Avenzo Therapeutics Inc. has announced IND clearance by the FDA for AVZO-1418 (DB-1418), an EGFR/HER3 bispecific antibody-drug conjugate (ADC). A first-in-human phase I/II study will begin later this year and will evaluate AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

Ascletis Pharma Inc. has announced IND clearance by the FDA for a phase I trial of ASC-50 for the treatment of mild to moderate plaque psoriasis. Dosing is expected to start in the third quarter of this year.

Avenzo Therapeutics Inc. has gained IND clearance from the FDA for AVZO-023 (formerly ARTS-023), a CDK4-selective inhibitor. The company also announced it has exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing and commercialization rights.

Mavrix Bio has received IND clearance from the FDA for MVX-220, an investigational AAV gene therapy for the treatment of Angelman syndrome. The company expects to initiate its first-in-human study, ASCEND-AS, in the second half of this year.

Ensoma Inc. has obtained IND clearance from the FDA for its lead program EN-374 in X-linked chronic granulomatous disease (X-CGD).

Capsida Biotherapeutics Inc. has gained IND clearance from the FDA for CAP-002, its first-in-class, intravenously administered gene therapy for syntaxin-binding protein 1 developmental and epileptic encephalopathy (STXBP1-DEE). Dosing in the phase I/IIa SYNRGY trial will begin in the third quarter of this year.

UTR Therapeutics Inc. has submitted an IND application to the FDA for UTRxM1-18, a novel therapeutic approach for targeting c-MYC-driven cancers. Pending approval, a first-in-human phase I trial is slated to begin next year.

Nutshell Therapeutics (Shanghai) Co. Ltd. has received IND clearance from the FDA to initiate a phase I trial in the U.S. with NTS-071 for anticipated use in solid tumors with a p53 Y220C mutation. The trial is expected to begin in the second half of this year.