Aravive Inc (NASDAQ: ARAV) posted an initial readout of the positive results from the phase 1b clinical study of AVB-500 in combination therapy with cabozantinib in advanced stage kidney cancer (clear cell renal cell carcinoma) patients.
Improved tolerability
The patients showed improved tolerance when administered with 15mg/kg of AVB-500 during the phase 1b portion of the Phase 1b/2 clinical trial. No unexpected findings are reported in the phase 1b clinical outcome.
Aravive will expand the phase 1b clinical study to additional three patients to assess the potential to commence a phase 2 clinical trial.
It will conduct a dose-escalation study using AVB-500 in Phase 1b clinical study subjects to collect additional pharmacodynamics, safety, and pharmacokinetics information.
Aravive’s CEO, Gail McIntyre, is excited with the favorable results from the phase 1b clinical trial of the drug in the first cohort to treat clear cell renal cell carcinoma.
The company wills evaluate the effectiveness and safety of AVB-500 in treating patients with advanced-stage kidney cancer and having a low survival rate. It plans to address unmet needs for patients with this rare disease on an urgent basis.
Enrolls 18 patients in phase 1b clinical trial
Aravive commenced the phase 1b clinical study of AVB-500 in March 2021 in ccRCC. The company plans to enroll up to eighteen subjects in the dose-escalation study.
It will evaluate the patients’ safety, the effectiveness of the formulation, and other essential parameters during the trial by increasing the dose of AVB-500 from 15 mg/kg and 20 mg/kg to 25 mg/kg in a combination treatment with cabozantinib.
In the phase 2 portion of the clinical study, the company would enroll up to 45 subjects and assess the effectiveness of AVB-500 administering the recommended dose in phase 1b clinical trial in combination therapy.
The therapeutic recombinant fusion protein – AVB-500 binds and neutralizes GAS6 activity. AVB-500 can selectively inhibit the signaling pathway of GAS6-AXL in multiple cancer types such as ovarian cancer.
GAS6-AXL inhibition showed anti-tumor activity in the pre-clinical trial involving combination therapies to treat cancer. The US FDA granted fast track designation for AVB-500 to treat PRROC (platinum-resistant recurrent ovarian cancer).
