Biotechnology Focus

June/July 2017

Biotechnology Focus is Canada's leading authority on Canada's life science news. From biopharma and healthcare to ag-bio and clean tech, our readership includes life science professionals, C-level executives and researchers.

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8 BIOTECHNOLOGY FOCUS June/July 2017 BUSINESS corner BioVectra Inc., a contract manufacturer for pharmaceutical and biotech companies, is investing $30 million in the construction of a new microbial fermentation facility in Windsor, Nova Scotia in order to substan- tially bump up its capacity. The PEI-based service provider said the planned 50,000 square-foot facility will be operational by December this year. The late-stage to commercial-scale micro- bial fermentation and complex chemistry facility is strategically located to be near the potential clients in the northeastern part of the United States. BioVectra's $30 million investment has equipped the facility with 40,000 liters of fermentation capacity, downstream pro- cessing equipment and new pre-clinical fer- mentation and potent chemistry suites. "The investment strengthens our unique position in the very competitive global BioVectra opening new site in Nova Scotia marketplace, enabling us to offer new and existing clients range of scale throughout the entire lifecycle of a product," said Oliver Technow, BioVectra's president. BioVectra provides scalable cGMP opera- tions from 30 L to 17,000 L. The company has the capability to handle the development and cGMP scale-up of high-potency active pharmaceutical ingredients (APIs), handling potent substances such as antibody-drug conjugate warheads, with occupational Biopharmaceutical company OBI Phar- ma Inc. has signed an agreement with Threshold Pharmaceuticals to acquire the San Francisco-based company's TH-3424 small-molecule protein drug. TH-3424 targets cancers overexpress- ing the enzyme aldo-ketoreductase 1c3 (AKR1C3). Obi Pharma is changing the name of the drug to OBI-3424. The drug is a first-in-class prodrug that selectively releases a potent DNA alkylat- ing agent in the presence of the AKR1C3 enzyme. This selective mode of activation dis- tinguishes OBI-3424 from traditional al- Threshold Pharmaceuticals' TH-3424 now OBI-3424 after acquisition by OBI Pharma exposure limit (OEL) levels of < 20 ng/m3 (Safebridge Band 3 and 4). The new facility increases BioVectra's ability to partner with global pharmaceutical com- panies by offering dual-site risk mitigation, according to Heather Delage, the company's vice-president of business development. To see this story online visit http://biotechnologyfocus.ca/biovectra- opening-new-site-in-nova-scotia/ kylating agents, such as cyclophosphamide and ifosfamide, which are non-selective. "We will continue the pre-clinical work and hope that OBI-3424 develops into a solid treatment option for patients with cancers that express AKR1C3," said Amy Huang, general manager of OBI Pharma. "This novel cancer therapeutic enhances our pipeline and moves us another step towards becom- ing a global cancer biopharma company." AKR1C3 overexpression has been docu- mented in a number of treatment-resistant and difficult to treat cancers. For example, hepatocellular carcinomas (HCC), which highly overexpress AKR1C3 in the majority of patients. OBI-3424 has demonstrated potent ac- tivities in preclinical models of HCC, in- cluding a model resistant to the standard of care treatment, sorafenib. "AKR1C3 is highly overexpressed in a number of cancers that represent unmet medical needs, including hepatocellular carcinoma, castrate-resistant prostate cancer, and T-cell acute lymphoblastic leukemia. OBI-3424 offers the possibility of early efficacy readouts based on objec- tive response rates in well-defined resis- tant patient populations," said Dr. Tillman Pearce, Threshold's chief medical officer. AKR1C3 is adaptively upregulated in re- sponse to castration; therefore, castrate- resistant prostate cancer is another logical unmet need population where OBI-3424 will be tested. In addition, the United States National Cancer Institute is performing preclinical evaluations of OBI-3424 for the potential treatment of T-cell acute lymphoblastic leukemia (T-ALL). To see this story online visit http://biotechnologyfocus.ca/ threshold-pharmaceuticals-th- 3424-now-obi-3424-after-acqui- sition-by-obi-pharma/

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