Paving the way of the future | 086

Share:

Listens: 0

Biotechnology Focus Podcast

Science


086 | Paving the way of the future      Welcome to another episode of Biotechnology Focus radio! This week Toronto got their socks knocked off by an announcement from Sanofi; a Chinese company expresses interest in some of Canada’s regenerative medicine technologies; the scope of clinical trials in Canada is divulged at the recent Clinical Trials Ontario conference; and Shana Kelley and her team from the University of Toronto use new technology to essentially ‘find a needle in a haystack’ when it comes to prostate cancer. Keep listening to hear the latest news of Canada’s biotech scene!  +++++  French company Sanofi announces one of their largest investments ever in a single building and knocks the socks off the Toronto life sciences community. Sanofi announces that they are investing €350 million (C$500 million) into their Toronto facility to significantly increase capacity to meet the growing demand for pediatric and booster vaccines and demonstrate their commitment to innovation and leadership in global health.  The announcement was held at Sanofi Pasteur’s Canadian headquarters in Toronto and was joined by the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development, and the Honourable Steven Del Duca, Minister of Economic Development and Growth.  Canada has a strong legacy in the research and development of vaccines. With this investment, Sanofi is renewing their longstanding commitment to making Canada central in the effort to protect and improve human health across the globe. Vaccines save three million lives every year and this new facility will be one step closer to a world where no one suffers or dies from a vaccine-preventable disease.  The new facility will allow Sanofi Pasteur, the vaccines global business unit of Sanofi, to meet the growing demand of five-component acellular pertussis (5-acP) antigen. The building itself is expected to be completed within three to four years, a year or two to get the quality management system up and running, and a year or two to do product development and testing. The site will be equipped to produce the antigens used in the diphtheria and tetanus vaccines.  Philippe Luscan, the executive vice president of Global Industrial Affairs, Sanofi says that this project is one of the most important investments for the Sanofi global industrial network. It demonstrates the continued commitment to manufacturing excellence and to better serving their vaccines portfolio to people all over the world.  ++++++  New opportunities are arising at every turn for the regenerative medicine community. Research is at the tip of the iceberg, but a company in British Columbia isn’t waiting for the ice to melt. RepliCel, a regenerative medicine company, has been developing autologous cell therapies to treat conditions linked to the deficit of healthy cells required for normal function and healing. Their cell therapies are designed to treat chronic tendinosis, UV-damaged or aged skin, and pattern baldness as an alternative method to surgery, pills, and chemicals.  Recently, YOFOTO, one of China’s largest health and wellness companies announced its intention to invest significant financial backing into the company to market RepliCel’s tendon repair and skin rejuvenation products –  and they are not the only one – Shiseido, another giant, has been developing RepliCel’s hair regeneration technology for the Asian market.  Last year hit significant milestones for the company with production of the first fully functioning prototypes of their next generation dermal injector that is optimal for the delivery of injectables into the skin. With patents already issued in the United States and in Europe, the functioning prototypes allow RepliCel to display the applications of the device with other potential partners as they move forward at finalising the mold for the commercial-ready devices.  Last year also saw new clinical data produced on all three biologics programs – thinning hair (androgenic alopecia), aging/sun-damaged skin, and chronic tendinopathy (Achilles Tendinosis). The phase 1 clinical data demonstrated overwhelming product safety and highly encouraging signals of product efficacy to regrow hair, rejuvenate skin, and regenerate tendon tissue.  In 2013, RepliCel executed a co-development and licensing agreement with Shiseido that covered all of Asia for their hair regeneration program. Now, with the potential for another deal emerging in Greater China, we have real opportunity to leverage these partnerships to be a leader in regenerative medicine platform across Asia.  According to Brad Loncar, who recently launched a China BioPharm Index Fund, following the success of his Cancer Immunotherapy Fund, the biotechnology and pharmaceutical sectors are headed for exponential growth in the next few years and cell therapies are a significant focus in Greater China where he believes they are “ahead of the curve”.  Indeed, last month, the Chinese government unveiled its Made In China 2025 industrial plan in which it laid out a strategy for revolutionizing the Chinese biopharmaceutical industry through major investments in the sector and its supporting infrastructure.  It is a very exciting time for RepliCel as they move forward with a CE mark for their device in Europe and their potential expansion in Asia, as well as refining their US strategy for the launch of their dermal injector. With fascinating development projects in queue and continuing to look for the right opportunities, there will be substantial progress that will come from this innovative regenerative medicine company in the near future.  ++++++  It would be too easy to say that the recent CTO 2018 Clinical Trials Conference was an immense success – but it was. A sold-out event with 400 people speaks for itself. It was held in Toronto at the Sheraton Centre Hotel over two days chalked full of intrinsic speakers and panels discussing clinical research, clinical trials, and patient engagement.  The first day brought wonderful opening remarks from the Honourable Reza Moridi, Minister of Research, Innovation and Science, and was followed by Brian Goldman as the morning’s keynote speaker.  Brian Goldman is an ER physician, author and radio broadcaster of CBC’s White Coat, Black Art but chose to direct his keynote towards clinical trials in the age of disruption. Disruptive innovation has become a powerful change in health care, amongst many other industries. He defined exactly what disruptive innovation was with recent examples and its potential implications in health care – clinical trials, big data, clinical research.  To kick off the first panel was Jason Field, president and CEO of Life Sciences Ontario as a moderator of the evolving clinical research environment. The panel facilitated discussion on how to adapt to changes and how patients, health care and the economy will be impacted now and in the future.  As the day progressed there were speakers touching on future strategies, why Canada has a health care system, the misalignment of evidentiary interests and clearing the path ahead. An engrossing one-on-one interview after lunch with Francis Plummer, professor of medicine and medical microbiology from the University of Manitoba about a lesson in preparedness and how his work with the Ebola vaccine was a prime example of pre-empting what may happen, so that when and if it does, society will have a cure or at least a way to face it.  Clinical trials simply do not happen without participants, so the second panel brought patients and caregivers of patients to the stage to share their stories and experiences. They brought to life what the health care community works for and to and their advice on helping others find and join a clinical trial was instrumental.  The second day did not disappoint. Robert Bell, Minister of Health and Long-Term Care gave the opening remarks and welcomed the keynote speaker Ken Getz, director of sponsored research programs and research associate professor from the Tufts Center for the Study of Drug Development. Coincidently, he was also the keynote speaker at the very first Clinical Trials Conference that CTO put on a few years back; allowing him to describe first-hand how much it had grown and the benefits and impact this conference has on the clinical trials environment. He examined the current global operating environment for clinical research and specific areas where patient engagement practices and initiatives are being implemented.  Patient engagement with clinical trials remains a hot topic and largely uncharted territory. The first panel explored these models of patient engagement to give a voice to patient perspectives, quality of life values, and treatment experiences so that the health care system can get access to the drugs patients need sooner and create more robust trials and outcomes.  Following that, Molly Shoichet, Ontario’s first Chief Scientist was the interviewee of the day and went into detail about Canada’s research strengths, her aspirations for Ontario and Canada, and the innovation economy.  The remaining panels covered current interests such as big data in healthcare to advance opportunity and mitigate privacy risks, and how to advance ways to streamline the conduct of clinical trials and make Ontario and Canada a better place to have them executed. They engaged the audience in fruitful discussions and answered many burning questions from the listeners.  The two days compressed a wealth of knowledge, aspirations, and innovative ideas for the future of clinical trials in Ontario and Canada and left guests with an eagerness to start down that road.  +++++  Researchers at the University of Toronto have developed an innovative technology to identify which patients might not respond to standard therapy for prostate cancer before it is delivered from a “liquid biopsy”.  Prostate cancer is the most common cancer in men (excluding non-melanoma skin cancers) and third leading cause of death in Canada, according to the Canadian Cancer Society 2017 statistics. While several viable treatment options for prostate cancer exist, many men affected with prostate cancer will not respond to first-line treatments.  Shana Kelley, a professor at the University of Toronto divulges that screening for drug resistance is key to improving treatment approaches for many cancers. It is important for patients not to be on a therapy that won’t help them and it’s also important for health-care systems to avoid, whenever possible, delivering ineffective treatments.  Creating an option for a “liquid biopsy” via a blood test instead of more invasive alternatives is a step in the right direction and will save time, money, and recuperation time.  Kelley, lead investigator on the study published in Nature Chemistry, explains how her team has advanced a completely new approach using magnetic nanoparticles with DNA capture probes on their surface that can target circulating tumour cells (CTCs) in blood samples to see if the cells contain biomarkers associated with drug resistance.  The team traps the individual magnetized cells in a microfluidic device built in the lab, isolating them from all the other cells in the sample and allowing them to perform highly sensitive analysis. The cells with the highest magnetic content will also have a high messenger RNA expression for the biomarker associated with drug resistance. This means that patients with high messenger RNA expression should be considered for other therapies because they won’t respond to the first-line treatment.  Being able to access the circulating tumour cells  CTC cells is critical in the fight against cancer, as they carry information from the primary tumour that will divulge the best form of treatment for the patient. They are, however, outnumbered by a billion-to-one by normal cells in a patient’s blood making catching them a very daunting task.  In 2016, Kelley and her team published a study in Nature Nanotechnology that first introduced the microfluidic device and how it could be used to trap and analyze circulating tumour cells CTCs. The current study builds on this work by further targeting a specific biomarker within the circulating tumour cells CTCs.  The blood samples analyzed were collected from a small cohort of patients undergoing treatment for metastatic prostate cancer. In 10 of the patients tested, circulating tumour cells CTCs were visualized but only four of the patients exhibited the biomarker associated with drug resistance. This finding demonstrates that the new method can provide both a circulating tumour cells  CTC count and an analysis of the clinically relevant biomarker.  “We are very excited because this is like finding a needle in a haystack,” says Kelley. “It paves the way for a straightforward and personalized screening tool that allows clinicians to see if a patient will respond to therapy or not. Our method is also rapid, accurate and inexpensive, which gives it real potential for clinical uptake.”  Further studies need to be conducted to ensure consistent findings. Kelley and her team would also like to take this technology and expand it to other forms of cancer and disease.  ++++++  Well that’s it for another episode of Biotechnology Focus radio! To read the stories in full check out our website at biotechnologyfocus.ca. Thank you for listening and have a great week ahead! From my desk to yours – this is Michelle Currie.