Exhibit 99.1
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Aravive Reports Preliminary Results ofAVB-500 from the First Cohort of the Phase 1b/Phase 2 Recurrent Platinum Resistant Ovarian Cancer Trial
AVB-500 in combination with standard of care demonstrates early proof of concept for anti-tumor activity in platinum-resistant ovarian cancer
Aravive to expand enrollment in Phase 1b Trial ofAVB-500 in platinum-resistant ovarian cancer
HOUSTON—July 31, 2019—Aravive, Inc. (Nasdaq: ARAV) today announced that preliminary efficacy data from their ongoing clinical trial withAVB-500 showed compelling anti-tumor activity in the 12 patients treated from the first cohort of the ongoing Phase 1b portion of the Phase 1b/2 trial ofAVB-500 in patients with platinum-resistant recurrent ovarian cancer where response to standard of care chemotherapy alone in patients is typically10-15 percent.
The open-label, Phase 1b safetylead-in portion of the efficacy and safety study ofAVB-500 in patients with platinum-resistant recurrent ovarian cancer enrolled patients into two cohorts, one investigating a combination ofAVB-500 with pegylated liposomal doxorubicin (PLD) and the other, a combination ofAVB-500 with paclitaxel (PAC). The overall best response rate (ORR) in theAVB-500 combination cohorts to date by investigator determined RECIST v1.1 criteria was greater than response rates observed historically with standard of care chemotherapy alone in this clinical setting.
The company plans to present the detailed safety, pharmacokinetic, pharmacodynamic and preliminary efficacy results for this cohort at an upcoming scientific meeting.
“We have decided to expand the clinical trial to validate that early positive efficacy signal,” said Laura Bonifacio, PharmD, Ph.D, Vice President of Aravive. “If we continue to see a robust efficacy signal, we plan to work with FDA to explore the most efficient regulatory pathway to bring this drug to the patients in need. We continue to pursue our other pipeline programs, including renal cell carcinoma and renal fibrosis” added Bonifacio.
About Ovarian Cancer
Each year in the United States, more than 22,000 women develop ovarian cancer and there are approximately 14,240 attributed deaths annually, making ovarian cancer the deadliest of gynecologic malignancies. Clinical studies over time have shown little response to treatment, especially for platinum-resistant ovarian cancer. In fact, on average, only10-15 percent of patients with platinum-resistant ovarian cancer have an objective response to currently approved therapies (Davis et al. Gynecologic Oncology 133 (2014) 624–631). Clearly, there is a need to develop new therapeutic strategies to improve the overall survival of patients who face less than optimal outcomes due to metastasis and treatment resistant ovarian cancer.
AboutAVB-500
AVB-500 (previously calledAVB-S6-500) is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity. In doing so,AVB-500 selectively inhibits theGAS6-AXL signaling pathway. In preclinical studies,GAS6-AXL inhibition has shown anti-tumor activity, both as a single agent or in combination with a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors is correlated to poor prognosis and survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies.