Pharma Notes

ProNAi Therapeutics Inc.

(Vancouver, BC) reports that the first patient with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) has enrolled in the company’s “Wolverine” Phase 2 study and has been treated with PNT2258. The patient was treated by Dr. Wael Harb, founder of the Horizon Oncology Center in Lafayette, Ind. The multi-center, single-agent, open-label, Phase 2 investigation of PNT2258 will characterize anti-tumour activity and collect safety data on approximately 60 patients with relapsed or refractory DLBCL. The primary endpoint is overall response rate, assessed by FDG-Positron Emission Tomography (PET) scan and compared to relevant historical controls. Secondary outcome measures include disease control rate, progression-free survival, overall survival, and exploratory predictors of outcome assessed by tumour biopsy and pharmacodynamics sample analysis.

OncoGenex Pharmaceuticals,

Inc. (Vancouver, BC) reports it has executed an initial agreement with

Teva Pharmaceutical Industries

Ltd. to regain the rights to custirsen, an investigational compound. The compound is currently being evaluated in a Phase 3 clinical trial as a treatment for prostate and lung cancers. The transfer of rights is connected with the termination of the collaboration agreement between OncoGenex and Teva executed in 2009. The initial agreement reached by OncoGenex and Teva provides that, following execution of the final agreement to terminate the collaboration between the parties, OncoGenex will receive a $27 million payment from Teva, subject to certain adjustments. In addition, OncoGenex will take over responsibility for all custirsen related expenses, including those related to the ENSPIRIT trial, as well as manufacturing and regulatory activities for custirsen programs, which are currently being managed by Teva.

Cipher Pharmaceuticals Inc.

(Mississauga, ON) reports it is expanding its dermatology product portfolio licensing the Canadian rights to Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, from Ferrer, a privately-held Spanish pharmaceutical company. In 2013, Ferrer successfully completed a first Phase 3 clinical trial of Ozenoxacin in adult and paediatric patients aged two years and older with impetigo.The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit. Ferrer commenced a second Phase 3 trial of Ozenoxacin in June 2014. The multicenter, randomized, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in approximately 412 patients aged two months and older with a clinical diagnosis of non-bullous or bullous impetigo. Ferrer anticipates that the second Phase 3 trial will be completed by the end of Q1 2015. Under the terms of the agreement, Ferrer will receive an upfront payment and is eligible for development milestones and revenues from product sales in Canada. Ferrer will manufacture Ozenoxacin and deliver the finished product to Cipher.

Cipher Pharmaceuticals Inc.

(Mississauga, ON) reports it has acquired the assets of Hershey, PA-based life science company Melanovus Oncology Inc.. The assets include seven pre-clinical compounds for the treatment of melanoma and other cancers. Founded in 2012, Melanovus acquired an exclusive global license to a library of compounds and related intellectual property from the Penn State Research Foundation. The compounds originate from work done by Dr. Gavin Robertson, professor of pharmacology, pathology, dermatology and surgery at Penn State University, and director of the Penn State Hershey Melanoma Center. The transaction includes an upfront payment to Melanovus of US$500,000, as well as the payment of certain IP expenses related to patent prosecution and maintenance.

Clinical stage company Aptose Biosciences Inc. (Toronto, ON) reports it has dosed the first patient in its Phase 1b clinical study of APTO-253 in patients with relapsed or refractory hematologic malignancies. APTO-253 is a first-in-class inducer of the Krüppel-like factor 4 (KLF4) tumour suppressor gene, and the only clinical-stage compound targeted for patients with suppressed KLF4 levels. The Phase 1b trial is a multicenter, open-label, doseescalation clinical trial. It is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic responses and efficacy of APTO-253 as a single agent. During the trial, APTO-253 will be administered twice weekly, over a 28-day cycle. The study is expected to enroll up to 30 patients with relapsed or refractory hematologic malignancies across two separate dose-escalation arms: (a) up to 15 patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients, and (b) up to 15 patients with lymphomas (Hodgkin and non- Hodgkin lymphoma) and multiple myeloma.

ProMetic Life Sciences Inc.

(Laval, QC) orally active anti-fibrotic lead drug candidate, PBI-4050, has been approved to commence a clinical trial in patients suffering from idiopathic pulmonary fibrosis (IPF), following the CTA clearance by Health Canada. The objectives of the 12 weeks open-label, single-arm, exploratory Phase 2 study are to evaluate the safety and tolerability of PBI-4050 in 40 patients suffering from IPF and to gather data on the effects of PBI-4050 on pulmonary function, disease progression and inflammatory/fibrotic markers. ProMetic successfully completed its PBI-4050 Phase 1 clinical trial in 40 healthy volunteers, in which it was found to be safe and well tolerated, with no serious adverse events. The company has also started enrolling patients with diabetic kidney disease (DKD) in the multi-dose part of the Phase 1b trial and is expected to report results thereon by the end of the first quarter of 2015.

Canadian biotech company Zymeworks Inc. (Vancouver, BC) has inked another deal with a biotech giant, this time teaming up with Celgene. Under the terms of the agreement, Zymeworks and Celgene will collaborate on the research and development of multiple bi-specific antibodies based on the Azymetric™ platform. The deal gives Celgene the right to develop and market an undisclosed number of antibody drug candidates that are designed to hit two biological targets instead of just one. Celgene will also have the option to advance the resulting bi-specific candidates through clinical development and subsequent commercialization. Zymeworks will receive an initial upfront payment, as well as an equity investment of $10 million from Celgene. Zymeworks is eligible to receive clinical, regulatory, and commercial milestones on successful candidates totaling up to US $164M per therapeutic candidate. Additionally, if any of the experimental drugs make it all the way to the market, Zymeworks will collect royalties on worldwide net sales. Further financial details are not disclosed.

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