US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors, Sponsored by the US National Cancer Institute

TAIPEI and SAN DIEGO,Oct. 14,2024 -- Senhwa Biosciences,Inc. (TPEx: 6492),a drug development company focusing on first-in-class therapeutics for oncology,rare diseases,and infectious diseases,today 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.

In addition to this monotherapy trial,the NCI is considering future clinical trials involving Pidnarulex (CX-5461) in combination with other therapies,such as immunotherapies and antibody-drug conjugates (ADCs). Should these trials proceed as planned,they will be led by the NCI,utilizing its vast medical expertise,scientific resources,and regulatory experience—support that could significantly accelerate the development of Pidnarulex.

Pidnarulex (CX-5461),developed by Senhwa,is a first-in-class small-molecule designed to stabilize G-quadruplex (G4) structures,which are frequently observed in promoters of oncogenes. By stalling replication fork progression,Pidnarulex induces DNA damage and promotes cancer cell death. Through this mechanism,Pidnarulex holds great potential as a therapeutic agent for various cancers.

In recent years,immunotherapy has been the fastest-growing category in the cancer drug market. According to the 2023 global best-selling drug market analysis,the first PD-1 inhibitor Keytruda(Pembrolizumab),developed by Merck,topped the sales charts with $25.11 billion. Immunotherapy and cancer drugs account for nearly half of the market sales. International clinical research indicates that combined immunotherapy can enhance tumor response rates,reduce mortality,and prolong patient survival. Given that only 20% to 25% of patients benefit from effective immunotherapy,Senhwa expects that in future immuno-combination therapy trials,CX-5461 will change the tumor microenvironment with its innovative mechanism,thereby enhancing the efficacy of immunotherapy,realizing the corporate mission of bringing hope to life.