Biopharma company Antengene Corporation Limited says ATG-101, the company’s in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
The company said the ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.
At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.
Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported more than 55,000 newly-diagnosed pancreatic cancer cases and 44,330 related deaths. Although it is still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.
Antengene’s ATG-101 is a novel PD-L1/4-1BB bispecific antibody designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile.
In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. ATG-101 has also shown an excellent safety profile in good laboratory practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S.
Bo Shan, Antengene’s chief scientific officer, said: “We are very encouraged by this orphan drug designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene’s first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world.”
Antengene is a Chinese commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors.
Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and five came with rights for Asia Pacific markets including the Greater China region.
To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted six new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO (selinexor) already approved in mainland China, South Korea, Singapore and Australia.