Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
Additional data from a phase II trial of S1P modulator icanbelimod (CBP-307) reinforced earlier positive results in ulcerative colitis (UC), potentially putting Connect Biopharma Holdings Ltd. in a better negotiating position as it seeks a partner to take the program forward, while in-house activities remain focused on an early 2024 regulatory filing for atopic dermatitis candidate CBP-201.
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.
Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
Hanall Biopharma Co. Ltd.’s phase III trial VELOS-3 of tanfanercept did not show effects on the central cornea of the eye or in eye dryness in the treatment of moderate to severe dry eye disease, the primary endpoints. Data from the trial did show improvements in tear production, a secondary endpoint.
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Junshi Biosciences Co. Ltd.’s PARP inhibitor, senaparib (JS-109/IMP4297), met the primary endpoint of progression-free survival in a phase III ovarian cancer study, according to a prespecified interim analysis.
Noxopharm Pty Ltd.’s stock plummeted nearly 40% on the morning of April 6 after the company announced it was quitting development of its lead program, Veyonda (idronoxil/formerly OX-66), shuttering its DARRT-2 and CEP-2 oncology clinical trials and disbanding its clinical trial team to contain costs.
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