The EMA has awarded orphan drug designation to GC Biopharma Corp.’s intracerebroventricular enzyme replacement therapy (ERT) candidate, GC-1130A, for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A), developed in collaboration with Novel Pharma Inc.

Immuno-oncology

NK Celltech announces US IND clearance for NK cell therapy NK-010

Jan. 23, 2024

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NK Celltech Co. Ltd. has announced FDA clearance for a clinical trial of NK-010, a nongenetically modified allogeneic peripheral blood natural killer (NK) cell drug.

Immuno-oncology

Strand’s STX-001 receives IND clearance from FDA to treat solid tumors

Jan. 23, 2024

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Strand Therapeutics Inc. has received IND clearance from the FDA to initiate a first-in-human phase I trial of STX-001 as a new approach for the treatment of solid tumors.

Neurology/Psychiatric

Endocannabinoid reuptake inhibitor SYT-510 granted EU IND

Jan. 19, 2024

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Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.

Ear, Nose & Throat

Sensorion's SENS-501 can enter clinic for genetic hearing loss

Jan. 19, 2024

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Sensorion SA has received approval in Europe for its clinical trial application (CTA) to initiate a...

Immuno-oncology

ROR1-targeting PBA-0405 cleared to enter phase 0 trial for solid tumors

Jan. 17, 2024

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Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.

Today's news in brief
BioWorld
BioWorld briefs for Dec. 20, 2024.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for December 20, 2024.
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