Today, in a late-breaking oral presentation at the European Society for Medical Oncology Congress, clinical-stage biopharmaceutical company Aravive Inc. (ARAV:NASDAQ), which is developing treatments designed to halt the progression of life-threatening diseases including cancer and fibrosis, presented positive data from the initial 12 patients of the ongoing Phase 1b portion of the company's Phase 1b/2 study of AVB-500 in ovarian cancer patients.
The company reported that the open-label, Phase 1b portion of the study of AVB-500 in patients with platinum-resistant recurrent ovarian cancer enrolled patients into two cohorts, one investigating a combination of AVB-500 with pegylated liposomal doxorubicin and the other, a combination with paclitaxel. The firm advised that in both study groups, AVB-500 treatment led to early proof of concept with overall best response rate by investigator determined RECIST v1.1 criteria and durable response in responders. AVB-500 was well tolerated with no dose limiting toxicities.
Investigator Bradley J. Monk, M.D., professor and director of the division of gynecologic oncology at Creighton University School of Medicine at St. Joseph's Hospital and Medical Center in Phoenix, Ariz., commented, "Due to its aggressive nature, ovarian cancer has been particularly challenging to address therapeutically, so we are encouraged by the early positive efficacy signal...This clinical study continues to support previous literature that highlights the potential for agents that can inhibit the GAS6/AXL pathway to provide new treatment options for ovarian cancer patients."
Aravive plans to report the detailed analysis once the data from the initial 30 patients on the current 10 mg/kg dose mature toward the end of the year. That data analysis will be evaluated to inform the regulatory strategy for AVB-500 as a treatment for platinum-resistant ovarian cancer. If current exposure response relationships are confirmed in the dose escalation portion of the expansion study by mid-2020, Aravive intends to explore the potential for an accelerated regulatory pathway for AVB-500 with the U.S. Food and Drug Administration (FDA). The FDA granted Fast Track Designation to Aravive Biologics' AVB-500 in platinum-resistant recurrent ovarian cancer in 2018.
The company states that it is further exploring feasibility of biomarker-driven individualized dose adjustments. Aravive also plans to incorporate the exposure-response information into its planned studies in clear cell renal cancer and renal fibrosis trials.
Gail McIntyre, Ph.D., chief scientific officer of Aravive, stated, "Understanding that there is an exposure-response relationship where higher clinical benefit is seen in patients achieving higher drug levels is very promising for our program at this stage...It demonstrates that AVB-500 is contributing to the clinical benefit and it informs the dose that should be tested in pivotal studies."
Aravive notes that more than 22,000 women in the U.S. develop ovarian cancer each year, and there are approximately 14,240 attributed deaths annually, making ovarian cancer the deadliest of gynecologic malignancies. Most women with ovarian cancer are diagnosed with advanced disease, after the tumor has already spread, and their disease rapidly becomes resistant to existing chemotherapies.
In a separate release today, Aravive announced that company management will participate at the upcoming Cantor Global Healthcare Investor Conference in New York on October 4, 2019.
Aravive Inc., formerly Versartis Inc., is based in Houston, Tex., and describes itself as a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis. The company identifies its lead product candidate as AVB-500, an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway. The firm explains that by capturing serum GAS6, AVB-500 starves the AXL pathway of its signal, potentially halting the biological programming that promotes disease progression and that AXL receptor signaling plays an important role in multiple types of malignancies by promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression. Aravive points out that the GAS6-AXL signaling pathway also plays a significant role in fibrogenesis. Aravive has initiated the Phase 1b portion of a Phase 1b/2 clinical trial of AVB-500 combined with standard of care therapies in patients with platinum-resistant ovarian cancer, and intends to expand development into additional oncology and fibrotic indications.
Aravive has a market capitalization of around $95.6 million with 11.28 million shares outstanding. ARAV shares opened slightly higher today at $8.66 (+$0.19, +2.24%) compared to yesterday's $8.47 closing price. The stock has traded today between $8.52 and $9.72/share setting a 52-week intraday high price and is presently trading at $8.84 (+$0.37, +4.4%).
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