Ibio Inc. has announced promising in vivo data for three immuno-oncology candidates, anti-EGFRvIII, CCR8 and a bispecific TROP-2 x CD3, advancing these programs to clinical candidate selection stage.
Less than a week after approving Johnson & Johnson’s bispecific antibody, Talvey (talquetamab-tgvs), for relapsed or refractory multiple myeloma (r/r MM) under accelerated review, the U.S. FDA has followed suit with Pfizer Inc.’s equivalent, Elrexfio (elranatamab-bcmm). The accelerated clearance of Elrexfio – a B-cell maturation antigen (BCMA) bispecific antibody that targets BCMA on myeloma cells and the CD3 receptor on T cells – covers it for adult patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Emerging from stealth mode, new immuno-oncology company Dotbio Pte. Ltd. closed an oversubscribed $5.6 million pre-series A round to accelerate development of its multifunctional and intracellular antibody therapies.
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.
Biocity Biopharmaceutics Co. Ltd. is advancing its pipeline of differentiated, modality-independent therapeutics for oncology that include small molecules, monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The Wuxi, China-headquartered company is focused on first-in-class molecules for different modalities that can be combined with other treatments, Biocity Co-founder and Executive Vice President Ivy Wang told BioWorld.
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis.
An updated trial protocol providing expanded bridging therapies are part of the agreement between the U.S. FDA and Arcellx Inc. that allows the lifting of the partial clinical hold on the company’s pivotal phase II study of CAR T-cell therapy CART-ddBCMA in multiple myeloma (MM).
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis. The randomized, controlled, open-label, multicenter phase III trial compared injectable SKB-264 (also known as KL-A264 and MK-2870) vs. investigator-selected regimens in patients who failed second-line or above prior standard-of-care therapies.
Almac Discovery Ltd. has described heterocyclic compounds acting as ubiquitin C-terminal hydrolase 7 (USP7; HAUSP) inhibitors reported to be useful for the treatment of cancer.
RSS
