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Aravive Biologics, Inc., a clinical-stage biotechnology company focused on development of treatments for cancer and fibrotic diseases, today announced the initiation of a Phase 1 clinical trial of AVB-S6-500 (previously referred to as Aravive-S6). The study is being conducted in the United States and will evaluate safety, pharmacokinetics and pharmacodynamics in approximately 40 healthy volunteers and is designed to demonstrate proof-of-mechanism for the company’s lead drug candidate.
“We are very pleased to achieve this key development milestone for AVB-S6-500, which in preclinical testing has shown potential in a variety of solid tumors and acute myeloid leukemia (AML),” said Gail McIntyre Ph.D., Senior Vice President of R&D at Aravive. “Extensive research by Aravive and others has shown the GAS6-AXL signaling pathway to be an important target in oncology, whose inhibition has the potential to overcome tumor resistance and increase the efficacy of a variety of anticancer agents.”
“AVB-S6-500 is unique as an inhibitor of the GAS6-AXL pathway in its high affinity for GAS6 and the high selectivity with which it inhibits AXL signaling,” said Stephen L. Eck M.D. Ph.D, Chief Executive Officer of Aravive. “Given the availability of our proprietary biomarker, the company hopes to establish the proof-of-mechanism for this first-in-class drug candidate as well as safety in Phase 1 clinical studies by demonstrating full target engagement and inhibition of GAS6 in the clinic.”
AVB-S6-500 is a novel biologic that is designed to bind GAS6 with high affinity and neutralize its activity. Research has shown GAS6-AXL signaling to be a key molecular pathway that scientists believe promotes tumor growth and metastasis, as well as tumor immune evasion and resistance to other anticancer agents. AXL and GAS6 expression correlate with poor prognosis in cancer and are thought by many experts to be attractive targets for cancer therapy. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent (including AVB-S6-500) or through combinations of a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. GAS6/AXL inhibition has also shown potential as a strategy for the treatment of certain fibrotic diseases.
About Aravive Biologics
Aravive Biologics is a privately held biopharmaceutical company developing novel, highly selective therapies designed to treat serious cancers and certain fibrotic diseases. The company’s lead program is focused on the GAS6-AXL pathway. Aravive Biologics has generated strong preclinical data for its lead drug candidate in a variety of cancer models. The company is based in Houston, Texas, and receives support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at http://www.aravive.com.
Forward Looking Statement
This press release contains forward-looking statements. Forward-looking statements contained in this press release include, without limitation, statements regarding AVB-S6-500’s potential to overcome tumor resistance and increase the efficacy of a variety of anticancer agents. These forward-looking statements are not guarantees of future performance and involve a number of unknown risks, assumptions, uncertainties and factors that are beyond Aravive Biologics’ control, including the ability of the Phase 1 study to demonstrate proof-of-mechanism for the company’s lead drug candidate, the potential of the inhibition of the GAS6-AXL signaling pathway to overcome tumor resistance and increase the efficacy of a variety of anticancer agents, the potential of GAS6/AXL inhibition as a strategy for the treatment of certain fibrotic diseases, the potential of AVB-S6-500 in a variety of solid tumors and acute myeloid leukemia, the ability of AVB-S6-500 to treat cancer, the ability of AVB-S6-500 to demonstrate safety and efficacy, as well as clinical results that are consistent with prior in vitro results, the ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, and our ability to retain our key scientists or management personnel. All forward-looking statements are based on Aravive Biologics’ expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, Aravive Biologics expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.
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