BioSpace Global Roundup, June 4
SwedenBIO – A new report from SwedenBIO, the life science organization in Sweden, released a new report that shows the drug discovery and development pipeline is expanding and maturing, with more projects starting up and moving into later phases. Additionally, the report shows more projects in Sweden are attracting international financing. The report also shows that about 80% of the companies are looking to expand over the next year. Oncology and neurology are the top indications for the companies, with rare diseases coming in third in areas of focus.
NicOx SA – France’s Nicox initiated the Phase III Mont Blanc trial evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. NCX 470 is the company’s novel, second-generation nitric oxide (NO)-donating bimatoprost analog. In a Phase II study, NCX 470 demonstrated both statistical non-inferiority and superiority to latanoprost, the U.S. standard of care for patients with open-angle glaucoma and ocular hypertension. The Phase III trial is expected to randomize more than 600 patients, primarily at clinical sites in the U.S. and at a small number of clinical sites in China.
Evonik – Germany-based Evonik launched the Resomer Precise platform of custom functional polymeric excipients to allow pharmaceutical companies to control the release profile of their parenteral drug products to a previously impossible level of accuracy and precision. The platform is expected to optimize drug product stability and reduce regulatory risk for a range of complex parenteral drug products.
Delta 4 – Based in Austria, Delta 4 announced positive preclinical data for drug candidates in rare kidney disease. In its lead program, which aims at developing a therapy for Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease affecting children and adults, Delta 4 concluded pre-clinical development with promising results. The company initiated patent filing and is currently preparing for clinical testing of selected drug candidates. Delta 4 also announced that, in addition to FSGS, it recently applied its drug discovery platform to COVID-19 to identify existing drugs that may have benefits in this disease. The company is currently evaluating a shortlist of potential COVID-19 therapies pre-clinically and is considering partners to further develop its most promising COVID-19 drug candidates.
Alizé Pharma 3 – France-based Alizé Pharma 3 is rebranding itself as Amolyt Pharma. The branding comes ahead of the company’s first clinical program and reflects its singular focus on building and advancing a portfolio of unique therapeutic peptides. Amolyt Pharma is developing AZP-3601, a parathyroid hormone analog specifically designed for the treatment of hypoparathyroidism, as well as AZP-3404, a peptide with a new and unique mechanism of action on fat and glucose metabolism.
Sanofi – Pharma giant Sanofi reported that Sarclisa (isatuximab) added to carfilzomib and dexamethasone (Sarclisa combination therapy) reduced the risk of disease progression or death by 47% compared to standard of care carfilzomib and dexamethasone in patients with relapsed multiple myeloma. These results from the Phase III IKEMA trial follow the topline announcement on May 12 that Sarclisa combination therapy met the trial primary endpoint at the pre-planned interim analysis. Interim results will be presented during a late-breaking session of the European Hematology Association (EHA) Virtual Congress on June 14 and will form the basis for global regulatory submissions later this year.
Chinook Therapeutics – Vancouver’s Chinook Therapeutics and Aduro Biotech are merging. The merger is expected to be completed in the second half of 2020. The new company will be named Chinook Therapeutics, Inc., and is expected to trade on the Nasdaq Global Market under the ticker symbol “KDNY.” The pipeline of the combined company will include Atrasentan, an investigational selective endothelin receptor antagonist, in clinical development for the treatment of IgA nephropathy and other primary glomerular diseases; BION-1301, an investigational humanized IgG4 monoclonal antibody that blocks APRIL binding to both the BCMA and TACI receptors, in clinical development for the treatment of IgA nephropathy; and CHK-336, an investigational small molecule, in preclinical development for the treatment of an ultra-rare orphan kidney disease. Aduro is currently exploring strategic alternatives for its legacy programs outside of kidney disease, including the STING agonist program in collaboration with Novartis, cGAS-STING inhibitor program in collaboration with Lilly, and anti-CD27 program out-licensed to Merck, as well as deprioritized programs such as the anti-SIRPα and anti-CTLA-4 antibodies.
Shorla Pharma – Ireland’s Shorla Pharma secured $8.3 million in a Series A financing round that will be used to advance the company’s portfolio of oncology therapeutics. Shorla has developed innovative oncology drugs with a focus on rare, orphan and pediatric cancers, delivering more effective products in indications where existing treatments are sub-optimal for the target patients.
Oncodesign – France-based Oncodesign formed a new strategic alliance with HitGen, a Chinese biotech company. This partnership complements Oncodesign’s technological platforms and enables the identification of novel hits for challenging biological targets. It also strengthens its Integrated Drug Discovery Service (IDDS) offer, known as DRIVE (DRug Integrative discoVEry).
Dotmatics – U.K.-based Dotmatics, an informatics software and services company, achieved certification to the internationally recognized standard ISO 9001:2015 for its quality management system. Achieving ISO 9001 affirms that Dotmatics’ operations meet customer requirements, demand and timelines and that it has appropriate QMS processes in place to develop and deliver software in a uniform and consistent manner. The accreditation also supports the company’s commitment to achieving continuous improvement, the company said.
Base Genomics – U.K. company Base Genomics closed a seed funding round of $11 million to develop its TAPS technology, initially focusing on developing a blood test for early-stage cancer and minimal residual disease. The funding round was led by Oxford Sciences Innovation and also included investors with industry expertise in genomics and oncology.
FSD Pharma – Toronto-based FSD Pharma received the green light from the U.S. Food and Drug Administration to submit an Investigational New Drug Application for the use of FSD-201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus. Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. FSD Pharma is focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
Follicum – Sweden’s Follicum will re-start its Phase IIa study of FOL-005 following a COVID-19-related halt. In two previous clinical studies, FOL-005 administered as an intradermal injection has been shown to be an effective and safe treatment for stimulation of hair growth. The current Phase II study aims to investigate the safety, efficacy and response of the drug candidate FOL-005 in a topical formulation.