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Home » Topics » Regulatory » IND

IND
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AI drug developer Aigen Sciences raises ₩12B series A

Oct. 22, 2024
By Marian (YoonJee) Chu
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines.
Read More
Antibodies attacking cancer cell
Immuno-oncology

FDA clears IND for Adcentrx’s ADC targeting STEAP1

Oct. 22, 2024
Adcentrx Therapeutics Inc. has received FDA clearance of its IND application for ADRX-0405 for the treatment of select advanced solid tumors. A first-in-human phase Ia/b trial of ADRX-0405 in patients with select advanced solid tumors, including metastatic castration-resistant prostate cancer, will begin enrollment and dosing this quarter.
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AI drug developer Aigen Sciences raises ₩12B series A

Oct. 16, 2024
By Marian (YoonJee) Chu
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines.
Read More
Illustration of pancreas, close up of islet
Endocrine/metabolic

Seraxis gains IND clearance for islet replacement therapy

Oct. 16, 2024
Seraxis Inc. has obtained IND clearance from the FDA for a phase I/II study of its novel islet replacement therapy SR-02 for type 1 diabetes. SR-02 is comprised of allogeneic pancreatic endocrine cell clusters that, when implanted to the omentum, form a functional endocrine pancreas outside of the native pancreas.
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Respiratory

Kymera’s oral STAT degrader KT-621 gains IND clearance from FDA

Oct. 10, 2024
Kymera Therapeutics Inc. has received IND clearance from the FDA for KT-621, an investigational first-in-class, once-daily, oral STAT6 degrader.
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Tape measure wrapped around scale
Endocrine/metabolic

Antag’s GIP receptor antagonist cleared to enter clinic in US

Oct. 9, 2024
Antag Therapeutics ApS has received IND clearance from the FDA for lead molecule, AT-7687. A phase I trial will evaluate AT-7687 in healthy lean and healthy obese subjects, including as monotherapy and in combination with semaglutide in the healthy obese individuals.
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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.
Read More
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