21 minute read
INNOVATOR
GettinG at the root of CanCer
One of the more interesting Canadian biotech stories of the 2013 calendar year took place back in April, when two Toronto-based companies, Stem Cell Therapeutics Corp. (SCT) and Trillium Therapeutics Inc. (Trillium), came together in a reverse merger transaction.
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It was interesting in the sense that the company undertaking the reverse takeover, Trillium, acquired all the assets of Stem Cell Therapeutics including its name.
The real value of the deal however according to the man heading up this new entity as president and CEO, Dr. Niclas Stiernholm, is that it gave Trillium access to the public markets.
“As Trillium, we were a private company that had survived for nearly a decade on venture capital investment and when that well dried up, we relied heavily on our licensing revenues,” says Stiernholm who for more than ten years was CEO of Trillium. No stranger to big transactions, one of the more famous licensing transactions involving Stiernholm and Trillium was with Genentech in 2004.
“That was big news, and represented our first real accomplishment. It put us on the map, in newspapers and on television. We worked with Genentech for about four years and over the life of the agreement generated between five and six million dollars in licensing revenues. We established similar deals with other companies. In a way it brought some validation to our science and we learned a lot from these partnerships and how to develop products successfully. The downside of course was that we sold off some of our most precious assets because we were always in survival mode.”
With a dwindling cash balance and increasing pressure from his investors, Stiernholm was left with two options to seek out new capital, one of which was to sell off another precious asset. Fortunately, that’s when SCT approached him about the possibility of the merger.
“SCT had essentially two things to offer. Firstly, they had a public listing on the TSX venture exchange, which would provide access to public fundraising. Secondly, they had a positive cash balance. They had no staff, a pipeline that was virtually nonexistent, a part-time executive chair and no facility as they had closed down everything in Calgary, AB. It wasn’t so much an asset transaction as a financial one.”
Some would call it an innovative solution to a problem that Canadian private biotech companies often face when considering the decision to go the Initial Public Offering (IPO) route. Specifically that the IPO route offers little certainty thanks to a volatile market with a shortage of available capital. “The merger was as such the best alterna-
tive.” says Stiernholm. So Trillium punched its ticket onto the public market with the deal and was provided the cash it needed to get by. The only thing that was sacrificed in the deal was the company name. This was a small price to pay for creating a larger company with a better chance to advance its early-stage products.
“The fact is, the company is still Trillium just with a different name and a different board of directors. We’re still in the same building with the same management and the same staff. And best of all, we didn’t have to sell our best product to get the deal done. This is important because I believe it’s necessary to keep your products in order to create value in a company.”
Remarkably, it’s not the first time the company has changed its name. Trillium Therapeutics was actually established in 1996 under the name Transplantation Technologies Inc. Back then it was a spin-out company from six academic institutions in Ontario. Its focus, as the name implies, was transplantation - specifically xenotransplantation, which involves transferring organs from genetically modified animals such as pigs to humans.
“Transplantation Technologies remained largely an academic exercise. It was mostly grant driven, with no real money or venture funding. The company stayed afloat, but the technology didn’t succeed. By the time 2002 rolled around, they had branched out to become more of a general immunology company, and that’s roughly the time I came on board,” says Stiernholm.
To this day the company’s focus continues to be on finding ways to manipulate the patient’s immune system to treat disease. Specifically, they are focusing on using immunotherapy to block negative pathways in malignant cells, including cancer stem cells. One such immunotherapy is the company’s lead product, SIRPαFc, the same product that Stiernholm was reluctant to sell believing it would inevitably drive value in the company.
“SIRPαFc blocks CD47, an extremely interesting and attractive target that is expressed not only on bulk cancer cells but also on cancer stem cells. CD47 is like a stop sign – it tells the immune system not to attack. Cancer cells overproduce this protein and use it to protect themselves from immunemediated destruction. Our drug binds CD47 and prevents it from delivering this suppressive signal, enabling the immune system to kill the tumour cells,” he explains.
The development of the SIRPαFc fusion protein originated from leading researchers in the field, including Drs. John Dick and Jean Wang of the University Health Network, and Dr. Jayne Danska of the Hospital for Sick Children, all of Toronto. SIRPαFc is being developed initially as a treatment for acute myeloid leukemia (AML), and has recently entered formal IND-enabling studies.
“I think we have some very interesting data showing that we are indeed blocking the CD47 stop signal and activating the immune system to do what it is capable of doing – killing tumour cells.”
According to Stiernholm, another exciting finding thus far is that it appears that blocking CD47 can be used in combination with several of the best-selling approved cancer antibodies.
“These are billion dollar products and it appears that our approach will augment their activity, providing the opportunity for combination therapy and a strong synergy- yet another positive feature of this program. We really think this is going to be the next big thing in immunotherapy and we see many potential pharmaceutical partners sharing that view,” he says.
The second product in the pipeline is also a cancer stem cell therapy. The tigecycline program was optioned from the University Health Network shortly after the merger. It is based on the work of Dr. Aaron Schimmer who discovered that tigecycline, an approved antibiotic sold by Pfizer, had strong anti-leukemic activity both on bulk cancer cells and cancer stem cells. Prior to the option agreement, it had already entered into a Phase 1 clinical trial in AML patients at four sites in North America.
“Dr. Schimmer’s research is focused on drug repurposing – finding new indications for approved therapeutics. Focusing on established drugs with known safety profiles can significantly lower the risk in the drug development process, saving time and costs.”
For this discovery, Dr. Schimmer received the 2012 Till McCulluch Prize and in 2013 won an award from the Canadian Cancer Society.
“We are really excited by this program and pleased to be working with Dr. Schimmer. He is a young, up-and-coming clinician-scientist and these awards validate the significance of his work.”
Stiernholm adds that this product demonstrates that SCT is more than just an immunotherapy company, because this product targets cancer’s metabolic pathways instead.
“It’s very different from immunotherapy, yet it is still complementary to what we do. It’s another way of getting at the tumour. Both tigecycline and SIRPαFc target the cancer stem cell. We think of cancer like a weed, with cancer stem cells forming the root. To kill a weed in the garden you need to remove the root. Likewise, to cure cancer you need to destroy the cancer stem cell ‘root’.”
The last product in the company’s pre-
clinical cancer immunotherapy pipeline is its fully human CD200-specifi c monoclonal antibody.
“The CD200 antibody is one of the foundational programs of Trillium. Recently we regained control of it when our partner was acquired by a third party. We don’t have the resources now to advance this program, so we are taking a wait and see approach.”
In addition to its preclinical portfolio, Stem Cell Therapeutics is also conducting a clinical trial with TTI-1612 in patients with interstitial cystitis, a chronic and painful bladder disease affecting a great many people, especially women.
“TTI-1612 is another Trillium legacy program which is outside of our core interests in immunotherapy and oncology. Nevertheless, it addresses a huge unmet medical need and a great market opportunity. Our strategy is to fi nd a partner to advance this program,” he says.
On the topic of the company’s core strategy going forward, Stiernholm’s aspirations are to strengthen the company’s position as a global contender in the cancer stem cell fi eld. This includes capitalizing on Canada’s world class cancer stem cell discoveries and building on the company’s existing links with Ontario’s leading cancer research organizations.
“We want to fi ll that niche by being a much needed commercial vehicle for Canada’s world class cancer stem cell discoveries. Toronto has a rich legacy of stem cell research, and there is a defi nite need for commercial receptors for the great discoveries that continue to emerge.”
He adds that immunology research is also strong in Toronto’s biomedical community, particularly at the University of Toronto, and there is a huge need for a receptor for their technologies.
“The reason I came to Toronto in the fi rst place was its reputation as an immunology leader. I truly believe that in order for a small company like ours to survive, it is essential to have a good strong relationship with academic institutions and researchers. One should never underestimate the importance of a supportive ecosystem. For us, the resources in Toronto, whether in immunology, stem cell research or oncology, are our lifeblood.”
Dr. Stiernholm is also not afraid to look elsewhere for opportunities. One example of an outside relationship that has been cultivated by SCT was its recent deal with an internationally renowned prostate cancer research group in the U.K. In this instance, SCT took an option on worldwide rights to a series of prostate cancer stem cell assets from the University of York. The assets originate from research funded by Yorkshire Cancer Research (YCR) and conducted in the YCR Cancer Research Unit, University of York, under the direction of professor Norman Maitland.
“This is a whole new area for us because we’re focused largely on leukemia and hematological malignancies. The way we structured the arrangement was that we took an exclusive option to license this technology/ intellectual property for a limited time. During this period we can do some preliminary work in our lab and make sure that we’re comfortable with the technology and that it behaves in our hands the same as it has in the inventor’s hands. That’s not a bad model, as too often people jump into big licenses and then fi nd out that perhaps it wasn’t exactly what they thought they were getting. So far, it’s turned out to be a very interesting program. We’ll just have to see where it takes us next.”
To see this story online visit http://biotechnologyfocus.ca/ getting-at-the-root-of-cancer
new card:Layout 1 1/31/2013 9:09 AM Page 1 Robert Foldes is president & CEO of Viteava Pharmaceuticals Inc. (www.viteava.com) and is a Principal Consultant at Cognovie Inc.
To see this story online visit http://biotechnologyfocus.ca/ new-approaches-to-managecancer-are-desperately-needed
Not to be confused with cancer chemoprevention or vaccines targeting generally healthy populations, cancer interception focuses on patients with an elevated risk of developing malignant cancer.
chemoprevention or vaccines targeting generally healthy populations, cancer interception focuses on patients with an elevated risk of developing malignant cancer. In most cases, pharmaceutical interventions do not exist for these patients. Moreover, existing drugs that have been approved for cancer indications have mostly failed to migrate towards the treatment of these early-stage patients, or are suboptimal, due to issues relating to efficacy, safety, and/or convenience. There’s also the risk of introducing early resistance, jeopardizing the potential for drug response if and when the disease progresses. In many ways, early stage cancer patients are ideal for pharmaceutical intervention, while innovative drugs and clinical trials targeting this population are as of yet, limited. Of course, the regulatory landscape is of critical importance to cancer drug development strategies. Traditional approval endpoints such as overall survival (OS) would render cancer interception strategies very difficult to pursue. A recent review by Michael Shea and colleagues (Clin. Cancer Res. 19: 3722-3731, 2013) revealed that 64 per cent of regular oncology drug approvals between 2002 and 2012 were approved on the basis of endpoints other than OS. Of relevance to cancer interception strategies, the FDA has previously approved cancer drugs based on improved time-to-progression (TTP) or response rate (RR).
The cancer field still requires knowledge of surrogate biomarkers that are predictive of disease progression. This would allow targeting pharmaceutical interventions to manage the surrogate biomarkers as previously accomplished with great success in other fields, such as in heart disease. The advent of drugs to suppress cholesterol synthesis, modify platelet aggregation or lower blood pressure has had a huge impact on clinical outcomes through an “interception” strategy. The cancer field is in some ways many years behind the cardiovascular field in its approach to disease management. However, the gap is starting to close.
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Pump KD Scientific’s new Allegro Peristaltic Pump System allows maintenance
free, continuous flow pumping for various fluids. The new pumping system can easily dispense in forward or reverse direction using its touch screen display. Additionally, all parameters are clearly displayed on the touch screen for easy viewing. The unit can be configured for a specific flow profile using the programmable multi-step operations available right on the pump. The Allegro System is available in three models: Allegro I uses a single channel pump head with flow rates up to 1500 ml/min; Allegro II uses a two channel pump head offering two individual flows or one combined flow up to 720 ml/min; Allegro III uses two single channel pump heads offering two individual flows or one combined flow up to 2,000 ml/min. Web: www.kdscientific.com
HPLC columns JM Science introduces a complete new line of Shiseido HPLC Columns. The CAPCELL PAK is an epochmaking HPLC column that integrates the separation performance of silica-based, polymer-coated packing material. CAPCELL PAK essentially provides columns of reversed phase partition mode, normal phase partition mode, and ion exchange mode. Web: www.jmscience.com
Anaerobic chamber Sheldon Manu-
facturing’s BactronEZ is an ideal first anaerobic chamber or replacement chamber for users looking to upgrade their existing chamber. The BactronEZ has a 13.7 cu.ft. workspace and a 300 plate capacity incubator. Bactron systems have airtight construction of stainless steel and rigid Plexiglas for unobstructed vision and integrity. The patented cuffs form a comfortable seal around the operator’s arms, permitting bare hand manipulation of plates and specimens inside the working chamber. Chamber atmosphere circulates through a condensate controller and then a catalyst which removes any trace amounts of oxygen. Specifically designed for use by smaller laboratories, it could also be economical for larger labs. Web: www.shellab.com
Balances Mettler-Toledo has introduced a new line of analytical balances. The new balances ensure a high level of process security, enhance reproducibility of weighing results and facilitate compliance with industry regulations. New technological advances, such as the StatusLight indicator, also allows users to confirm the calibration and routine testing status of balances. In addition, the StaticDetect sensor technology ensures that weighing results are not influenced by electrostatic charge, thereby guaranteeing the accuracy and reliability of weighing results and improving laboratory operational efficiency. Web: www.mt.com
Vapour pressure tester AMETEK
Petrolab Company, the distributor for Grabner Instruments, introduces Grabner’s new automatic tester for low-volatility measurements. Grabner developed the
MINIVAP VPXpert-L to automate the manual ASTM D2879 Standard Test Method for Vapor Pressure by Isoteniscope. The analyzer measures gasoline, jet fuels, solvents and chemicals as well as food, flavor and fragrance products with vastly improved precision. The analyzer is optimized for a pressure range from 0.1 to 100 kPa and shows a measuring repeatability better than 0.1 kPa. The instrument requires only 1 mL of sample per test, eliminates the need for vacuum pump and manual filling, and yields results within minutes. Web: www.petrolab.com
Sterilizer The SteriMax Smart sterilizer from WLD-TEC is ideal for all laboratories, anaerobic environments and safety cabinets.It uses specifically focused infrared light which generates an IR hotspot for sterilizing inoculating loops at a temperature of 650° to 1100°C in only 5 to 10 seconds immediately and without any preheating. The sterilizer also has adjustable sterilization and cool-down timers for two users by front panel operation, and annealing tube made of special quartz glass or optional wear-resistant ceramics. Web: www.WLD-TEC.com
Kit EMD Millipore introduces its CpGenome™ Direct Prep Bisulfite Modification Kit. This kit performs bisulfite conversion directly from cells, tissues, blood and formalin fixed paraffin embedded (FFPE) samples without DNA purification. By eliminating the need to isolate genomic DNA prior to performing bisulfite analysis, the kit provides a simple and reliable protocol for one-step bisulfite conversion. The new kit offers conversion efficiencies of more than 99.5% and only requires limited amounts of input material, working with as few as 10 cells or as low as 50 pg of DNA. It is suitable for downstream analysis by methylation specific PCR, restriction digestion, sequencing and microarray hybridization, and its in-column desulfonation allows for the recovery of DNA without additional precipitation steps, producing more consistent results. Web: www.millipore.com/catalogue/ item/17-10451
Fume hood Air Science has introduced its new Purair ECO™ line of Energy-Saving Ductless Fume Hoods. The hoods are designed for both chemical and particulate protection for a wide range of laboratory and industrial applications. The Purair ECO is available with a choice of controllers including the company’s new ECOair™ touchpad control with color display interface. An optional BACnet network interface connects all cabinet control, monitoring and alarm functions to an open-source facility monitoring system. The system is based on an industry-wide, non-proprietary ASHRAE compliant protocol for green building management.Purair ECO is available in five standard sizes from 30” wide to 69” wide.
Media dishes Sartorius Stedim Biotech (SSB) introduces Microsart @media to
complement Microsart @vance, a product line for microbiological quality control in these sectors.Microsart @media are agar media dishes for Microbial Limits Testing. They are pre-filled with various agar media types, such as Tryptic Soy Agar or R2A Agar, sterile packaged and ready-touse in combination with Microsart @filter units. The new media dishes feature an innovative patented lid that allows touchfree transfer of the filter membrane onto the media without using any tweezers. This liftable lid gives easy access to the colonies after incubation. The touch-free membrane transfer eliminates membrane manipulation and handling, thereby minimizing a major source of secondary contamination.
Web:www.airscience.com
Pipettes Denville Scientific Inc. has launched its Ultra EZpetteTM Ultra High Precision Digital Pipettors. The new Ultra EZpetteTM provides both accurate and precise liquid dispensing in a comfortable ergonomic design. The pipettes are available in the choice of pink or blue with eight different models that cover volume ranges from 0.1µL to 10mL. The ejector has a unique “clik-to-fix” system to easily adjust the tip ejection. The Ultra EZpetteTM also includes a calibration tool for easy in-lab recalibration. Web: www.denvillescientific.com Web: www.sartorius.com
Microplate reader Berthold Tech-
nologies introduces the second generation of its Multimode Microplate Reader Mithras. The Mithras2 LB943 comes with monochromator and filter technology for reading technologies including UV/VIS Absorbance, Fluorescence and FRET, and BRET and BRET². The company’s patentpending optical concept ONE-4-ALL is employed for sensitive luminescence, fluorescence and absorbance measurements – with performances as in dedicated instruments – in the Mithras² for filterbased reading. Additionally the instrument is equipped with two double monochromators with high blocking efficiency and f-number (increased transmission) for filter-less measurements of absorbance and fluorescence. For sensitivity in luminescence, a third specially selected and noise-reduced detector is engaged in the HiSens position which is used for Alpha and BRET readings as well. Web: www.Berthold.com/bio
Liquid handling The PDS-100 from Fluid Metering Inc. is a new solution for high precision, micro-volume production dispensing of fluids used in the manufacturing and assembly of medical catheters, stents, & blood tubes. The PDS-100 is a programmable fluid metering and dispens-
ing system which uses Fluid Metering’s patented CeramPump® valveless pump technology with precision, programmable drive motor control. The pump head internals are made from chemically resistant, sapphire-hard ceramics, ideal for dispensing a broad range of fluids. The PDS-100 is available in both single and dual pump head configurations. The PDS-100 can dispense from 3 uL per dispense up to 2 L/ min continuous flow at 1 per cent precision or better. Web: www.fmipump.com
november 2013
November 13-14
12th Annual Market Access Summit, Canada Venue: Toronto, ON Tel: 1-866-298-9343 Fax: 1-866-298-9344 Email: customercare@strategyinstitute.com Web: www.marketaccesscanada.ca
November 18-20
Therapeutic Area Partnerships Venue: The Hyatt Regency- Boston, MA Tel: 949-797-7147 Cell: 949-413-0072
November 20-22
Canadian Science Policy Conference (CSPC) Venue: Toronto, ON Email: lauren.ashton@sciencepolicy.ca Web: www.cspc2013.ca
November 26
Global Health Conference Venue: Toronto, ON Tel: 519-661-2111 Email: healthinnovation@ivey.ca Web: http://sites.ivey.ca/healthinnovation/
DECEMBEr 2013
December 1-6
2013 MRS Fall Meeting & Exhibit Venue: Boston, MA Tel: 724-779-3003 Fax: 724-779-8313 Email: info@mrs.org Web: www.mrs.org
December 2-4
10th Annual Canadian Renewable Fuels Summit Venue: Montréal, QC Tel: 613-594-5528 Email: a.kent@greenfuels.org Web: www.greenfuels.org/en/industryinformation/summit.aspx
December 7-10
2013 ASH Annual Meeting and Exposition Venue: New Orleans, Louisiana Web: http://www.hematology.org/Meetings/ Annual-Meeting/
December 11
LSO Annual Fall Symposium: Catalyzing Collisions & Clusters Venue: Mississauga, ON Tel: 416-426-7293 Email: admin@lifesciencesontario.ca Web: www.lifesciencesontario.ca
December 11-12
FDA/CMS Summit Venue: Washington, DC Tel: 949-797-7147 Cell: 949-413-0072
January 2014
January 6-11
Venue: Amelia Island, FL Email: wc2014@chem.usmass.edu Web: http://icpinformation.org
January 18-22
SLAS 2014 Venue: San Diego, California, United States Web: http://www.biotech.ca/en/ what- we-do/2013events.aspx
January 30
Biotransfer Venue: Toronto, ON Tel: 514-285-1922 Email: biotransfer@cnrc-nrc.gc.ca Web: www.biotransfer2014.ca
June 2014
June 23-26
Bio International Convention Venue: San Diego, CA Tel: (202) 962-6655 Web: convention.bio.org
Company & advertiser index
CoMpanY pagE WEBSItE
AeternaZentaris .......................................................................................... 10 ......................................................................................www.aezsinc.com Albert at Bay ......................................................................................................31 .................................................................................... www.albertatbay.com Angiochem .................................................................................................. 6..................................................................................www.angiochem.com Best Western Victoria Park Suites ..................................................................31 ...................................................................................www.victoriapark.com Cardiome ..................................................................................................... 9.....................................................................................www.cardiome.com City of Mississauga ...........................................................................................2 ............................................................................ www.winthehumanrace.ca CSPC 2013 ...........................................................................................................11 ............................................................................................ www.cspc2013.ca EMD Millipore.............................................................................................. 26.................................................................................... www.millipore.com Eppendorf ..........................................................................................................32 ......................................................................................... www.eppendorf.ca JM Science .................................................................................................. 26...................................................................................www.jmscience.com JSS Medical Research .................................................................................. 10.................................................................................www.jssresearch.com KD Scientific................................................................................................ 26................................................................................ www.kdscientific.com Mandel ................................................................................................................15 ............................................................................................... www.mandel.ca MedMira...................................................................................................... 10.................................................................................... www.medmira.com Merck KGaA................................................................................................. 10...............................................................................www.merckgroup.com Mettler Toledo ............................................................................................ 26.............................................................................www.mt.com/liquidator Mimetogen Pharmaceuticals ...................................................................... 6.................................................................................www.mimetogen.com OBIO......................................................................................................................7 ......................................................................................................www.obio.ca POI Business Interiors ......................................................................................29 ....................................................................................................... www.poi.ca Roche Canada ............................................................................................. 11.............................................................................. www.rochecanada.com World Stem Cell Summit 2013 ..........................................................................5 ..................................................................www.worldstemcellsummit.com
