BioSpace Global Roundup, Aug. 29


Velabs Therapeutics – Germany-based Velabs, a company specializing in the fast generation of functional therapeutic antibodies, struck a deal with Chiome Bioscience, Inc., Tokyo to jointly discover modulatory and functional antibodies for one of Chiome’s GPCR target genes. The deal will attempt to capitalize on Velabs’ microfluidics-based technology in the field of functional antibody screening. Under the terms of the agreement and after successful completion of an initial feasibility phase, Velabs will receive milestone payments upon the achievement of specific development and regulatory events. In addition, Velabs will also be eligible to receive tiered royalties and milestones on the worldwide sales of products that arise from the collaboration. Velabs Therapeutics is a startup company of the European Molecular Biology Laboratory and financed by Swiss-based Xlife Sciences Ltd. Velabs is currently also establishing its own proprietary pipeline of therapeutic antibody candidates for further joint development with pharma partners.

Inventiva – Inventiva, based in France, announced its abstract on the evaluation of lanifibranor in a pre-clinical model of cirrhosis has been selected by the American Association for the Study of Liver Diseases for an oral presentation at the upcoming The Liver Meeting 2019 in Boston. The study focused on lanifibranor in a pre-clinical model of cirrhosis. The results clearly showed that lanifibranor exerts beneficial effects producing a marked regression of liver fibrosis and decreasing portal hypertension. In addition, lanifibranor strongly reduced hepatic inflammation, and improved the phenotype of liver sinusoidal endothelial cells and hepatic stellate cells. These promising results demonstrate the potential of lanifibranor for the treatment of advanced chronic liver disease.

Also, this week, Inventiva announced the European Patent Office granted the company a new patent protecting the use of lanifibranor in 38 European countries in the treatment of several fibrotic diseases, including non-alcoholic steatohepatitis (NASH), until June 2035.

Gradientech – Sweden-based Gradientech has received a Notice of Allowance from the United States Patent and Trademark Office for its patent application, “Use of Fluidic Device.” The patent application covers the proprietary minimum inhibitory concentration determination of a bacterial sample within a microfluidic controlled environment that is part of the technology platform of the company’s diagnostic system QuickMIC for ultra-rapid AST in development.

CARMAT – France-based Carmat, developing an artificial heart project that aims to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced the approval to resume patient enrollment for the second part of the company’s PIVOTAL study being conducted in Denmark. Following the changes implemented at prosthesis manufacturing process level, the company was obliged to resubmit clinical trial authorization requests in these countries. The competent authorities in Denmark are the first to give Carmat their approval to continue the clinical study with the new prostheses. The implants will be performed at the Rigshospitalet's Department of Cardiology in Copenhagen in accordance with the requirements of its ethical committee.

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rfXcel – Nevada-based rfxcel, a leader in supply chain track and trace solutions, doubled the size of its workforce in Russia and is pursuing deals in new industries, most notably retail and branded goods. The new Russian staff joining rfxcel’s Moscow-based operations bring expertise in key areas of supply chain management and technology. rfxcel entered the Russian market with a roster of clients in the pharmaceutical industry. It is helping companies meet the country’s complex regulatory requirements, including strict serialization guidelines that will go into effect on January 1, 2020. Russia’s pharmaceutical market is expected to reach $38 billion by 2021.

Atlantic Research Group – Atlantic Research Group, a contract research organization based in Virginia, opened offices in Amsterdam and Warsaw to complement its existing European offices in London. ARG has managed clinical studies in The Netherlands and Poland since 2006. By opening offices in Amsterdam and Warsaw, ARG will significantly strengthen its reach across Europe and enhance its capability to better serve small to mid-sized biotech companies.

Okyo Pharma Ltd. – London-based Okyo announced potent anti-inflammatory activity of OK-113, a proprietary agonist of Chemerin GPCR, in an experimental model of dry eye disease (DED) in mice. These preclinical efficacy data, identifying a lead drug candidate, will facilitate initiation of clinical studies for DED treatment in 2020. Topical treatment, as eye drops, with OK-113 showed potent anti-inflammatory effects to reduce corneal permeability and other symptoms of dry eye in a mouse model of DED. In these studies, OK-113 was as potent as cyclosporine, an immunosuppressive drug which is the active ingredient of Allergan’s Restasis. Targeting GPCR has proven to be an innovative approach for treatment of a wide range of inflammatory diseases, cancers and non-opioid analgesics for management of chronic pain. More than 40% of the drugs available in the global market target GPCR.

Medtec China -- Medtec China 2019 will be inaugurated on Sept. 25 in Shanghai. Compared to last year, the scale of Medtec China 2019 will expand by 30%, hitting a new high in its history. Medtec China will gather more than 450 exhibitors from medical design and development, raw materials, precision parts, molds, medical automation equipment, regulatory consulting and other fields. Medtec China 2019 expects to receive 25,000 professional visitors this year. As the event enters the last-month countdown, here we would like to introduce the seven key focal components of Medtec China 2019.

Lannett Company – Philadelphia-based Lannett entered into an agreement with China-based Sinotherapeutics, Inc., a specialty pharmacy company, to be the exclusive U.S. distributor of Posaconazole Delayed-Release Tablets 100mg. Sinotherapeutics has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Posaconazole Delayed-Release Tablets 100mg, which is an AB-rated generic equivalent of Merck's Noxafil Delayed-Release Tablets. Lannett expects to commence shipping the product shortly. Under the agreement, Lannett will make milestone payments based on market dynamics and performance. The company will provide sales, marketing and distribution and will receive a share of the profits. Other terms were not disclosed. The brand product's annual U.S. sales were approximately $325 million for the 12 months ended June 2019, according to IQVIA, although actual generic market values are expected to be lower, the company said.

SenzaGen – Sweden-based SenzaGen expanded its portfolio with the launch of GARDskin Medical Device – a new test to assess whether medical devices can cause skin allergies. The launch of GARDkin Medical Device will take place at the Eurotox congress in Helsinki on Sept. 8-11. The Medical Devices market is a large and very interesting market for the company. The target group for GARDskin Medical Device is initially medical device companies that perform sensitization tests during their product development and have high quality and safety requirements for the risk assessment related to their materials. With this test, SenzaGen meets the needs of an additional customer group and strengthens its position in the global market for cell-based in vitro tests.

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