Research Desk Line-up: Clovis Oncology Post Earnings Coverage
LONDON, UK / ACCESSWIRE / November 8, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) ("AVEO"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=AVEO. The biopharmaceutical Company, focused on targeted therapeutics for oncology and other areas of unmet medical needs, announced on November 06, 2017, together with EUSA Pharma, a specialty pharmaceutical Company with a focus on oncology and oncology supportive care, that they have presented promising results from the ongoing Phase-1 portion of the TiNivo study at the 16th International Kidney Cancer Symposium on November 03, 2017. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Clovis Oncology, Inc. (NASDAQ: CLVS) for due-diligence and potential coverage as the Company reported on November 01, 2017, its financial results for Q3 2017 which ended on September 30, 2017 and also provided an update on the Company's clinical development programs and regulatory outlook for the remainder of 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on Clovis Oncology when we publish it.
At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on AVEO; also brushing on CLVS. Go directly to your stock of interest and access today's free coverage at:
http://protraderdaily.com/optin/'symbol=AVEO
http://protraderdaily.com/optin/'symbol=CLVS
About Tivozanib (FOTIVDA)
- Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), specifically designed for the treatment of adult patients with advanced renal cell carcinoma. Tivozanib, which is AVEO's lead candidate, is a potent, selective, and long half-life inhibitor of all three VEGF receptors, which optimizes VEGF blockage while reducing off-target toxicities, leading to improved efficacy and minimal dose modifications.
- It was discovered by Kyowa Hakko Kirin and has been approved for treatment in the European Union, Norway, and Iceland.
- As of now, it has been investigated in several tumors types, including renal cell, colorectal, and breast cancers.
- AVEO is constantly leveraging multiple partnerships for developing and commercializing Tivozanib in oncology indications outside of North America.
TiNivo Study Design and Results
Study Design
- The TiNivo study is a Phase-1/2 multicenter trial of Tivozanib 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 Phase-1 part this trial enrolled six patients, three with previously untreated metastatic RCC, and three who had received first-line treatment. RCC tumor histology comprised five-clear cell (one with sarcomatoid features), and one papillary.
- In the Phase-1 portion of the trial, 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.
- Currently, enrollment of around 20 patients for the Phase-2 portion of the trial is ongoing.
Results
- It was found that that this combination of Tivozanib and Nivolumab was well tolerated to the full dose and schedule of single agent Tivozanib, with no dose limiting toxicities.
- The most common adverse events noted in the trial included hypertension, asthenia, and decreased appetite.
- No grade 4 adverse events were reported while two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT) although these were managed concurrently and did not lead to study discontinuation.
- The unconfirmed best response to date comprised a 67% partial response rate and a 100% disease control rate.
Oral Presentation at the 16th International Kidney Cancer Symposium
Dr. Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study presented the results for this trial at the 16th International Kidney Cancer Symposium in Miami on November 03, 2017, in an oral presentation titled "TiNivo: A Phase IB Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma".
Dr. Albiges highlighted that the combination of VEGF TKIs and PD-1s has the potential for synergistic activity against renal cell carcinoma. However, these combinations could exhibit a high rate of toxicity. But in this case, Tivozanib has some distinguishing properties that could enhance its ability to combine with checkpoint inhibitors, including highest in-class selectivity for the VEGF-Receptor (types 1, 2, and 3). This allows fewer off-target effects, and boosts the ability to lessen regulatory T cells, which in turn improves the immune activity against the tumor.
Dr. Albiges mentioned that the pivotal TIVO-1 study validated Tivozanib's favorable tolerability profile against sorafenib. Similarly, early results from the TiNivo study also confirm this tolerable combination and evidence of promising activity.
Results for Phase-2 Expected in Later Half of 2018
Michael Needle, M.D., and Chief Medical Officer at AVEO, expressed that his team is encouraged by the preliminary tolerability and activity results from the TiNivo study as it emphasizes the unique potential of Tivozanib-immunotherapy combinations.
Since these immunotherapy combinations are showing improved outcomes in patients with RCC, it is becoming extremely important to leverage the best-in-class VEGF therapies and immunotherapies to optimize efficacy and tolerability in defined populations within this disease.
Needle trusts that Tivozanib is well positioned in this evolving landscape. He shared that AVEO looks forward to presenting the Phase-2 portion of TiNivo in the first half of 2018. Besides, the Company could also initiate additional combination studies in the coming quarters.
Last Close Stock Review
At the closing bell, on Tuesday, November 07, 2017, AVEO Pharma's stock climbed 1.70%, ending the trading session at $2.99. A total volume of 2.95 million shares have exchanged hands. The Company's stock price soared 4.91% in the last three months, 394.21% in the past six months, and 424.56% in the previous twelve months. Moreover, the stock skyrocketed 453.70% since the start of the year. The stock currently has a market cap of $337.18 million.
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