Senhwa Biosciences Submits IND to FDA for Pidnarulex Study in Advanced Tumors

TAIPEI and SAN DIEGO, Sept. 17, 2024 - Senhwa Biosciences, Inc. (TPEx: 6492), a company specializing in developing first-in-class therapeutics for oncology, rare diseases, and infectious diseases, has announced the submission of an Investigational New Drug (IND) application for Pidnarulex to the U.S. FDA by the National Cancer Institute (NCI). This investigational drug, also known as CX-5461, has been selected as an experimental drug in the NCI's Experimental Therapeutics (NExT) cancer program. The program is managed by the Division of Cancer Treatment and Diagnosis (DCTD), which is part of the U.S. National Institutes of Health (NIH). The NCI will use Pidnarulex in a pharmacodynamic pilot study targeting patients with advanced solid tumors over a five-year period.

The initial trial will evaluate the response of various biomarkers to Pidnarulex (CX-5461) in patients with or without homologous recombination deficiency (HRD). The NCI is also considering additional clinical trials to test Pidnarulex in combination with other therapies. These future trials could include pairing Pidnarulex with immunotherapy, antibody-drug conjugates (ADCs), and PARP inhibitors (PARPi). The NCI's involvement is significant, as it brings an extensive medical team, a wide scientific talent network, and regulatory resources, which are typically beyond the reach of most smaller biotech firms. This support is expected to fast-track the development and approval of Pidnarulex, thereby bringing it to market sooner to benefit patients.

Pidnarulex (CX-5461) is a first-in-class small molecule developed by Senhwa Biosciences. It functions by stabilizing G-quadruplex (G4) structures, which are commonly found in the promoters of oncogenes. By halting the progression of the replication fork, Pidnarulex induces DNA damage, leading to the death of cancer cells. This unique mechanism positions Pidnarulex as a promising therapeutic candidate for various types of cancer.

In the evolving landscape of cancer treatment, immunotherapy has emerged as the fastest-growing segment of the market. The development of antibody-drug conjugates (ADCs) is another important trend in biopharmaceuticals. Major pharmaceutical companies such as Pfizer, AbbVie, AstraZeneca, and Merck have invested significantly in acquiring or licensing these technologies. A report from market research firm Evaluate projects that the ADC market will reach $30 billion by 2028, while the global cancer immunotherapy market is expected to surpass $224 billion by 2030.

However, only about 20% to 25% of cancer patients respond effectively to immunotherapy alone. This has led to a growing focus on combination therapies, which can target multiple pathways within the complex tumor microenvironment. By combining different treatment modalities, there is potential to enhance the efficacy of immunotherapy, making this a key area of interest for major pharmaceutical companies. Consequently, Senhwa Biosciences is optimistic about the NCI’s plans to advance clinical trials of Pidnarulex (CX-5461) in combination with immunotherapy and ADCs.

Senhwa's collaboration with the NCI represents a significant step in accelerating the development of Pidnarulex. If successful, these trials could pave the way for new, more effective cancer treatments, offering hope to patients and potentially transforming the oncology therapeutic landscape.