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ATHENEX, INC. filed this Form 10-Q on 05/09/2019
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In April 2018, the FDA granted Orphan Drug status to Oraxol for the treatment of angiosarcomas.

In August 2018, we received a positive recommendation by the Data Safety and Monitoring Board (DSMB) of the second interim analysis of the Oraxol Phase 3 Clinical Trial, a randomized controlled clinical trial comparing Oraxol monotherapy against IV paclitaxel monotherapy in patients with metastatic breast cancer.

In October 2018, we presented encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients obtained from a Phase 2 clinical trial conducted in Taiwan at the European Society for Medical Oncology (ESMO) Congress. Results from twenty-four patients with metastatic breast cancer were reported showing that eleven patients (45.8%) achieved partial remission, ten patients (41.7%) had stable disease, and three patients (12.5%) had progressive disease. Drug-related serious adverse events consisting of grade 4 neutropenia were observed in three patients and all recovered completely, and there was no dose limiting neuropathy observed.

In November 2018, we initiated a Phase 1/2 clinical study to assess the safety, tolerability and activity of Oraxol in combination with an anti-PD1 antibody (pembrolizumab) in patients with advanced solid malignancies, in collaboration with Mayo Clinic. Also in November 2018, we licensed the rights to develop and commercialize Oradoxel (oral docetaxel and HM30181A) in Taiwan, Singapore, and Vietnam to PharmaEssentia Corporation.  

In December 2018, our global Phase 1b clinical trial of Oraxol plus ramucirumab (monoclonal antibody to VEGF-R2) in gastric cancer patients who failed previous chemotherapies completed the second cohort of patients and results indicated positive signals of efficacy. For the second cohort of six patients on an escalated Oraxol dose of 250 mg/m2, partial response, according to RECIST criteria, occurred in 3 patients (50%), compared to the first cohort of six patients who were treated with a 200 mg/m2 dose where partial responses were observed in 2/6 patients (33.3%) and stable disease observed in 1/6 patient (16.7%). The Oraxol dose is currently being further escalated to 300 mg/m2 in the third cohort of patients and the study is ongoing.

In January 2019, the target enrollment of 360 evaluable patients in the Oraxol Phase 3 clinical trial in metastatic breast cancer was achieved. In March 2019, we presented a poster highlighting the preclinical data of Oraxol in angiosarcoma, an FDA approved orphan indication for Oraxol, at the American Association of Cancer Research Annual Meeting. In May 2019, we announced preliminary data showing promising early clinical responses in the first part of a two-part study of Oraxol monotherapy in patients with unresectable cutaneous angiosarcoma. We also continued to advance the development of other Orascovery candidates. For instance, in October 2018, the FDA allowed the IND application for Eribulin ORA, our oral version of eribulin plus HM30181A (or encequidar).

If we receive approval from the FDA, our strategy is to develop and commercialize oral paclitaxel and encequidar in the US through our Commercial Platform. We also plan to evaluate go-to-market options outside the US, including using our internal resources, partnering with others, or out-licensing the product. If our Phase Three study in metastatic breast cancer (MBC) is successful, we intend to establish oral paclitaxel and encequidar as the chemotherapy of choice for patients receiving chemotherapy for MBC and intend to file a New Drug Application with the FDA to secure regulatory approval of oral paclitaxel and encequidar for MBC. If successful, we will then explore establishing oral paclitaxel and encequidar in other oncology indications where taxanes have been and we expect will continue to be foundational treatments. During 2019, we plan to focus on:


quantitative and qualitative market research to understand our customers, patients, and the market;


preliminary forecasts;


examining our competitive landscape;


developing and completing brand strategy;


developing key opinion leader relationships;


attending priority medical conferences to increase awareness of the Company and oral paclitaxel and encequidar;


creating a market access strategy;


developing and executing a scientific publication plan;


developing our distribution and patient support plans;


completing our organizational design to determine the overall size of our go-to-market commercial team based on our market opportunity; and


beginning hiring for key commercial and medical affairs leadership roles.