Be Biopharma Inc. has announced the FDA’s clearance of its IND for BE-101, an autologous potentially first-in-class B-cell medicine in development for the treatment of hemophilia B.

Abdera Therapeutics Inc. has received FDA clearance of its IND application for ABD-147, the first δ-like ligand 3 (DLL3)-targeting radiopharmaceutical for the treatment of small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma.

The FDA has cleared an IND application for GC-1130A, a treatment for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) being jointly developed by GC Biopharma Corp. and Novel Pharma Inc.

Verismo Therapeutics Inc. has received IND clearance from the FDA to conduct a phase I trial with Synkir-310 for non-Hodgkin lymphoma (NHL).

Ajax Therapeutics Inc. has received clearance for its IND application from the FDA to initiate a phase I study of AJ1‑11095, a first-in-class type II JAK2 inhibitor, for the treatment of patients with myelofibrosis.

Biotheryx Inc. has gained FDA clearance for its IND application for BTX-9341, a novel cyclin-dependent kinase 4/6 (CDK4/6) bifunctional degrader.

Bioatla Inc. has received FDA clearance of its IND application for BA-3361, a conditionally active biologic (CAB)-Nectin-4 antibody-drug conjugate (ADC) for the treatment of multiple tumor types.

Eisbach Bio GmbH has announced FDA clearance of its IND application for EIS-12656, a first-in-class orally bioavailable and blood-brain barrier-penetrant allosteric inhibitor of ALC1 (CHD1L), a key molecular machine in DNA repair. Enrollment will open in the second quarter in a phase I/II trial in patients with genetically defined advanced solid tumors, including patients progressing under PARP inhibitor treatment.

Context Therapeutics Inc. has received FDA clearance of its IND application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.