CBP-1019 has received FDA Orphan Drug Designation

Coherent Biopharma announced today that their proprietary second-generation dual-ligand conjugate drug, CBP-1019, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) on September 20, 2023, for the treatment of pancreatic cancer. The recognition will contribute to the clinical development, market authorization application, and commercialization of CBP-1019 for pancreatic cancer indications in the United States.

Dr. Robert Huang, Founder, Chairman, and CEO of Coherent Biopharma, stated, ” We are delighted that CBP-1019 has received FDA orphan drug designation. As the second-generation product of CBP’s Bi-XDC technology platform, this project has been highly anticipated. Currently, CBP-1019 is being tested in international multicenter clinical trials. With the drug design advantages of CBP-1019, we hope to overcome the current limitations in pancreatic cancer treatment and truly bring hope to patients worldwide.”

About CBP-1019

CBP-1019 is the second-generation product of CBP’s Bi-XDC technology platform, which utilizes a dual-ligand system to deliver derivatives of camptothecin. Building upon CBP-1008, CBP-1019 has undergone further innovation and optimization. It retains and enhances the dual-ligand component while modifying the linker, resulting in improved stability and increased safety. The clinical application target of this drug is late-stage malignant tumor patients with dual expression of related target receptors in metastatic or recurrent conditions. This includes but is not limited to late-stage pancreatic cancer, late-stage lung cancer, late-stage colorectal cancer, late-stage ovarian cancer, late-stage endometrial cancer, and late-stage cervical cancer. In preclinical pharmacological evaluations, CBP-1019 has demonstrated significant tumor inhibition effects in PDX tumor models, with a positive correlation observed with dosage. Additionally, animals receiving CBP-1019 treatment exhibited minimal weight loss, indicating good safety.

About Orphan Drugs

Orphan drugs, also known as rare disease drugs, are medications used for the prevention, diagnosis, and treatment of rare diseases. The FDA grants orphan drug designation to facilitate the development of candidate drugs that may provide therapeutic benefits to patients with rare diseases in the United States (defined as diseases affecting fewer than 200,000 individuals). This designation provides the product with various policy supports throughout subsequent research, registration, and commercialization processes. These supports include tax credits for clinical trial expenses, waiver of new drug application fees, and seven years of market exclusivity in the United States without being affected by patents.

About Pancreatic Cancer

Pancreatic cancer, known as the “king of cancers,” is characterized by its high degree of malignancy among various types of cancer. Approximately two-thirds of patients die within one year of diagnosis, and the five-year survival rate is less than 5%, with a median survival period of only about 6 months. According to the World Health Organization (WHO), in 2020, pancreatic cancer ranked 12th in terms of global incidence and 7th in terms of mortality among malignant tumors. In 2022, the United States alone reported over 62,200 new cases of pancreatic cancer, with 49,800 deaths attributed to the disease. Pancreatic cancer remains an orphan disease, and it is projected that by 2030, it will become the second leading cause of cancer-related deaths.