$10M awarded to IRIC for the development of new cancer-fighting drugs and immunotherapies

MONTREAL, June 4, 2019 /CNW Telbec/ - The Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal (UdeM) has been awarded a 10-million dollar grant from the government of Quebec's Fonds d'accélération des collaborations en santé (FACS), to develop new cancer-fighting drugs in collaboration with biopharmaceutical company Bristol-Myers Squibb and collaborators from seven academic research centres from Quebec and abroad. This major announcement was made today by Mr. Pierre Fitzgibbon, Minister of Economy and Innovation, on the occasion of the opening of the Quebec Pavilion at the BIO International Convention, held in Philadelphia June 3-6, 2019.

Financial support that provides hope 

Entrusted with transforming, whenever possible, academic research into therapeutic solutions that will benefit patients, IRIC has joined with industry partners to pursue, over the next four years, a series of projects aimed at turning research efforts into therapeutic solutions that are accessible to patients. The program developed with Bristol-Myers Squibb is built on a portfolio of four oncology and cardiovascular disease projects based on innovative drug discovery concepts. They include developing drugs to reduce the side effects of treatments, using the immune system to vanquish cancer and the advancement of precision therapy to increase the effectiveness of the treatments offered. 

"This great news once again confirms IRIC's vision and the relevance of our drug development model. It is recognition of the results stemming from the cutting-edge discoveries, technologies, and know-how of our institute's Investigators. It also perfectly illustrates the key role that fundamental research plays in making therapeutic solutions accessible for the benefit of patients", said Michel Bouvier, Project Director, CEO and Principal Investigator at IRIC. 

By presenting cancer, immunotherapy and drug discovery research projects in collaboration with the biopharmaceutical community and seven Quebec academic research centres, IRIC fully met the objectives set by the FACS aimed at fostering collaborations between the players involved in the life sciences ecosystem. Among them, Michel Bouvier, Anne Marinier, Dr. Guy Sauvageau, Sylvain Meloche, Investigators at IRIC, Dr. Marc Bilodeau, Investigator at the CRCHUM, Dr. Frédéric Barabé, Investigator at the Centre de recherche du CHUL, Yoshua Bengio, founder of MILA, Dr. Nada Jabado, Investigator at the McGill University Health Centre, Morag Park,  Investigator at the Rosalind and Morris Goodman Cancer Research Centre of McGill University  and Richard Leduc, Investigator at the Centre de recherche du CHUS.

Through this initiative, the government of Quebec is banking on their individual strengths to bolster research excellence and ensure the international acclaim of Quebec as an innovative province in the field of life sciences. 

"Implementing a program of collaboration between the public and private sector creates synergies that the health sector, and later the patients, will benefit from. We are delighted about this initiative", pointed out Robert Tessier, Chairman of the Board of the Caisse de dépôt et placement du Québec and Chairman of the Board, IRIC.

"It gives me great pleasure to underline this invaluable support that will enhance the excellence of the Quebec research network and that commends the efforts made on a daily basis by IRIC to find solutions to the scourge that now affects one in two Canadians", said Marie-Josée Hébert, Vice-Rector of Research, Discovery, Creation and Innovation at the Université de Montréal.

Through the Fonds d'accélération des collaborations en santé, the government of Quebec is making a long-term investment and reasserting its eagerness to support the cycle from academic research  to drug discovery. It also underscores its desire to highlight research infrastructures and thereby guarantee the efficacy of the healthcare system and maximize the economic spinoffs for Quebec and the field of health sciences. 

About the Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal

An ultra-modern research hub and training centre located in the heart of the Université de Montréal, the Institute for Research in Immunology and Cancer of the Université de Montréal was created in 2003 to shed light on the mechanisms of cancer and discover new, more effective therapies to counter this disease. The IRIC operates according to a model that is unique in Canada. Its innovative approach to research has already led to discoveries that will, over the coming years, have a significant impact on the fight against cancer. For more information: iric.ca

Consult our virtual press kit: https://www.iric.ca/overview/#MN-00  

SOURCE Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal

Spectrum Therapeutics provides update on its global clinical research program and unveils pharmacovigilance program

SMITHS FALLS, ON, June 5, 2019 /CNW/ - Spectrum Therapeutics ("Spectrum"), the medical division of Canopy Growth Corporation (TSX: WEED) (NYSE: CGC) (the "Company" or "Canopy Growth") is pleased to share an update on its efforts to develop and commercialize validated cannabis medicines through clinical trials. Demand for cannabinoid-based medicines is emerging around the world. With a highly experienced scientific team and the resources needed to conduct robust clinical trials, Spectrum Therapeutics is pursuing research to introduce products for the therapeutic areas of pain, mood and sleep and to gain access to new markets independent of medical cannabis laws.

CLINICAL RESEARCH
Spectrum Therapeutics is focused over the next 24 months to further the science of cannabinoids and provide evidence by way of clinical trials on what conditions medical cannabis can treat. This research includes product design and ingredient selection, formulation, and safety and efficacy testing towards the development of standardized cannabis drug formulations and dose delivery systems. Research activity is occurring in two main areas: registration trials and exploratory studies.  

Registration trials begin with phase I studies of cannabinoid products covering a spectrum of proprietary THC and CBD ratios. These initial trials provide critical dosing and safety data to inform subsequent phase II trials. Spectrum Therapeutics is pleased to announce that two phase I trials have already been completed, one each in Canada and Chile. 

Exploratory "proof of concept" studies use a range of Spectrum products and design methodologies to explore different dose responses, and safety and efficacy signals for target conditions. Those that show promising results will be added to the registration trial pipeline and their initial findings will allow for optimal phase II trial design. The first proof of concept phase IIb "in human" clinical trial previously announced by the Company, to evaluate the use of medical cannabis for treating insomnia, is in progress in partnership with Drs. Julie Carrier and Alex Desautels at the Université de Montréal. It is expected to be completed by calendar Q2 2020 with results announced by calendar Q3 2020.

Other proof of concept studies are currently underway in partnership with researchers including Dr. Bernard Le Foll at the Centre for Addiction and Mental Health, Dr. Mary-Ann Fitzcharles at McGill University, and Dr. Angela Genge at the Montreal Neurological Institute. Over twenty conditions are being examined across these studies, including pain, sleep, and mood/anxiety disorders. Spectrum Therapeutics is also exploring areas such as neurodegenerative disorders in addition to the previously announced research partnership with NEEKA Health Canada and the NHL Alumni Association which is examining the efficacy of CBD-based therapies as part of a treatment for concussion symptoms. This clinical trial is expected to register its first patients by October 2019 with preliminary results by July 2020. 

Recently acquired C³ Cannabinoid Compound Company ("C³") is currently progressing a clinical trial for the use of dronabinol to treat spasticity due to multiple sclerosis. Additionally, research on the potential of medical cannabis to treat cancer-related pain is also in the works with Beckley Canopy Therapeutics, a partnership established between U.K. drug research institute, The Beckley Foundation and Canopy Growth. Patient registrations for this trial are expected in September 2019. 

To support its research program, Spectrum Therapeutics is pleased to announce the appointment of Dr. Marcel Bonn-Miller as Global Clinical Scientific Director. He brings to the team 18 years of experience researching cannabinoids and their various effects, has received funding for 27 research grants, and has led or contributed to 19 clinical trials. His work has been featured in 139 academic publications and 161 conference presentations, and he also serves on the editorial boards of five academic journals. Dr. Bonn-Miller previously worked as Director of Cannabinoid Research for Zynerba Pharmaceuticals, a leading transdermal cannabinoid pharmaceutical company. He is also an adjunct Assistant Professor at the University of Pennsylvania Perelman School of Medicine, known for his work examining the potential of cannabis in treating post-traumatic stress disorder. 

Dr. Bonn-Miller will be supported by Hunter Land and Drs. Ryan Lanier and Erica Peters as Associate Directors. Land was instrumental in bringing the first cannabis-derived CBD medicine developed for patients with treatment-resistant forms of epilepsy, including Dravet and Lennox-Gastaut syndromes, to FDA approval. Dr. Peters was the lead clinical cannabis scientist for four years at Battelle, the world's largest non-profit research and development organization, and Dr. Lanier worked for Analgesic Solutions where he consulted on the development of pain medications for FDA approval. 

PHARMACOVIGILANCE

In the interest of patient safety and good clinical practice, Spectrum Therapeutics is pleased to announce the implementation of a unique global pharmacovigilance program to capture and document adverse events reported from the worldwide use of its medical cannabis products in addition to the Company's Canadian recreational cannabis brands including Tweed and DNA Genetics, and its CBD product offerings.  

Pharmacovigilance, also known as drug safety, is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects from the use of pharmaceutical products. While Spectrum Therapeutics and Canopy Growth were already reporting any adverse reactions to its cannabis products as per Health Canada regulations, the launch of this global pharmacovigilance program ensures that all employees are trained on how to identify and report adverse events. The Company's internal Pharmacovigilance team is responsible for analyzing and entering events into a global safety database compliant with regional regulatory requirements. 

A global independent safety monitoring board chaired by Professor Yola Moride at the Université de Montréal will periodically review adverse event summaries and advise the Spectrum Therapeutics scientific team regarding product safety and clinical trial design. 

"We believe that this strategic approach to global clinical research, in collaboration with outstanding investigators and institutions, and supported by our first-rate team of scientists, will generate innovative products for a number of indications with significant unmet needs," commented Dr. Mark Ware, Chief Medical Officer, Canopy Growth. "We are also pleased to announce the launch of our global pharmacovigilance program whereby every one of our 3000+ staff worldwide are trained in reporting adverse events. It's an important step towards establishing drug safety and will advance our efforts to provide patients with accepted, clinically validated cannabis medicines while transparently demonstrating the relative risks of cannabis."

Here's to (Clinically Validated) Future Growth.

About Canopy Growth Corporation
Canopy Growth (TSX:WEED, NYSE:CGC) is a world-leading diversified cannabis, hemp and cannabis device company, offering distinct brands and curated cannabis varieties in dried, oil and Softgel capsule forms, as well as medical devices through the Company's subsidiary, Storz & Bickel GMbH & Co. KG. From product and process innovation to market execution, Canopy Growth is driven by a passion for leadership and a commitment to building a world-class cannabis company one product, site and country at a time. The Company has operations in over a dozen countries across five continents.

The Company's medical division, Spectrum Therapeutics is proudly dedicated to educating healthcare practitioners, conducting robust clinical research, and furthering the public's understanding of cannabis, and has devoted millions of dollars toward cutting edge, commercializable research and IP development. Spectrum Therapeutics sells a range of full-spectrum products using its colour-coded classification Spectrum system as well as single cannabinoid Dronabinol under the brand Bionorica Ethics.

The Company operates retail stores across Canada under its award-winning Tweed and Tokyo Smoke banners. Tweed is a globally recognized cannabis brand which has built a large and loyal following by focusing on quality products and meaningful customer relationships.

From our historic public listing on the Toronto Stock Exchange and New York Stock Exchange to our continued international expansion, pride in advancing shareholder value through leadership is engrained in all we do at Canopy Growth. Canopy Growth has established partnerships with leading sector names including cannabis icons Snoop Dogg and Seth Rogen, breeding legends DNA Genetics and Green House Seeds, and Fortune 500 alcohol leader Constellation Brands, to name but a few. Canopy Growth operates ten licensed cannabis production sites with over 4.4 million square feet of production capacity, including over one million square feet of GMP certified production space. For more information visit www.canopygrowth.com

Notice Regarding Forward Looking Statements
This news release contains "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Canopy Growth or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. Examples of such statements include "expected to be completed by Q2 2020 with results announced by Q3 2020", and "those that show promising results will be added to the registration trial pipeline". Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including clinical trial results, product supply, and such risks contained in the Company's annual information form dated June 27, 2018 and filed with Canadian securities regulators available on the Company's issuer profile on SEDAR at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking information or forward-looking statements in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information and forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities laws.

SOURCE Spectrum Therapeutics

Amgen Highlights the Versatility of the BiTE® Immuno-Oncology Platform in Multiple Tumour Types at ASCO 2019

Updated Phase 1 Data of Investigational AMG 420 in Relapsed and/or Refractory Multiple Myeloma Highlighted in Oral Presentation and Accepted for Best of ASCO^®

Investigational AMG 212 (Pasotuxizumab) Phase 1 Study Explores Use of BiTE Platform in a Solid Tumour

MISSISSAUGA, ON, June 5, 2019 /CNW/ - Amgen (NASDAQ:AMGN) today announced new data from Phase 1 studies evaluating investigational bispecific T cell engager (BiTE^®) molecules were presented at the 55^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Data presented included updated investigational AMG 420 results in patients with relapsed and/or refractory multiple myeloma (R/R MM), as well as initial results from the investigational AMG 212 (pasotuxizumab) first-in-human trial in patients with metastatic castration-resistant prostate cancer (mCRPC). BiTE technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to a tumour-specific antigen, activating the cytotoxic potential of T cells. Both products are investigational only and are not currently approved in any country.

"Our BiTE immuno-oncology platform offers unique versatility, with the potential to treat various tumours through targeting tumour-associated antigens," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "As a leader in the development of targeted immuno-oncology therapies, we continue to investigate and advance more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumours. These data at the ASCO Annual Meeting reinforce the potential of BiTE technology for difficult-to-treat cancers like multiple myeloma and prostate cancer."

ASCO Annual Meeting Abstract #8007: Evaluation of AMG 420, An Anti-BCMA Bispecific T Cell Engager (BiTE) Immunotherapy, In R/R Multiple Myeloma (MM) Patients: Updated Results of a First-in-Human (FIH) Phase 1 Dose-Escalation Study

Updated results from a Phase 1, first-in-human dose-escalation trial of investigational AMG 420, a B-cell maturation antigen (BCMA)-targeting BiTE molecule, in patients with R/R MM were shared during an oral presentation at the ASCO Annual Meeting. This abstract was also selected for inclusion in the Best of ASCO^® educational program. The objectives of the study included assessment of the safety, tolerability and anti-tumour activity of AMG 420 per International Myeloma Working Group 2006 Uniform Response Criteria for Multiple Myeloma. In the study, 42 patients with R/R MM who had progression after at least two prior lines of treatment (including a proteasome inhibitor and an immunomodulatory drug) received AMG 420 at varying doses [0.2 to 800 µg/day (d)]. Of the doses tested in this study, 400 µg/d was the maximum tolerated dose (MTD). 

As of the latest readout, AMG 420 induced clinical responses in 13 of 42 patients across the dosing cohorts. Of the six patients that achieved a minimal residual disease (MRD)-negative complete response (CR), five were treated at the 400 µg/d dose. In addition, at the 400 µg/d dose, one patient achieved a very good partial response, and one achieved a partial response. The overall response rate at 400 µg/d was 70 per cent (7/10). The median duration of response was nine months (range 5.8-13.6 months). Median time to response was one month, with 11 of 13 patients responding in the first cycle. 

Serious adverse events (AEs) were reported in 19 patients (45 percent). Sixteen required hospitalization and four had prolonged hospitalization. No grade 3 or 4 central nervous system toxicities were observed. Serious AEs occurring in more than one patient included infections (n=13) and peripheral polyneuropathy (n=2). Treatment-related serious AEs included polyneuropathy (n=2, both grade 3) and edema (n=1, grade 3). Grade 3 cytokine release syndrome (CRS) was seen in one patient. Two patients died during the study from AEs not considered treatment-related. One patient died from acute respiratory distress due to concurrent flu and aspergillosis. The second patient died from liver failure secondary to a viral infection during the course of treatment.

ASCO 2019 Abstract #5034: Phase 1 Study of Pasotuxizumab (BAY 2010112), a PSMA-targeting BiTE (Bispecific T Cell Engager) Immunotherapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Initial results from a Phase 1 dose-escalation study of investigational AMG 212 (pasotuxizumab, formerly known as BAY 2010112), in patients with mCRPC who are refractory to standard therapy were presented in a poster at the ASCO Annual Meeting. AMG 212 is an investigational BiTE molecule which is designed to target prostate-specific membrane antigen (PSMA), a promising target in mCRPC. In the trial, 16 patients with mCRPC were enrolled into five dosing cohorts, with a target dose range of 5 to 80 µg/d delivered by continuous intravenous infusion. The primary objective was to determine safety and MTD and secondary objectives included pharmacokinetics (PK), biomarkers and tumour response. Antitumour activity as indicated by decline in serum level of prostate-specific antigen (PSA) was dose dependent. PSA decreases of ≥ 50 percent occurred in three patients (n=1 each in 20 µg/d, 40 µg/d and 80 µg/d cohorts). One long-term responder was treated for 14 months (40 µg/d) and one for 19.4 months (80 µg/d). The latter patient showed a complete regression of soft-tissue metastases and regression of bone metastases, as well as an improvement in disease-related symptoms. Recruitment in the trial was stopped before MTD was reached to facilitate initiation of a new study sponsored by Amgen.

"Metastatic castrate-resistant prostate cancer is considered a heterogenous disease and despite advances made over the last few years, the majority of patients face a poor outlook¹," said Horst-Dieter Hummel, M.D., University Hospital of Wuerzburg, Germany, and AMG 212 clinical study investigator. "In the first clinical study investigating the potential of a BiTE molecule in solid tumours, AMG 212 showed clinical activity, including two long-term responders. We look forward to studying AMG 212 further in this patient population."

The most common drug-related AEs were fever (94 percent, n=15) and chills (69 percent, n=11). A drug-related serious AE (fatigue) was reported in one patient. CRS was reported for three patients (19 percent); two were grade 2 and one was grade 3. No grade 5 AEs occurred.

Additional Updates on Amgen's BiTE Immuno-Oncology Platform at ASCO 2019

Amgen continues to investigate the BiTE immuno-oncology platform across a broad range of solid and hematologic malignancies. Amgen is investigating more than a dozen BiTE molecules across a range of solid and hematologic malignancies, with an additional two trials-in-progress being presented at the ASCO Annual Meeting. 

During poster sessions, researchers shared information on the studies of AMG 596, an investigational BiTE molecule targeting epidermal growth factor receptor variant III (EGFRvIII) in glioblastoma (GBM), and AMG 757, an investigational BiTE molecule targeting delta-like ligand 3 (DLL3) in small-cell lung cancer (SCLC). GBM and SCLC are both aggressive and difficult-to-treat forms of cancer where there is a significant unmet medical need for patients.

Forty-three percent of GBM tumours test positive for amplification or mutation of the EGFR, the most common of which is the EGFRvIII gain-of-function mutation.² A Phase 1, first-in-human, open-label, sequential dose-escalation and dose-expansion study is ongoing for investigational AMG 596, evaluating its safety, tolerability, and PK and pharmacodynamics in patients with EGFRvIII-postive glioblastoma. The study is expected to enroll 82 patients in two groups: one with recurrent GBM and a second in newly diagnosed patients in the maintenance treatment phase following standard of care treatment.

DLL3 is an inhibitory ligand of notch receptors that is expressed in most SCLC tumours but minimally expressed in normal tissues.³ An ongoing open-label, ascending, multiple-dose, Phase 1 study is evaluating investigational AMG 757 in adult patients with SCLC which has progressed or recurred after at least one platinum-based chemotherapy regimen. Primary objectives are to evaluate safety and tolerability and to determine the MTD or recommended Phase 2 dose. Secondary objectives are to characterize PK and evaluate preliminary anti-tumour activity.

For more information on these and other ongoing clincial trials, visit www.AmgenTrials.com.

About BiTE^® Technology

BiTE^® (Bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to any tumour-specific antigen, activating the cytotoxic potential of T cells with the goal of eliminating detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumour types through tumour-specific antigens. The BiTE platform has the goal of off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of solid and hematologic malignancies, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

About Amgen Canada

As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen Inc., including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project.  Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. 

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

SOURCE Amgen Canada

Amgen Announces First Clinical Data Evaluating Investigational KRAS(G12C) inhibitor AMG 510 at ASCO 2019

AMG 510 is the First KRAS^G12C Inhibitor to Reach Clinical Stage After Three Decades of RAS Research

First-In-Human Results Show Preliminary Data and Anti-Tumour Activity 
in KRAS Mutant Solid Tumours

MISSISSAUGA, ON, June 5, 2019 /CNW/ - Amgen (NASDAQ: AMGN) today announced the first clinical results from a Phase 1 study evaluating investigational AMG 510, the first KRAS^G12C inhibitor to reach the clinical stage. In the trial, there were no dose-limiting toxicities at tested dose levels. AMG 510 showed anti-tumour activity when administered as a monotherapy in patients with locally-advanced or metastatic KRAS^G12C mutant solid tumours. These data were presented during an oral session at the 55^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

"KRAS has been a target of active exploration in cancer research since it was identified as one of the first oncogenes more than 30 years ago, but it remained undruggable due to a lack of traditional small molecule binding pockets on the protein. AMG 510 seeks to crack the KRAS code by exploiting a previously hidden groove on the protein surface," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "By irreversibly binding to cysteine 12 on the mutated KRAS protein, AMG 510 is designed to lock it into an inactive state. With high selectivity for KRAS^G12C, we believe investigational AMG 510 has potential as both a monotherapy and in combination with other targeted and immune therapies."

The Phase 1, first-in-human, open-label multicenter study enrolled 35 patients with various tumour types (14 non-small cell lung cancer [NSCLC], 19 colorectal cancer [CRC] and two other). Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumour type and stage of disease. The primary endpoint is safety, and key secondary endpoints include pharmacokinetics, objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts - 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day. 

Five out of 10 evaluable patients with NSCLC experienced a partial response (PR), and another four had stable disease (SD), for a disease control rate (DCR) of 90 per cent (9/10).¹ All five patients with response to therapy had a treatment duration of 7.3-27.4 weeks at data cutoff and remain active on treatment. One patient with PR improved further to a complete response of the target lesions at week 18, post data cutoff.

In addition, 13 of 18 evaluable patients with CRC achieved SD, with the majority of CRC patients treated at the first two dose levels. Twenty-six patients remain on study and nine have discontinued.

Treatment-related adverse events (AEs) were primarily grade 1 events (approximately 68 per cent). Two grade 3 treatment-related AEs were reported (anemia and diarrhea). No grade 4 treatment-related AEs and no serious treatment-related AEs were reported. Enrollment into dose expansion is underway.

"While there's been significant progress in treating solid tumour cancers overall with targeted therapies, patients with the KRAS^G12C mutation have not benefited from these advances," said Marwan G. Fakih, M.D., clinical study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, Calif. "In this early Phase 1 trial, investigational AMG 510 showed anti-tumour activity. We look forward to further investigating AMG 510 with the goal of closing the treatment gap for patients with this type of mutation."

About KRAS

The subject of more than three decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.^2,3 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumours.³ A specific mutation known as KRAS^G12C accounts for approximately 13 per cent of non-small cell lung cancers, three to five per cent of colorectal cancers and one to two per cent of numerous other solid tumours.⁴ Amgen is exploring the potential of KRAS^G12C inhibition across a broad variety of tumour types.

About Amgen Canada

As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen Inc., including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. 

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by Health Canada, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

References

SOURCE Amgen Canada

Finalists announced in competition that will recognize top innovators in Canada's technology and aging sector

Events will showcase innovative solutions to support healthy aging  

TORONTO, June 5, 2019 /CNW/ - Fifteen Canadian startups have been selected to compete in the AGE-WELL National Impact Challenge: Startup Edition, it was announced today.

The competition is for startups whose technologies or services can improve quality of life for older adults or their caregivers. Finalists will be challenged to explain how their technology-based solution can positively impact older Canadians and/or caregivers. 

Five finalists will compete in each of three regional pitch events held in Montreal, Vancouver and Toronto. The winner of each regional competition will receive $15,000 in cash plus in-kind prizes. 

Finalists competing in Montreal (June 13): 

HomeEXCEPT
Soft Biomed
Tenera
Urban Farms Organic
Walk-Well Universe

Finalists competing in Vancouver (July 16): 

AltumView Systems
Luxsonic Technologies
StrongerU Senior Fitness
Tochtech Technologies
True Angle Medical Technologies

Finalists competing in Toronto (July 25): 

BISEP
Cosm Medical
iMerciv
Just Vertical
LPM on the Brain

Read more about the finalists here.

To register to attend an event, please visit the competition main page. 

"We're thrilled to be hosting this competition that will recognize top startups in Canada's technology and aging sector, and support entrepreneurship," says Dr. Alex Mihailidis, Scientific Co-Director and CEO of the AGE-WELL Network of Centres of Excellence.

"AGE-WELL thanks all the startups who submitted applications and congratulates the finalists. We can't wait to see which ones emerge as winners and to welcome them to our network where their innovations will be nurtured in order to have the greatest impact possible."

AGE-WELL, Canada's Technology and Aging Network, brings together researchers, older adults, caregivers, partner organizations and future leaders to accelerate the delivery of technology-based solutions that make a meaningful difference in the lives of Canadians. 

"As Canada's aging population grows, AGE-WELL is connecting inventive minds to work together to deliver real-world solutions to support seniors and caregivers―and to build Canada's capacity as a global leader in technologies for healthy aging," says Dr. Mihailidis.

Finalists in the AGE-WELL National Impact Challenge: Startup Edition were selected by a panel drawn from AGE-WELL's business development team, Core Facility in Entrepreneurship and Older Adult and Caregiver Advisory Committee.

Sponsors of the competition are: CARP, Fasken, Hacking Health, The Impact Centre at the University of Toronto, MEDTEQ, Ontario Brain Institute, and YouAreUNLTD. 

About AGE-WELL:

AGE-WELL NCE Inc. (https://www.agewell-nce.ca/, @AGEWELL_NCE) is a pan-Canadian network that brings together researchers, older adults, caregivers, partner organizations and future leaders to accelerate the delivery of technology-based solutions that make a meaningful difference in the lives of Canadians. AGE-WELL researchers are producing technologies, services, policies and practices that improve quality of life for older adults and caregivers, and generate social and economic benefits for Canada. AGE-WELL is funded through the federal Networks of Centres of Excellence program.

SOURCE AGE-WELL Network of Centres of Excellence (NCE)

For further information:

Margaret Polanyi, Senior Communications Manager, AGE-WELL: margaret@agewell-nce.ca 416-597-3422, ext. 7710

Ontario Sets New Record for Organ Donors in April

TORONTO, June 5, 2019 /CNW/ - Today, Trillium Gift of Life Network announced a record high number of organ donors during BeADonor Month in April 2019. Thirty-seven generous donors and their families gave the gift of life – more than any previous BeADonor Month, and the third highest number in a single month in Ontario's history.

"This new record reflects our power to save lives when we rally together to raise the decibel on registering for organ and tissue donation," says Ronnie Gavsie, President and CEO, Trillium Gift of Life Network. "But we must continue to work together year-round to accentuate the importance of registering. Today 1,600 of our own family members, friends and colleagues are waiting for a medically urgent life-saving transplant. Their lives are depending on us." 

During BeADonor Month, the number of families giving their consent for donation grew from the previous month, contributing to the record number of organ donors in April. "When Ontarians register and speak to their families about their wish to donate, they relieve their family of the burden of making a decision. Families respect and honour their loved one's wishes if the opportunity to donate arises," says Gavsie.

Trillium Gift of Life Network's efforts during BeADonor Month also contributed to an increase in the number of registered donors. The first annual Green Shirt Day on April 7 bolstered efforts, which honoured the legacy of Logan Boulet, the young man who donated his organs following the Humboldt tragedy a year ago. Logan gave the gift of life to six Canadians in need. 

In April 2019, nearly 20,000 Ontarians registered for donation. 

"It is tremendously encouraging to see Ontarians showing their support during BeADonor Month by registering for organ and tissue donation," says Gavsie. "The simple act of registering can affect so many people – one organ donor has the power to save up to eight lives and enhance as many as 75 more through the gift of tissue."

Today, 34 per cent of Ontarians are registered, but research suggests 85 per cent of the population support donation. Visit www.BeADonor.ca to register or learn more. 

Quick facts:

• Today, more than 1,600 people are waiting for a lifesaving organ transplant, and every three days someone dies waiting because there aren't enough organs to meet the need. 
• Everyone has the potential to be an organ and tissue donor. To date, the oldest Canadian organ donor was 92, and the oldest tissue donor was over 100. 
• Registration only takes two minutes at www.BeADonor.ca. 

Trillium Gift of Life Network is the Government of Ontario agency responsible for planning, promoting, coordinating and supporting organ and tissue donation and transplantation across the province and for continually improving the system so that more lives can be saved.

SOURCE Trillium Gift of Life Network

PrescribeIT™ Welcomes Intrahealth as New EMR Vendor

TORONTO, June 5, 2019 /CNW/ - Canada Health Infoway (Infoway) is pleased to announce that it has signed an agreement with Intrahealth Canada Limited (Intrahealth), an electronic medical record (EMR) provider, bringing the total number of PrescribeIT™ EMR vendors to 11. 

"EMRs are critical to the success of PrescribeIT™, so we are very excited to have Intrahealth onboard," said Michael Green, President and CEO of Infoway. "EMRs enable prescribers to send electronic prescriptions directly to a patient's pharmacy of choice, making prescribing safer and more secure, easier and more convenient, and eliminating the use of paper or faxed prescriptions."

Intrahealth, which is based in Vancouver, serves primary care markets in New Brunswick and British Columbia, as well as community health clinics in Ontario.

"We are thrilled to begin offering PrescribeIT™ through our EMR," said Silvio Labriola, General Manager, Intrahealth. "This e-prescribing service is a perfect fit for our patient-first approach to using technology to reduce costs and improve convenience, while also improving services for the health care provider community."

"We launched PrescribeIT™ in New Brunswick last fall as part of our ACCESS Atlantic initiative to improve health outcomes by improving access to care," Green said. "There is tremendous opportunity to scale the PrescribeIT™ service in the province, so we look forward to working with Intrahealth on those plans."

In addition to New Brunswick, PrescribeIT™ is also operating in Ontario and Alberta. There are agreements in place with seven other provinces and territories and roll-out plans are being developed. In addition, PrescribeIT™ works with 32 community pharmacy companies representing more than 3,400 pharmacies, as well as 11 EMR vendors and four Pharmacy Management System (PMS) vendors.

Learn more about PrescribeIT™ at www.PrescribeIT.ca. Prescribers and pharmacists interested in implementing the service are invited to submit an application of interest.

About Intrahealth Canada Limited
Incorporated in 2005, Intrahealth Canada provides medical software solutions to general practitioner clinics and public health authorities. Privately owned and founded by two New Zealand medical doctors, the company offers robust, secure, and scalable solutions via innovative technology that keeps pace with today's mobile lifestyles. The platform functions across multiple community-based practice types — primary care, specialist physician, community care, home care, residential care, and more. Our solutions meet the needs of front-line professionals by delivering core information to coordinating hubs, implementing programs more rapidly, and reducing the compliance burden on physicians and other clinicians. We help our customers capture structured data that holds context, meaning, and can be analyzed and processed automatically. 

About PrescribeIT™
Canada Health Infoway is working with Health Canada, the provinces and territories, and industry stakeholders to develop, operate and maintain the national e-prescribing service known as PrescribeIT™. PrescribeIT™ will serve all Canadians, pharmacies and prescribers and provide safer and more effective medication management by enabling prescribers to transmit a prescription electronically between a prescriber's electronic medical record (EMR) and the pharmacy management system (PMS) of a patient's pharmacy of choice. PrescribeIT™ will protect Canadians' personal health information from being sold or used for commercial activities.

About Canada Health Infoway
Infoway helps to improve the health of Canadians by working with partners to accelerate the development, adoption and effective use of digital health across Canada. Through our investments, we help deliver better quality and access to care and more efficient delivery of health services for patients and clinicians. Infoway is an independent, not-for-profit organization funded by the federal government.

Media Inquiries: 
Karen Schmidt 
Director, Corporate Communications, Canada Health Infoway 
416.595.3167 
kschmidt@infoway-inforoute.ca 
Follow @Infoway 

Inquiries about PrescribeIT™: 
Tania Ensor 
Group Director, PrescribeIT™ Marketing Strategy & Stakeholder Relations, Canada Health Infoway 
416.595.3411 
tensor@infoway-inforoute.ca 
Follow @PrescribeIT_CA 

Inquiries about Intrahealth: 
Silvio Labriola 
General Manager, Intrahealth Canada Limited 
604.980.5577 ext. 112 
Silvio.Labriola@intrahealth.com

SOURCE Canada Health Infoway

The Cornucopia Institute Examines Plant-Based Beverages 

Advertising Promotes Them as a Health Food—But Are They? 

https://www.cornucopia.org/2019/06/plant-based-beverage-report-release/
Cornucopia, WI — Cornucopia’s new report, “Pouring” Over Plant-Based Beverages, takes an in-depth look at what these beverages really offer consumers, how they are marketed, and how they compare to cow’s milk. Amid health concerns and dire climate crisis predictions, more consumers are buying plant-based beverages than ever before. But are they the right choice for everyone? 

Beverages made from seeds, fruits, nuts, legumes, and cereals often contain shockingly little plant material. Manufacturers heavily sweeten the drinks to improve their flavor and add thickeners and gums, such as the gastrointestinal inflammatory agent carrageenan, to make them seem creamy. 

“Astonishingly, some of these beverages advertised as ‘healthy’ alternatives to dairy have a sugar content equal to or greater than some soft drinks,” said Anne Ross, the report’s lead author and Cornucopia’s Director of International Policy. 

To help consumers find the most nutritious plant-based beverages containing the fewest additives, Cornucopia developed a comprehensive scorecard rating over 300 products from 49 brands. 

The global market for plant-based beverages is estimated to climb to nearly $20 billion by 2023 with an anticipated annual growth rate of 12%. Several of the country’s largest food marketers have recently acquired plant-based and alternative protein companies. Is the company that pushes Coca-Cola also making your “healthy” plant-beverage? 

“Massive conglomerates are eager to get into the plant-beverage market,” observed Ross. “It is a lucrative venture because these products sometimes consist of only a handful of nuts or seeds, water, and additives, while producing high profit margins.” 

Marketing suggests that plant-based beverages are equivalent substitutes for dairy milk, but nutrient profiles show these beverages are fundamentally different types of food. 

For individuals without dietary restrictions, cow’s milk provides a natural source of bioavailable calcium and micronutrients, often at demonstrably higher levels than in plant-based beverages. Organic milk produced by cows that graze on pasture has nutritional qualities that are naturally superior to conventionally produced cow’s milk and plant-based beverages.

There has been a lot of debate over which “milks,” dairy or plant-based, are better for the environment. The environmental impact of any beverage depends not only on the plant or animal product itself, but how it was grown or produced, sourced, and processed. All conventional beverages have roots in the destruction of native habitat and the use of toxic chemicals. 

Cornucopia’s research is a valuable tool for anyone trying to figure out which plant-based beverage is right for them or whether highly nutritious, grass-based, organic cow’s milk is the better option. 

The best choice, whether it be a glass of plant-based product or cow’s milk, is always USDA certified organic.