Emergent BioSolutions Announces Initiation of Phase 3 Cinical Trial of Hyperimmune Intravenous Immunoglobulin to Treat COVID-19 Patients

Emergent BioSolutions | October 09, 2020

NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent’s COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19. Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure. Emergent BioSolutions, Inc. Inc. (NYSE:EBS) today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called “Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC),” is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study will evaluate the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent’s COVID-HIG, with a background therapy of remdesivir in all groups.

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Pharmactive Enters Strategic Partnership with Nutraconnect for APAC

Pharmactive | June 08, 2022

Pharmactive Biotech Products, S.L.U., announces a new strategic partnership with Singapore-based Nutraconnect Pte, Ltd. to bring innovative, scientifically backed nutraceutical ingredients to the Asia-Pacific marketplace (not including Australia and New Zealand). The partnership will combine the strengths of both companies into a greater whole. Pharmactive will provide its well-supported, clean-label botanical extract ingredients, while Nutraconnect will function as a growth engine for the region, connecting Pharmactive with local and regional nutraceutical players seeking high-quality, pure ingredients. Nutraconnect Pte., Ltd. is a start-up led by Rohit Noronha, co-founder and Chief Growth Officer, and Nikhil Prabhakar Sawant, co-founder and CEO. Both are highly experienced leaders in the nutraceutical industry. We are very fortunate to partner with Nutraconnect, as their team possesses a great deal of market and customer information and strategic insight, allowing for quick responses to potential customers in their local time-zone, Asia is a tremendous growth-hub for Pharmactive. We already have had successes in Korea, Japan, Vietnam, and Malaysia with Affron® pure saffron extract and Aged Black Garlic [ABG+®]. Many Asian industry players, formulators, and brand owners approach us about new compounding formats or innovative product concepts to cross the nutraceutical/functional food and beverage divide. Asia is clearly the frontrunner in terms of new ingredient concepts." Jean-Marie Raymond, CEO and Founder of Pharmactive. About Pharmactive Pharmactive Biotech Products, S.L.U., is a Madrid-based pioneering biotechnology company that develops and manufactures differentiated natural ingredients supported by science, such as pure saffron extract and aged black garlic. The company's mission is to make a daily positive and significant impact on people's health and well-being through premium botanical ingredients backed by scientific studies and approved by ethics committees. Pharmactive grows, cultivates, and produces farm-to-fork botanical ingredients with a minimal ecological footprint. About Nutraconnect Founded in 2022, Nutraconnect Pte., Ltd., is a nutraceutical business growth acceleration service headquartered in Singapore. The company provides end-to-end solutions for global nutraceutical ingredient manufacturers that are looking to establish a foundation for sustainable growth in the fragmented, but booming APAC market.

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MEDICAL

Fluent BioSciences and NanoCellect announce joint collaboration to improve resolution of single-cell RNA sequencing analysis of rare cell populations

Fluent BioSciences | June 18, 2022

Fluent BioSciences, a biotechnology company focused on making single-cell analysis simple and accessible to every researcher, and NanoCellect Biomedical, Inc., a leader in the development and manufacturing of innovative and affordable solutions for cell sorting, jointly announced a collaboration to improve resolution and efficiency of single-cell RNA sequencing (scRNA-seq) analysis of rare cell populations. Single-cell researchers are increasingly requiring scalable, flexible and accessible workflow solutions, and the combination of cell sorting on the NanoCellect platform followed by scRNA-seq on a novel, instrument-free platform for scRNA-seq based on Pre-templated Instant Partitions (PIPseq™) from Fluent can be a highly efficient solution for a wide range of single cell applications across oncology, immunology and neuroscience. For single-cell sequencing to truly become mainstream researchers need benchtop solutions that fit their diverse experimental needs rather than compromising the science with complex, expensive, and inflexible platforms. I am very pleased that Fluent and NanoCellect are able to leverage and combine the unique advantages of our respective technologies to expand the use of single-cell RNA sequencing for rare cell populations." Sepehr Kiani Ph.D., co-founder, and CEO of Fluent BioSciences. Reliable and reproducible sample preparation is critically important to the scRNAseq workflow, NanoCellect's WOLF® and WOLF G2® Cell Sorters can function as a valuable step in the scRNA-seq workflow by isolating only cells of interest while removing dead cells and debris, thus improving scRNA-seq resolution of rare cell populations of interest and overall sequencing data quality." Jose Morachis, Ph.D., President and co-founder at NanoCellect. About Fluent BioSciences Fluent's mission is to accelerate the understanding of single-cell biology through accessible, affordable, and scalable solutions for every researcher. Our breakthrough PIPseq™ technology enables extremely sensitive and unbiased preparation of proteins and nucleic acids for a broad range of applications. About NanoCellect Biomedical NanoCellect is committed to empowering every scientist to make discoveries one cell at a time, by ensuring high cell viability required to advance cell-based research. We develop and deliver microfluidic based solutions that are affordable, compact, and easy-to-use. Our expanding portfolio of instruments and consumables enable biomedical scientists to analyze and sort cells required for drug discovery, single cell-omics, cloning, antibody discovery, and basic research.

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MEDICAL

Invest Ontario Supports New Biomanufacturing Facility in Hamilton

Invest Ontario | April 01, 2022

Invest Ontario is supporting OmniaBio Inc. in launching a new biomanufacturing facility that will catalyze Ontario life sciences jobs and innovation while advancing pioneering medicine with the potential to cure, not just treat, many forms of cancer, cardiovascular diseases, Parkinson's and diabetes. OmniaBio, a Canadian cell and gene therapy contract development and manufacturing organization (CDMO), will be the anchor tenant in a new biomanufacturing campus being built in Hamilton's McMaster Innovation Park. Subject to reaching a definitive agreement, Invest Ontario will provide a loan of up to $40 million, contributing to an overall project investment of over $580 million, creating 250 jobs by 2031. Invest Ontario will also be providing non-financial support to OmniaBio, including helping the company meet its future talent needs and promoting opportunities to enhance local skills development partnerships. As a contract manufacturer, OmniaBio will support a broad range of cell and gene therapy companies – both homegrown and international – by providing process development and clinical/commercial production services in compliance with global health standards. The OmniaBio investment supports Ontario's new Life Sciences Strategy that will advance the province's leadership as a North American life sciences hub offering a collaborative ecosystem for the development, commercialization and adoption of innovative health products and services. OmniaBio is being spun out of the Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio will build on CCRM's existing global client base, with the project ultimately creating a six-fold increase in biomanufacturing capacity. Ontario's life sciences sector is the largest in Canada (representing more than 50 per cent of related economic activity) and comprises about 1,900 firms employing around 66,000 people.

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CELL AND GENE THERAPY

Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine

HDT Bio Corp. | January 17, 2022

HDT Bio Corp., a U.S. developer of immunotherapies for oncology and infectious diseases and SENAI CIMATEC, an important Brazilian education, research, and innovation institute, have dosed the first healthy volunteers in Brazil in a Phase 1 trial of HDT Bio’s RNA COVID-19 vaccine, HDT-301. SENAI CIMATEC will conduct the clinical trial under the name Vaccine RNA MCTI-CIMATEC-HDT. The vaccine uses HDT Bio’s proprietary lipid nanoparticle RNA-delivery technology. “This clinical trial in Brazil is the second international study to get under way in our efforts to help partners in historically underserved nations fight this pandemic by transferring our unique technology to provide them local control over development, manufacturing and distribution of a COVID-19 RNA vaccine. The first was in India with our partner Gennova Biopharmaceuticals which has moved the vaccine into Phase 2 and Phase 3 trials.” HDT Bio CEO Steve Reed HDT Bio has other partnerships for its RNA COVID-19 vaccine, including in South Korea and China. “These partnerships are part of our company’s mission and business strategy aimed at bringing our advanced immunotherapies to underserved nations to help address global health inequities,” Reed explained. "Through the partnership with HDT Bio Corp., SENAI CIMATEC is incorporating in Brazil the development and qualification for a state-of-the-art technology in an exclusive way, as well as the first clinical study involving an RNA self-amplifying vaccine. This moment can be considered as an important demonstration of the potential of Brazilian science, represented in this study by SENAI CIMATEC,” said President of Federation of Industries of the State of Bahia Ricardo Alban “We also highlight the important funding received through the Ministry of Science, Technology and Innovations which has supported the execution of the initial clinical phases, “Alban added. “From the clinical studies of the Vaccine RNA MCTI CIMATEC HDT we expect to obtain sufficient data to demonstrate the efficacy and safety of this product to the population. In this way, the development of the Vaccine RNA MCTI CIMATEC HDT represents a crucial milestone for the modernization of the national health system, since it can later be produced in the country itself,” said infectious disease doctor and Principal Investigator of the clinical studies in Brazil Roberto Badaró. SENAI CIMATEC’s double-blind, placebo-controlled, dose-ranging Phase 1 clinical trial will enroll 90 healthy adult volunteers. The trial will assess the safety, tolerability, and immunogenicity of the vaccine at three dose levels, 1 µg, 5 µg and 25 µg. Safety and tolerability will be the primary endpoints assessed by incidence of adverse events for each dose through 12 months after the vaccination. Scheduled interim evaluations to measure immunogenicity also will be conducted. HDT Bio’s innovative vaccine, which also will undergo a Phase 1 trial in the U.S., uses its proprietary lipid nanoparticle carrier system for delivery of RNA. The vaccine is significantly different from existing commercially available RNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine activates the immune system at a much lower dose than commercially available vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the nanoparticle delivery system rather than being encapsulated within it, providing for enhanced stability. ABOUT HDT BIO CORP. HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas. The company seeks to harness the body’s immune system to deliver therapies that narrowly target the specific areas of the body where they are needed. HDT Bio’s work focuses on oncological and infectious disease applications. HDT Bio’s founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants. One of the company’s core technologies, RNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. ABOUT SENAI CIMATEC SENAI CIMATEC focuses on higher education, research and innovation for the development of industry. Its manufacturing and technology integrated campus is one of the most advanced centers for education specialized services, applied research and innovation projects in Brazil. CIMATEC operates in more than 40 different areas of competence, with emphasis on computer technology, engineering, health and biotechnology, with the main objective to support industries, including the Brazilian Industrial Health Complex.

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