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AVEO Pharmaceuticals, Inc. (AVEO)

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AVEO ONCOLOGY, Inc. (AVEO) 


Company website: 
http://www.aveooncology.com/

AVEO Pharmaceuticals, Inc., a biopharmaceutical company, develops targeted therapies for cancer and related diseases. The company's pipeline of product candidates include Tivozanib, a vascular endothelial growth factor (VEGF) to optimize VEGF blockade; Ficlatuzumab, a hepatocyte growth factor (HGF) inhibitory antibody, which has completed Phase II trial that inhibits the activity of the HGF/c-Met pathway; and AV-203, an anti-ErbB3 specific monoclonal antibody that has completed a Phase I dose escalation study. Its development programs also comprise AV-380, a humanized IgG1 inhibitory monoclonal antibody for the treatment or prevention of cachexia; and the AV-353 platform for the potential treatment of pulmonary arterial hypertension. The company has strategic partnerships with CANbridge Life Sciences Ltd.; EUSA Pharma (UK) Limited; Novartis International Pharmaceutical Ltd.; Biodesix, Inc.; St. Vincent's Hospital Sydney Limited; Biogen Idec International GmbH; and Kyowa Hakko Kirin Co., Ltd. The company was formerly known as GenPath Pharmaceuticals, Inc. and changed its name to AVEO Pharmaceuticals, Inc. in March 2005. AVEO Pharmaceuticals, Inc. was incorporated in 2001 and is based in Cambridge, Massachusetts.

   

Product pipeline candidates include Tivozanib, Ficlatuzumab, AV-203, AV-353 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

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 aveobd@aveooncology.com to discuss partnership opportunities with AVEO’s development pipeline.

European Medicines Agency (EMA), has recommended FOTIVDA™ (tivozanib) for approval as a treatment (Solid Dose) for patients with advanced renal cell carcinoma (RCC)
 

Ficlatuzumab

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
 

AV-203

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.

AV-353

AV-353 is the Company’s potent, selective, high affinity inhibitory antibody specific to Notch 3. The Notch 3 signaling pathway is important in cell-to-cell communication involving gene regulation mechanisms that control multiple cell differentiation processes during the entire life cycle. Scientific literature has implicated the Notch 3 receptor pathway in multiple diseases, including cancer, cardiovascular diseases and neurodegenerative conditions. Publications, including Nature Medicine (2009), have implicated the Notch 3 pathway in Pulmonary Arterial Hypertension (PAH). PAH is a rare and life-threatening disorder that affects approximately 250,000 people worldwide and is caused by enlargement of the arterial walls in small arteries between the heart and the lungs, resulting in restricted blood flow.

Current treatments in PAH focus only on controlling symptoms by avoiding vasoconstriction and increasing vasodilation of vessels and do not reverse the underlying cause of the disease. In contrast, with the results of a recently concluded preclinical animal studies supported by AVEO, AV-353 has generated a growing body of preclinical data that supports AV-353’s ability to potentially reverse the disease phenotype, which would represent a potential disease-modifying approach to treatment. AVEO is currently seeking a partner to develop and commercialize AV-353 worldwide in PAH.

For additional information, or to inquire about potential partnering opportunities, please contact Nikhil Mutyal (nmutyal@aveooncology.com).

 
www.aveopharma.com
Shares Outstanding   110,363,000
Insider Ownership 17%
Institutional + Mutual Fund Ownership  51%
20 Full Time Employees
http://investor.aveooncology.com/phoenix.zhtml?c=219651&p=irol-irhome
 
  
One Broadway 14th Floor
Cambridge, MA 02142

Investor Relations
Phone: 617-588-1960
E-mail: ir@aveooncology.com

 
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AVEO News: Statement of Changes in Beneficial Ownership (4) 08/21/2017 05:33:17 PM
AVEO News: Current Report Filing (8-k) 08/17/2017 04:47:34 PM
AVEO News: Current Report Filing (8-k) 08/10/2017 04:38:21 PM
AVEO News: Current Report Filing (8-k) 08/09/2017 08:46:26 AM
AVEO News: AVEO Reports Second Quarter 2017 Financial Results and Provides Business Update 08/09/2017 07:00:00 AM
PostSubject
#2586  Sticky Note AVEO Oncology Announces $14M in Aggregate Gross Proceeds ProfitScout 06/27/17 11:08:53 AM
#1839  Sticky Note $AVEO recent news/filings mick 11/17/15 10:42:39 AM
#3020   Looking good here again today! Bullwinkle77 08/23/17 02:27:53 PM
#3019   hey shorty, yur gonna get fried. EU is harry crumb 08/23/17 12:33:39 PM
#3018   WHY IS IT DIFFERENT THIS TIME? The BobDoleYahoo 08/23/17 10:36:54 AM
#3017   Here's a little hint. June 8th, 2017 Institutional BobDoleYahoo 08/23/17 10:03:52 AM
#3016   3.70's just about here harry crumb 08/23/17 09:57:20 AM
#3015   Even AFstein is positive on aveo! june 2017 harry crumb 08/22/17 08:31:01 PM
#3014   agree, theres no way someone could even pay harry crumb 08/22/17 08:27:19 PM
#3013   another strong positive day for aveo. many many harry crumb 08/22/17 04:32:02 PM
#3012   I think it's trading with EMA factored in. tonyjh 08/22/17 04:18:18 PM
#3011   Supposed to be 67 days from CHMP recommendation. tonyjh 08/22/17 04:11:19 PM
#3010   Can approval come anytime or is it at Pip611 08/22/17 04:00:19 PM
#3009   Hmmmm makes sense......... n3m3sis 08/22/17 03:47:49 PM
#3008   It will probably post on the EMA website tonyjh 08/22/17 03:37:23 PM
#3007   48 hours? Apophis 08/22/17 03:33:34 PM
#3006   A Question? n3m3sis 08/22/17 03:31:28 PM
#3005   At some point there will be no more Apophis 08/22/17 01:15:23 PM
#3004   Looking good now. Like I said Crazyjake27 08/22/17 12:45:53 PM
#3003   Buy and Sell volume dead even so far Apophis 08/22/17 11:43:38 AM
#3002   TODAY IT WILL :) Apophis 08/22/17 10:21:33 AM
#3001   Little by little . I love it. Crazyjake27 08/22/17 10:06:00 AM
#3000   Let the games begin Bullwinkle77 08/22/17 09:54:41 AM
#2999   Clinical and Regulatory Progress Boosting Biotech Sector ProfitScout 08/22/17 09:40:33 AM
#2998   upon another review of aveo's catalysts, which there harry crumb 08/22/17 09:06:10 AM
#2997   break 3.50 an an 3.70's next! $$$ harry crumb 08/22/17 08:42:00 AM
#2996   Any week now, it can take as little Apophis 08/22/17 08:32:45 AM
#2995   HIT 3.48 IN PREMARKET Apophis 08/22/17 08:30:08 AM
#2994   hi Pip - i no longer have private mrgoodtrade 08/21/17 10:33:22 PM
#2993   that form 4 option j is a transfer harry crumb 08/21/17 07:49:02 PM
#2992   When do you see the rules decision coming? Crazyjake27 08/21/17 07:08:13 PM
#2991   Great day today Crazyjake27 08/21/17 04:04:47 PM
#2990   I think we could hit $3.50 today the Pip611 08/21/17 03:12:43 PM
#2989   $3.30 Close here? Crazyjake27 08/21/17 02:43:08 PM
#2988   I would love to see some great things Crazyjake27 08/21/17 02:41:24 PM
#2987   Jelly of the month club ... It's the Bullwinkle77 08/21/17 02:39:54 PM
#2986   That would be awesome . Looking for Crazyjake27 08/21/17 01:37:40 PM
#2985   There's the P3 futility test news at hand, twistedfreak 08/21/17 12:19:47 PM
#2984   yes, $400 -700 million just from Europe sales. Apophis 08/21/17 12:15:16 PM
#2983   the 2 year projection in my mind(assuming positive twistedfreak 08/21/17 12:12:19 PM
#2982   I want to see some minor news before Apophis 08/21/17 12:09:14 PM
#2981   I have been accumulating here. Hoping for 10k Crazyjake27 08/21/17 11:46:54 AM
#2980   yes, but not short term. I think $7-$8 twistedfreak 08/21/17 11:44:38 AM
#2979   What people thinking here . Is $10 Crazyjake27 08/21/17 10:50:17 AM
#2978   liking that last 8k filed, 3 an 4 harry crumb 08/21/17 08:30:52 AM
#2977   very good possibility it will b or higher! $$$ harry crumb 08/20/17 10:40:28 AM
#2976   Options, which I have not gotten into, evidently twistedfreak 08/19/17 01:34:37 PM
#2975   I thought we would end up over $3.50 Apophis 08/19/17 09:56:47 AM
#2974   consolidation is good people. harry crumb 08/18/17 12:15:18 PM
#2973   My Policy is to never........... n3m3sis 08/17/17 02:32:42 PM
#2972   yes sir, agree! dont get me wrong, we harry crumb 08/17/17 02:26:07 PM
#2971   Straight Up Harry! n3m3sis 08/17/17 12:19:02 PM
PostSubject