BioSpace's Global Biopharma Roundup: March 21

World Map made up of colorful Pills

Mutation Analysis Facility -- The Mutation Analysis Facility at Karolinska University Hospital in Stockholm is launching a range of genetic analysis services targeting the growing European research and clinical market in diverse fields such as cancer profiling for solid tumors and liquid biopsy and pharmacogenetics markets. MAF said it will offer a broad portfolio of services including genome-wide analysis, targeted epigenetic analysis, DNA methylation supporting precision medicine research and clinical decisions in routine. Kristina Duvefelt, MAF Laboratory Manager, predicts initial interest will be in MAF’s SNP Genotyping expertise.

Cytovation – Norway-based Cytovation AS treated the first patients in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as a new topical therapy for HPV-induced warts. Cytovation said the start of the trial marks the beginning of clinical development of CyPep-1 in dermatology and oncology applications. Later this year, the company will initiate a Phase I trial of CyPep-1 in malignant tumors. CyPep-1 is a first-in-class lytic agent with broad application across benign and malignant tumors as a result of its novel mechanism of action. CyPep-1 selectively targets tumor cells, forming pores that destabilize and rupture the membrane to kill the cell and release neoantigens into the microenvironment and circulation, while leaving healthy cells intact. Cytovation has formulated CyPep-1 as a cream for the topical treatment of HPV-induced warts, a large medical need for which there are currently no approved drug therapies. The Company has also developed CyPep-1 as a solution for intra-tumoral injection, as a single agent or in combination with checkpoint inhibitors.

Orphanion – Orphanion AG, a CRO/CMO based in Switzerland, finalized a partnering agreement with Kentucky-based LGM Pharma, LLC, a leader in API sourcing, warehousing and distribution services to the pharmaceutical and biotechnology industries. Under the terms of the agreement, Orphanion’s specialty services, such as production of difficult-to-synthesize molecules for niche applications, will be available to LGM Pharma clients. Details of the agreement were not disclosed. Guido Bossi, managing director of Orphanion, said access to LGM’s international experience and global clientele will enable Orphanion to extend our operational reach and broaden the company’s service portfolio in niche market segments.

Mogrify – Cell Mogrify Ltd. secured $555,000 in financing from Innovate UK, the innovation agency based in the United Kingdom. The funding will support the application of Mogrify’s bioinformatic approach to transition three cell therapy products to preclinical stage, with potential application in wound healing, and oncology immunotherapy, the company said. Mogrify will use its patented systematic big-data approach) to identify, from next-generation sequencing and gene-regulatory networks, the sets of highly influential and non-redundant transcription factors (in vitro) or small molecules (in vivo), needed to drive the direct conversion of one mature cell type into another, such as T cells. The reprogramed cells will then be subjected to a number of functional tests to demonstrate bioequivalence and potential as cell therapies, such as CAR-T for the treatment of cancers.

Ono Pharmaceutical – Japan-based Ono Pharmaceutical forged an agreement with twoXAR, Inc., an artificial intelligence (AI)-driven biopharmaceutical company, to jointly discover and develop novel, efficacious treatments to address unmet medical needs in a specific neurological disease. twoXAR will use its proprietary AI technology to identify a set of lead compounds which demonstrate a novel mechanism of action and will be further optimized by Ono for potential drug candidates. twoXAR will also predict a set of hypotheses which suggest the efficacy and safety of such lead compounds for the therapy. The companies will select several compounds with their hypotheses from this set to test in further validation studies. Ono will retain exclusive rights to develop and commercialize the compounds obtained through this collaboration throughout the world, and in return, twoXAR will receive research and license fees from Ono as well as development and sales milestones.

Gradientech -- Speaking at the Novel Antimicrobials and AMR Diagnostics Conference in Berlin, Gradientech, developer of the QuickMIC rapid IVD system for antibiotic susceptibility testing (AST), stressed the importance of adopting new diagnostic approaches in the fight against antimicrobial resistance. Antibiotic resistance is one of the biggest threats to global health today. Its impact is perhaps seen most clearly in the continuing rise in deaths from infections due to bacteria resistant to antibiotics –- at least 33,000 annually in Europe alone. Sara Thorslund, CEO of Gradientech, said the company foresees its IVD QuickMIC system, which is in final development, “will make a real difference by diagnosing bacterial resistance in patients with suspected sepsis in as short as two hours based on bacterial growth.”

Optibrium –U.K.-based Optibrium entered into a collaboration with Germany’s InfoChem GmbH. Optibrium, a developer of software for drug discovery, and InfoChem GmbH will provide StarDrop users with easy access to ICSYNTH light, an entry-level version of InfoChem’s computer-aided synthesis design (CASD) software to generate synthesis pathways for a target molecule. By stimulating new and unbiased ideas, researchers can explore alternative or novel synthetic routes with the potential to save time and reduce costs.

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Nippon Shinyaku Co. – Japan-based Nippon Shinyaku, Co. and California-based Zogenix, Inc. entered into an exclusive distribution agreement regarding the potential commercialization of Zogenix’s Fintepla in Japan. Zogenix is developing Fintepla internationally for the treatment of Dravet syndrome and Lennox-Gastaut syndrome (LGS), two rare and often catastrophic childhood-onset epileptic encephalopathies. Nippon Shinyaku will receive exclusive commercial rights to Fintepla in Japan. In exchange, Zogenix will receive payments totaling $20 million. Zogenix will also be eligible to receive future regulatory and sales-based milestone payments. Zogenix recently completed its rolling submission of a New Drug Application to the U.S. Food & Drug Administration and the submission of a Marketing Authorization Application to the European Medicines Agency for Fintepla

Enterome – France-based Enterome entered into a research and development collaboration with Boston’s Dana-Farber Cancer Institute to evaluate and develop gut microbiome-derived antigens as potential cancer immunotherapies. Enterome is developing an innovative approach to cancer immunotherapy, based on the concept of “molecular mimicry,” whereby microbiome-derived bacterial antigens show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs). The collaboration brings together Enterome’s ability to identify potential TAAs and TSNAs as well as to generate bacterial onco-mimics for the selected TAAs and TSNAs with the complementary translational expertise from the research groups at Dana-Farber Cancer Institute.

Knopp Biosciences—Pittsburgh-based Knopp, a privately-held company, formed a collaborative agreement with a consortium of leading medical researchers in the United Kingdom to evaluate the ability of Knopp’s lead drug candidate, dexpramipexole, to reduce exacerbations in people with severe eosinophilic asthma. Knopp is advancing dexpramipexole into Phase II development in severe asthma and Phase III development in hypereosinophilic syndrome (HES). Eosinophils are white blood cells that play a central role in several debilitating conditions, including asthma, HES, and other inflammatory diseases. In the Phase II UK trial, dexpramipexole or placebo will be administered to 100 asthmatic patients with elevated eosinophil counts.

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