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Athenex (ATNX) announced a clinical trial collaboration and supply agreement with Merck (MRK). 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 for certain NSCLC patients. 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 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."

As of March 31, 2022, the company had cash and cash equivalents of $27.2 million, restricted cash of $13.8 million, and short-term investments of $10.2 million, for a total of $51.2 million. The company is implementing cost savings programs and monetizing non-core assets, and as the company completes such activities, the company plans to extend its cash runway into next year.

Athenex now expects product sales growth to be in the range of 20-25% over the prior year period, versus the prior range of 15-20% growth, year-over-year, due to the strong performance of Athenex's APD/APS division, earlier than expected NY State license, and the robust pipeline of launches planned for the remainder of 2022.

Athenex announced data from the ANCHOR Phase 1 study of KUR-502 during an oral presentation by Carlos Ramos, M.D., professor, Center for Cell and Gene Therapy, Baylor College of Medicine, at the Tandem Meetings of the American Society of Transplantation and Cellular Therapy, ASTCT, and the Center for International Blood & Marrow Transplant Research, CIBMTR, taking place April 23 to 26, in Salt Lake City, UT. "Encouraging data from the interim update of the ANCHOR study further support the promising efficacy and favorable safety profile of KUR-502 in heavily pretreated patients with hematological malignancies," said Dan Lang, M.D., President of Athenex Cell Therapy. "It is exciting to see the therapeutic benefit of our CAR-NKT cell therapy persists as the ANCHOR study matures, particularly in patients who have already progressed on autologous CAR-T therapy. We intend to collect additional patient data as we expand the study to include more sites and look forward to providing another update later this year." Highlights from the interim update include response data from seven evaluable patients, including two additional patients who were previously too early to assess: One patient with NHL had stable disease, and a second patient with ALL had progressive disease at the 4-week assessment; Two CRs persisted for more than 6 months with one at 34 weeks and still ongoing; Two responses were observed in patients who had relapsed after previous autologous CAR-T therapy; Excellent safety with no immune effector cell-associated neurotoxicity syndrome and no graft versus host disease attributable to CAR-NKT cells; Grade 1 cytokine release syndrome in 2 ALL patients.