begin in the fourth quarter of this year.
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3D rendering of drug linked to antibody
Immuno-oncology

Alentis Therapeutics’ anti-CLDN1 ADC gains IND clearance

Oct. 3, 2024
Alentis Therapeutics AG has obtained IND clearance from the FDA for ALE.P02, an anti-Claudin-1 (CLDN1) antibody-drug conjugate (ADC) with a tubulin inhibitor payload.
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Apimeds prices $11.5M IPO for bee venom-based therapy

Oct. 1, 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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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.
Read More
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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