Press Release
Aravive and AstraZeneca Announce Initiation of Randomized Phase 1/2 Study of AVB-500 in Combination with Durvalumab in Patients with Platinum-Resistant Recurrent Epithelial Ovarian Cancer
“GAS6/AXL signaling plays a key role in immune evasion, suggesting that inhibition of this pathway has the potential to augment the anti-tumor effects of an anti-PD-L1 agent to achieve better outcomes for patients,” said
This open-label trial will begin with a Phase 1b safety lead-in phase to determine the recommended Phase 2 dose (RP2D) for the combination of AVB-500 and durvalumab. In the Phase 2 portion, eligible subjects will participate in a 6-week monotherapy cycle randomized to either AVB-500 or durvalumab before receiving the combination therapy at the RP2D. Patients will receive treatment until progression or unacceptable toxicity with combination therapy. The study is listed on clinicaltrials.gov NCT04019288.
“There is a significant need for effective treatments that don’t add to the treatment burden for women with ovarian cancer,” said
About Ovarian Cancer
Each year in
About AVB-500
AVB-500 (previously AVB-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 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 Aravive
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, concerning the belief that there is a strong mechanistic and clinical rationale for exploring the potential of AVB-500 in combination with a checkpoint inhibitor in the treatment of ovarian cancer, the suggestion that inhibition of the GAS6-AXL pathway has the potential to augment the anti-tumor effects of an anti-PD-L1 agent to achieve better outcomes for patients, 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 2019 into additional oncology and fibrotic indications, the Company’s dependence upon AVB-500, AVB-500’s ability to have favorable results in clinical trials or receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; 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 forAravive : Investors:Christina Tartaglia Stern Investor Relations christina@sternir.com Media: Heidi ChokeirCanale Communications heidi@canalecomm.com 619-203-5391
Source: Aravive, Inc.