Pharma Notes

Contract development and manufacturing company Therapure Biopharma Inc. (Mississauga, ON) will participate as a subcontractor for DynPort Vaccine Company LLC (Frederick, MD) to support the development of a prophylactic countermeasure to prevent the effects of organophosphorus nerve agent poisoning. DynPort was awarded the contract by the U.S. Department of Defense. Therapure’s sub contract under the above prime contract includes process optimization as well as manufacture of all clinical and nonclinical materials (drug product) to support DVC’s contract to develop, test and obtain the US Food and Drug Administration (FDA) approval for human plasma derived butyrylcholinesterase (HuBChE), a blood plasma protein that binds and inactivates nerve agents.

Xenon Pharmaceuticals

Inc. (Vancouver, BC) has exercised its option to an exclusive worldwide license to XEN701, an antisense drug discovered in collaboration with Isis Pharmaceuticals (Carlsbad, CA). For the license of XEN701, Isis earns a $2 million payment from Xenon. XEN701 is designed to inhibit the production of hepcidin, a target Xenon identified utilizing its extreme genetics platform for the treatment of anemia of chronic disorders (ACD). XEN701 is currently being evaluated in studies to support clinical development. Xenon plans to initially develop XEN701 for patients with chronic kidney disease who are intolerant of or who are poor responders to erythropoietin (Epo) therapy. XEN701 is the first drug to enter development from Xenon’s collaboration with Isis Pharmaceuticals Inc.

Zenith Epigenetics

Corp. (Calgary, AB) has commenced operations as an early stage research company. Zenith was formed as a result of a plan of arrangement involving Resverlogix

Corp., RVX Therapeu-

tics Inc. and Zenith. The management team of Zenith will be led by the management team of Resverlogix, including Donald McCaffrey as president and CEO, Brad Cann as CFO, Kenneth Lebioda as senior VP Business & Corporate Development, Dr. Norman Wong, as CSO and chairman of the Scientific Advisory Board, Dr. Jan Johansson, as senior VP Medical Affairs, Dr. Gregory Wagner, as senior VP Research and Development and Dr. Allan Gordon, as senior VP Clinical Development. The board of directors of Zenith consists of Dr. Peter Johann, Donald McCaffrey, Kenneth Zuerblis, Dr. Eldon Smith, Kelly McNeill and Arthur J. Higgins.

Medicago Inc. (Québec, QC) has received clearance by Health Canada to initiate its Phase 2 dose-sparing clinical trial for a H5N1 Avian Influenza VLP vaccine candidate. All clinical lots have been produced and the trial will commence with interim results expected in the summer of 2013. To date, three clinical trials have been performed on a total of 403 subjects. Medicago’s H5N1 vaccine candidate was found to be safe and well tolerated and induced a solid immune response in a U.S. Phase 1 study that was recently completed using a 20 µg dose of the H5 VLP vaccine with or without the Alhydrogel® (alum adjuvant) or the glucopyranosyl Lipid A (GLA-AF) adjuvant, given either intradermally (ID) or intramuscularly (IM). The results obtained revealed that all formulations were safe and well-tolerated and both alum and GLA induced antibody levels met the three CHMP criteria for licensure of influenza vaccines. The Phase 2 dose-sparing study is designed as a multi center, observer blind, placebocontrolled study using the IM route of administration, with alum or GLA-based adjuvant in healthy adults 18 to 60 years of age. A total of 390 subjects will be randomized to receive two doses of the H5 VLP vaccine formulated with alum adjuvant or GLA-SE adjuvant or placebo. The primary endpoints are immunogenicity evaluated 21 days after each administration as well as safety and tolerability after each administration and 12 months after the last injection. As a secondary endpoint, the immunogenicity and crossreactive antibodies induced by the H5 VLP vaccine will be evaluated. The trial is anticipated to take 15 months to complete with initial safety and immunology data expected during the summer of 2013.

Transition Therapeutics

Inc. (Toronto, ON) announces that Eli Lilly and Company (Lilly) has exercised its option to assume all development and commercialization rights to type 2 diabetes drug candidate TT-401. In conjunction with this assumption of rights, Transition will receive a US$7 million milestone payment. Lilly and Transition have amended their agreement to address future development of TT-401 and associated financial arrangements. Lilly will assume all costs and perform all future development and commercialization activities of TT-401. Transition will contribute payment of US$14 million to Lilly in three separate installments during the Phase 2 clinical study. If TT-401 is successfully commercialized, Transition will be eligible to receive approximately US$240 million in additional milestone payments. Transition will also be eligible to receive a double-digit royalty on sales of TT-401 products and a low single digit royalty on related compounds.

BELLUS Health Inc.

(Laval, QC) has agreed to acquire Thallion Pharmaceuticals Inc. (Dorval , QC) for approximately $6.332 million. Thallion is developing Shigamabs®, a monoclonal antibody therapy being evaluated for the treatment of Shiga toxin-producing E. coli (STEC) bacterial infections. STEC infections can lead to hemolytic uremic syndrome (HUS), a condition principally affecting the kidneys that often leads to dialysis and in certain cases death. BELLUS Health’s lead program is KIACTA™, a drug candidate currently in a Phase 3 confirmatory study for the treatment of AA amyloidosis, a rare disease resulting in kidney dysfunction that often rapidly leads to dialysis and death.

Following Health Canada approval, TauRx Therapeutics Ltd. (Aberdeen, UK) and Toronto Memory Program (Toronto, ON) have jointly announced the Canadian launch of a group of Phase 3 clinical trials for TauRx Therapeutics’ LMTX™, the company’s investigational treatment aimed at slowing or halting the progression of mild to moderate Alzheimer’s disease. The Toronto Memory Program is the first of at least five medical centres in Canada that will carry out the Phase 3 Alzheimer’s trials. TauRx’s clinical trials for mild to moderate Alzheimer’s and for behavioral variant Frontotemporal Dementia, a rare neurodegenerative disease caused by a similar form of pathology as in Alzheimer’s, are the first Phase 3 trials of a Tau Aggregation Inhibitor (TAI), which targets and dissolves ‘tau tangles’ in the brain, and is directly linked to the development of the disease. If successful, LMTX™ will be the first tau-based treatment approach for Alzheimer’s disease. The TauRx Phase 3 study program will involve over 1,700 patients in more than 20 countries.

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