aveo pharmaceuticals inc (AVEO) Key Developments
AVEO Oncology and Biodesix, Inc. Announces Presentation of Results from A Retrospective Exploratory Analysis Using Veristrat
Sep 29 14
AVEO Oncology and Biodesix, Inc. announced the presentation of results from a retrospective exploratory analysis using VeriStrat, a commercially available serum protein test, to identify patients most likely to benefit from the addition of ficlatuzumab, AVEO's HGF inhibitory antibody, to epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) therapy in a randomized Phase 2 study of ficlatuzumab and gefitinib (IRESSA) in previously untreated Asian subjects with non-small cell lung cancer (NSCLC). The results, presented in a poster session (abstract #8195) at the 2014 Congress of the European Society for Medical Oncology (ESMO), suggest that VeriStrat may be selective of positive clinical response for ficlatuzumab plus gefitinib over gefitinib alone. A total of 188 patients were enrolled in a randomized Phase 2 study (P6162) designed to compare the combination of ficlatuzumab and gefitinib with gefitinib alone in treatment-naïve Asian patients with non-small cell lung adenocarcinoma. For this retrospective exploratory analysis, 180 serum samples were assigned a VeriStrat label of either "Good" (VSG) or "Poor" (VSP) (VSG=145, VSP=35). While the study failed to demonstrate improved overall survival (OS) or progression-free survival (PFS) over gefitinib alone in the intent-to-treat population, the addition of ficlatuzumab to gefitinib provided significant clinical benefit to the VSP subgroup. No benefit was observed in the VSG subgroup in either OS (Median 24.7 mo for ficlatuzumab + gefitinib [n=69] vs not reached for gefitinib alone [n=76]; HR 1.18, p=0.492) or PFS (Median 5.6 mo for ficlatuzumab + gefitinib vs 5.6 mo for gefitinib alone; HR 1.06, p=0.753). Despite the small sample sizes, similar patterns in OS and PFS based on VeriStrat stratification were also observed in patients with known EGFR mutations (n=71) and VSP classification (n=11). Based on these data, in April 2014, AVEO and Biodesix(R) entered into a worldwide agreement to develop and commercialize ficlatuzumab with a Biodesix companion diagnostic test. As part of this agreement, AVEO and Biodesix plan to conduct a confirmatory Phase 2 study using a Biodesix VeriStrat "Poor" classification as a selective biomarker for the combination of ficlatuzumab and an EGFR-TKI, versus an EGFR TKI alone, in previously untreated, EGFR mutation-positive patients with advanced non-small-cell lung cancer. The study is expected to initiate before year-end.
AVEO Oncology Announces Presentation of AV-380 Preclinical Data at 2(nd) Cancer Cachexia Conference
Sep 26 14
AVEO Oncology announced the presentation of results from four preclinical studies of AV-380, the Company's potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), in various in vivo cachexia models and in vitro assays at the 2(nd) Cancer Cachexia Conference, being held September 26-28, 2014, in Montreal, Canada. AV-380 is a potential first-in-class GDF15 inhibitor, discovered using AVEO's proprietary Human Response Platform(TM), that provides the company unique insights into cancer and related disease biology. The first-in-human clinical trial of AV-380 is planned for the second half of 2015. Initial clinical development is expected to be for the treatment of cancer cachexia. AVEO plans to evaluate opportunities for partnerships to expand the development of AV-380, including in cachexia associated with non-cancer indications, including chronic heart failure, chronic kidney disease and chronic obstructive pulmonary disease to leverage the full potential of this asset. Cachexia: Cachexia is a serious and common complication in patients with advanced cancer and other chronic diseases, characterized by symptoms of unintentional weight loss, progressive muscle wasting and loss of appetite (anorexia). Cachexia affects some five million individuals in the United States. It is estimated that 60-80% of patients with advanced cancer have cachexia and approximately 30% of cancer patients die due to cachexia. AVEO: AVEO Oncology is a biopharmaceutical company committed to discovering and developing targeted therapies designed to provide substantial impact in the lives of people with cancer by addressing unmet medical needs. AVEO's proprietary Human Response Platform(TM) provides the company unique insights into cancer and related disease biology and is being leveraged in the discovery and clinical development of its therapeutic candidates.
AVEO Oncology Announces Lease Termination and Amendment to Debt Financing Facility
Sep 26 14
AVEO Oncology announced that, as part of its plan to decrease operational expenses, the Company has entered into a termination of its lease agreement pertaining to the Company's headquarters in Cambridge, Massachusetts, reducing its existing lease obligations by $110 million. In addition, the Company has amended its debt financing facility with Hercules Technology Growth Capital (HTGC). Combined, these transactions do not impact the Company's prior financial guidance, with existing cash, cash equivalents and marketable securities providing resources to fund its operating plan into the fourth quarter of 2015 with an expected 2014 year-end cash balance of $50-55 million. Under the terms of its amended lease agreement with BMR-650 E Kendall B LLC, AVEO will terminate its long term lease dated May 9, 2012, in exchange for a termination fee of approximately $7.8 million due upon execution of the agreement, and $7.8 million payable over the subsequent nine months. AVEO will immediately vacate the unused portions of its premises at 650 East Kendall St. and will exit the remaining occupied portions of its premises within twelve months. Pursuant to its amended loan agreement with HTGC, AVEO has received a new $10 million loan, which is in addition to an outstanding principal of $11.6 million from an existing loan agreement. The new loan carries an interest only repayment period of twelve months, with the ability to extend such period for up to an additional twelve months based on the achievement of certain milestones, and has a maturity date of January 1, 2018. The existing loan carries an interest only period of three months, and is expected to be fully repaid by December 2015. In conjunction with the new loan, the Company has issued a warrant to purchase an aggregate of 608,696 shares of AVEO's common stock, at a price of $1.15 per share.
AVEO Oncology Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014
Aug 11 14
AVEO Oncology reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported net loss of $17,959,000 or $0.35 per basic and diluted share against net loss of $31,913,000 or $0.62 per basic and diluted share a year ago. Collaboration revenue was $1,846,000 and loss from operations was $17,465,000 against collaboration revenue was $324,000 and loss from operations was $31,072,000 a year ago. The company had net cash outflows of approximately $23,000,000 compared to $30,000,000 in first quarter of 2014. The company's construction related capital expenditures were $4,000,000, down from $7,800,000 in first quarter of 2014. These construction-related capital expenditures are associated with AVEO's corporate headquarters at 650 E. Kendall St., Cambridge, MA.
For the six months, the company reported net loss of $24,409,000 or $0.47 per basic and diluted share against net loss of $65,998,000 or $1.31 per basic and diluted share a year ago. Collaboration revenue was $17,135,000 and loss from operations was $23,357,000 against collaboration revenue was $647,000 and loss from operations was $64,227,000 a year ago.
AVEO Pharmaceuticals, Inc.(NasdaqGS:AVEO) dropped from Russell 2000 Index
Jun 30 14
AVEO Pharmaceuticals, Inc. will be removed from the Russell 2000 Index.