Oratecan (oral irinotecan/encequidar) / Athenex, Hanmi, Guangzhou Xiangxue Pharma, PharmaEssentia - LARVOL DELTA

A dose regimen-finding study to evaluate the safety, tolerability, pharmacokinetics, and activity of oratecan in subjects with advanced malignancies. (PubMed, Cancer Chemother Pharmacol) - "The MTD of oratecan was encequidar methanesulfonate 15 mg plus irinotecan 280 mg/m. Exposure for irinotecan and SN-38 increased with increased dose. Potential antitumor activity was observed at the 280 and 320 mg/m dose levels. The safety profile of oratecan was comparable to that of intravenous irinotecan."

Journal • PK/PD data • Oncology • Solid Tumor

A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Athenex, Inc. | Recruiting ➔ Completed | N=70 ➔ 35

Enrollment change • Trial completion • Oncology • Solid Tumor

Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - P1; N=21; Completed; Sponsor: Hanmi Pharmaceutical Company Limited; Recruiting -> Completed ; Trial primary completion date: Aug 2012 ->Apr 2012

Trial completion • Trial primary completion date • Biosimilar • Oncology

Athenex expands its strategic partnership with Guangzhou Xiangxue Pharmaceutical through a licensing agreement for its product candidates oral paclitaxel and oral irinotecan, as well as tirbanibulin ointment, in China, Hong Kong and Macao (GlobeNewswire) - “Athenex, Inc…announced that it has expanded its strategic partnership with Chinese drug company, Guangzhou Xiangxue Pharmaceutical Co., Ltd. (‘Xiangxue’), to exclusively develop and commercialize Athenex’s oncology product candidates Oral Paclitaxel (both the capsule and the tablet formulations), Oral Irinotecan, as well as Tirbanibulin (KX2-391, also known as KX-01) Ointment, including for the treatment of actinic keratosis (AK) in the Territory…. Under the terms of the license agreement…Athenex will receive an upfront payment of $30 million. Athenex will also be eligible to receive development, sales and other milestone payments up to $170 million…The total deal size is potentially $200 million, excluding the royalty payments.”

Licensing / partnership

A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Athenex, Inc.; Trial completion date: Mar 2019 ➔ Mar 2020; Trial primary completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date