Biopharma companies from across the globe provide updates on their pipeline and business.
Cytovation – Norway-based Cytovation AS announced that SMS-Oncology has been selected as the contract research organization that will conduct the company’s Phase I/II trial with CyPep-1 in patients with advanced solid cancers. In recent months, Cytovation has progressed through preclinical and toxicology studies with its lead candidate CyPep-1, a first-in-class lytic agent. CyPep-1 selectively targets and lyses tumor cell membranes based on their altered molecular composition. This mode of action kills cancer cells, releases tumor antigens, and potentially induces a tumor-specific immune response by in-situ immunization. Cytovation is currently initiating a first-in-human trial with intratumoral injection of CyPep-1 and aims to reach a first in patient milestone by the end of 2019. The Phase I/II study is designed as an open-label, dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of intratumoral CyPep-1 in patients with advanced solid cancers. CyPep-1, in a cream formulation for topical application, is currently being evaluated in a phase I trial in patients with HPV-induced cutaneous tumors.
Start Codon – U.K. life sciences accelerator Start Codon partnered with Clustermarket, a leading online equipment sharing and booking platform and Science Entrepreneur Club, a life sciences network. The partnership is expected to drive the translation of healthcare research into commercially successful companies. Founded in April, Start Codon has an aim to “identify and recruit high potential life science and healthcare companies from across the UK and beyond, provide seed-funding, and leverage the world-class resources of the Cambridge Cluster to reduce risk and prepare them for a successful Series A fundraise.” Jason Mellad, CEO at Start Codon, said the partnership with Clustermarket and Science Entrepreneur Club reflects the accelerator’s “collaborative approach to working with leading platform providers to help ensure our portfolio companies receive a full suite of support, which includes having easy, affordable access to pioneering research equipment and services.”
Halix – Netherlands-based Halix, contract development and manufacturing organization, hit a major milestone with the interim delivery of the company’s new 6,700 m2 cGMP facility in Leiden Bio Science Park. The new five-level production facility contains a state-of-the-art manufacturing line for viral vaccines and viral vectors and a separate protein manufacturing area with a capacity up to 1,000 Liter single-use bioreactors. In addition, lab space is available for process development, analytical development and quality control. All cleanroom areas have a unidirectional process flow and are designed to allow commercial manufacturing of biopharmaceuticals products.
e-Therapeutics – Cambridge, U.K.-based e-therapeutics plc struck a one-year agreement to work with an unnamed top-five pharmaceutical company to work on the development of treatments for neurodegeneration that can lead to diseases like Parkinson’s and Alzheimer’s. Under the 12-month agreement, e-therapeutics will use its proprietary Network-Driven Drug Discovery approach to identify novel disease pathways and small molecules, both of which have the potential to modulate the biology of interest. As part of the project, the company will test the compounds resulting from e-therapeutics’ NDD platform in its in-house assays. e-therapeutics will be reimbursed for certain costs it incurs during the execution of this work. Intellectual property rights and know-how from e-therapeutics have not been granted to the company and the results and inventions produced by e-therapeutics during the project will be the sole property of e-therapeutics. The pharma partner has also a review period, during which time they will decide whether to negotiate a collaboration with e-therapeutics. In the absence of such an agreement, e-therapeutics will be able to use the results from this project, the company said.
Paragonix Technologies – Massachusetts-based Paragonix announced that the Paragonix SherpaPak Cardiac Transport System, approved by both the FDA and EMA, was used for the first time in South America at the Favaloro Foundation University Hospital in Argentina. The system is used for donor heart transport and storage, from donor to recipient. The Paragonix system incorporates clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection.
Micralyne Inc. – Edmonton, Alberta-based Micralyne acquired a Versalis fxP Cluster System from SPTS Technologies, a KLA company and equipped it with a Rapier plasma etch model in order to increase production capacity. Micralyne is a key provider of MEMS sensors and other microstructures. The addition of SPTS’s Versalis fxP system will allow Micralyne to offer its MEMS customers a broader range of process technologies and production capabilities with improved throughput and yield. The central module of the system is a Rapier silicon deep reactive ion etch (DRIE) chamber that offers unparalleled process capability with world-class productivity.
TerrAscend Corp. – Toronto-based TerrAscend, the only cannabis company licensed for sales in Canada, the U.S. and E.U., completed its first international shipment of dry cannabis flower to its German distribution partner iuvo Therapeutics GmbH. The shipment was made from TerrAscend’s EU GMP certified manufacturing facility in Mississauga, Ontario, Canada. As the Company ships additional product to Germany in partnership with iuvo, it will continue to expand its footprint in Europe and other international markets. It is expected that the German cannabis market will generate more than $5 billion in revenue by 2025. With more than 30,000 current medical cannabis patients in Germany and upwards of 7,200 kg in annual medical patient consumption, the TerrAscend-iuvo partnership presents an exciting opportunity to fulfill the growing needs of medical cannabis patients in Germany, the company said in its announcement.
Harvest One Inc. – Vancouver-based Harvest One, through its subsidiary Satipharm Ltd., announced positive results of a Phase II clinical trial of its CBD GelPell capsules in the management of Treatment-Resistant Epilepsy. The results were published in Epilepsy & Behaviour, a bimonthly peer-reviewed medical journal covering behavioral aspects of epilepsy. The data showed a median reduction of monthly seizures of about 82 percent over a 12-week period. Additionally, the company said 56% who started the treatment had a reduction of at least 50% in total number of seizures during the entire treatment period.
Appnovation – Also based in Vancouver, Appnovation secured $15 million (Canadian) in equity financing to accelerate its international growth and expansion strategy in Canada, the U.K. and beyond.
Roche – Swiss pharma giant Roche’s Canadian pharma business announced that Health Canada approved Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The approval marks the first new treatment for the disease in 20 years, the company said. Tecentriq is the first and only approved cancer immunotherapy agent in Canada for first-line small cell lung cancer. This approval is based on results from the Phase III IMpower133 study, which is the first Phase III study with an immunotherapy-based combination to show improvement in overall survival and progression-free survival in first-line treatment of ES-SCLC.
