The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination.

Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone.

Novartis AG has had another setback in its attempt to get canakinumab to work in oncology, after the interleukin-1beta (IL-1β) inhibitor flunked a phase III trial in first-line advanced lung cancer.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aadi, Akeso, Athira, Endo, Helixmith, Horizon, Humanigen, Leo, Metacrine, Ocular, OS, Reven, Sanofi, Servier.

Metacrine Inc.’s departure, in the wake of mixed phase IIa results, from the fiercely competitive nonalcoholic steatohepatitis (NASH) space with farnesoid X receptor (FXR) agonist MET-642, put a serious dent in shares and brought implications for other players. The San Diego-based firm’s stock (NASDAQ:MTCR) closed at $1.63, down $2.20, or 57%, as its plans to shift emphasis from NASH to inflammatory bowel disease (IBD) were made known.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Beyondspring, Biocardia, Biontech, Crescendo, Frequency, Genfleet, Karyopharm, Matinas, Morphosys, PDS, Remynd, Revolo, Scynexis, Sio, Sumitomo Dainippon, Zai.

Sio Gene Therapies Inc. CEO Pavan Cheruvu said the company sees no “significant rate limiters to moving forward” with FDA fast-tracked AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. Shares of the New York-based firm (NASDAQ:SIOX) closed at $2.36, up 21 cents, as Wall Street welcomed positive interim data from the ongoing phase I/II study with the adeno-associated viral vector 9-based gene therapy for GM1 gangliosidosis.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alterity, Ammax, Axalbion, Bridge, Compass, Enzychem, Jupiter, Menarini, Neotx, Numinus, Obseva, Prilenia, Radius, Rocket, Senhwa, Synairgen, Telix.