US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex PD in Patients with Advanced Solid Tumors
“Senhwa Biosciences, Inc. announced that FDA issues Study May Proceed letter for its developing drug Pidnarulex (CX-5461) in trial entitled “Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors” sponsored by the US National Cancer Institute (NCI). The study will assess whether Pidnarulex (CX-5461) induces a Rad51 response, in patients with and without homologous repair deficiency (HRD) genetic mutations. This pilot study also aims to explore potential biomarkers beyond BRCA1/2 and PALB2 that may demonstrate synthetic lethality with Pidnarulex (CX-5461). The findings from this study may identify patients who are more responsive to Pidnarulex (CX-5461) treatment, potentially expanding its therapeutic applications, and may accelerate its path to market approval.”
Share:
More News
“We are honored to receive Orphan Drug Designation for PLT012, a milestone that reflects our dedication to addressing the urgent need for innovative therapies in liver and intrahepatic bile duct cancer,” said Dr. Raven Lin, CEO and Co-founder of Pilatus Biosciences. Prof. Ping-Chih Ho, Chair of the Scientific Advisory Board
“Immune checkpoint inhibitors play a vital role in the treatment of melanoma, yet patients who progress on or are intolerant to them have limited options,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Targeted therapies including MEK and RAF inhibitors have shown promise in melanoma but historically are severely
“This approval marks KEYTRUDA’s fourth lung cancer indication in China, embarking on a new journey of treating certain patients with earlier stage non-small cell lung cancer,” said Anna Van Acker, Senior Vice President of MSD and President of MSD in China. “KEYTRUDA has established an important role in immunotherapy for
“T-cell engagers targeting CD3 have successfully exploited the first signal in T-cell receptor signaling to treat liquid tumors, significantly expanding the treatment options for these cancers. However, solid tumors represent a much greater unmet clinical need that has yet to benefit from advances in immune-engaging bispecific antibodies,” said Nathan Trinklein,
