Aravive, Inc. (Nasdaq:ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced that updated data from its Phase 1b trial evaluating AVB-500 in platinum resistant ovarian cancer (PROC) will be presented at the 2021 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. Additionally, a trial in progress poster will be presented on an open label Phase 1/2 investigator-sponsored trial of AVB-500 in combination with durvalumab in patients with platinum resistant, recurrent epithelial ovarian cancer. The meeting is being held virtually on March 19-25, 2021.
Oral Presentation Details:
       
Title:     Phase 1 Study of GAS6/AXL Inhibitor (AVB-500) in Recurrent, Platinum Resistant Ovarian Carcinoma
       
Presenter:     Katherine Fuh, MD, Associate Professor in Obstetrics and Gynecology, Washington University School of Medicine
       
Date:     March 19, 2021
       
Time:     2:35 PM CT
       
Session:     Scientific Plenary I: Innovation and Progress in Gynecologic Oncology
       
Poster Presentation Details:
       
Title:     Phase I/II study of AVB-S6-500 in Combination with Durvalumab (MEDI4736) in Patients with Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
       
Authors:     Emily Hinchcliff, Shannon N. Westin, Virginia Bayer, Weiyi Peng, Linghua Wang, Bryan Fellman, Ying Yuan, Anil Sood, Karen Lu, Amir Jazaeri
       
Date:     March 19-25, 2021
       
Time:     8:00 PM – 11:00 PM CT
       
Session:     TiP Poster Session

“Results from the Phase 1b trial evaluating AVB-500 in PROC, for which new treatment options are urgently needed, are very encouraging in light of the improved progression free survival and duration of response, coupled with the tolerable safety profile,” said Reshma Rangwala, MD, PhD, Chief Medical Officer of Aravive. “We remain focused on advancing the ongoing pivotal Phase 3 trial of AVB-500 to address the unmet needs of patients with ovarian cancer.”        

For additional information, please visit the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer website: www.sgo.org.

About AVB-500 AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer and clear cell renal cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity 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 has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals.

About Aravive Aravive, Inc. is a clinical-stage oncology company developing transformative therapeutics designed to halt the progression of life-threatening diseases. Aravive is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. Aravive’s lead product candidate, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and has initiated a registrational Phase 3 trial of AVB-500 at a dose of 15 mg/kg. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. For more information, please visit www.aravive.com.

Forward-Looking StatementsThis communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and includes statements regarding plans to advance the ongoing pivotal Phase 3 trial of AVB-500. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: the Company’s ability to advance the ongoing pivotal Phase 3 trial of AVB-500, the impact of COVID-19 on the Company's clinical strategy, clinical trials, supply chain and fundraising, the Company's ability to expand development into additional oncology indications, the Company's dependence upon AVB-500, AVB-500's ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that AVB-500 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing AVB-500; if AVB-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company's intellectual property rights; the Company's reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

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Investors:Luke Heagle, W2Olheagle@w2ogroup.com(910) 726-1372