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Home » Topics » Regulatory » IND

IND
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Antibody-drug conjugate illustration
Immuno-oncology

FDA clears IND for B7-H4-targeting ADC

Dec. 11, 2024
Nextcure Inc. has reported IND clearance from the FDA enabling initiation of a phase I trial of LNCB-74, a B7-H4-targeting antibody-drug conjugate (ADC) being developed for various cancers.
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Cancer

Olema’s KAT6 inhibitor OP-3136 gains IND clearance from FDA

Dec. 9, 2024
Olema Pharmaceuticals Inc. has obtained IND clearance from the U.S. FDA.
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Natural killer cell attacking cancer cell
Immuno-oncology

NK-510 approved to enter clinic in US and China

Dec. 9, 2024
Base Therapeutics (Shanghai) Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical trials for advanced solid tumors.
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Art concept for tumor
Cancer

Avistone’s next-gen ROS1/NTRK TKI cleared to enter clinic for advanced tumors

Dec. 5, 2024
Beijing Avistone Biotechnology Co. Ltd. has obtained IND clearance from the FDA for ANS-03, a next-generation tyrosine kinase inhibitor (TKI) targeting both ROS proto-oncogene 1 (ROS1) and neurotrophic tropomyosin receptor kinase (NTRK).
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Antibodies attacking cancer cell
Immuno-oncology

Oncoc4 gains US IND approval for bispecific antibody for advanced solid tumors

Dec. 3, 2024
Oncoc4 Inc. has obtained IND approval from the FDA for AI-081, a PD-1 and VEGF bispecific antibody for the treatment of advanced solid tumors.
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Neurology/psychiatric

Sangamo’s ST-503 receives IND clearance for idiopathic small fiber neuropathy

Nov. 20, 2024
Sangamo Therapeutics Inc. has received IND clearance from the FDA for ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN).
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Dermatologic

Enveda advances ENV-294 into clinic for atopic dermatitis

Nov. 14, 2024
Enveda Therapeutics Inc. has received U.S. IND clearance and advanced into phase I trials with ENV-294, its naturally derived anti-inflammatory.
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3D illustration showing presence of tumor inside prostate gland
Diagnostics

Antelope Surgical’s AS-1986NS cleared to enter clinic

Nov. 13, 2024
Antelope Surgical Solutions Inc. has received commercial IND approval from the FDA for its novel prostate cancer technology, AS-1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, will be evaluated in trials with the aim of addressing prostate cancer identification and surgical margin delineation.
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Transmission electron microscope image of H5N1 virus particles
Immune

Arcturus gains IND clearance for H5N1 influenza sa-RNA vaccine candidate

Nov. 12, 2024
Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
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Monoclonal antibody illustration
Inflammatory

Hifibio Therapeutics’ BTLA agonist antibody gains US IND clearance

Nov. 5, 2024
Hifibio Therapeutics Inc. has gained IND clearance from the FDA for HFB-200604, a potentially best-in-class BTLA agonist monoclonal antibody for inflammatory and immunology diseases.
Read More
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