Adcencdo ApS has obtained FDA clearance of its IND application for ADCE-D01 in patients with metastatic and/or unresectable soft tissue sarcoma (STS). A first-in-human phase I/II study in patients with metastatic and/or unresectable STS will recruit in the U.S. and Europe.

Recursion Pharmaceuticals Inc. has gained IND clearance from the FDA for a phase I/II trial of REC-1245 in a biomarker-enriched patient population, including patients with solid tumors and lymphoma. The trial is expected to begin in the fourth quarter of this year.

Alentis Therapeutics AG has obtained IND clearance from the FDA for ALE.P02, an anti-Claudin-1 (CLDN1) antibody-drug conjugate (ADC) with a tubulin inhibitor payload.

The FDA has awarded orphan drug designation to Papillon Therapeutics Inc.’s PPL-002, an experimental gene-modified CD34+ hematopoietic stem and progenitor cell (HSPC) therapy, for the treatment of Danon disease.

Precision Biosciences Inc. has submitted its first clinical trial applications (CTAs) to initiate a phase I study evaluating PBGENE-HBV, an in vivo gene editing program designed to potentially cure chronic hepatitis B virus (HBV).

Palisade Bio Inc. has submitted a clinical trial application (CTA) for PALI-2108 for the treatment of ulcerative colitis, following a pre-CTA consultation meeting with Health Canada. Pending clearance, the company anticipates initiating a phase I study by year-end.

The FDA has awarded U.S. orphan drug designation to Eydisbio Inc.’s EYD-001 (formerly HS-276), a highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis. Eydisbio plans to initiate clinical trials in the near future.

The FDA has cleared an IND application for a phase I/II study of KSQ-004EX, KSQ Therapeutics Inc.’s second engineered tumor-infiltrating lymphocyte (eTIL) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing.