Dispatch Biotherapeutics Inc. has obtained IND clearance from the FDA for DISP-10, enabling the initiation of a phase I study in patients with solid tumors. Initial clinical evaluation will begin in gastrointestinal cancers, with plans to expand into multiple additional solid tumor indications following clinical proof of concept.
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.
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.
Depending on who you ask, AI will take over the world and save it; or ruin it. Certainly, it is changing it. Science magazine dedicated its first editorial of 2026 to AI. Despite its title – “Resisting AI slop“ – editor-in-chief Holden Thorp gave the sort of nuanced review that is typical of him. “Like many tools, AI will allow the scientific community to do more if it picks the right ways to use it,” he wrote. “The community needs to be careful and not be swept up by the hype surrounding every AI product.”
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.
Crescent Biopharma Inc. has announced regulatory clearances of IND applications for CR-001 (SKB-118), a PD-1 x VEGF bispecific antibody, and CR-003 (SKB-105), an integrin β-6 (ITGB6)-targeted antibody drug-conjugate (ADC), both being developed for the treatment of advanced solid tumors.
Ascentage Pharma Group International has obtained IND approval from the FDA for its BTK-targeted protein degrader APG-3288. A phase I study will be conducted in patients with relapsed or refractory B-cell malignancies.
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