Image Source: Pixabay

Trials and Approvals

The following is a brief list of the trials and approvals seen throughout the past week.

• Taiwan’s Allgenesis Biotherapeutics reported positive early data from a US Phase IIa trial of a bi-specific Fc-fusion protein designed to block VEGFs and integrins for Diabetic Macular Edema.
• Shanghai Antengene announced the US FDA awarded two Orphan Drug Designations for ATG-022, a Claudin 18.2 antibody drug conjugate, one for gastric cancer and another for pancreatic cancer.
• Ascentage Pharma posted a summary of four abstracts for novel cancer drug candidates that will be presented at the upcoming 2023 ASCO Annual Meeting.
• ProfoundBio, a Suzhou-Seattle ADC biotech, started a US Phase I/II trial of its CD70 ADC for solid tumors or mesothelioma, and it was approved to start a similar trial in China.
• Hangzhou Lynk Pharma dosed the first cohort of psoriatic patients in a China Phase Ib trial of LNK01004 ointment, a topical third-gen, pan-JAK inhibitor aimed at psoriasis.
• Accropeutics Bioscience of Suzhou was approved to start a Phase I trial of its oral small molecule TYK2/JAK1 inhibitor in Australia to treat inflammatory and autoimmune diseases.
• Shanghai BioRay Pharma will start China trials of BRY812, an ADC that targets human LIV-1, to treat advanced malignant tumors.
• Hangzhou Minghui Pharma dosed the first subject in a China Phase Ia trial of a novel fusion protein candidate aimed at thyroid eye disease, an autoimmune condition.
• Laekna, a Shanghai biopharma, was approved to start US Phase I/II trials of its LAE102 antibody, a novel ATP inhibitor, in patients with non-small cell lung cancer.
• Hangzhou Hanx Biopharma will start US trials of its first-in-class recombinant anti-CD47/PD-1 bispecific antibody in patients with relapsed/refractory lymphoma.

More By This Author: