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BioWorld - Wednesday, June 25, 2025
Home » Topics » Regulatory » IND

IND
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Immuno-oncology

Simcere Zaiming’s CDH6-binding ADC to enter clinic in US, China

Jan. 7, 2025
Simcere Zaiming Pharmaceutical Co. Ltd. has announced clinical trial approvals in China and the U.S. for its CDH6-targeting antibody-drug conjugate (ADC), SIM-0505, for advanced solid tumors. A global clinical study will evaluate SIM-0505 in various malignant tumors, including ovarian cancer and renal cancer.
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Musculoskeletal

Epirium’s MF-300 cleared to enter clinic for sarcopenia

Dec. 24, 2024
Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
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DNA illustration
Endocrine/metabolic

Arbor gains IND clearance for rare disease gene editing therapy

Dec. 20, 2024
Arbor Biotechnologies Inc. has gained IND clearance from the FDA for ABO-101, a novel gene editing therapeutic designed to address primary hyperoxaluria type 1 (PH1). A phase I/II study in adult and pediatric patients with PH1 is expected to begin in the first half of 2025.
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Medical vector illustration showing cross section of an eyeball with close up of the macula
Ocular

Vigeneron’s mRNA trans-splicing gene therapy for Stargardt disease receives IND clearance

Dec. 19, 2024
Vigeneron GmbH has received IND approval from the FDA for VG-801, a novel mRNA trans-splicing gene therapy to treat Stargardt disease and other retinal dystrophies associated with mutations in the ABCA4 gene. IND clearance enables initiation of a phase I/II trial, with a clinical trial application (CTA) submission to the EMA also planned in the coming months.
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DNA illustration
Ocular

Splicebio’s protein splicing gene therapy gains IND clearance for Stargardt disease

Dec. 12, 2024
Splicebio S.L. has gained IND clearance from the FDA for its lead program SB-007, a protein splicing gene therapy to address the root genetic cause of Stargardt disease.
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3D illustration of the cross-section of skin layers with atopic dermatitis
Dermatologic

Astria’s OX40 antagonist gains US IND clearance for atopic dermatitis

Dec. 11, 2024
Astria Therapeutics Inc. has gained IND clearance from the FDA for STAR-0310, a monoclonal antibody OX40 antagonist being developed for atopic dermatitis.
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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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