On May 16, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada) (Press release, Athenex, MAY 16, 2022, View Source [SID1234614661]). The agreement applies to the expansion phase of the Phase 1 clinical trial evaluating Athenex’s oral paclitaxel in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for certain NSCLC patients.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The agreement will support the expansion phase of the trial to further investigate the preliminary encouraging results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain NSCLC patients. The two companies will form a Joint Development Committee to review the clinical trial results.
"We are keen to collaborate with Merck to further investigate the therapeutic potential of Oraxol plus KEYTRUDA in patients with NSCLC patients who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "If the preliminary efficacy and safety data can be confirmed, it may lead to a new paradigm in the treatment of certain NSCLC patients."
KX-ORAX-011 is an ongoing Phase 1 trial evaluating Oraxol in combination with pembrolizumab in patients with advanced solid tumors. Following completion of the dose escalation phase, the expansion phase is currently evaluating the combination therapy in patients with NSCLC who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy. The NSCLC expansion cohort is actively recruiting and aims to enroll approximately 50 patients.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar ("oral paclitaxel") is in the earlier stages of development for solid malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and low absorption of encequidar enables the oral administration of IV chemotherapies.