BioSpace Global Roundup, March 5
Evonetix Ltd. – U.K.-based Evonetix closed a $30 million Series B financing round that will be used to accelerate internal technology development, including the integration of Evonetix’s technology to enable the synthesis of DNA on a chip. The investment will fund the company through to the introduction of its desktop DNA platform which, once fully developed, will facilitate and enable the rapidly growing field of synthetic biology, with application across industries including healthcare, pharma, biotech, food and agriculture and data storage. The investment will also support the company’s recruitment plans, as it continues to increase headcount across scientific, operational and commercial staff located at Evonetix’s state-of-the-art facility at Coldhams Business Park, Cambridge, U.K. The financing round was led by new investor Foresite Capital. Existing investors, Draper Esprit, DCVC (Data Collective), the Morningside group, Providence Investment Company, Cambridge Consultants Ltd, Rising Tide Fund, and Civilization Ventures, also all participated in the round.
Implandata – Germany-based Implandata Ophthalmic Products GmbH (Implandata) announced that study enrolment of its international ARGOS-SC01 clinical study was completed with the inclusion of the 24th study patient. This first-in-human clinical study is conducted to validate the suprachoroidally placed EYEMATE-SC sensor implant for continual monitoring of intraocular pressure (IOP). While Implandata’s already CE marked EYEMATE-IO intraocular sensor implant is intended for use at glaucoma patients undergoing cataract surgery, the EYEMATE-SC device allows implantation at glaucoma patients not indicated for cataract surgery yet, thus complementing Implandata’s product offering and expanding the indication of use of the EYEMATE-system.
TTP Plc – TTP, based in the U.K., and Italy-based DiaSorin, signed an exclusive license and technology agreement to combine DiaSorin’s molecular test offering with TTP’s Puckdx platform to develop a single-use, sample-to-answer, molecular diagnostics point-of-care platform for human IVD applications. TTP’s proprietary Puckdx platform provides a quick and inexpensive solution for translating diagnostic assays for human and animal health and life science research to an easy-to-use desktop device.
CN Bio – Cell culture company CN Bio Innovations, based in the U.K., raised $9 million to support commercial development and strengthen CN Bio’s position in its key market, the US, while also expanding operations across Europe. The funding will help drive sales of the company’s products and services including the PhysioMimix platform. CN Bio has also announced the relocation and expansion of its headquarters to the Cambridge Science Park, UK, including 4,000 sq. ft. of laboratory space. CN Bio’s micro-physiological systems enable researchers to study drug metabolism, toxicology and specific disease models on single- and multi-organ systems.
MeiraGTx – London-based MeiraGTx Holdings plc announced the European Medicines Agency (EMA) granted Priority Medicines (PRIME) and Advanced Therapy Medicinal Product (ATMP) designations to AAV-RPGR, MeiraGTx’s investigational gene therapy for the treatment of x-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene. MeiraGTx is developing AAV-RPGR with Janssen Pharmaceutical. The designations were granted based on clinical data from MeiraGTx and Janssen’s ongoing Phase 1/2 trial of AAV-RPGR in patients with XLRP. AAV-RPGR is the only gene therapy in development for the treatment of XLRP to receive PRIME designation.
Takeda – Japan-based Takeda announced the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Alunbrig (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is a next-generation tyrosine kinase inhibitor (TKI) that was designed to target and inhibit ALK genetic alterations. The positive opinion for Alunbrig will now be reviewed by the European Commission for potential approval.
Transgene -- France’s Transgene and Sweden’s BioInvent International AB joined together to present preclinical data on BT-001 at several upcoming scientific congresses in March and April 2020. BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent. It is based on Transgene’s Invir.IO platform and patented, large-capacity VVcopTK-RR- oncolytic virus. BT-001 has been engineered to encode a Treg-depleting, anti-CTLA4 antibody derived from BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, as well as the cytokine GM-CSF.
Mimetas – Netherlands-based Mimetas announced the first product release of its Assay Ready product line, OrganoPlate Caco-2. The product consists of 38 intestinal tubules that are grown under flow conditions against an extracellular matrix. The OrganoPlate Caco-2 features 38 Caco-2 tubules and two controls. Caco-2 is a human colon adenocarcinoma cell line with well-preserved barrier, receptor, and transporter characteristics. It will be the first in a line-up of products that will further support the adoption of Organ-on-a-Chip.
MiNA Therapeutics – RNA-activation therapeutics company MiNA Therapeutics, based in London, announced the first patient treated in its Phase I/Ib clinical study of MTL-CEBPA in combination with anti-PD1 checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is designed to assess the safety, tolerability, pharmacology and clinical activity of MTL-CEBPA in combination with pembrolizumab in these patients. The drug candidate is also being investigated in an ongoing multi-center Phase Ib clinical trial in patients with advanced liver cancer in combination with sorafenib. In pre-clinical studies MTL-CEBPA has been shown to improve the anti-tumor activity of anti-PD1 checkpoint inhibition by reducing immune suppression from dysregulated myeloid cells in the tumor microenvironment.
Viroclinics Biosciences – Netherlands-based Viroclinics acquired DDL Diagnostic Laboratory, a leading diagnostic solutions provider. The transaction enhances the combined group's leading global position in anti-viral and vaccine testing and will serve to accelerate their ambitious growth strategy. Viroclinics is the global leader in influenza and other viral targets, such as RSV and Polio, while DDL also specializes in the fields of Hepatitis and HPV. The combined organization will operate from four testing laboratories located in Europe and China, with access to a global network of processing facilities across 20 countries to coordinate sample collection in strategic regions worldwide to serve global trials. The combined business will employ 240 specialized scientists, researchers, technicians and support staff.
Novasep – France-based Novasep launched its new Biopharma Solutions Business unit helmed by Cédric Volanti. The new business unit encompasses all of Novasep Belgium's activities. Over the past few years, and especially with the construction of the new bioproduction units have undergone unprecedented development as well as a cultural shift to match this move toward manufacturing on an industrial scale. This is a response to the growing demands of the Biopharma market, particularly in the Gene Therapy and Viral Vector segments, the company said.
Iktos – France’s Iktos, an AI-focused company, and SRI International, a research center headquartered in Menlo Park, Calif., announced that the companies have entered into a collaboration agreement designed to accelerate discovery and development of novel anti-viral therapies. Under the collaboration, Iktos’ generative modeling technology will be combined with SRI’s SynFini, a fully automated end-to-end synthetic chemistry system, to design novel, optimized compounds and accelerate the identification of drug candidates to treat multiple viruses, including influenza and the Wuhan coronavirus (COVID-19). By combining platforms for the accelerated molecular design and automated production of target molecules with established high-throughput biology, Iktos and SRI hope to demonstrate a new paradigm in extremely rapid drug discovery against high-value pharmaceutical targets.
TISSIUM – Privately-held France-based Tissium secured a financing tranche that will accelerate its development of a drug-eluting tissue adhesive to address the unmet needs of Chronic Rhinosinusitis (CRS) patients. Approximately 60% of CRS patients are not responsive to medical treatment. Furthermore, surgical procedures do not directly address the underlying inflammation, and more than 65% of patients end up with returning symptoms.
NuCana – Scotland’s NuCana plc announced the EMA’s Committee for Orphan Medicinal Products issued a positive opinion for orphan drug designation of Acelarin for the treatment of patients with biliary tract cancer. Acelarin, in combination with cisplatin, is currently being evaluated in a global Phase III study for the first-line treatment of patients with biliary tract cancer. NuCana previously received Orphan Drug Designation for Acelarin from the FDA’s Office of Orphan Products for the treatment of patients with biliary tract cancer.
Cellink – Based in France, Cellink received funding from Vinnova for a project in collaboration with ibidi GmbH and Sweden’s Naturwissenschaftliches und Medizinisches Institut (NMI). The project will start in August this year and is expected to run until 2023. The project aims to develop a new organ-like in vitro model of the proximal tubule in a microfluidic perfusable device in multiwell plate format for use in drug development and testing, the company said. It is hoped the project can develop a screening system for developing therapies for renal diseases. These diseases affect both men and women, as well as young and elderly individuals.
Ilya Pharma – A Phase I wound care therapy trial conducted by Sweden’s Ilya Pharma has progressed to multiple dosing. The trial is assessing ILP100, the first drug based on genetically engineered lactic acid bacteria to be approved to enter trials as a topical treatment. ILP100 represents both a novel drug delivery technology and a novel investigational new product (IMP) and is classified as an advanced therapy medicinal product by the EMA and as a low risk gene therapy candidate by the FDA. The company is preparing for Phase II.