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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 approved on 8/28/17  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  58%
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) 12/12/2018 04:46:20 PM
AVEO News: Statement of Changes in Beneficial Ownership (4) 12/12/2018 04:45:28 PM
AVEO News: Statement of Changes in Beneficial Ownership (4) 12/12/2018 04:45:03 PM
AVEO News: Statement of Changes in Beneficial Ownership (4) 12/12/2018 04:44:37 PM
AVEO News: Statement of Changes in Beneficial Ownership (4) 12/12/2018 04:44:11 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 12/12/2018 04:46:20 PM
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#3087  Sticky Note AVEO Oncology Announces FOTIVDA® (tivozanib) Approved in the Maple tree 08/28/17 06:46:30 AM
#3876   Hey Harry, I see another POS company has Biotech Pharmer 12/12/18 09:25:02 AM
#3875   I guess we are kind of on hold strongbio 12/08/18 09:45:43 AM
#3874   When somebody speak about AVEO crash, ...AVEO allways pfelgueiras 12/07/18 09:57:07 AM
#3873   About to crash to under $1, 1 flicker harry crumb 12/07/18 09:12:46 AM
#3872   People are betting the boat with option contracts Apophis 12/04/18 10:28:09 AM
#3871   Caught that and that they already have run Ragnaroc 11/29/18 05:54:54 PM
#3870   Very nice institutional owner 22%. Apophis 11/28/18 10:13:48 PM
#3869   $15 bucks by June 2019. Apophis 11/28/18 01:09:07 PM
#3868   It is a nightmare for a poorly selected strongbio 11/25/18 07:34:05 PM
#3867   It must be irritating to be short and BJ_Cooper 11/20/18 06:49:53 PM
#3866   * * $AVEO Video Chart 11-20-18 * * ClayTrader 11/20/18 05:34:08 PM
#3865   AVEO is on the way to 6,00 pfelgueiras 11/20/18 02:58:00 PM
#3864   Aveo will never c 16$, it wont c harry crumb 11/20/18 10:19:21 AM
#3863   $16 Bucks next summer. Apophis 11/19/18 02:41:38 PM
#3862   Aveo correction for u, not 10$,u meant 1$! harry crumb 11/15/18 04:11:08 PM
#3861   Time to break out the popcorn. The suspense BJ_Cooper 11/14/18 05:22:33 PM
#3860   AVEO Almost $2,00 pfelgueiras 11/14/18 05:04:53 PM
#3859   AVEO is going up pfelgueiras 11/14/18 10:15:52 AM
#3858   Almost to 1$, as predicted! Short short short! $$$$ harry crumb 11/13/18 11:52:13 AM
#3857   Aveo heading to bankruptcy! harry crumb 11/13/18 12:58:31 AM
#3856   AVEO Pharma (AVEO) pfelgueiras 11/12/18 11:08:46 AM
#3855   Buy LOW sell HIGH Zacks Rank "2" BUY, 1y pfelgueiras 11/12/18 08:10:00 AM
#3854   This will never see 2$ again, just like harry crumb 11/10/18 08:30:16 AM
#3853   New 52 week low an no support! Lets harry crumb 11/09/18 01:52:40 PM
#3852   Hey longs, sometimes ya got to listen! Shorted harry crumb 11/09/18 01:41:04 PM
#3851   Weeeeeeeeeeeak lol tonyjh 11/08/18 11:54:10 AM
#3850   Lol tonyjh 11/07/18 08:31:37 PM
#3849   * * $AVEO Video Chart 11-07-18 * * ClayTrader 11/07/18 05:03:55 PM
#3848   Tomorrow, 1.75! Wwweeeee $$$$$ harry crumb 11/07/18 03:37:11 PM
#3847   Long AVEO! News: https://seekingalpha.com/article/4218 buy_buy_buy13 11/06/18 11:07:26 PM
#3846   Long AVEO! News: https://seekingalpha.com/article buy_buy_buy13 11/06/18 11:05:31 PM
#3845   Long AVEO! News: https://seekingalpha.com/article buy_buy_buy13 11/06/18 11:05:24 PM
#3844   Yep. I did lol tonyjh 11/06/18 05:14:37 PM
#3843   * * $AVEO Video Chart 11-06-18 * * ClayTrader 11/06/18 05:07:12 PM
#3842   time to buy? DD 11/06/18 04:46:46 PM
#3841   You will be sorry, shorted more at the harry crumb 11/06/18 03:32:44 PM
#3840   I am glad went down I loaded more youssef 11/06/18 11:48:49 AM
#3839   Yousef, learn to trade this junk, i am harry crumb 11/06/18 09:44:33 AM
#3838   Its getting crushed as i mentioned! Will be harry crumb 11/06/18 09:42:56 AM
#3837   I think someone will buy them youssef 11/05/18 10:07:35 PM
#3836   11.00 bucks in a few months Apophis 11/05/18 09:33:24 PM
#3835   It s going to be up tomorrow youssef 11/05/18 09:15:53 PM
#3834   Big deal, doesnt mean anything, lots of mini harry crumb 11/05/18 09:02:34 PM
#3833   News after hours youssef 11/05/18 05:49:27 PM
#3832   You funny guy, right here we are as harry crumb 11/02/18 01:03:44 PM
#3831   Hopefully get a dip here on earnings to strongbio 10/30/18 08:29:30 PM
#3830   Come on Dirty Harry, grow a pair. Biotech Pharmer 10/29/18 01:41:38 PM
#3829   Where's dirty Harry today? Mr. Predictability Biotech Pharmer 10/26/18 01:36:48 PM
#3828   Will this tank under 2 today, we will see. harry crumb 10/25/18 08:54:41 AM
#3827   Due some dd on acad, nothing but positive harry crumb 10/24/18 10:16:01 PM
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