AVEO ONCOLOGY, Inc. (AVEO)
Company website: http://www.aveooncology.com/ AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for Renal Cell Carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). Product pipeline candidates include tivozanib, ficlatuzumab, AV-203 and AV-380.
AV-380 (GDF-15 Program)
In August 2015, AVEO announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody.
GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Current evidence suggests that a pro- inflammatory state may be responsible for many of the symptoms associated with cachexia, a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions.
Preclinical data show that inhibition of GDF15 results in a switch from catabolism to anabolism, suggesting that GDF15 inhibition with AV-380 may reverse the effects of cachexia.
Cachexia is a serious and common complication in patients with advanced cancer and other chronic diseases. It affects some five million individuals in the United States.
Tivozanib, is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities.
AVEO remains encouraged by the clinical outcomes from its Phase 2 and Phase 3 studies in renal cell carcinoma and the efficacy and tolerability profile that tivozanib may offer to patients suffering from this challenging disease. In addition, promising biomarker results were observed in a Phase 2 study of tivozanib in colorectal cancer.
In August of 2014, AVEO regained all rights to tivozanib. In November 2014, AVEO entered into an option agreement with Ophthotech to investigate tivozanib for the potential treatment of non-oncologic diseases of the eye. In August 2015, AVEO entered into an exclusive license agreement with Pharmstandard OJSC for the development, manufacturing and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications excluding ocular conditions. The Company is actively pursuing partnerships in Europe to advance the development and commercialization of tivozanib in solid tumors.
AVEO is interested in collaborating with potential partners who share our vision for cancer drug development and positively impacting patients’ lives. Please contact AVEO [email protected] to discuss partnership opportunities with AVEO’s development pipeline.
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities.
AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab, with VeriStrat®, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). Under the terms of the agreement, AVEO and Biodesix are conducting a proof-of-concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using BDX001, a serum protein test similar to the VeriStrat test.
An exploratory analysis from AVEO’s Phase 2 study in first-line NSCLC suggested that VeriStrat was prognostic for outcome in the epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)-treated patients and predicted differential treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone. The predictive effect was observed in both progression-free survival and overall survival endpoints
AVEO scientists have demonstrated through the use of our Human Response Platform™ the importance of ErbB3 in promoting tumor growth. An increasing body of evidence also implicates the activation of ErbB3 in tumorigenesis and the development of resistance to anti-cancer agents. AV-203 is a clinical-stage ErbB3 (HER3) inhibitory antibody candidate designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers, and AV-203 has demonstrated preclinical activity in a number of different tumor models including breast, head and neck, lung, ovarian and pancreatic cancers.
AVEO has successfully completed a Phase 1 safety study showing no dose limiting toxicities at maximum dose of 20mg/kg and CLIA (Clinical Laboratory Improvements Amendment) validation has been completed for a biomarker for potential patient selection. www.aveopharma.com One Broadway 14th Floor
Cambridge, MA 02142
E-mail: [email protected]