Domain Therapeutics SA has received clinical trial application (CTA) clearances in France and Belgium for its immuno-oncology program DT-9081, allowing the initiation of a phase I trial for solid tumors.
China's National Medical Products Administration (NMPA) has cleared an IND application for a clinical trial of Shanghai Henlius Biotech Inc.'s HLX-60 for the treatment of solid tumors and lymphomas.
Nkgen Biotech Inc. has received IND clearance from the FDA for a phase I study of its cryopreserved off-the-shelf allogeneic blood-derived natural killer (NK) cell therapy SNK-02, to evaluate safety and tolerability in participants with pathologically confirmed solid tumors refractory to standard-of-care therapy.
Akeso Inc. has received approval from China's National Medical Products Administration (NMPA) for a phase Ib/II trial of ivonescimab (AK-112) combined with drebuxelimab (AK-119) for the treatment of advanced solid tumors.
Mablink Bioscience SAS raised €31 million (US$30.3 million) in a series A funding round and set its sights on a phase I trial of its lead next-generation antibody-drug conjugate (ADC), MBK-103, which is in development for a range of solid tumor indications. Sofinnova Partners and Mérieux Equity Partners co-led the round.
Araris Biotech AG has raised $24 million in a second round of funding, as it completes preparations to take its lead antibody-drug conjugate (ADC) into the clinic. The company continues to accumulate preclinical data indicating its novel linker technology makes for an improved therapeutic index compared to approved ADCs, and the lead product is expected to begin clinical development next year.
Immuneering Corp. has received FDA clearance of its IND application for IMM-1-104, paving the way for the company to initiate a phase I/IIa trial of this oral, once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
Scientifically at least, the biggest story coming out of the European Society for Medical Oncology (ESMO) 2022 Congress is the success of cell therapy in solid tumors. “During this ESMO, there is a lot of novelty coming from T-cell therapies,” John Haanen told the audience at his joint keynote speech with Ton Schumacher – so much so that Haanen and Schumacher, both group leaders at the Netherlands Cancer Institute, left antibodies out of their keynote session in order to do justice to the advances in cell therapies.
