April's top stories: SynbiCITE's synthetic biology foundry, Omeros's phase II clinical trial of OMS721
SynbiCITE opened a commercial synthetic biology foundry at Imperial College London, and Omeros began dosing patients in its new Phase ll clinical trial of OMS721 in corticosteroid-dependent renal diseases. Drugdevelopment-technology.com wraps up the key headlines from April 2016.
UK-based innovation and knowledge centre (IKC) SynbiCITE, for synthetic biology, opened a commercial synthetic biology foundry at Imperial College London.
Claimed to be the first of its kind in the UK, SynbiCITE's Foundry provides automated end-to-end design, construction and validation of synthetic biologic components, combined with an open-access and sharing software that helps researchers accelerate innovation by sharing their biodesign protocols with various labs worldwide.
The newly opened foundry will help automated manufacturing processes that meet industry requirements for use of synthetic biology applications in life sciences and several other industries, such as fine and special chemicals, energy, agriculture and waste remediation.
US-based Omeros began dosing patients in its new Phase ll clinical trial of OMS721 in corticosteroid-dependent renal diseases.
OMS721 is the company's main mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor being developed for complement-related diseases.
The Phase ll trial is evaluating the effects of OMS721 on kidney function in patients with corticosteroid-dependent renal diseases.
Ignyta found positive results from its Phase 1 clinical trials of entrectinib, its proprietary oral tyrosine kinase inhibitor that targets solid tumours harbouring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK.
The trials included the ALKA-372-001 study and the STARTRK-1 study, which is claimed to be first of the 'Studies of Tumour Alterations Responsive to Targeting Receptor Kinases'.
Both trials were designed to determine the maximum tolerated dose (MTD) and / or recommended Phase 2 dose (RP2D), as well as preliminary anti-cancer activity, of single agent entrectinib in patients with solid tumours with the relevant target alterations, TrkA (encoded by NTRK1), ROS1 or ALK for ALKA-372-001 and TrkA/TrkB/TrkC (encoded by NTRK1/2/3), ROS1 or ALK for STARTRK-1.
GlaxoSmithKline (GSK) started a Phase II study to assess the efficacy and safety of GSK3196165, a new anti-granulocyte macrophage colony-stimulating factor monoclonal (anti GM-CSF) antibody to treat patients with inflammatory hand osteoarthritis.
Osteoarthritis is a type of disease that causes damage to the surface of joints in the body, leading to joint pain and stiffness, while it can adversely affect work and normal daily activities in some patients.
The multi-centre, double-blind, randomised, placebo-controlled, parallel group Phase II trial will investigate the efficacy and safety of subcutaneous injections of GSK3196165 in 40 adult subjects with inflammatory hand osteoarthritis.
The global treatment market for non-hematological cancers was expected to almost double from $72.9bn in 2014 to $140.8bn by 2021, at a compound annual growth rate of 9.9%, according to a new report from GBI Research.
The report, entitled 'Global Non-Hematological Cancers Market to 2021 - Strong Growth Driven by Increased Uptake of Low Toxicity Targeted Treatments and Versatile Biologics', mentions that the predicted growth will occur despite the patent expiries of several commercially successful products, such as Avastin, Erbitux and Herceptin.
Avastin will first expire in the European Union (EU) in 2018, with the two others drugs listed having already expired in 2014.
According to the report, market drivers will include the growing prevalence of cancer globally, and launch of more targeted treatments expected to improve the overall survival of poor-performance-status patients, as well as enable additional rounds of chemotherapy to be administered.
Biopharmaceutical company Array BioPharma planned to stop the MILO study, an international, randomised phase 3 trial of binimetinib for treatment of patients with low-grade serous ovarian cancer.
After undertaking a planned interim analysis, which revealed that the Hazard Ratio for Progression Free Survival (PFS) crossed the predefined futility boundary, Array decided to discontinue the study.
Array stated that it will work with investigators to appropriately conclude the MILO study in a way that considers the best interest of each patient, while more detailed results will be shared with the scientific community in the future.
SanBio received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to conduct a Phase 2 clinical trial for using allogeneic stem cells to treat chronic traumatic brain injuries.
The company submitted its clinical trial notification of the regenerative cell therapy (SB623) for traumatic brain injury to PMDA last month.
Claimed to be the first of its kind, the stem cell therapy for traumatic brain injury (STEMTRA) trial will study the safety and efficacy of SB623 cell therapy in treating patients with chronic motor impairments following a traumatic brain injury.
Rigel Pharmaceuticals ended enrolment for both studies in the FIT Phase 3 clinical programme of fostamatinib drug, its oral spleen tyrosine kinase (SYK) inhibitor, in immune thromboycytopenic purpura (ITP) disease.
While the first study of this programme completed enrolment at the end of January, the second study recently finished.
The first study results are expected by mid-2016, and results for the second study are expected shortly afterwards.
The FIT phase 3 clinical programme comprises two similar studies with around 75 patients in each.
Patients were diagnosed with constant or chronic ITP, and had blood platelet counts consistently below 30,000 per microlitre of blood. Patients will remain on treatment for up to 24 weeks.
The primary efficacy endpoint of the programme is a stable platelet response by the last week, with platelet counts at or above 50,000 per microlitre of blood for at least four of the final six qualifying blood draws.
Pfizer completed enrolment in the global SPIRE-2 cardiovascular outcome trial of its investigational agent bococizumab, in high-risk patients without a history of cardiovascular events.
Bococizumab is a Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) being studied for its potential to lower LDL-C and improve cardiovascular outcomes in high-risk primary and secondary prevention patients.
SPIRE-2 study expects to evaluate the efficacy and safety of bococizumab compared to placebo, by reducing the risk of major cardiovascular events among 10,600 patients at high risk for cardiovascular disease, including those without a prior history of the events and who are also on highly-effective statins or with documented statin intolerance.
BTG announced plans to begin the TheraSphere Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment (TARGET) study.
The study will evaluate two-compartment dosimetry, including normal tissue and tumour absorbed dose, in hepatocellular carcinoma patients in interventional oncology.
The trial aims to have a more personalised approach than before to 90Y radioembolisation therapy for liver cancer patients.