GT Biopharma Inc. has filed an IND application with the FDA for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3-expressing solid tumor cancers. Pending approval, the planned phase I basket trial will evaluate GTB-5550 administered subcutaneously in solid tumors.

The U.S. FDA has cleared Tessera Therapeutics Inc.’s IND application for TSRA-196, its lead in vivo gene editing therapy for α-1 antitrypsin deficiency (AATD). The Australian Human Research Ethics Committee (HREC) has also granted approval for the company to begin the phase I/II clinical study.

Askbio Inc., a subsidiary of Bayer AG, has received IND clearance from the FDA for AB-1009, an AAV gene therapy being developed for the treatment of late-onset Pompe disease.

Whitehawk Therapeutics Inc. has obtained IND clearance from the FDA for HWK-007, its PTK7-targeted antibody-drug conjugate (ADC).

A2 Biotherapeutics Inc. has gained IND clearance from the FDA for A2B-543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced or metastatic solid tumors.

Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.

Ottimo Pharma Ltd. has obtained IND clearance from the FDA and advanced OTP-01 (jankistomig), an anti-PD-1/VEGFR2 antibody, into phase I for solid tumors. The first patient has been dosed and the study is open at sites in the U.S. and Australia.

Arbele Pte Ltd.’s ARB-1002 has been awarded orphan drug designation by the FDA for the treatment of pancreatic cancer. ARB-1002 is an antibody-drug conjugate comprising an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent.