Senhwa Biosciences' Second Program IND for MYC-Aberrant Lymphoma Trial Clears FDA

Senhwa Biosciences has submitted an IND for a clinical trial of CX-5461, a first-in-class therapeutic targeting MYC-aberrant lymphoma, sponsored by the US National Cancer Institute. This reduces Senhwa's clinical development expenditures, easing R&D financial demands while enhancing project value and commercialization potential. The market for B-cell lymphoma therapies is expected to exceed USD 10 billion annually, with a strong demand for novel targeted therapies for relapsed and refractory lymphoma patients.

Senhwa Biosciences, Inc. (TPEx: 6492) has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a clinical trial targeting MYC-aberrant lymphoma. The trial is sponsored by the U.S. National Cancer Institute (NCI) and focuses on Senhwa's first-in-class therapeutic, CX-5461.

The submission of the IND marks a significant milestone in the development of CX-5461, a drug that precisely stabilizes G-quadruplex (G4) structures in DNA within cancer cells, suppressing MYC gene expression and effectively disrupting tumor growth pathways. Preclinical research has shown strong inhibitory effects against MYC-overexpressing tumors, particularly in difficult-to-treat lymphomas.

The NCI sponsorship significantly reduces Senhwa's clinical development expenditures, easing its research and development (R&D) financial demands. According to Senhwa's internal estimates, this sponsorship could reduce clinical development costs, enhancing development efficiency and accelerating commercialization progress. The NCI is covering clinical trial design, operational personnel, trial sites, regulatory, and data management resources.

The global market for B-cell lymphoma therapies is expected to exceed USD 10 billion annually, with a strong demand for novel targeted therapies for relapsed and refractory lymphoma patients. The market is projected to grow at a compound annual growth rate (CAGR) of 5.79%, reaching USD 8.9 billion by 2035 [1].

CX-5461 is the world's first and most advanced anti-cancer investigational drug targeting G-quadruplex DNA structures. The upcoming NCI-sponsored trial will evaluate CX-5461 dose optimization and treatment efficacy in patients with MYC-aberrant, specific subtypes of aggressive B-cell non-Hodgkin lymphoma who have received at least one prior line of therapy and have no other available treatment options.

The submission of the IND is a positive step for Senhwa Biosciences, reducing R&D costs and enhancing the overall project value and commercialization potential. The company is well-positioned to enter the high-value niche market upon successful progression into late-stage clinical trials and potential regulatory approval.

References:
[1] https://finance.yahoo.com/news/us-nci-sponsors-senhwa-biosciences-063500699.html
[2] https://www.businesswire.com/news/home/20250805705515/en/Diffuse-Large-B-cell-Lymphoma-Market-Analysis-and-Forecast-Report-2025-2035-Pharma-Giants-Such-as-AbbVie-Merck-F-Hoffman-La-Roche-Johnson-Johnson-Accelerate-Innovation-to-Tackle-Unmet-Needs---ResearchAndMarkets.com