BioSpace Global Roundup, May 16
Gecko Biomedical – Paris-based Gecko is rebranding. The privately-owned life science company is changing its name to TISSIUM as part of an overall rebranding of the company. The new name more accurately reflects the company’s mission to develop novel solutions for tissue reconstruction for multiple clinical indications, the company announced. TISSIUM has robust product development and manufacturing capabilities and is able to bring new products to market independently, or in partnership with other industry players. Christophe Bancel, chief executive officer of TISSIUM, said the rebranding was undertaken as part of an opportunity to showcase the company’s platform of biomorphic programmable polymers that are designed to change the way the industry thinks about tissue reconstruction. The rebranding reflects that intent, Bancel said in a statement.
Valbiotis – France-based Valbiotis completed its Phase IIa study of Valedia in pre-diabetic subjects. The results of the study will be presented at a medical conference before July 31, the company said. The international Phase IIA study evaluated the efficacy of TOTUM-63, the active ingredient of Valedia, in reducing one or more of the three risk factors of type 2 diabetes. In addition to these prediabetes results, the study will evaluate other physiological parameters, including, for example, triglyceride regulation or intestinal microbiota composition.
ValGenesis, Inc. -- Validation Lifecycle Management System (VLMS) software solutions provide ValGenesis opened a new office in Munich. The new office expands the California-based company’s international presence and will support its overall growth strategy and values. The company said it plans to strengthen its presence in the region in order to better serve its European customers. Located in the heart of Munich, ValGenesis said the new office will allow the company to work more closely with customer ecosystems. ValGenesis also maintains offices in the Netherlands and India.
SensID GmbH – Sweden-based SensID and Germany-based TATAA Biocenter AB forged a distribution agreement. SensID gives TATAA full access to its continuously growing product portfolio for Molecular Diagnostics, and TATAA will represent SensID in Sweden, Denmark, Norway, Finland, Czech and Slovak Republics. Björn Nowack, CEO and co-founder of SensID said the agreement with TATAA Biocenter is “further confirmation of the high commercial value of our product concept and business model.”
NeuClone Pharmaceuticals Ltd. – Biosimilar maker NeuClone will begin a Phase I study of its biosimilar to Johnson & Johnson’s Stelara, an IL-12 and -23 inhibitor, in the second half of this year. Stelara (ustekinumab) is a human monoclonal antibody approved for treatment of moderate to severe plaque psoriasis in adults and children 12 years or older. It is also approved to treat active psoriatic arthritis and moderate to severe Crohn’s disease in adults. Australia-based NeuClone’s biosimilar is called ‘NeuLara’. The multi-center Phase I trial of NeuLara will be a three-arm, randomized, double-blind, single-dose study comparing the pharmacokinetics and safety of NeuLara, to the U.S.- and EU-sourced Stelara in healthy volunteers. This is the second biosimilar to enter clinical development from the company’s 10-biosimilar product portfolio with manufacturing partner Serum Institute of India.
Theranica – Israel-based Theranica, a med-tech company, announced that Omron Ventures has backed the company’s $35 million Series B financing round. Omron has committed to providing key insight and support to Theranica as the remote electrical neuromodulation startup continues to develop its unique approach to acute treatment of migraine. The new funds will allow Theranica to mass produce its product, Nerivio Migra, the company's remote electrical neuromodulation device for acute treatment of migraine. The company’s first low-cost, low side effect wearable, the Nerivio Migra addresses migraines and is currently under review of the FDA.
Zymeworks Inc. – Canada-based Zymeworks entered into a licensing agreement with Iconic Therapeutics, Inc. that grants the company non-exclusive rights to Zymeworks’ proprietary ZymeLink antibody-drug conjugate (ADC) platform for the development of its ICON-2 Tissue Factor ADC for cancer. This is the first collaboration leveraging the ZymeLink platform and represents Zymeworks’ third technology platform licensed to a collaborator. Under the terms of the agreement, Zymeworks will be eligible to receive development and commercial milestone payments and tiered royalties on worldwide net sales. The agreement also provides Zymeworks co-promotion rights with increased royalties for products developed using the Iconic ADC program. If Iconic out-licenses the program, in lieu of co-promotion rights, Zymeworks will receive a share of the revenue Iconic receives from any partners as well as tiered royalties on worldwide net sales.
Plant Bioscience – U.K.-based Plant Bioscience Ltd. granted Leaf Expression Systems Ltd. the exclusive rights to sub-license the Hypertrans transient expression system, the core technology underpinning Leaf’s biologics and vaccines contract development and manufacturing services business. This effectively transfers to Leaf full control of the Hypertrans technology and associated patented intellectual property, the company announced. The Hypertrans system allows for the simultaneous production of multiple gene products in a controlled and coordinated manner within the tissues of plants.
InteRNA -- Netherlands-based InteRNA Technologies announced the publication of data from a collaboration with University Medical Center Utrecht that shows the downregulation of miR-135a levels can reduce seizure activity after the onset of spontaneous recurrent seizures (SRS) in chronic-stage Mesial Temporal Lobe Epilepsy (mTLE) in mouse models. miR-135 is a microRNA (miRNA) known to control neuronal morphology and synaptic function that is upregulated in neurons in the epileptic brain. The data support the overall potential of miRNAs as a treatment modality in complex diseases and also underscore InteRNA’s expertise in the application of miRNAs as a new therapeutic approach. The research paper titled, Antagonizing increased miR-135a levels at the chronic stage of experimental TLE reduces spontaneous recurrent seizures” was published in the Journal of Neuroscience on April 23.
GenSight – GenSight Biologics, based in Paris, reported positive 96-week Phase III data from its REVERSE trial evaluating the safety and efficacy of a single intravitreal injection of GS010 as a treatment for vision loss due to Leber Hereditary Optic Neuropathy (LHON). The results point to continued efficacy of GS010 two years past injection, with best-corrected visual acuity (BCVA) sustaining a clinically meaningful improvement over baseline. At Week 96, GS010-treated eyes showed a clinically meaningful level of improvement in visual acuity.