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Triphase secures FDA orphan drug designation for Marizomib in Malignant Glioma

MI_triphaseTORONTO and SAN DIEGO (November 19, 2015) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for marizomib to treat patients with malignant glioma.

Malignant glioma is an aggressive form of brain cancer for which there is a significant unmet need in current treatments due to the disease’s poor prognosis. Triphase is evaluating marizomib, a novel and highly potent proteasome inhibitor, in combination with bevacizumab in patients with recurrent glioblastoma.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the United States.

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Triphase announces Health Canada approval to initiate Marizomib Phase 1 study in recurrent glioma patients

Triphase-logo-WebTORONTO and SAN DIEGO (September 25, 2015) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced that it has received approval from Health Canada to initiate its Phase 1 clinical study of marizomib in combination with bevacizumab (Avastin®) in patients with recurrent malignant glioma in Canada. Marizomib is a novel and highly potent proteasome inhibitor that readily penetrates the blood brain barrier. It prevents the breakdown of proteins involved in signal transduction, which inhibits tumor growth.

The study will be conducted in Canada at the Princess Margaret Hospital in Toronto and led by principal investigator Warren Mason, M.D., medical director of the Brain Tumour Centre and Kirchmann Family Chair in Neuro-oncology Research at Princess Margaret Hospital.

“Malignant gliomas are rarely curable, and the prognosis for patients with high-grade gliomas is generally poor. One of the few treatment options currently available for recurrent gliomas is bevacizumab. As a result, new treatment options are urgently needed for patients suffering from this universally fatal disease,” said Dr. Mason. “Published literature indicates that targeting the proteasome in glioma cells has shown significant anti-tumor activity. Given that marizomib is a first-in-class pan-proteasome inhibitor that is brain penetrant, I am looking forward to evaluating this combination regimen in my patients.” 

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Ontario Government, University of Toronto, and MaRS secure Johnson & Johnson Innovation, JLABS for Toronto – first JLABS Incubator outside of United States

Partners for JLABS @ Toronto include Janssen Inc., MaRS Innovation and seven of MI’s 15 member institutions

 Minister of Economic Development, Employment and Infrastructure Brad Duguid announces the arrival of JLABS @ Toronto in the MaRS Discovery District. First row, left to right: Chris Halyk, president of Janssen Inc.; Melinda Richter, head of JLABS, Johnson & Johnson; Dr. Meric Gertler, president, University of Toronto; Minister Duguid; Dr. Ilse Treuricht, CEO MaRS Discovery District; Dr. Raphael (Rafi) Hofstein, president and CEO MaRS Innovation, and Robert Urban, head of Johnson & Johnson Innovation Boston. Second row: Dr. Robert Howard, president and CEO St. Michael's Hospital; Dr. Catherine Zahn, president and CEO CAMH; Dr. Barry McLellan, president and CEO Sunnybrook Health Sciences Centre; Dr. Peter Pisters, president & CEO University Health Network; Dr. Jim Woddgett, director of research, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital; and Dr. Michael Apkon, president and CEO, The Hospital for Sick Children.

Minister of Economic Development, Employment and Infrastructure Brad Duguid announces the arrival of JLABS @ Toronto in the MaRS Discovery District. First row, left to right: Chris Halyk, president of Janssen Inc.; Melinda Richter, head of JLABS, Johnson & Johnson; Dr. Meric Gertler, president, University of Toronto; Minister Duguid; Dr. Ilse Treuricht, CEO MaRS Discovery District; Dr. Raphael (Rafi) Hofstein, president and CEO MaRS Innovation, and Robert Urban, head of Johnson & Johnson Innovation Boston. Second row: Dr. Robert Howard, president and CEO St. Michael’s Hospital; Dr. Catherine Zahn, president and CEO CAMH; Dr. Barry McLellan, president and CEO Sunnybrook Health Sciences Centre; Dr. Peter Pisters, president & CEO University Health Network; Dr. Jim Woddgett, director of research, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital; and Dr. Michael Apkon, president and CEO, The Hospital for Sick Children.

 

TORONTO, Sept. 8, 2015 — The Ontario Government, University of Toronto, and MaRS Discovery District (MaRS) today announced a collaboration with Janssen Inc. to launch the successful Johnson & Johnson Innovation, JLABS incubator model in Toronto.

This announcement has been covered in the Toronto Star, Metro News Canada, Sing Tao Daily, OurWindsor.ca, FierceBiotech, BioCentury, MedCity News, BioSpace, Biotechnology Focus, Lab Product News, ChinaNews.com, Pan European Networks, Economic Development Blog, BetaKit, Torontoist, and TechVibes.

It was also featured news on Rx&D‘s and Life Sciences Ontario‘s websites.

The new facility, called JLABS @ Toronto, will open in spring of 2016 at MaRS Discovery District and will support start-ups with lab space, programs, and potential investment partners as they work to build important, successful early-stage companies.

“The arrival of the Johnson & Johnson Innovation, JLABS model to MaRS’ West Tower reinforces Ontario’s position as one of the world’s leading life sciences clusters,” said Brad Duguid, Minister of Economic Development, Employment and Infrastructure. “JLABS @ Toronto will support researchers and entrepreneurs across the province and accelerate the development of Ontario companies while connecting Toronto to potential Johnson & Johnson collaborators and investors.”

“Research and innovation are fundamental to the mission of the University of Toronto,” said Dr. Meric S. Gertler, President, University of Toronto. “We host a vibrant entrepreneurial ecosystem featuring nine campus-led accelerators under the umbrella of our Banting & Best Centre for Innovation and Entrepreneurship. The addition of JLABS to this ecosystem will further propel the creation of new companies and new jobs, and ultimately new healthcare solutions that will benefit individuals and our society for years to come.”

“Toronto is home to a vibrant and prolific healthcare and life sciences community led by academic hospitals, world-class research institutions, top scientists, and a strong start-up ecosystem. For these reasons, Toronto is a natural choice for our first international expansion of JLABS,” said Melinda Richter, Head of JLABS. “The Johnson & Johnson Family of Companies has long been active within the Toronto Ontario community, forming many important collaborations. Today we are pleased to begin an even deeper relationship with this important community. Our new location, within a University of Toronto site, close to our hospital collaborators, and neighbouring the financial centre of Canada, will deliver great opportunities and impact for emerging biomedical technology entrepreneurs.”

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MaRS Innovation featured in International Innovation magazine

International Innovation feature on MIMaRS Innovation and its member institutions are is profiled in International Innovation‘s July issue (#191) in a feature interview with Dr. Rafi Hofstein, MI’s president and CEO, written by Rosemary Peters.

The article is posted on the publication’s website and viewable through a digital interface (pages 80 and 81).

Here’s an excerpt from Dr. Hofstein’s comments:

“Canada’s academic research community is internationally highly competitive, but it has been argued that its scientific commercial success tags behind other countries such as the U.S. and the U.K. While this remains a matter of debate, I do agree that we need to continually encourage additional sources of seed capital to join is so as to allow for accelerated advancement of early-stage technologies. Industry needs to become much more engaged in advancing early-stage (and promising!) technologies emerging from the academic sector, which are usually young and in significant attention, navigation, management expertise and seed capital provisions. These are areas of rising importance in Canada, as many innovations fall into the ‘valley of death’ due to a lack of proper funding, or they leave the country and flourish in the U.S. where funding is more abundant.

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Triphase Accelerator Corporation initiates phase I study of marizomib and bevacizumab in patients with Glioblastoma

Triphase-logo-WebTORONTO and SAN DIEGO, (April 22, 2015) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase II proof-of-concept, today announced that it has initiated a Phase I proof-of-concept clinical study of marizomib. The study is evaluating an intravenous (IV) formulation of marizomib, a novel and highly potent proteasome inhibitor, in combination with bevacizumab (Avastin®) in patients with glioblastoma, the most common and aggressive malignant primary brain tumor.

The study is recruiting and enrolling patients at the UC Irvine Health Comprehensive Brain Tumor Program at the University of California, Irvine, with Daniela Bota, M.D., Ph.D., and at The Preston Robert Tisch Brain Tumor Center at Duke University Hospital with Annick Desjardin, M.D.

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