BioSpace Global Roundup, May 14
Avacta Group – U.K.-based Avacta is shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners. Avacta Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva-based COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States. The reagents are also being provided to Adeptrix with whom Avacta has announced that it will develop a COVID-19 laboratory test to run on hospital mass spectrometers using Adeptrix’s proprietary BAMS assay platform.
Mologic – Mologic Ltd. and BioSure teamed up to produce a COVID-19 antibody self-test. By combining Mologic’s independently verified COVID-19 lateral flow test with BioSure’s market-leading design, the companies have created a self-test for COVID-19 that can be used without any training being required. The innovative design has been proven to be extremely easy to use, requires only a fraction of a drop of blood and gives the user their own result in just 10 minutes. The BioSURE COVID-19 Antibody Self-Test will be ready for mass production at the beginning of June. It will be available to the U.K. and global markets and will also be available to be directly purchased by end-consumers.
Hitachi Chemical – Hitachi Chemical Advanced Therapeutics Solutions and Germany’s apceth Biopharma GmbH, both of which are subsidiaries of Hitachi Chemical Co., expanded their development and manufacturing relationship with bluebird bio.
GENFIT – France-based GENFIT announced interim results from its Phase III trial evaluating once-daily elafibranor in adults with non-alcoholic steatohepatitis (NASH) failed to meet the predefined primary endpoint of NASH resolution without worsening of fibrosis in the intent-to-treat population of 1,070 patients. The response rate in the 717 patients enrolled on study drug was 19.2% for patients who received elafibranor compared to 14.7% for patients in the placebo arm. On the fibrosis key secondary endpoint, 24.5% of patients who received elafibranor achieved fibrosis improvement of at least one stage compared to 22.4% in the placebo arm. The other key secondary endpoint related to metabolic parameters did not achieve statistical significance.
Affibody – Sweden’s Affibord and China’s Inmagene forged a strategic partnership to develop ABY-035, a Phase II drug candidate with best-in-class potential as a treatment for autoimmune diseases. ABY-035 is an innovative fusion protein targeting IL-17. Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in Inmagene’s commercialization territory. Additionally, Inmagene will share the global development costs of select clinical trials and be eligible to receive payments and royalties from Affibody relating to certain global development and commercialization milestones. Affibody will be responsible for the manufacturing and supply of ABY-035 for development and commercialization.
Polyganics – Netherlands-based Polyganics, a medtech company, received €1.2 million from the European Fund for Regional Development to support clinical validation of its Liver and Pancreas Sealant Patch. The grant will support a safety and performance study, which is scheduled to take place later this year in multiple renowned clinical centers across Europe. The patch functions both as a sealant, withstanding the impact of aggressive bile and pancreatic fluids, and as a hemostat, controlling mild-to-moderate bleeding.
BioMed X – Germany’s BioMed X launched its Rapid Antiviral Response Platform. In response to the devastating COVID-19 pandemic, BioMed X strives to develop an arsenal of ultrafast new antiviral drug discovery, development and mass-manufacturing tools that will allow users to go from the identification of a new viral pathogen to 10,000 doses of a safe and potent new medication in less than six months.
CARMAT – France-based CARMAT, the developer of a total artificial heart, announced the Centers for Medicare & Medicaid Services approved coverage of the device and routine care items and services supplied to Medicare beneficiaries to be enrolled in the clinical feasibility study. The study aims to include 10 transplant-eligible patients, and the primary endpoint corresponds to patient survival at 180 days after the implant or a successful heart transplant within 180 days of the implant.
Follicum – Sweden’s Follicum filed an international patent application (PCT) covering the formulation of FOL-005 developed by the company. The patent application is based on new experimental data that supports the use of the formulation for peptides other than FOL-005. The formulation of FOL-005 intended for topical application on the skin has been shown to provide good hair-stimulating effect in an animal model and has been tested in alopecia patients since the beginning of the year in a Phase II clinical study in Germany. If the patent application is granted, it will extend the protection also to cover peptides other than FOL-005.