RESEARCH
Evelo Biosciences, Inc. | January 18, 2022
Evelo Biosciences, Inc. a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced data for EDP1815, the Company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis. The data were presented in two posters on Saturday, January 15, 2022, at the 2022 Winter Clinical Dermatology Congress in Koloa, Hawaii.
“The data presented today build on the substantial evidence accumulated through our clinical and preclinical work, deepening our understanding of the mechanism by which EDP1815 drives its clinical effects. They explain how an oral, gut-restricted SINTAX medicine can interact with the immune system in the gut, leading to systemic inflammation resolution without immunosuppression or concerning side-effects. We are particularly pleased to share these results with the clinical community as we progress EDP1815 into later stages of development for the treatment of psoriasis and atopic dermatitis, two inflammatory diseases that affect millions of people worldwide.”
Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo
Preclinical data from the studies presented at the Winter Clinical Dermatology Congress confirm that EDP1815 modulates systemic inflammation through its initial interaction with innate immune receptors, including TLR2, leading to downstream changes in circulating immune-cell phenotypes. In addition, the data demonstrate that preclinical effects in Th17 models translate into signs of clinical benefit in psoriasis, and that preclinical effects in Th2 models translate into signs of clinical benefit in atopic dermatitis, supporting further clinical development of EDP1815 in these indications. A Phase 2 study of EDP1815 in patients with mild to moderate psoriasis is ongoing, and a Phase 2 study of EDP1815 in patients with mild, moderate, and severe atopic dermatitis is expected to initiate dosing in the first quarter of 2022.
About EDP1815
EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from multiple independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act on the small intestinal axis, SINTAX™, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The Company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases.
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MEDICAL
Bio-Techne Corporation | April 13, 2022
Bio-Techne Corporation launched 3G assay for automated process impurity assessment on the EllaTM immunoassay platform ( NASDAQ: TECH ) and Cygnus Technologies, a division of Maravai LifeSciences ( NASDAQ: MRVI ).
In cell and gene therapy applications, the purification of viral particles to reduce host cell protein (HCP) contamination is an important part of the viral production workflow. To guarantee HCP impurity clearance is performed in compliance with regulatory criteria, accurate quantification throughout process phases is required.
The novel Simple Plex HEK 293 HCP 3G test uses a cartridge-based microfluidic design to deliver uniform and controlled assay conditions for HCP detection that is extremely accurate and reproducible. The test has a hands-free procedure and provides data in 90 minutes, providing pharmaceutical developers with a reliable and convenient tool for HCP impurity quantification. Simple Plex assays on the Ella platform, classic immunoassay methods, provide built-in calibration to reduce set-up time and user-dependent variability.
The gold standard in HEK 293 HCP impurity quantification is Cygnus Technologies' HEK 293 HCP ELISA Kit, 3G. With high-tech antibody affinity extraction and heavy spectrometry procedures, the kit's antibody was tested for reactivity to almost 3,000 distinct HCPs present in HEK 293 strains. The kit has been tested with various viral vector-based medicinal compounds and in-process samples, demonstrating that it possesses the specificity and sensitivity to detect HEK 293 HCP contaminants with the reproducibility needed to meet regulatory requirements. The Simple Plex HEK 293 HCP 3G assay uses the same HEK 293 HCP antibodies from market leader Cygnus Technologies, ensuring the Cygnus ELISA's extensive HCP detection coverage and industry-recognized specificity, as well as the automated Ella platform's workflow advantages.
We continue to enjoy the fruits of the Bio-Techne-Cygnus Technologies partnership as it provides the therapeutic development and manufacturing community an automated platform-based approach for HEK 293 host cell impurity testing, Fast and efficient process development and monitoring is crucial for biopharmaceutical companies providing a safe and efficacious product in a cost-effective manner."
Will Geist, President of Bio-Techne's Protein Sciences Segment.
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CELL AND GENE THERAPY
Y-Biologics | November 23, 2020
The South Korean biotech organization Y-Biologics and the French pharmaceutical group Pierre Fabre have declared their arrangements to frame a key association in the field of immuno-oncology research. The choice has been recognized through a letter of aim endorsed by the two players and will be affirmed in the coming a very long time through an itemized arrangement. The joint effort is set to run for a very long time, with the chance of a two-year expansion.
Y-Biologics, which spends significant time in the revelation of monoclonal antibodies, and the Pierre Fabre gathering, France's second-biggest private drug lab, plan to join their subject matters with the point of recognizing and creating novel restorative monoclonal antibodies focusing on key immunosuppressive mechanisms activated within solid tumors.
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