Summary
- Athenex tumbled on mixed data.
- Boston Scientific received an approval, DARE an IND.
- Conformis Biosciences got an FDA warning.
- Looking for more stock ideas like this one? Get them exclusively at The Total Pharma Tracker. Get started today »
Athenex (ATNX) stock tumbled as it released pivotal trial results for its lead drug candidate, an experimental combination treatment for metastatic breast cancer. The Phase 3 trial tested oral paclitaxel along with encequidar, an inhibitor that aims to make chemotherapies more effective. The data showed that the combination offered a stronger response rate and higher median overall survival as compared to infused paclitaxel.
Despite these results, the stock responded negatively but later recovered as the market fully digested the outcome of the trial. The study showed that oral paclitaxel shrank tumors for 35.8% of patients suffering from advanced-stage breast cancer, compared with just 23.4% of patients treated with IV paclitaxel. However, the treatment showed higher rates of neutropenia, infection, and gastrointestinal issues. On the plus side, the trial showed less nerve damage.
In April this year, we covered the stock when it was trading around $12. We liked the logic of the therapeutic approach. The company's lead discovery in this area is a p-gp pump inhibitor. P-glycoprotein (P-gp) is a plasma membrane protein with a peculiar function - it pumps out important therapeutic drugs, called P-gp substrates, out of their area of therapeutic action. Major P-gp substrates are a number of cancer chemotherapy drugs, including paclitaxel, which was part of the drug arm in the current trial, a number of HIV drugs, and a few other drugs.
In the current trial, the details of the efficacy data are as follows:
- In the intent-to-treat population, the tumor response rate in the oral paclitaxel group was 35.8% (n=95/265) versus 23.4% (n=32/137) (p=0.011). In the population with evaluable post-baseline scan, the response rates were 50.3% and 29.6%, respectively (p=0.0005). Median duration of response was greater in the oral group (27.9 months) compared to the IV group (16.9 months).
- Median overall survival (OS) was 27.9 months compared to 16.9 months for IV paclitaxel (p=0.035).
- Median progression-free survival favored oral paclitaxel, 9.3 months vs. 8.3 months, but the separation thus far was not statistically significant (p=0.077).
The efficacy data, as we see here, is quite decent. However, safety data wasn't as good. It appears that the function of the p-gp protein is actually to safer for the body in so far as it removes the chemotherapy drugs; in the absence of this function, the safety results were, therefore, worse than control. What is lacking here is targeting; modern oncotherapy does a good job of producing molecules that target tumor cells with high selectivity.
Meanwhile, the company has managed to address its cash concern. First, it was able to receive a $100mn private placement in May. Then, very recently, it added another $30mn in upfront payment to its coffers. We also note that the company is now regularly publishing Corporate Presentations, a lack of which we deplored in our coverage. Overall, at current prices, we would stay away from this company; however, note that the stock rose almost 100% since our initial coverage.
