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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: AVEO Oncology to Present Updated Interim Results from the Phase 2 Portion of the TiNivo Study of Tivozanib & Nivolumab (OPDIV... 10/09/2018 07:00:00 AM
AVEO News: AVEO Oncology to Participate in Upcoming Conferences 09/25/2018 07:00:00 AM
AVEO News: AVEO Oncology to Participate in Upcoming Conferences 08/28/2018 07:00:00 AM
AVEO News: Statement of Changes in Beneficial Ownership (4) 08/22/2018 04:48:10 PM
AVEO News: Statement of Changes in Beneficial Ownership (4) 08/22/2018 04:47:45 PM
PostSubject
#3087  Sticky Note AVEO Oncology Announces FOTIVDA® (tivozanib) Approved in the Maple tree 08/28/17 06:46:30 AM
#3811   Back down it will go, hows that my harry crumb 10/17/18 08:50:31 AM
#3810   Listening to Timothy Sykes brag about shorting penny BJ_Cooper 10/16/18 05:24:56 PM
#3809   You're as predictable as a herpes outbreak. Why Biotech Pharmer 10/16/18 12:37:06 PM
#3808   Continuing to drop like a rock! Luvn harry crumb 10/15/18 11:41:12 PM
#3806   Updated results, not a good sign an people harry crumb 10/11/18 11:22:33 AM
#3805   How come the village idiot has no village? Biotech Pharmer 10/04/18 11:18:55 AM
#3804   Thats about all you gonna get with aveo harry crumb 10/03/18 08:44:54 PM
#3803   It’s good to have a dream. BJ_Cooper 10/03/18 06:14:58 PM
#3802   Dropping dropping an dropping! Luvn this junk! harry crumb 10/03/18 10:50:35 AM
#3801   I tell ya what, when we make our harry crumb 10/02/18 09:00:53 AM
#3800   I love your sense of humor. Watch BJ_Cooper 10/01/18 11:53:00 AM
#3799   Ah, lmfao, you mean .91, i have corrected harry crumb 10/01/18 11:16:05 AM
#3798   AVEO News, Nov 12, 2018..... AVEO reports positive results BJ_Cooper 10/01/18 11:04:27 AM
#3797   Complete failure or they would have recommended immediate harry crumb 10/01/18 10:51:25 AM
#3796   Dropping like a rock! 2$ today, watch an harry crumb 10/01/18 10:47:12 AM
#3795   Committee will recommend complete failure with results, watch harry crumb 10/01/18 10:42:11 AM
#3794   Perfect! This will fail as you can see. harry crumb 10/01/18 10:40:27 AM
#3793   Shorted more of this junk! 1$ coming! harry crumb 09/28/18 03:51:14 PM
#3792   Short it some more Harry. How's that short Biotech Pharmer 09/28/18 11:14:55 AM
#3791   This will never hold above 3, as u harry crumb 09/26/18 01:44:23 PM
#3790   And what was that again? Will never see aura 09/25/18 10:48:59 PM
#3789   Where from here, nice move past the $3 wall Apophis 09/25/18 05:38:07 PM
#3788   Aveo Pharmaceuticals Apophis 09/24/18 01:38:58 PM
#3787   Stooge. And that's a dis to Larry, Curly, Biotech Pharmer 09/06/18 07:20:49 PM
#3786   Aveo will never see 3$ again! harry crumb 09/05/18 05:53:09 PM
#3785   Will be a bank when it hits 1$, harry crumb 09/05/18 05:45:58 PM
#3784   Lmao!! Mac5932002 09/01/18 10:34:53 PM
#3783   Nice call at shorting another 30K shares on Biotech Pharmer 08/30/18 11:55:25 AM
#3782   Are you still in this? Apophis 08/29/18 01:04:35 PM
#3781   This may be the AVEO bull run that Apophis 08/26/18 07:52:38 AM
#3780   Ha! Dirty Harry says a buck! Biotech Pharmer 08/24/18 03:48:05 PM
#3779   Are we going back under $2.00 next week? Apophis 08/24/18 03:23:47 PM
#3778   Big new coming soon , big run coming. Apophis 08/18/18 10:18:09 PM
#3777   $1! harry crumb 08/18/18 01:16:33 PM
#3776   $1.80-$1.50 coming imo ?? Rogerthat1 08/17/18 07:55:10 AM
#3775   Told everyone big selloff coming. Dilution dilution an harry crumb 08/16/18 09:42:53 PM
#3774   Love the selling on the news? Apophis 08/14/18 01:47:42 PM
#3773   That happens often lol tonyjh 08/14/18 01:14:32 PM
#3772   Hmmmm. It looks like you're wrong. Biotech Pharmer 08/14/18 09:24:47 AM
#3771   Huge selloff coming! $$$ harry crumb 08/08/18 09:42:26 PM
#3770   Losing your shirt? JUST 10-11-12 08/08/18 02:49:31 PM
#3769   $1.90 is huge support here. That is the Biotech Pharmer 07/28/18 07:59:29 AM
#3768   * * $AVEO Video Chart 07-23-18 * * ClayTrader 07/23/18 05:15:32 PM
#3767   Aveo Pharmaceuticals (AVEO) mick 07/23/18 04:43:38 PM
#3766   * * $AVEO Video Chart 07-19-18 * * ClayTrader 07/19/18 05:21:49 PM
#3765   no way this is going lower than $1.70 MakinBank 07/19/18 10:32:15 AM
#3764   I’m sorry bud I know nothing about the Rogerthat1 07/18/18 11:05:16 PM
#3763   damn, this is way oversold. Didn't think there MakinBank 07/18/18 10:40:26 PM
#3762   Ummm what did I say. https://investorshub.advfn.com/boards/m_read_msg.aspx?messa Rogerthat1 07/18/18 07:24:41 PM
#3761   * * $AVEO Video Chart 07-18-18 * * ClayTrader 07/18/18 05:26:03 PM
PostSubject