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Laboratory Focus August/September 2015
PHARMA NOTES
Amorfix Life Sciences Ltd. (Toronto, ON) has changed its company name to ProMIS Neurosciences Inc. with its common shares now trading on the Toronto Stock Exchange under the stock symbol (PMN). With a focus on precision medicine solutions for early detection and treatment of neurodegenerative diseases, the company is developing antibody therapeutics and specific companion diagnostics for Alzheimer’s disease (AD) and amyotrophic lateral sclerosis (ALS). Among the diagnostics that ProMIS Neurosciences is developing is ProMIS (Trademark symbol) a computational discovery platform that predicts disease specific epitopes on the molecular surface of misfolded proteins. Canadian CRO Dalton Pharma Services (Toronto, ON) reports it has signed a drug development and manufacturing contract with fellow Canadian company Ramsey Lake Pharmaceutical Corp. (RLPC) (Sudbury, ON). RLPC is a privately held company developing therapies currently focused on proteasome inhibitors. Its lead candidate, VR23, is a small molecule cancer therapeutic that has shown potential as a next generation proteasome inhibitor, inhibiting tumour growth as a single agent that used in combination with gold-standard anticancer drugs, increases efficacy while reducing toxicity. It has also shown potential in overcoming drug resistance. The product was developed in the laboratory of Dr. Hoyun Lee of RLPC. Dalton Pharma will assist RLPC in toxicology studies for VR23 and the agreement includes the synthesis of the molecule by Dalton as well as the development of analytical testing methods and execution of a stability study. Immunovaccine Inc. (Halifax, NS) has entered into a non-exclusive clinical trial collaboration with Incyte Corporation (Wilmington, DE) to evaluate the combination of its T-cell activating immunotherapy, DPX-Survivac, with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat. Both firms say they will co-fund and conduct a Phase 1B trial to evaluate the safety, tolerability and efficacy of the new combination in platinum-sensitive ovarian cancer patients who are at high risk of recurrence. The investigational new drug (IND) application for the study, which will test the triple combination of DPX-Survivac, epacadostat
and low dose oral cyclophosphamide, is expected to be filed this year in the U.S. and Canada and the study is expected to enroll approximately 20 patients. Results from this study may lead to an expansion of the clinical collaboration to investigate other cancers. Telesta Therapeutics Inc. (Montreal, QC) says that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MCNA. MCNA is a biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy. It is derived from the cell wall fractionation of a non-pathogenic bacteria.The FDA has a 60-day filing review period to determine whether Telesta’s BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA’s official filing communication known as the “Day-74 letter.” Telesta will communicate the FDA’s filing decisions upon receipt. Additionally, the company has received a waiver from the FDA exempting the company from a $US2.3 million payment for a BLA application fee. Aeterna Zentaris Inc. (Quebec City, QC) reports it has reached its goal of recruiting 500 patients for its Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study in women with advanced, recurrent or metastatic endometrial cancer. The ZoptEC trial is being conducted in more than 120 sites in North America, Europe and Israel. It is an open-label, randomized-controlled study, comparing the efficacy and safety the hybrid molecule that is composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). The primary efficacy endpoint is improvement in overall survival. Clementia Pharmaceuticals, Inc. (Montreal, QC) reports the completion of a US$60 million mezzanine round of financing to support the development of its lead com-
pound palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP). Palovarotene, an investigational retinoic acid receptor gamma agonist, is currently in Phase 2 clinical trials for patients with FOP. It was in-licensed from Roche, who previously were testing it as a treatment for COPD. New Enterprise Associates (NEA) was the lead investor with participation by UCB, RA Capital Management, Rock Springs Capital Management, EcoR1 Capital, and a fund advised by Janus Capital Management LLC as well as existing investors OrbiMed Advisors and BDC Capital Healthcare Venture Fund. Qu Biologics Inc. (Vancouver, BC) reports it is collaborating with the laboratory of Dr. Bruce Vallance at the Child & Family Research Institute at BC Children’s Hospital and the University of British Columbia. The company is developing Site Specific Immunomodulators (SSIs) that aim to restore normal immune function in targeted diseased organs. It has tasked Dr. Vallance’s team with studying the therapeutic effects of its SSI treatment for inflammatory bowel disease (Crohn’s disease and ulcerative colitis) in a mouse model that mimics the underlying innate immune system defect and chronic bacterial infection associated with these diseases. Well recognized for his expertise in the study and modeling of IBD and enteric bacterial infections, Dr. Vallance was named the Canada Research Chair in Pediatric Gastroenterology and a Michael Smith Research Scholar in 2004. He has authored more than 60 peer reviewed manuscripts addressing the mechanisms underlying IBD and infectious diseases. Cipher Pharmaceuticals (Mississauga, ON) reports Ferrer International SA has successfully completed the second Phase 3 clinical trial for Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher acquired the Canadian commercialization rights to Ozenoxacin from Ferrer in January 2015. The study, which involved Ozenoxacin formulated as a topical treatment for dermatological infectious conditions in adults and peadiatric patients aged two months and older, demonstrated that Ozenoxacin 1% cream, applied twice daily for five days, versus placebo on both the clinical and bacteriological endpoints by end of
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therapy visit (day 6-7) performed well and was shown to be safe and very well tolerated in the adult and paediatric population. Cardiome Pharma Corp. (Vancouver, BC) has submitted a supplemental new drug submission (sNDS) to Health Canada’s Therapeutic Products Directorate for AGGRASTAT®. The sNDS includes data to support: 1) high dose bolus administration of AGGRASTAT (tirofiban hydrochloride); and 2) an indication expansion for the reduction of major cardiovascular events in patients with acute myocardial infarction (STEMI) intended for primary PCI. AGGRASTAT, in combination with heparin and ASA is currently indicated in Canada for the management of patients with unstable angina or non-Q-wave myocardial infarction, including patients who may subsequently undergo PTCA (percutaneous transluminal coronary angioplasty), to decrease the rate of refractory ischemic conditions, new myocardial infarction and death. Cardiome acquired the Canadian AGGRASTAT commercialization rights through its acquisition of Correvio LLC in November 2013. Aequus Pharmaceuticals, Inc. (Vancouver, BC) has successfully completed an in vivo feasibility study with AQS-1301, a proprietary transdermal patch containing the psychoactive drug aripiprazole. The pharmacokinetic study was conducted in animals in order to estimate the effectiveness of the formulation in delivering therapeutic amounts of the drug over a seven day period. According to Aequus CEO and chairman Douglas Janzen, the patch delivered the drug at a very consistent rate. The company also said it has received a Notice of Allowance from the U.S. Patent Trademark Office (USPTO) for a pharmaceutical formulation patent application that covers AQS-1301. Similar applications have been filed with the European Patent Office (EPO) and the Patent Cooperation Treaty (PCT). The European Commission has granted ProMetic Life Sciences (Laval, QC) orphan drug designation status to its human plasma derived plasminogen drug. ProMetic is currently investigating the safety, tolerability and pharmacokinetics of the drug in patients suffering from plasminogen deficiency. The company expects to provide a preliminary report on its program shortly
