Press Release
Aravive Announces Initiation of Investigator-Sponsored Phase 1/2 Study of AVB-500 in Combination with Avelumab in Patients with Advanced Urothelial Carcinoma (COAXIN)
“Locally advanced or metastatic urothelial carcinoma is an aggressive cancer with poor long-term survival,” said
The COAXIN study is a multi-center, single arm, Phase 1/2 trial evaluating safety and preliminary antitumor efficacy of avelumab in combination with AVB-500 in patients with advanced UC. The trial starts with a Phase 1 cohort to establish the maximum tolerated dose (MTD) of AVB-500 in combination with avelumab and to allow for assessment of potential dose-limiting toxicities. The primary endpoint of the study is objective response rate. Secondary outcome measures include progression free survival, clinical benefit rate, duration of response and overall survival. The trial is listed on clinicaltrials.gov NCT04004442. Patient enrollment and continuation on study may be impacted by COVID-19.
About Urothelial Cancer
Globally, urothelial cancer accounts for approximately 450,000 new cancer cases and 165,000 deaths every year (World Cancer Report, 2013). Platinum-based combination chemotherapy has been the cornerstone of treatment for patients with incurable metastatic disease. Gemcitabine and cisplatin (GC) and conventional or dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) are the commonly utilized regimens in this setting. Although initial responses are seen in approximately 40% of patients, most eventually experience disease progression. A significant proportion of patients are ineligible for cisplatin due to suboptimal renal function, poor performance status, congestive heart failure, neuropathy or hearing loss. Until recently, single agent chemotherapy or best supportive care were the only treatment options for such patients and the median overall survival (OS) was around 5 to 7 months.
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 doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity, both as a single agent and 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.
About
Forward-Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended), express or implied, such as targeting additional mechanisms of immunosuppression and tumor growth such as Gas6/AXL signaling could be synergistic with immunotherapy and may improve outcomes in this challenging disease, the potential of AVB-500 to be used both in combination with existing therapies, as well as a maintenance drug, the potential of AVB-500 to halt the biological programming that promotes disease progression and the expansion of the development of AVB-500 into additional oncology and fibrotic indications. 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 expand development in 2020 into additional oncology and fibrotic indications, the Company’s dependence upon AVB-500, AVB-500’s ability to have favorable results in clinical trials, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical studies, 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 outbreak; 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 and Form 10-K/A for the fiscal year ended
Contacts for
Investors:
Stern Investor Relations
christina@sternir.com
Media:
heidi@canalecomm.com
619-203-5391
Source:
Source: Aravive, Inc.