Regeneron Starts Phase REGN-COV2 Phase 3 COVID-19 Prevention Trial

Regeneron | July 07, 2020

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19. A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19. This clinical progress follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19. The Phase 3 prevention trial is being conducted at approximately 100 sites and is expected to enroll 2,000 patients in the U.S.; the trial will assess SARS-CoV-2 infection status. The two Phase 2/3 treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer. All trials are adaptively-designed, and the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase 2 studies.

Spotlight

Technologies of the Fourth Industrial Revolution1 are blurring the lines between the physical, digital and biological spheres of global production systems. The current pace of technological development is exerting profound changes on the way people live and work. It is impacting all disciplines, economies and industries, perhaps none more so than production, including how, what, why and where individuals produce and deliver products and services.

Spotlight

Technologies of the Fourth Industrial Revolution1 are blurring the lines between the physical, digital and biological spheres of global production systems. The current pace of technological development is exerting profound changes on the way people live and work. It is impacting all disciplines, economies and industries, perhaps none more so than production, including how, what, why and where individuals produce and deliver products and services.

Related News

AI

Charles River and Valence Discovery Declare Strategic Partnership to Provide AI-Enabled Drug Design Capabilities to Clients

Valence Discovery, Charles River | April 08, 2021

Charles River Laboratories International, Inc. and Valence Discovery today reported the arrangement of an essential association to give customers admittance to Valence's computerized reasoning stage for sub-atomic property expectation, generative science, and multiparameter improvement. Expanding on research done by Valence's establishing group at Mila, the world's biggest profound learning research organization, the Valence stage empowers the plan of little atom drug up-and-comers in novel districts of compound space, trailed by quick streamlining against project-explicit strength, selectivity, security, and pharmacology rules. Valence has spearheaded the utilization of few-shot learning in drug configuration, permitting the organization to open forecast errands for which just modest quantities of preparing information are accessible, defeating a basic constraint of existing AI advances in drug revelation. Banding together to Accelerate Discoveries By consolidating top tier AI advances with Charles River's start to finish abilities, the coalition can possibly essentially speed up revelation endeavors from hit plan through lead improvement. Through the cooperation, Charles River customers will have the alternative to get to Valence's foundation to help their medication revelation endeavors. When exploiting this alternative, customers can expect expanded variety in substance matter being examined, in mix with more fast improvement against complex, project-explicit plan measures, at last diminishing courses of events and improving achievement rates for drug revelation projects. Affirmed Quotes "This coordinated effort reflects Charles River's continuous obligation to improving our arrangement of creative innovation arrangements. We anticipate utilizing Valence's exceptional stage to improve results for our customers." – Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services, Charles River "The Valence stage offers a stage change improvement over existing again plan advancements. We've been reliably intrigued by Valence Discovery's capacity to create top notch synthetic matter that is promptly synthesizable, in novel areas of compound space, from datasets not in any case open to AI strategies." – Grant Wishart, PhD, Director of Computer Aided Drug Design, Charles River "We are excited to collaborate with Charles River, a worldwide pioneer trusted by numerous individuals of the world's top drug and biotech organizations. This cooperation is a significant advance in facilitating our central goal of engaging each medication disclosure researcher with the most recent developments in AI-empowered medication plan."– Daniel Cohen, CEO of Valence Discovery About Valence's AI-Enabled Drug Design Platform The Valence stage develops the scholarly community driving exploration done by the organization's establishing group at Mila, the world's biggest profound learning research foundation. Specifically, Valence has spearheaded the use of not many shot learning in drug configuration, permitting the organization to open forecast assignments for which just limited quantities of preparing information are accessible, including novel targets and complex ADME models, while additionally guaranteeing that AI-produced particles are of high therapeutic science quality and promptly synthesizable. Also, Valence utilizes dynamic learning and iterative improvement procedures to guarantee that lone the most data rich mixtures are chosen for amalgamation, empowering the plan of mixtures meeting the objective strength, selectivity, and ADME models in less emphasess, and with undeniably less information, than in any case conceivable. About Valence Discovery Valence is focused on opening the genuine capability of profound learning in drug plan by binding together top tier profound learning innovations with instinctive foundation to make these advances all the more extensively open to R&D associations, everything being equal. Valence's AI-empowered medication plan stage has been widely approved and is right now being utilized to distinguish and configuration drug applicants as a team with industry-driving accomplices. The organization is spearheading the utilization of few-shot learning in drug plan and is creating and conveying novel AI strategies for sub-atomic property expectation, generative science, and multiparameter advancement. Valence (once in the past InVivo AI) was established in 2018, is exhorted by profound learning pioneer, Dr. Yoshua Bengio, and is gladly settled in Montreal at Mila, the world's biggest profound learning research foundation, with an office in Cambridge, Mass. About Charles River Charles River gives fundamental items and administrations to help drug and biotechnology organizations, government offices and driving scholastic foundations all throughout the planet speed up their exploration and medication improvement endeavors. Our devoted workers are centered around giving customers precisely what they need to improve and assist the disclosure, beginning phase advancement and safe production of new treatments for the patients who need them.

Read More

MEDTECH

Alloy Therapeutics Acquires deepCDR Biologics to Bring Bioinformatics and Machine Learning to its Antibody Discovery Offering

Alloy Therapeutics | December 10, 2021

Alloy Therapeutics, a biotechnology ecosystem company, announced it has acquired deepCDR Biologics, a Basel, Switzerland-based developer of deep learning technology for antibody discovery and optimization. The team and technology stack will form new bioinformatics and machine learning capabilities for Alloy and will be fully integrated into Alloy Discovery Services complementary workflow and processes. Alloy will expand the Basel deepCDR site as a permanent Alloy research facility and will hire additional computational scientists and developers as it grows with the Alloy network. The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles. The company was a spinoff of ETH Zurich and Department of Biosystems Science and Engineering and was founded by Sai Reddy, an Associate Professor of Systems and Synthetic Immunology at ETH Zurich and an expert in immunogenomics and machine learning-guided protein engineering. “Uniting deepCDR and Alloy reflects our conviction in the power of network effects and scientific collaboration—together our companies’ capabilities are amplified to better serve the global scientific community in its pursuit of finding the best medicines for patients. Our network of partners will be able to work with deepCDR’s machine learning engine in a way that otherwise would have been cost prohibitive or inaccessible. The ongoing technology improvements will enhance the output of Alloy platforms and Alloy Discovery Services for the benefit of all of our drug discovery partners.” Alloy Therapeutics CEO and Founder Errik Anderson DeepCDR’s technology will strengthen Alloy Discovery Services capabilities with patent-pending machine learning-powered antibody repertoire screening, in silico library screening, and mammalian display. DeepCDR thoughtfully integrates wet lab antibody screening and characterization with the computational tools to enable a powerful learning loop generating real world results. The deepCDR team will form Alloy’s new Basel, Switzerland operations and comprises expertise in antibody engineering and optimization, bioinformatics, and in silico library screening. “We are thrilled to join Alloy on its mission of empowering scientific entrepreneurs and democratizing foundational drug discovery capabilities,” said deepCDR founder Sai Reddy. “The data sets and infrastructure within Alloy unlock powerful new opportunities for the deepCDR technology and team that will in turn enable us to help drug discovery teams more effectively and efficiently find the best antibody candidates. We envision a future where Alloy will be a leader in unifying real-world patient, genomic, and protein sequence data to empower integrated AI and ML drug discovery and engineering.” About Alloy Therapeutics Alloy Therapeutics is a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners, Alloy democratizes access to tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics. The company facilitates affordable, non-exclusive access to the entire drug discovery community from academic scientists, small and medium biotech, to the largest biopharma. Alloy’s lead offering, the ATX-Gx™ platform, is a human therapeutic antibody discovery platform consisting of a growing suite of proprietary transgenic mice strains. Alloy is a leader in bispecific antibody discovery and engineering services, utilizing its proprietary ATX-CLC common light chain platform integrating novel transgenic mice and phage display. Alloy is headquartered in Boston, MA with labs in Cambridge, UK; Basel, CH; San Francisco, CA; and Athens, GA. As a reflection of Alloy’s relentless commitment to the scientific community, Alloy reinvests 100% of its revenue in innovation and access to innovation.

Read More

CELL AND GENE THERAPY

Sysmex and ThinkCyte Have Entered into An Agreement for Joint Development and Capital Alliance

Sysmex Corporation | May 17, 2021

Sysmex Corporation and ThinkCyte, Inc. announced today the signing of joint development and investment agreements for the commercialization of an AI-based cell analysis technology in May 2021. The development of novel testing and diagnostic technologies of high clinical utility is being pursued to improve the precision of diagnoses and maximize treatment as healthcare becomes more accurate and personalized at an increased pace - in combination with the advancement of technology. Meanwhile, telehealth, AI-powered medical imaging analysis, and automated testing of robots are all gaining traction in the healthcare industry. Sysmex has been acquiring technologies for studying cells, genes, and proteins with high accuracy and sensitivity on a proactive basis. A cell analysis platform is one of the technologies that has been used in a variety of Sysmex products. In this field, Sysmex's current emphasis is on developing technologies that specifically analyze cells using different types of information such as cell function and responsiveness, as well as seeking faster cell analysis. ThinkCyte has "Ghost Cytometry technology," which analyses morphological information of cells in a quick and simple process, while the information gathered by this technology is much richer than what can be collected using conventional flow cytometry (FCM) technique. This technology, in addition to counting and analyzing cells based on their basic morphological features, helps users to identify each cell based on its specific morphological details in terms of its characteristics and functions. This high-resolution analysis will allow for highly accurate clinical condition determination using body fluids such as blood, improve precision in a wide variety of cell-based diagnoses, and contribute to more personalized healthcare. On March 31, 2021, Sysmex and ThinkCyte signed a memorandum of understanding to begin full-fledged joint development of the novel AI-based cell analysis technology as a result of ongoing collaborative research between the two companies to increase the viability of applying Ghost Cytometry technology to diagnostic techniques of high clinical value. In addition, on May 1, 2021, the two companies agreed to collaborate on joint development, with the aim of commercializing cell analyzers and testing techniques based on Ghost Cytometry technology for cell analysis (including research) in the field of in-vitro diagnostics (IVD). Meanwhile, on May 11, 2021, Sysmex agreed to make an equity investment in ThinkCyte, which will enable the two companies to enhance their strong partnership. Sysmex and ThinkCyte have formed an alliance to develop novel cell analysis technology and research techniques by combining Sysmex's IVD capabilities with ThinkCyte's proprietary Ghost Cytometry technology, thereby contributing to the advancement and evolution of healthcare around the world. About Sysmex Corporation Sysmex works to contribute to the development of healthcare and people's healthy lives in accordance with its goal of "shaping the advancement of healthcare," as described in the Sysmex Group's corporate ideology, the "Sysmex Way." Sysmex performs integrated R&D, manufacturing, and sales, as well as providing support services for its in vitro blood, urine, and other bodily fluids testing instruments, reagents, and software. Sysmex's products are sold to medical institutions in over 190 countries and regions around the world. Sysmex has been expanding its business in the life science domain in recent years, using proprietary technologies to develop new testing and diagnostic value, provide healthcare personalized to individual patients, and help patients minimize burdens and improve quality of life.

Read More