BioSpace Global Roundup, Sept. 26


Bayer -- The European Medicines Agency approved Bayer’s Vitrakvi (larotrectinib) for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors that have NTRK gene fusion. With this approval, Vitrakvi is the first therapy in Europe with a tumor-agnostic indication, meaning that it works across many different tumor types (lung, colon, thyroid and various other sarcomas) that have the same NTRK genomic abnormality. The approval comes just ahead of Bayer’s presentation of Vitrakvi data at the European Society for Medical Oncology Congress in October. New data on the durability of response in adult and pediatric patients with TRK fusion cancer treated with Vitrakvi will be highlighted in a poster discussion. Vitrakvi was approved by the U.S. Food and Drug Administration in November 2018 under accelerated approval based on overall response rate and duration of response. Vitrakvi is approved for the treatment of adult and pediatric cancer patients with solid tumors with an NTRK gene fusion.

GlaxoSmithKline – Pharma giant GSK will share interim data on the effectiveness of mepolizumab in severe eosinophilic asthma patients from multiple countries in a real-world setting at the European Respiratory Society congress in Madrid. The presentation will be the first global prospective real-world study of a biologic treatment in patients with severe eosinophilic asthma. Real-world studies are designed to test the effectiveness and safety of a medicine compared to existing treatments as patients go about their daily lives, rather than the efficacy and safety of a medicine in a tightly controlled environment, which is how traditional randomized clinical trials are designed. In addition to the study results, GSK will present results of scientific studies designed to further understanding of the pathology and biology of respiratory diseases.

BioMed X – Germany-based BioMed X completed its first research collaboration project with Roche Diagnostics in the field of nanomaterial-based biosensors for near-patient testing. BioMed X successfully achieved the proof of principle for a new sensor platform allowing the analysis of several different parameters from blood samples with one single device, the company said. The project using BioMed X’s proprietary crowdsourcing platform for project proposals was initiated in 2015. As a result of an international innovation challenge, a team of early-career researchers from five different countries worked in Heidelberg on the design of a field-effect transistor-based multimodal sensing platform for proteins, blood gases and electrolytes, metabolites and enzymes with a single-use disposable material for point-of-care diagnostics. Following BioMed X’s strategy, the intellectual property has been transferred to Roche Diagnostics for further development.

Inventiva – France-based Inventiva secured a capital increase of €8.2 million subscribed by New Enterprise Associate, a leading US biotech investor and by BVF Partners L.P. and Novo Holdings A/S. Gross proceeds from the transaction will primarily be used for general corporate purposes including funding operations and the development of the company’s products, especially lanifibranor and odiparcil. Frederic Cren, Inventiva’s chairman and chief executive officer, said the company is looking forward to the clinical results of lanifibranor and odiparcil, which are expected in the first half of 2020 and by the end of this year respectively.

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Affibody AB – Sweden-based Affibody and GE Healthcare forged a strategic partnership to develop and commercialize Affibody-based PET imaging tracers, with initial focus on HER2 and PD-L1. Financial terms of the deal were not disclosed. The PD-L1 binding Affibody molecule is being developed as a diagnostic tool to improve the selection and monitoring of patients with immuno-oncology treatments. The collaboration with GE Healthcare will accelerate studies through to a stage of clinical proof of concept.

GenSight Biologics – Gene therapy-focused GenSight presented results from 96 weeks of its Phase III RESCUE trial evaluating the safety and efficacy of GS010 (rAAV2/2-ND4) in patients with vision loss due to Leber Hereditary Optic Neuropathy. The results point to continued efficacy of GS010 two years past injection, with best-corrected visual acuity (BCVA) sustaining a clinically meaningful improvement over nadir, France-based GenSight said. Having been treated early in the course of the disease, RESCUE patients’ vision initially deteriorated to a worst point, or nadir, before beginning to recover. According to data from the company’s Phase III RESCUE trial, which included participants whose vision loss started up to six months before treatment, 58% of patients experienced clinically relevant recovery from their lowest visual acuity measurement. For these patients, this improvement is the difference between being diagnosed as legally blind, a diagnosis given when a patient is unable to read the first five letters of an ETDRS eye chart. Based on these results, GenSight plans to schedule a pre-submission meeting with the European Medicines Agency early next year and to submit an application for marketing approval by the third quarter of 2020.

Deinove – France-based DEINOVE expanded its technological platform with an advanced genetic tool, the CRISPR-cas9 system, to enhance its ability to optimize various microorganisms. The objective for DEINOVE is to be able to directly manipulate the strains producing antimicrobial activities or to transfer these activities into phylogenetically close frames. This has been successfully achieved by the Company which has made the Streptomyces chassis an effective producer of a pharmaceutical intermediate initially produced by Microbacterium arobescens.

St. George Street Capital – A U.K. registered charitable organization, St. George signed a license agreement with AstraZeneca to develop two compounds in the clinic: one for idiopathic male infertility, and the other for renal transplant rejection. The agreement enables additional compounds to be added in the future. The two compounds to be developed are part of AstraZeneca’s Emerging Innovation Unit, which explores drug re-purposing for novel indications by working with academic institutions through its Open Innovation program. Following clinical development, AstraZeneca has a right of first negotiation to take the compounds back for further development through to Phase III and commercialization. 

GE Healthcare -- ÄKTA go, a new compact liquid chromatography system, developed at GE Healthcare Life Sciences in Uppsala, Sweden, will be commercially available at the end of 2019. It has been developed to support researchers in academia and biotech companies to achieve desired protein purity in a simple and reliable manner. Features of Atka go include routine protein purification, intuitive method creation in minutes and interactive process picture for full control and easy access to manual controls during method runs.

SpringWorks Therapeutics -- The European Commission granted Orphan Drug Designation to SpringWorks’ nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of soft tissue sarcoma. SpringWorks is currently enrolling patients in the Phase III DeFi trial of nirogacestat for the treatment of adult patients with progressing desmoid tumors, a type of soft-tissue tumors that are often treated by sarcoma specialists. Desmoid tumors are rare and often debilitating and disfiguring, and can aggressively invade surrounding healthy tissues and cause significant morbidities, including severe pain, internal bleeding, incapacitating loss of range of motion, and, in rare cases, death.

NorthSea Therapeutics – Netherlands-based NorthSea dosed the first patient in a Phase IIb trial with icosabutate, an experimental treatment for NASH (Non-alcoholic Steatohepatitis). The ICONA study (ICOsabutate in NASH) aims to randomize 264 patients to one of three different treatment groups; placebo, icosabutate 300mg and icosabutate 600mg with a treatment period of 52 weeks. The study’s primary endpoint is the resolution of NASH without worsening of fibrosis, based on changes in liver biopsy parameters from baseline to 52 weeks. Icosabutate, NST’s lead product, is a structurally designed fatty acid that regulates pivotal pathways involved in hepatic lipids, inflammation and fibrosis.

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