On March 21, 2018 AVEO Oncology (NASDAQ: AVEO) reported the publication of long-term follow-up results from Study 902, where patients were treated with tivozanib (FOTIVDA) as second-line treatment in advanced renal cell carcinoma (aRCC), in the European Journal of Cancer (Press release, AVEO, MAR 21, 2018, View Source;p=RssLanding&cat=news&id=2339191 [SID1234525460]). The publication, titled "Efficacy of Tivozanib Treatment after Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover of a Phase 3 Study," was published online first and is available here. Tivozanib is an oral, once-daily, potent and highly selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

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In Study 902, a total of 161 patients with aRCC received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Phase 3 TIVO-1 study. As previously reported, median progression-free survival and median overall survival were 11.0 months and 21.6 months, respectively. Overall response rate was 18% and stable disease was 52% for an overall disease control rate of 70%. Tivozanib was generally well tolerated, with adverse events consistent with those observed in previous tivozanib trials. The activity shown in TKI refractory patients compares favorably with data published for other TKI agents in a similar population.

"Publication of Study 902 underscores the activity of tivozanib in the refractory setting, with evidence of encouraging clinical responses, disease control and overall survival outcomes in patients previously treated with a VEGFR TKI," said Michael Needle, M.D., chief medical officer of AVEO. "We believe these efficacy and safety findings in refractory patients support the rationale for our ongoing Phase 3 TIVO-3 study. We anticipate that the results of the TIVO-3 study, together with the results of the previously completed TIVO-1 trial of tivozanib in the first-line treatment of aRCC, will serve as a key component for a potential regulatory approval of tivozanib in the U.S. as a first- and third-line treatment for aRCC. When completed, TIVO-3 will be among the only large randomized datasets in third-line disease, a sizable and growing treatment segment thanks to advances in earlier lines of treatment, and in patients progressing on prior immunotherapy. Based on the current rate of progression-free survival events, we expect top-line results from this study to read out in the second quarter of this year."

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 (aRCC) 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 shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy. As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

Enzon has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Enzon, 2018, MAR 21, 2018, View Source [SID1234524926]).

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On March 21, 2018 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported that Christopher K. Mirabelli, Ph.D, Chairman, President, and Chief Executive Officer, will present a corporate overview at the 2018 Needham & Company 17TH Annual Healthcare Conference, being held in New York City on March 27-28, 2018 (Press release, Leap Therapeutics, MAR 21, 2018, View Source;p=RssLanding&cat=news&id=2339079 [SID1234524920]).

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2018 Needham & Company 17TH Annual Healthcare Conference – Leap Presentation Details:
Date: Wednesday, March 28, 2018
Time: 12:15 P.M.

The presentation will be webcast live and may be accessed on the Investors page of the company’s website at www.investors.leaptx.com, where a replay of the event will also be available for a limited time.

On March 20, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that the Company submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2 (Press release, Cotinga, MAR 20, 2018, View Source [SID1234533158]). The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.

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"Based on the strength of encouraging interim data from our ongoing Phase 1 trial, as well as preclinical studies demonstrating that COTI-2 was efficacious and synergistic when administered alongside standard of care chemotherapeutics, we are excited to push forward the development of COTI-2 as part of a combination therapy regimen," said Alison Silva, President and Chief Executive Officer. "After close consultation with our academic collaborators and investigators, we submitted a substantially updated regulatory package to the FDA seeking approval to evaluate COTI-2 as a combination therapy in our ongoing trial. In addition to evaluating our lead asset as a combination therapy for gynecological malignancies and head and neck squamous cell carcinoma (HNSCC), the protocol amendment will also broaden the trial to include other solid tumors. We look forward to implementing this amendment and dosing the first patient with a combination therapy regimen in the months ahead."

Phase 1 Trial of COTI-2

The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and HNSCC. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The protocol amendment submitted by the Company in March 2018 aims to expand the ongoing Phase 1 trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. The current gynecological malignancies arm will be expanded to evaluate COTI-2 in combination with bevacizumab and paclitaxel/doxorubicin. The current dose-escalation HNSCC arm will be expanded to evaluate COTI-2 in combination with cisplatin in HNSCC and other solid tumors. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval and subject to sufficient financing, the Company expects to implement this protocol amendment for the ongoing Phase 1 trial of COTI-2 in May 2018.

On March 20, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that Paul B. Cleveland, a member of the Company’s Board of Directors, has been appointed to serve as Interim President and Chief Executive Officer, effective immediately. Mr. Cleveland will continue to serve as a director of the Company (Press release, , 20 20, 2018, View Source [SID1234524905]).

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Mr. Cleveland’s appointment follows the mutual determination by Randall C. Schatzman and the Board that now is the right time for Dr. Schatzman to step down as President, Chief Executive Officer and as a director. Dr. Schatzman has agreed to serve as a consultant to the Company for an interim period in order to help ensure a smooth transition. Alder has retained Russell Reynolds Associates, a leading executive search firm, to assist with identifying a permanent successor.

Mr. Cleveland has more than two decades of leadership experience with significant operational and financial expertise. He currently serves as the Chairman of the Board of Adverum Biotechnologies, Inc., where he previously served as the President and Chief Executive Officer. Prior to that, he was President and Chief Executive Officer of Celladon Corporation, where he previously served as that company’s Chief Financial Officer. Mr. Cleveland served as Executive Vice President, Corporate Strategy and Chief Financial Officer at Aragon Pharmaceuticals before its acquisition by Johnson & Johnson, and prior to Aragon, he was General Partner and Chief Operating Officer at Mohr Davidow Ventures and Executive Vice President, Corporate Development and Chief Financial Officer for Affymax. Mr. Cleveland was previously a Managing Director at J.P. Morgan Chase and Co. and a predecessor firm, Hambrecht & Quist, and a corporate lawyer at Cooley LLP, Sidley Austin LLP, and Davis Polk & Wardwell LLP.

"I joined the Alder Board in 2015 because of my deep appreciation of Alder’s mission to transform the treatment paradigm for migraine prevention," said Mr. Cleveland. "I look forward to leveraging my prior CEO and CFO experience in this interim role as we work to identify a permanent successor and further build out the team for the next stage of Alder’s growth and development. On behalf of the Board and the Alder team, I want to thank Randy for his immense dedication and invaluable contributions since co-founding the Company in 2004. Randy’s leadership has positioned Alder for continued growth as we advance towards the commercial launch of eptinezumab."

Dr. Schatzman said, "It has been an honor to lead Alder since co-founding the Company in 2004 and work with such a bright and passionate group of employees to change the lives of highly impacted episodic and chronic migraine patients. I am proud of all that we have accomplished at Alder during my tenure including the development of two late-stage therapeutic candidates, eptinezumab and clazakizumab, assembling a talented team of over 190 employees, the majority of which are scientists and drug developers, and positioning Alder to positively impact the lives of migraine sufferers. Now is the right time to pass the baton to the next generation of leadership. I am confident that Alder is well-placed to set a new standard for what can be achieved in migraine prevention to benefit patients and their families."

Mr. Cleveland concluded, "Alder has made tremendous progress over the last year. We achieved positive Phase 3 pivotal data for both episodic and chronic migraine patients, demonstrating that eptinezumab’s clinical profile is highly differentiated and consistently delivered predictable results for rapid, effective and sustained migraine prevention across the spectrum of migraine disease. We plan to share additional data from our PROMISE 1 and PROMISE 2 pivotal trials, and the results from our open-label safety study of eptinezumab, in the first half of this year. We also continue to expect our pharmacokinetic comparability study to be completed in the second half of 2018. In addition, through our recent IP settlement and licensing agreement with Teva, we now have a non-exclusive license to Teva’s CGRP patent portfolio, which, importantly, clarified our ability to develop, manufacture and commercialize eptinezumab in the U.S. and globally. The submission of our planned Biologics License Application (BLA) for eptinezumab is the top priority, and we continue to make progress on all key clinical data milestones, BLA and commercial preparedness activities, including our CMC and manufacturing initiatives. I look forward to reviewing these programs thoroughly in my new role and plan to provide a business update in connection with the announcement of our first quarter 2018 financial and operating results."

As of February 28, 2018, Alder had cash, cash equivalents, short-term investments and restricted cash totaling more than $600 million.