MEDICAL

Alligator Bioscience Announces IND Approval for CD40 Targeting Antibody Mitazalimab

Alligator Bioscience | December 07, 2020

Alligator Bioscience declares an affirmed IND (Investigational new Drug) for the CD40  targeting antibody mitazalimab. IND endorsement by the US Food and Drug Administration (FDA) is an essential to begin clinical preliminaries in the USA. As of late, new benchmark information was distributed indicating that mitazalimab can possibly be top tier in the CD40 field. The comparison demonstrated the potent immune-activating properties and anti-tumor effects of mitazalimab.

"While the upcoming clinical Phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe, the IND opens up for later expansion in the US. This is essential for the future success of the product", said Per Norlén, CEO of Alligator Bioscience.", said Per Norlén, CEO of Alligator Bioscience. "Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU", he added.

The mitazalimab drug candidate has recently reported positive clinical information from a Phase I study performed by Janssen Biotech Inc., showing a manageable safety profile just as early signs of efficacy.

Spotlight

Over 2009 to 2014 a sample of over 250 medical biotechnology companies showed CAGR trend of less than 0.1% increase in employment while the revenue trend was 4% CAGR. The remainder of the sector is composed of the specialist service & supply chain that supports both the medical biotechnology and pharmaceutical sectors.

Spotlight

Over 2009 to 2014 a sample of over 250 medical biotechnology companies showed CAGR trend of less than 0.1% increase in employment while the revenue trend was 4% CAGR. The remainder of the sector is composed of the specialist service & supply chain that supports both the medical biotechnology and pharmaceutical sectors.

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MEDICAL

SOPHiA GENETICS Launches New Solution to Advance Chronic Lymphocytic Leukemia Care, in Collaboration with IDIBAPS

biotech, biotechnology, cell, gene, tissue | June 10, 2022

SOPHiA GENETICS (Nasdaq: SOPH), the Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) of Barcelona, and the Spanish Diagnóstica Longwood today announced from the European Hematology Association Congress in Vienna that they have combined their expertise to develop a new Chronic Lymphocytic Leukemia (CLL) solution to advance CLL care. This collaboration will unify the wide variety of current guideline recommendations into one single application aiming to improve CLL characterization and CLL research practices in Iberia. SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM™ Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas. The Platform computes a wide array of genomic variants needed to continually hone machine learning algorithms designed to accurately detect rare and challenging cases. The growing number of users of the SOPHiA DDM™ community can share and access insights by pulling the relevant signals detected from the noise, ultimately saving time and helping to make better-informed decisions. The new CLL solution allows for progress of Chronic Lymphocytic Leukemia research using genomic analysis. This could lead to better detection of the disease, which accounts for 25-30% of all leukemia cases in Western countries and affects yearly more than 100,000 people globally[1], and ultimately improve patient care. Thanks to the SOPHiA DDM™ Platform and IDIBAPS, hematopathologists can now access guidelines for the mutational status of TP53, immunoglobulin (IG) gene rearrangements and their somatic hypermutation status, while benefitting from the identification of 23 CLL-specific genes for SNVs, InDels and CNVs including NOTCH1, SF3B1, ATM, IGLV3-21, BTK, PLCG2, BCL2, del13q14, and trisomy 12, all in one single NGS workflow. The new CLL solution has already been used in routine in Spain, with further opportunities throughout the country, and in Latin America through Diagnóstica Longwood's distribution channels. We are proud to work together with some of the most renowned experts in the field of Chronic Lymphocytic Leukemia research around the world. This partnership is a great example of how combining advanced data analytics with emerging CLL strategies can move the possibilities of data-driven medicine forward." Lara Hashimoto, Chief Business Officer at SOPHiA GENETICS. It is a great satisfaction to see how thanks to the partnership with SOPHiA GENETICS and Diagnóstica Longwood we will be able to transfer into clinical practice the relevant information generated for so many years in the research of CLL using a simple and robust assay." Elías Campo, principal investigator and director of IDIBAPS. About SOPHiA GENETICS SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 790 hospital, laboratory, and biopharma institutions globally. About IDIBAPS The August Pi i Sunyer Biomedical Research Institute (IDIBAPS) is a biomedical research center of excellence that addresses the most common diseases in our environment. It is a public consortium comprising the Catalan Government (Generalitat de Catalunya), the Hospital Clínic Barcelona, the Faculty of Medicine and Health Sciences at the University of Barcelona and the CSIC Institute of Biomedical Research of Barcelona. About 1,500 professionals are organized in a hundred research groups. IDIBAPS undertakes translational research. It focuses on ensuring that the questions that arise at the patient's bedside have a response in the laboratory, and that advances made in the laboratory are promptly applied to patients. With over 1,200 articles published annually, it is the leading biomedical research center in Spain.

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DIAGNOSTICS

Cancer Cell Paper Identifies "Avidity Enhancement" As New Strategy for Improving CAR T Therapy for Acute Myeloid Leukemia

LUMICKS | May 26, 2022

LUMICKS, a leading life science tools company that develops instruments for dynamic single-molecule and cell avidity analysis, today announced the publication in Cancer Cell of preclinical research identifying "Avidity Enhancement" as a new strategy to improve therapeutic outcome of Chimeric Antigen Receptor (CAR) T cell immunotherapy in Acute Myeloid Leukemia (AML). AML poses significant clinical challenges due to its resistance to therapies and its bleak prognosis. Approximately 20,000 people in the US and 300,000 worldwide die from AML every year, making it the most common form of acute leukemia in adults and a major public health issue. The Cancer Cell paper (May 9, 2022), entitled "Non-cleavable hinge enhances avidity and expansion of CAR-T cells for acute myeloid leukemia," was authored by a team of CAR T cell researchers led by Dr. Marcela V. Maus, Associate Professor of Medicine at Harvard Medical School and Director of the Cellular Immunotherapy program at Massachusetts General Hospital. The study details a novel strategy for better cancer treatment with CAR T cells for AML. "Avidity Enhancement", increasing cell-cell binding from both the tumor and CAR T cell side, led to a more effective eradication of tumors in mouse models of AML. In this paper, data generated using the LUMICKS z-Movi® Cell Avidity Analyzer provided superior correlation with CAR T cell activity in vivo compared to the standard in vitro assays in assessing the potency of CAR variants. Building upon previous research from the Maus Lab indicating 'avidity escape' as an evasion mechanism when CAR T cell therapies are deployed against solid tumors, "avidity enhancement" is a promising strategy for improving clinical success of CAR T therapies. We continue to be excited about the pivotal research emerging from The Maus Lab and other leading laboratories that demonstrates how researchers can leverage the technological and scientific power of measuring cell avidity with the z-Movi® Cell Avidity Analyzer, This work further solidifies the idea that cell avidity can be a unique biomarker to improve the selection of CAR T therapies for superior therapeutic outcomes in hematological malignancies as well as in solid tumors. We are delighted to collaborate with researchers worldwide in uncovering meaningful new insights, such as the new treatment approaches suggested for AML contained in this new paper in Cancer Cell." Andrea Candelli, Ph.D., Chief Scientific Officer of LUMICKS. The z-Movi Cell Avidity Analyzer measures cell avidity, or level of binding, between immune cells and their targets, enabling researchers to identify the most potent immunotherapeutic effector cells. This unique technology provides predictive, reproducible, and fast results at single-cell resolution. LUMICKS' cell avidity solutions use acoustics to measure forces and interactions between cells, with the goal of shortening the drug development cycle of immunotherapies and reducing failure rates in clinical trials. First introduced in 2020, the z-Movi is being rapidly adopted by academic and biopharma laboratories around the world. About LUMICKS LUMICKS is a leading life science tools company that develops equipment for Dynamic Single-Molecule and Cell Avidity analysis, two rapidly emerging areas in biology research and immuno-oncology. LUMICKS' tools allow researchers to build the crucial and yet unfinished bridge between structure and function at both a molecular and a cellular level. This is achieved by applying and measuring forces around biological interactions, enabling the detailed real-time analysis of underlying biological mechanisms. LUMICKS' C-Trap® Optical Tweezers – Fluorescence & Label-free Microscopy, allows scientists to analyze complex biological processes in real-time. Similarly, the z-Movi® Cell Avidity Analyzer enables the measurement and selection of immune cells based on their real-time interactions with target cells.

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INDUSTRIAL IMPACT

Ginkgo Bioworks and the Rwanda Development Board Announce Plans to Develop and Implement New Biosecurity Capabilities in Rwanda

Ginkgo Bioworks | August 12, 2022

Ginkgo Bioworks the leading horizontal platform for cell programming, and the Rwanda Development Board representing the government of the Republic of Rwanda, today announced that they have entered into a Memorandum of Understanding with the intent of developing and implementing new biosecurity capabilities in Rwanda. The initial goal of the planned partnership is to support Rwanda's public health institutions as they work to address biosecurity challenges in the region. Ginkgo, through its biosecurity and public health initiative, Concentric by Ginkgo, plans to collaborate on the ground with RDB to equip these institutions with biosecurity tools and training as well as the secure data infrastructure they need to leverage automation, data analysis, bioinformatics capabilities, and other critical genomic sequencing technologies. Concentric leverages a nationwide laboratory network to provide pathogen monitoring capabilities across thousands of sites in the U.S., including schools, airports, and other congregate settings. Concentric aims to build sustainable global biosecurity infrastructure to prepare for the next new variant or novel pathogen, and this planned partnership with RDB is a significant milestone in its international expansion as it continues to scale its biosecurity offering. RDB, a Rwandan government institution, was established in 2008 to accelerate Rwanda's economic development by enabling private sector growth. Ginkgo will build relationships with Rwandan public health institutions and private sector-led biotechnology initiatives in Rwanda; the RDB will contribute expertise in skills development and on-the-ground support for the partnership. Concentric and RDB recognize the importance of international collaboration and cooperation to promote global health security as biological threats emerge. Effective pathogen monitoring and data sharing capabilities can empower government officials, community leaders, and other stakeholders to make informed public health decisions. In the long-term, these capabilities can also be leveraged to form the foundation for a sustainable regional bioeconomy. For example, in the context of this MOU, Ginkgo and RDB plan to collaborate to inform workforce development priorities in the areas of biotechnology, biomanufacturing, and bioengineering, and to explore potential opportunities for Rwanda to leverage its biodiversity as a foundation for innovation within its bioeconomy. "The future of biosecurity is global—COVID-19 has shown us all that pathogens don't recognize national borders. To prepare for the next biological threat, we need the infrastructure in place to build a global weather map tracking the spread and evolution of infectious diseases. We deeply appreciate Rwanda's leadership working to define a new era of biosecurity, and we are incredibly excited to use our platform to support Rwanda's public health institutions with critical capabilities that we believe will help them face challenges ranging from this pandemic to agricultural and travel biosecurity." Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks Clare Akamanzi, Chief Executive Officer of the Rwanda Development Board, noted, "The COVID-19 pandemic has exposed the need for robust public health and biotechnology infrastructure in Rwanda and around the world. We are excited about our plans to partner with Ginkgo to bring cutting-edge biosecurity capabilities to Rwanda across various sectors including health and agriculture. We believe this will stimulate our growing bioeconomy and help us learn more about our biodiversity." About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. About the Rwanda Development Board The Rwanda Development Board is a government agency responsible for leading the country's transformation into a dynamic global hub for business, investment, tourism and innovation. Its mission is to fast-track economic development in Rwanda by enabling private sector growth.

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