Aravive’s phase 3 ovarian cancer trial has bombed, taking another chunk out of its share price. And, with cash down to $18 million at the end of the second quarter, the biotech has a matter of months to find a way out of its predicament.
The phase 3 trial enrolled 366 patients with platinum-resistant ovarian cancer. Half of the participants had taken Roche's Avastin before joining the trial. Patients received the chemotherapy paclitaxel or Aravive’s decoy protein batiraxcept plus paclitaxel. Aravive assessed progression-free survival (PFS) in Avastin-naive patients before analyzing the overall trial population.
Neither analysis painted batiraxcept in a positive light. In the bevacizumab-naive subgroup, PFS was the same, 5.4 months, in the batiraxcept and paclitaxel arms. Batiraxcept performed numerically worse than paclitaxel in the overall study population, with its median PFS clocking in at 5.1 months compared to 5.5 months in the control cohort. No new safety signals were identified.
Aravive is still evaluating the phase 3 data. The review will inform the next steps, which were supposed to include the initiation of a phase 3 trial in clear cell renal cancer in the second half of 2023. The failure in the lead indication has created uncertainty.
“We are conducting additional analyses on the AXLerate-OC phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer,” Aravive CEO Gail McIntyre, Ph.D., said in a statement. Phase 1b/2 data on batiraxcept in pancreatic adenocarcinoma are due soon.
Aravive is running out of time. The biotech ended the second quarter with $18 million in cash, a sum it expects to fund operations until early in the fourth quarter. Batiraxcept is the only drug candidate in Aravive’s pipeline.
The biotech bet its future on the candidate in the belief it represented a $3 billion revenue opportunity. The belief was underpinned by evidence that batiraxcept could improve outcomes in three indications by mimicking the AXL receptor and inhibiting the AXL/GAS6 pathway.