Huons said that it has signed an exclusive licensing agreement for developing, manufacturing and commercializing TSD-001, a bladder cancer treatment drug, with Lipac Oncology, a U.S. anticancer drug developer. The company also acquired all future indications that TSD-001 may add.
According to Lipac, TSD-001 targets superficial bladder cancer, which accounts for the majority of bladder cancer patients.
The cancer has two classifications -- superficial (non-invasive) bladder cancer and invasive bladder cancer – and about 75 percent of all bladder cancer patients suffer from superficial bladder cancer.
Hospitals usually treat superficial bladder cancer by removing the tumor with an endoscopic resection through the urethra, followed by intra-bladder immunotherapy and chemotherapy to prevent recurrences. However, the cancer has a 70 percent recurrence rate up to five years, while 10 to 15 percent of these cases can lead to invasive bladder cancer.
"The clinical trials of bladder cancer patients in the U.S. confirmed that TSD-001 has fewer side effects as the cancer did not recur until 12 months and did not have systemic exposure," Lipac said.
The company is currently completing phase 1 and 2a clinical trials in the United States and plans to conduct phase 2b trials in 2020. Huons will enter phase 3 clinical trials in Korea in conjunction with the progress of the U.S. clinical trials.
Both companies expect to receive approval from the U.S. Food and Drug Administration for TSD-001 as the first treatment for a superficial bladder cancer treatment based on their comprehensive assessment during the developmental stage and clinical effectiveness of the treatment.
Lipac also plans to launch the drug in 2026 globally.
"Huons has become the first partner in Lipac Oncology's global development project," Lipac Oncology President Will Roberts said. "The company plans to rapidly expand into countries through its partnership with Huons, which has exceptional pharmaceutical technology and overseas know-how."
Huons CEO Um Key-an also said, "The agreement is significant in that the partnership with Lipac Oncology has allowed the company to secure a new pipeline that has the potential of becoming a very competitive anticancer drug."
The commercialization of TSD-001 will also be a good treatment option for patients with superficial bladder cancer in Korea, Um added.