Athenex Oncology Pipeline
Mastering the art of patient-focused treatment
Taking on the challenges inherent in today’s cancer treatments isn’t easy…but we’re up for it. We are Athenex—a team of scientists, investigators, and innovators driven by the patients we serve. Our robust investigational pipeline of novel small molecule, biologic, and cellular therapies is focused on both improving outcomes and improving the cancer treatment experience for patients around the world.
Program
Drug candidate
Indication
Pre-clinical
Phase 1
Phase 2
Phase 3
Orascovery
(P-gp inhibitor [encequidar] + chemoRx agents)
Metastatic breast cancer
Angiosarcoma
Oral topotecan + encequidar
Solid tumors
Oral eribulin + encequidar
Solid tumors
Dual Inhibition
ATNX-04 (CYP / P-gp)
Multiple tumors
Src Kinase Inhibition
Tirbanibulin (KX2-391) ointment
Actinic keratosis
Psoriasis
Skin Cancers
Tirbanibulin (KX2-391) oral
Liquid tumors / Ovarian cancer
KX2-361 (KX-02)
Glioblastoma
TCR-T Immunotherapy
TAEST16001
Multiple tumors
Arginine Deprivation Therapy
(PT-01) Pegtomarginase
Multiple tumors
Posted pipeline was current on August 5, 2019. Pipeline may not reflect changes in phase of development after August 5, 2019.
*Encequidar is the international nonproprietary name (INN) for HM30181A, our novel P-gp pump inhibitor molecule.
**Collaboration with Eli Lilly and Company, makers of ramucirumab.
Clinical Platform
Orascovery
(P-gp inhibitor [encequidar] + chemoRx agents)
Angiosarcoma
Oral topotecan + encequidar
Solid tumors
Oral eribulin + encequidar
Solid tumors
Clinical Platform
Dual Inhibition
ATNX-04 (CYP / P-gp)
Multiple tumors
Clinical Platform
Src Kinase Inhibition
Tirbanibulin (KX2-391) ointment
Actinic keratosis
Psoriasis
Skin Cancers
Tirbanibulin (KX2-391) oral
Liquid tumors / Ovarian cancer
KX2-361 (KX-02)
Glioblastoma
Clinical Platform
TCR-T Immunotherapy
TAEST16001
Multiple tumors
Clinical Platform
Arginine Deprivation Therapy
(PT-01) Pegtomarginase
Multiple tumors
Posted pipeline was current on August 5, 2019. Pipeline may not reflect changes in phase of development after August 5, 2019.
*Encequidar is the international nonproprietary name (INN) for HM30181A, our novel P-gp pump inhibitor molecule.
**Collaboration with Eli Lilly and Company, makers of ramucirumab.
Poster Presentations
An international randomized cross-over bio-equivalence study of oral paclitaxel + HM30181 (Oraxol) compared with weekly intravenous (IV) paclitaxel 80mg/m2 in advanced solid tumors. Poster presented at: European Society for Medical Oncology (ESMO); September 27 – October 1, 2019; Barcelona, Spain.
A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010). Poster presented at: European Society for Medical Oncology (ESMO); September 27 – October 1, 2019; Barcelona, Spain.
A Phase 1b Study of Oraxol in combination with ramucirumab in patients with gastric or esophageal cancers who failed previous chemotherapy. Poster presented at: European Society for Medical Oncology (ESMO); September 27 – October 1, 2019; Barcelona, Spain.
Design, engineering, and characterization of a novel long-acting (pegylated) single isomer human arginase for arginine-depriving anti-cancer treatment. Poster presented at: American Society of Clinical Oncology; May 31-June 4, 2019; Chicago, IL.
An open label, randomized, multicenter, phase 3 registrational study to determine the safety, tolerability, and tumor response of oral paclitaxel and encequidar (formerly HM30181A) and its comparability to IV paclitaxel in patients with metastatic breast cancer (MBC) (NCT-02594371). Poster presented at: American Society of Clinical Oncology; May 31-June 4, 2019; Chicago, IL.
A phase 1 study of the oral administration of irinotecan in combination with the potent P-glycoprotein (P-gp) inhibitor encequidar (NTC02250157). Poster presented at: American Society of Clinical Oncology; May 31-June 4, 2019; Chicago, IL.
1084- Oral paclitaxel in the treatment of metastatic breast cancer (MBC) patients. Poster presented at: American Society of Clinical Oncology; May 31-June 4, 2019; Chicago, IL.
An open-label, single-arm pharmacokinetic study of oral paclitaxel and HM30181 in metastatic breast cancer patients. Poster presented at: European Society for Medical Oncology; October 19-23, 2018; Munich, Germany.
An open label, randomised cross-over bioavailability and extension study of oral paclitaxel and HM30181 (Oraxol) compared to weekly intravenous paclitaxel 80mg/m2 in advanced solid tumours. Poster presented at: European Society for Medical Oncology Asia; November 17-19, 2017; Singapore.
An open label, randomised cross-over bioavailability study of Oral Paclitaxel (Oraxol) compared to intravenous paclitaxel 80mg/m. Poster presented at: American Society of Clinical Oncology Annual Meeting; June 5, 2016; Chicago, IL.
A phase I study to evaluate safety, tolerability, pharmacokinetics and activity of Oraxol in patients with advanced malignancies. Poster presented at: American Society of Clinical Oncology Annual Meeting; June 4, 2018; Chicago, IL.
Effective preclinical management of angiosarcoma with oral paclitaxel. Poster presented at: the American Association for Cancer Research (AACR) Annual Meeting; March 29-April 3, 2019; Atlanta, GA.
An open label, randomised cross-over bioavailability and extension study of Oral Paclitaxel and HM30181 (Oraxol) compared to weekly intravenous paclitaxel 80 mg/m2 in advanced solid tumours. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 1-5, 2018; Chicago, IL.
Articles
A phase I study of oral paclitaxel with a novel p-glycoprotein inhibitor, HM30181A, in patients with advanced solid cancer. Cancer Res Treat. 2014;46(3):234-242.
Phase I/II study of weekly Oraxol for the second-line treatment of patients with metastatic or recurrent gastric cancer. The Oncologist. 2015;20:896-897.