Business Wire

AVEO Oncology and EUSA Pharma Announce Promising Phase 1 Results from the Phase 1/2 TiNivo Study of Tivozanib and Nivolumab in Renal Cell Carcinoma

Jaa

AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma today announced the presentation of promising results from the ongoing Phase 1 portion of the TiNivo study, a Phase 1/2 multicenter trial of tivozanib (FOTIVDA®) in combination with Bristol-Myers Squibb’s nivolumab (OPDIVO®), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma (RCC). The results were presented on Friday, November 3, at the 16th International Kidney Cancer Symposium in Miami, in an oral presentation titled “TiNivo: A Phase Ib Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma” by Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study. A copy of the presentation is available at www.aveooncology.com or further information can be obtained via EUSA Pharma Medical Information.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171106005388/en/

The Phase 1 portion of the trial enrolled six patients, three with previously untreated metastatic RCC and three who had received first-line treatment. RCC tumor histology included five clear cell (one with sarcomatoid features) and one papillary. Tivozanib was administered to patients in two escalating dose cohorts (1.0 mg/QD and 1.5 mg/QD) in combination with nivolumab at a constant 240 mg every 2 weeks. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Unconfirmed best response to date includes a 67% (4/6) partial response (PR) rate and a 100% disease control rate (PR + stable disease). Enrollment of approximately 20 patients in the Phase 2 portion of the trial is ongoing.

“Combining VEGF TKIs and PD-1s holds the potential for synergistic activity against renal cell carcinoma, yet most such combinations demonstrate a high rate of toxicity in the clinic,” said Dr. Albiges. “Tivozanib has several distinguishing properties that may enhance its ability to combine with checkpoint inhibitors, including a highest in-class selectivity for the VEGF-Receptor (types 1, 2 and 3), and therefore fewer off-target effects, and the ability to significantly reduce regulatory T cells, thereby enhancing immune activity against the tumor. Tivozanib’s favorable tolerability profile has been demonstrated against sorafenib in the pivotal TIVO-1 study, and early results from the TiNivo study show a tolerable combination and evidence of promising activity.”

“We are encouraged by the preliminary tolerability and activity results from the TiNivo study, as we believe they begin to underscore the unique potential of tivozanib-immunotherapy combinations,” said Michael Needle, M.D., chief medical officer of AVEO. “With immunotherapy combinations continuing to demonstrate improved outcomes in patients with RCC, it will become increasingly important to leverage the best-in-class VEGF therapies and immunotherapies to optimize efficacy and tolerability in defined populations within this disease. We believe tivozanib is well-positioned within this evolving landscape, and we look forward to presenting the Phase 2 portion of TiNivo in the first half of next year. We also anticipate moving into additional combination studies in the coming quarters.”

Lee Morley, EUSA Pharma’s Chief Executive Officer said, “Following the recent European approval of tivozanib (FOTIVDA®) for the first-line treatment of patients with advanced RCC, emerging data from the TiNivo study indicates the potential for tivozanib in the setting of combination treatment with immunotherapies. The initial results of the TiNivo study are promising and, in partnership with AVEO, we look forward to developing new and innovative options based on the unique profile of tivozanib which will be important for the future management of patients.”

About Tivozanib (FOTIVDA ® )

Tivozanib (FOTIVDA®) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

About AVEO

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 seeking to develop and commercialize 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 aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Leichtenstein, Norway and Iceland. For more information, please visit the company’s website at www.aveooncology.com.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with a focus on oncology and oncology supportive care. The company has commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world. EUSA Pharma is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information visit www.eusapharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: clinical, regulatory and commercial plans of AVEO and its partner EUSA Pharma to progress the development of FOTIVDA® (tivozanib); the role and expected benefits of tivozanib and other TKIs on a stand-alone basis, or in combination with or following immunotherapy; the expected enrollment of the TiNivo trial and presentation of TiNivo results; expectations about the potential for additional payments by EUSA Pharma; the value of AVEO's partnerships in advancing its pipeline; and AVEO’s strategy, prospects, plans and objectives, including as they pertain specifically to tivozanib. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to AVEO’s ability to enter into and maintain its third party collaboration agreements, and its ability, and the ability of its licensees and other partners, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including tivozanib. AVEO faces other risks relating to its business as well, including risks relating to its ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” and in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2016 and in other periodic filings that AVEO makes with the SEC in the future. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as required by law. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

References

  1. Fotivda (Tivozanib) SmPC August 2017
  2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.

Contact information

AVEO:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com
or
EUSA:
EUSA Pharma
Lee Morley, +44 (0)330 5001140
Chief Executive

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Versum Materials Celebrates the Grand Opening of Its Research and Development Facility in Hometown, PA19.4.2018 23:37Tiedote

Versum Materials, Inc. (NYSE: VSM), a leading materials supplier to the semiconductor industry, announced today the grand opening of its new research and development (R&D) facility at its semiconductor materials manufacturing site in Hometown, Pennsylvania. The ribbon-cutting ceremony took place April 10, 2018. Versum employees, members of the community, local government, customers and strategic partners attended the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419006305/en/ Versum Materials ribbon-cutting ceremony at the company's new R&D facility in Hometown, PA. (Photo: Business Wire) The state-of-the-art R&D laboratory is dedicated to new materials used in the manufacture of semiconductors. Scientists in the facility will synthesize and purify new molecules down to parts per billion impurity levels and below using the latest technologies available in the industry. The researchers can assess the applications f

Pharnext to Showcase PLEOTHERAPY™ R&D Platform at the 8th Annual Global Orphan Drug Conference19.4.2018 18:45Tiedote

Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big data genomics and artificial intelligence, today announced that Rodolphe Hajj, Ph.D., the Company’s Chief Pharmacology Officer, will present at the 8th Annual Global Orphan Drug Conference. The presentation will take place as follows: Date & Time: Wednesday April 25th at 4:40 pm EST Title: “Next generation drug repurposing using network pharmacology to develop new therapeutic entities for rare diseases” Venue: Gaylord National Harbor Hotel, Oxon Hill, MD, U.S. Pharnext’s team will also attend the 2018 American Academy of Neurology Annual Meeting as a first-time exhibitor (booth 908). The meeting will take place on April 21-27, 2018 in Los Angeles, CA, U.S. If you are interested in meeting the Pharnext management team during these events, please send an email to contact@pharnext.com. About Pharnext Pharne

New Study Investigates the Utility of Masimo SpHb® in Post-operative Red Blood Cell (RBC) Transfusion Best Practices19.4.2018 18:01Tiedote

Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the 2018 Annual Meeting of the Network for the Advancement of Patient Blood Management, Haemostatis and Thrombosis (NATA), in which researchers investigated the utility of Masimo noninvasive and continuous hemoglobin (SpHb®) in supporting and enhancing red blood cell (RBC) transfusion best practices as part of post-operative patient blood management (PBM).1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419005949/en/ Masimo Radical-7® with SpHb® and RD rainbow SET™ Sensor (Photo: Business Wire) In the study, Prof. Baricchi and colleagues in the Transfusion Medicine Unit, AUSL-IRCCS of Reggio Emilia and at the Department of Medicine and Surgery at the University of Parma, Italy, sought to evaluate the appropriateness of post-operative RBC transfusion over a three-year period (2013-2015), before and after implementation of a patient blood managem

Synteract Repositions Itself with Centers of Therapeutic Development and Unveils Updated Brand Platform19.4.2018 17:06Tiedote

Synteract, an innovative contract research organization (CRO) providing full-service, Phase I-IV services to biopharma companies bringing new medicines to market, has enhanced its focus. The CRO today announced the creation of therapeutic centers of development that include some of the most progressive in the biopharma industry: oncology, especially leading edge immunotherapy studies, neuro-degenerative disorders, pediatrics, and rare and orphan disease. In addition, Synteract revealed its new market positioning with an updated logo, tagline, and website to reinforce its core capabilities. Synteract’s leadership has been proven in these core development areas, over its nearly 30-year history, through its contributions to more than 240 product approvals. Formal establishment of its new centers of development bring more visibility to Synteract’s longstanding, specialized expertise in these complex areas of clinical research. Synteract CEO Steve Powell says, “By aligning operational excel

Nel ASA: Receives Additional Purchase Order from Nikola19.4.2018 17:00Tiedote

Nel ASA (Nel, OSE: NEL) has received a USD 5.5 million purchase order from Nikola Motor Company (Nikola), as part of the previously announced hydrogen stations. “We are very proud to announce that we have received an additional order from Nikola related to the electrolyzer and fueling solution for their prototype trucks. The order marks a strengthening of our partnership and is a recognition of the level of competence our team and hydrogen solutions can offer. We look forward to supplying the demo stations, which will lay the groundwork for the world’s largest, most efficient network of low-cost hydrogen production and fueling sites,” says Jon André Løkke, Chief Executive Officer of Nel. On November 15, 2017, Nikola and Nel announced the exclusive partnership and a purchase order for two so-called demo hydrogen refueling stations for Nikola's fleet of prototype hydrogen trucks. The partnership aims at developing low-cost, renewable hydrogen production and fueling sites for the potentia

Voith and Franka Emika Form a Strategic Partnership19.4.2018 16:39Tiedote

The technology company Voith and the Munich-based robotics company Franka Emika have entered into a strategic partnership. Part of the strategic partnership is the establishment of a new joint venture called Voith Robotics – A Voith and Franka Emika Company. The company, with headquarters in Munich, is to become a global system supplier for robot-assisted automation in the digital age. Voith Robotics will offer self-teaching lightweight robots made by Franka Emika, along with software solutions, apps, services and process consulting, to customers in various industries and markets throughout the world. As part of the strategic partnership Voith will also have a direct stake in Franka Emika, thus emphasizing the long-term and strategic commitment by the two companies to cooperation. Martin Scherrer, formerly a member of the Board of Management of Voith Paper, will be the new chief executive officer of Voith Robotics, which is to be managed by Voith. The still very young market for collab

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme