Aravive Inc. (NASDAQ: ARAV) shares skyrocketed on Wednesday after the firm announced early-stage data for its ovarian cancer treatment. Specifically, the results are from the ongoing Phase 1b portion of the Phase 1b/2 clinical trial of AVB-500 in platinum-resistant recurrent ovarian cancer patients.
The data from the first 31 patients treated at the 10mg/kg dose are maturing and affirm earlier findings on the relationship between AVB-500 levels and anti-tumor response.
In this data analysis, high serum drug levels of AVB-500 were strongly predictive of anti-tumor activity with statistically significant correlation to progression-free survival (PFS). PFS is the primary endpoint for platinum-resistant ovarian cancer clinical trials.
At the 10 mg/kg dose, patients that met or exceeded the minimal efficacious concentration of AVB-500 demonstrated a greater than fourfold increase in median PFS over those with low exposure and roughly twofold improvement in overall response rate, including one complete response.
Patients who achieved sufficient AVB-500 exposure also showed improvements in duration of response (from 7.6 to 3.9 months) and clinical benefit rate.
Katherine Fuh, M.D., Ph.D., Assistant Professor in Obstetrics and Gynecology, Washington University School of Medicine, and an investigator in the study, commented:
Platinum-resistant ovarian cancer is one of the most difficult diseases to treat, not only because of the poor prognosis, but because of the toxicities associated with chemotherapies. The safety profile of AVB-500 along with the emerging data showing improvement in clinical benefit rate and progression-free survival, support the use of AVB-500 to change the treatment landscape for these patients.
Wedbush even came out with a report calling for roughly 160% upside. The boutique brokerage firm issued an Outperform rating and a $28 price target. Its report had this to say:
Importantly, AVB-500’s emerging clinical profile, which already is exhibiting clinically-meaningful differentiation to single-agent chemo in PROC (historical ORRs in the range of 15-20%), is still in its early stages of dose-escalation. The study showed that the drug’s MEC of 13.8 mg/L, which is consistent with at least 95% target engagement based on PK modeling, could be achieved in 50% of treated pts with the 10 mg/kg dose. However, Aravive is currently enrolling pts at the higher dose cohorts of 15 and 20 mg/kg (target n=6-12 and 12 pts, respectively), which based on PK modeling, 20 mg/kg should allow greater than 90% of pts to achieve the MEC, or high drug exposure levels that was most efficacious in patients in the 10 mg/kg dose group. In sum, we believe AVB-500’s emerging clinical profile in PROC and encouraging exposure-response relationship continues to support our view of its best-in-class status among AXL pathway inhibitors, and therefore, we would be buyers of Aravive shares ahead of the preliminary readout from the higher 15 and 20 mg/kg dose groups, which we expect to be positive, that’s anticipated in mid-2020.
Shares of Aravive traded up about 70% at $11.06, in a 52-week range of $3.07 to $15.60. The consensus price target is $15.00.
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