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BioWorld - Monday, April 13, 2026
Home » Topics » Regulatory » IND

IND
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Breast cancer cells.
Immuno-oncology

FDA clears Briacell’s personalized cellular immunotherapy to enter clinic

Nov. 6, 2023
Briacell Therapeutics Corp. has received IND clearance from the FDA to begin clinical studies with Bria-OTS, the first generation of the company’s personalized off-the-shelf cellular immunotherapy for breast cancer.
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Immuno-oncology

Prokarium’s ZH-9 cleared to enter clinic in US for bladder cancer

Nov. 3, 2023
Prokarium Ltd. has obtained FDA clearance of its IND application for ZH-9 for patients with non-muscle invasive bladder cancer.
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Antibody-drug conjugate
Immuno-oncology

Angiex cleared to begin phase I study of TM4SF1-directed ADC

Nov. 3, 2023
Angiex Inc. has received FDA clearance of its IND application for AGX-101, a novel TM4SF1-directed antibody-drug conjugate (ADC) being developed for the treatment of solid cancers.
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Immuno-oncology

Chimeric's CHM-2101 gains IND clearance for GI cancers

Oct. 31, 2023
Chimeric Therapeutics Ltd. has received FDA clearance of its IND application for CHM-2101, a first-in-class CDH17 chimeric antigen receptor (CAR) T cell therapy for gastrointestinal (GI) cancers.
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Cancer

HLX-42 is EGFR-targeting ADC with activity in several cancer models

Oct. 31, 2023
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
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Antibody-drug conjugate illustration
Immuno-oncology

HLX-43, a next-generation PD-L1-targeting antibody-drug conjugate

Oct. 27, 2023
There is a need for new agents targeting PD-1/PD-L1 because many patients either do not respond or develop resistance to treatment.
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Cancer

Mustang Bio cleared to advance MB-109 into clinic in US

Oct. 27, 2023
The FDA has accepted Mustang Bio Inc.’s IND application of MB-109 for the treatment of recurrent glioblastoma (GBM) and high-grade astrocytoma. MB-109 is a treatment regimen combining MB-101 (City of Hope-developed IL13Rα2‐targeted CAR T-cell therapy) and MB-108 (Nationwide Children’s Hospital-developed HSV-1 oncolytic virus).
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Heart and DNA
Cardiovascular

FDA clears Tenaya Therapeutics’ IND for gene therapy product candidate

Oct. 27, 2023
Tenaya Therapeutics Inc. has received clearance from the FDA of the company’s IND application to initiate clinical testing of TN-401.
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Tumor microenvironment
Immuno-oncology

Ankyra Therapeutics receives clearance in US and Canada to advance its anchored immunotherapy agent into clinical trials

Oct. 25, 2023
Ankyra Therapeutics Inc. has received approval of its IND application by the FDA and its clinical trial application (CTA) by Health Canada for its lead agent, ANK-101, a novel tumor-directed anchored immune medicine.
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Concept art for "cancer cells destroyed by oncogenic virus"
Immuno-oncology

FDA clears IND for systemic oncolytic vaccinia virus therapy ASP-1012 for solid tumors

Oct. 24, 2023
Kalivir Immunotherapeutics Inc. has announced FDA clearance of an IND application for a phase I study of ASP-1012 (formerly VET2-L2) in participants with locally advanced or metastatic solid tumors. The trial is expected to begin in the first quarter of next year.
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