On May 26, 2016 AVEO Oncology (NASDAQ:AVEO) reported that the first patient has been dosed in the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC) (Press release, AVEO, MAY 26, 2016, View Source [SID:1234512802]). Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). Schedule your 30 min Free 1stOncology Demo! The Phase 3 trial is expected to enroll approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. Top line readout of the study is currently projected for the first quarter of 2018.
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The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a first and third line indication for tivozanib in the U.S. Marketing authorization applications seeking approval of tivozanib as a treatment for first line renal cell cancer are currently pending in Europe and Russia based on applications submitted by AVEO’s partners EUSA Pharma and Pharmstandard in those respective territories.
"While significant advances have been made in the treatment of renal cancer, there remains a need for effective yet more tolerable treatments, both for single agent and combination use," said Brian Rini, M.D., Professor of Medicine at the Cleveland Clinic Lerner College of Medicine. "In past studies, tivozanib has demonstrated a unique tolerability profile among VEGF targeted therapies, owing to its high selectivity for the VEGF pathway, that have resulted in fewer dose interruptions or reductions. I am pleased to see tivozanib return to the clinic, with the goal of better understanding its single agent potential through TIVO-3, and I look forward to realizing its potential for combination use with checkpoint inhibitors in future studies."
"Launch of the pivotal TIVO-3 trial marks a vital step forward for our North American development and registration strategy for tivozanib, and is a defining moment in the turnaround story unfolding at AVEO," said Michael Bailey, president and chief executive officer of AVEO. "In less than 18 months, we have meaningfully progressed our defined clinical development and regulatory paths forward for tivozanib in the US and Europe, executed multiple partnerships to advance and de-risk our pipeline while retaining substantial North American rights to our three oncology therapeutic assets, and strengthening our balance sheet. We look forward to diligently executing on this study, and to a number of potential value creating milestones, including those that could arise from tivozanib approval decisions, in the quarters ahead."
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.
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8-K – Current report
On May 25, 2016 Medivation, Inc. (NASDAQ: MDVN) reported that it urged its stockholders to reject Sanofi’s attempt to replace the company’s entire Board of Directors with hand-picked nominees through a proposed consent solicitation, which Medivation believes is a tactic for Sanofi to facilitate its substantially inadequate and opportunistically-timed proposal to acquire Medivation (Filing, 8-K, Medivation, MAY 25, 2016, View Source [SID:1234512818]). Medivation expects to promptly file consent revocation materials with the U.S. Securities and Exchange Commission.
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On April 29, 2016, the Medivation Board unanimously rejected Sanofi’s unsolicited, non-binding proposal to purchase Medivation for $52.50 per share in cash because it substantially undervalues the company, its leading oncology franchise and its innovative, late-stage pipeline. The Medivation Board reached its conclusion about Sanofi’s proposal based on a thorough analysis of the commercial momentum and outlook of the company’s marketed product, XTANDI; its excellent pipeline of prospects; its track record of successful drug development; and its history of delivering superior returns to stockholders.
David Hung, M.D., Founder, President and Chief Executive Officer of Medivation, said, "Medivation’s experienced Board of Directors has been instrumental in overseeing a strategy that has created a leading oncology franchise, delivered consistently strong financial performance, and positioned the company for future growth through its innovative late-stage pipeline. Under the leadership of its Board of Directors, Medivation has achieved great success and rewarded its stockholders with extraordinary results, delivering total stockholder returns of more than 1,440% since 2009. In contrast, Sanofi has no duty to act in the best interests of Medivation or its stockholders. Its proposal to replace our existing directors with its own hand-picked nominees is simply a tactical maneuver to facilitate a transaction that will transfer value that rightly belongs to Medivation stockholders to Sanofi."
Kim Blickenstaff, Chairman of Medivation’s Board of Directors, said, "Sanofi is seeking to take control of our Board in a clear attempt to circumvent objective deliberations over what course of action is in the best interests of all Medivation stockholders. The unattractive economics of Sanofi’s proposal – which the Board has already determined to be substantially inadequate – have not changed. The Medivation Board remains committed to ensuring that our stockholders retain the ability to benefit from the significant value creation potential of our Company."
Evercore and J.P. Morgan are serving as financial advisors to Medivation, and Wachtell, Lipton, Rosen & Katz and Cooley LLP are acting as legal counsel.
Israeli startup HIL Applied Medical Ltd. acquires US-Based Nanolabz Inc. – en route to developing advanced cancer radiotherapy systems
On May 26, 2016 HIL Applied Medical Ltd. a Jerusalem, Israel medical technology startup reported the acquisition of Nanolabz Inc. – a Reno, Nevada company born out of University of Nevada research and focused on developing and fabricating smart targets for laser-based proton acceleration (Press release, HIL Applied Medical, MAY 25, 2016, View Source [SID:1234512815]). HIL Applied Medical is developing a new class of ultra-compact, high-performance Proton Beam Therapy systems, based on high-intensity lasers and nano-engineered smart targetry.
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"Today’s announcement is important on several levels," Mr. Sagi Brink-Danan, Chief Executive Officer of HIL, said, "The acquisition immediately doubles HIL’s patent portfolio, thus further fortifying our already-strong IP position in our field. It also adds strong, complimentary talent to our team, and provides a strong base for HIL’s US operations. We are looking forward to working together with the NanoLabz and UNR teams towards our joint goal of building the world’s first laser-based cancer proton therapy system."
NanoLabz co-founders Dr. Jesse Adams and Mr. Steven Malekos said they are thrilled to have found a great partner for NanoLabz’ technology with HIL, adding that "we are looking forward to working with HIL’s world-class, committed and capable team on translating cutting-edge technology into products that will benefit cancer patients worldwide."
Co-founder and president of Nanolabz, Mr. Grant Korgan, added: "It’s a joy to see us reach this milestone. It is a testament to hard work and the power of positivity." Mr. Korgan suffered a major spinal cord injury in 2010, and has since become a local and global inspiration, TED-lecturer and sought-after public speaker.
UNR president Dr. Marc Johnson stated that he was pleased to see this milestone, which highlights the institution’s role as an internationally respected, high-impact research university.
What is Proton Therapy: A proton beam is a form of focused radiation used to treat solid tumors. It is superior to traditional radiation therapy (X-Ray, or Photons) in that it reduces damage to surrounding healthy tissue by 2X-6X, thereby reducing toxicities and improving patient survival and quality of life. Proton therapy is used routinely for treating many types of cancer; it is FDA-cleared (510k) and reimbursed by both Federal and private insurers.
Proton Therapy’s Unmet Need: Proton beam therapy can help an estimated 300,000 cancer patients every year in the US – yet last year only 10,000 received it (that’s less than 4%). Protons are arguably the most advanced form of radiation therapy – yet there are only 19 active proton-therapy centers in the US today; compare with over 2,700 traditional (X-Ray) radiation therapy centers. The main barrier to widespread adoption is the large size (football stadium) and high cost ($150-250M) of building and operating a proton therapy center. Single-room solutions are slowly being introduced by some vendors for $30-50M. The key to making protons available to every patient in every midsize hospital is a scalable, add-on, single-room solution for half the current price tag or less. HIL’s technological breakthrough promises to bring about this revolution.
Sunesis Pharmaceuticals Announces Support of First-Ever Acute Myeloid Leukemia Awareness Month in June
On May 25, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported its support for the first-ever Acute Myeloid Leukemia Awareness Month to be held in June. The goal of the campaign, which is being sponsored by CancerCare, is to put a spotlight on the disease, a rare and difficult-to-treat blood cancer that typically affects older adults (Press release, Sunesis, MAY 25, 2016, View Source;p=RssLanding&cat=news&id=2172293 [SID:1234512773]).
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Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and can worsen quickly if left untreated. According to the National Institutes of Health, it is estimated that there will be 19,950 new cases of acute myeloid leukemia in 2016 and an estimated 10,430 people will die from the disease. AML is more common in older adults, who are also the most difficult to treat, with 67 as the median age of diagnosis. While progress in treating leukemia has been made, there has been only one AML treatment approved by the U.S. Food and Drug Administration in the past 30 years (and that drug was subsequently withdrawn from the market).
Patricia J. Goldsmith, CEO of CancerCare, said, "AML Awareness Month will feature in-depth information about AML on the organization’s website, including a video that features NBA broadcaster Craig Sager who is battling the disease, as well as his son, Craig, Jr., who donated his bone marrow twice in an effort to save his father. The website will also offer people living with AML and their caregivers easy-to-use, informative resources to understand their condition. We thank Sunesis Pharmaceuticals for their unrestricted educational grant which has helped to support the development of these resources."
"We are delighted to be supporting CancerCare’s efforts to raise awareness of acute myeloid leukemia," said Daniel Swisher, Chief Executive Officer of Sunesis. "Because it is a rare disease with an older patient population, there has been little attention focused on AML. As a company that is determined to deliver a new treatment option for this disease, we want to support the AML community by helping to provide more education and information for patients and caregivers."
Goldsmith added, "The AML community’s voice has not always been heard because the disease itself is so rare and the mortality rate is so high. We hope to put a spotlight on AML in June and help focus attention on the urgent need these patients and their families have for hope."
Patients and caregivers can find educational resources on AML online at www.cancercare.org; an unrestricted educational grant from Sunesis has helped to support the development of the informational resources on AML which also includes a patient and caregiver workshop webinar to be held on June 17.
About CancerCare
Founded in 1944, CancerCare is the leading national organization providing free, professional support services and information to help people manage the emotional, practical and financial challenges of cancer. Our comprehensive services include counseling and support groups over the phone, online and in-person, educational workshops, publications and financial and co-payment assistance. All CancerCare services are provided by oncology social workers and world-leading cancer experts. Headquartered in New York, NY, CancerCare maintains three additional locations in Norwalk, CT, Ridgewood, NJ and Syosset, NY.
Iceni Pharmaceuticals launches as new company focusing on repurposing therapies in the field of oncology
On May 25, 2016 Iceni Pharmaceuticals reported its launch as a new company, focusing on developing repurposed and reformulated cancer therapies (Press release, iceni, MAY 25, 2016, View Source [SID:1234512803]). Schedule your 30 min Free 1stOncology Demo! The company’s lead product Cilcane (generic name cilengitide) is being repurposed by Iceni as a first-in-class treatment for multiple myeloma. Iceni has demonstrated in pre-clinical studies that Cilcane is effective as a combination therapy when given with proteasome inhibitors such as bortezomib, and that this approach may also be applicable to breast and other cancers. Iceni has a broad intellectual property portfolio covering the formulation and methods of use of Cilcane. Cilengitide was formerly in late-stage clinical trials in glioblastoma with Merck Serono.
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Iceni Pharmaceuticals is planning a Phase II safety/efficacy trial of Cilcane starting in 2017 aimed at relapsed refractory patients who have already received one prior therapy of proteasome inhibitor. The Company has appointed several leading authorities on cilengitide and multiple myeloma to its scientific advisory board, including:
Annalisa Jenkins, previously Head of Global Research & Development at Merck Serono, during the time cilengitide was in development.
Dr Bruno Osterwalder, previously Senior VP (Oncology) at Merck Serono.
Gareth Morgan, MD, PhD, FRCP, FRCPath, professor of medicine and pathology and director of the Myeloma Institute for Research and Therapy at the University of Arkansas for Medical Sciences (UAMS), one of the world’s foremost myeloma treatment centres.
Dr Horst Kessler, Munich Technical University, and a named inventor of cilengitide.
Dr John March, CEO at Iceni Pharmaceuticals, commented: "We are excited by the prospect of repurposing cilengitide as a novel combination therapy for the treatment of multiple myeloma and building on its established safety profile to improve the clinical outcome and quality of life of patients. Our prestigious team of world renowned scientific advisors are testament to the belief in the product and its potential."
The company’s new corporate website is available at www.icenipharma.com