AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

pipelinereview | April 24, 2019

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.3 In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).1 "The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

Spotlight

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

Spotlight

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

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INDUSTRIAL IMPACT, MEDICAL

SOPHiA and MSKCC Partner to Combine Cancer Analysis Technology for Liquid Biopsies

SOPHiA GENETICS | January 13, 2023

SOPHiA GENETICSTM, a leading cloud-native software firm in the healthcare industry, recently announced that it has partnered with Memorial Sloan Kettering Cancer Center (MSKCC) to provide physicians and researchers with new testing and analytic capabilities. The collaboration includes the incorporation of proprietary Comprehensive Genomic Panel (CGP) sequencing tests, such as MSK-ACCESS®, which SOPHiA GENETICS will market as the first comprehensive ctDNA liquid biopsy test powered by the SOPHiA DDMTM platform. By integrating predictive algorithms, the power of the global SOPHiA GENETICS network, and the clinical knowledge of MSK in cancer genomics, specialists hope to broaden their access to capabilities for precision cancer analysis. SOPHiA GENETICS and MSK will work together to further develop MSK-ACCESS®, ensuring that the solution leverages the advanced analytics of the SOPHiA DDMTM platform. The enhanced assay will be designed to align with the latest guidelines and clinical trial data reflecting major actionable biomarkers. As part of this agreement, SOPHiA GENETICS plans to develop a new clinical-genomic, cloud-native analytics platform that enhances the impact of MSK’s extensive precision oncology data. This involves the application of sophisticated machine learning algorithms to examine vast amounts of multimodal data points to get new insights. The new SOPHiA CarePathTM module's goal, in conjunction with MSK's CGP sequencing assays, aims to improve cancer care worldwide. About SOPHiA GENETICS SOPHiA GENETICS is a cloud-native software company committed to establishing data-driven medicine as the standard of care and for life sciences research. It offers the SOPHiA DDM™ as a cloud-based SaaS platform that enables healthcare organizations to obtain quick and accurate insights from their data. The platform is currently being used by a broad network of hospitals, laboratories, and biopharma institutions globally. By applying its technology to diseases such as cancer and hereditary disorders, it facilitates the integration of genomic and phenotypic data, which is crucial for supporting discoveries, treatment decisions, and drug development activities. In addition, SOPHiA GENETICS supports its mission of bringing data analytics solutions to market through the global adoption of SOPHiA AI, built using techniques such as statistical inference, pattern recognition, and machine learning.

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INDUSTRIAL IMPACT

IPA’s Subsidiary BioStrand and BriaCell Announce Artificial Intelligence Collaboration and License Agreement

BriaCell Therapeutics Corp. | December 01, 2022

IPA an advanced biotherapeutic research and technology company, announced that BioStrand BV an AI in silico discovery subsidiary of IPA, has entered into a research collaboration and license agreement with BriaCell Therapeutics Corp. a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer. The collaboration will leverage BioStrand’s LENSai™ software, built upon IPA’s proprietary HYFT™ Universal Fingerprint™ technologies, and will focus on in silico antibody discovery to generate relevant clinical molecules for potential development. Under the terms of the Agreement, BioStrand and BriaCell will collaborate on the design, discovery, and development of anti-cancer antibodies. Upon successful antibody discovery, BioStrand will receive an upfront payment of US$500,000, and will be eligible to receive future success-based development milestones, including those for the submission of Investigational New Drugs clinical milestone payments, and commercial royalties on net sales of products. Further terms are not disclosed. “We are very excited to begin this program with BriaCell and apply our technology to the development of biologics that may have a huge clinical impact. Shortening timelines, while also integrating as much information as possible upstream to improve the efficiency of the process, is extremely important in the development of highly targeted therapies. It is a step towards realizing our long-term vision of significantly advancing precision medicine.” Dr. Ingrid Brands, General Manager and co-founder of BioStrand “We believe that BioStrand’s revolutionary AI-powered technology, combined with its cutting-edge protein engineering platform, will allow us to design and discover potent anti-cancer therapeutics,” stated Miguel A. Lopez-Lago, PhD, Chief Scientific Officer of BriaCell. “This approach would complement BriaCell’s current immunotherapy pipeline of innovative anti-cancer therapeutics.” About BriaCell Therapeutics Corp. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. ImmunoPrecise Antibodies Ltd. ImmunoPrecise Antibodies Ltd. has several subsidiaries in North America and Europe including entities such as Talem Therapeutics LLC, Biostrand BV, ImmunoPrecise Antibodies Ltd. and ImmunoPrecise Antibodies B.V. The IPA Family is a biotherapeutic research and technology group that leverages systems biology, multi-omics modelling and complex artificial intelligence systems to support its proprietary technologies in bioplatform-based antibody discovery. Services include highly specialized, full-continuum therapeutic biologics discovery, development, and out-licensing to support its business partners in their quest to discover and develop novel biologics against the most challenging targets.

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MEDTECH, INDUSTRIAL IMPACT

Cybin Announces Key Findings From Sponsored Kernel Flow® Feasibility Study

Cybin | January 19, 2023

On January 18, 2023, Cybin Inc., a leading biopharmaceutical firm focused on advancing Psychedelics to Therapeutics®, announced the key findings from a feasibility study undertaken by its partner Kernel, which evaluated Kernel's Flow® wearable technology to assess ketamine's psychedelic effect on cerebral cortex hemodynamics. The findings of this Cybin-sponsored study are meant to guide the program's future direction. The key highlights of the feasibility study are It offered important proof-of-concept for Kernel Flow as a portable functional system that delivers real-time measurements of blood oxygenation changes in the brain linked with neural activity utilizing Time Domain Near Infrared Spectroscopy (TD-fNIRS). Exhibited changes in functional brain biomarkers caused by ketamine that are related to potential therapeutic effects, including changes in cortical function associated with psychedelic experiences. Compared to saline, ketamine reduces the global brain connectivity of the prefrontal region and decreases the brain-wide fractional amplitude of low-frequency fluctuations (fALFF). It has been proposed that fALFF is of particular functional significance within the default mode network, which has been demonstrated to be modulated by psychedelics and is associated with several neuropsychiatric conditions. A model incorporating neurological and physiological metrics successfully predicted mystical experience scores on the Revised Mystical Experience Questionnaire, which has been shown to mediate reductions in depressive symptomatology in prior studies. Displayed reliable pulse rate variability (PRV) and physiological measurements of pulse rate (PR) from TD-fNIRS recordings that correspond to those obtained from commercial external photoplethysmography sensors, thereby eliminating the need for external sensors to measure cardiac activity in future experiments. Ketamine increased PR, decreased PRV, increased absolute oxy-hemoglobin concentrations and decreased deoxy-hemoglobin concentrations while increasing electrodermal activity (measured by an external sensor), providing additional physiological measures of the impact of the ketamine doses administered in the study. The main goal of the feasibility study was to find out how people who had been given ketamine felt about wearing Kernel Flow while in an altered state of consciousness. The feasibility study was granted FDA Investigational New Drug approval in October 2021 and US Institutional Review Board approval in January 2022. About Cybin Founded in 2019 and headquartered in Canada, Cybin is a biotechnology company that develops psychedelic pharmaceutical treatments for a variety of psychiatric and neurological disorders. It collaborates with a network of world-class partners and internationally recognized scientists to develop safe and effective treatments for patients dealing with a wide range of mental health conditions. The company is currently operating in the United States, Canada, the United Kingdom, Ireland, and the Netherlands.

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