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.
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.
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.
Shanghai Henlius Biotech Inc. has announced acceptance of IND applications by China’s National Medical Products Administration (NMPA) for three differentiated candidates for the treatment of solid tumors.
Simcere Zaiming Pharmaceutical Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SIM-0610 to be studied in patients with locally advanced or metastatic solid tumors.
Ipsen SA has signed an exclusive licensing agreement with Simcere Zaiming Pharmaceutical Co. Ltd. for global rights outside of Greater China for SIM-0613, an LRRC15-targeting antibody-drug conjugate developed by Simcere Zaiming for solid tumors. The program is expected to enter phase I development in the second half of next year.
Mondego Bio Lda has selected protein tyrosine phosphatase non-receptor type 2 (PTPN2) inhibitor ZE00-0388 as its lead clinical candidate. The company is targeting initiation of a first-in-human phase I study in the first half of next year.
Zelluna ASA has submitted a clinical trial application (CTA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1 (ZIMA-101), the company’s lead candidate. ZI-MA4-1 is a novel MAGE-A4-targeting T-cell receptor-natural killer (TCR-NK) therapy.
Pilatus Biosciences Inc. has obtained IND clearance from the FDA for PLT-012, a first-in-class anti-CD36 monoclonal antibody, for the treatment of solid tumors. Pilatus plans to initiate a first-in-human phase I trial with this metabolic checkpoint antibody in the first quarter of next year.
Crescent Biopharma Inc. has announced a new partnership with Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. and reported progress across its pipeline, with three distinct programs set to enter the clinic next year.
