Biomica Announces the Advancement to Large-scale Production of BMC128, Its Live Bacterial Product Candidate Consortium

Biomica | October 13, 2020

Biomica Announces the Advancement to Large-scale Production of BMC128, Its Live Bacterial Product Candidate Consortium
Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), announced today the advancement to large-scale production of BMC128, its Live Bacterial Product (LBP) candidate consortium. The microbes, which will be produced in large-scale are expected to support Biomica's first-in-man proof-of-concept clinical trials for its immuno-oncology program, anticipated to begin in 2021. BMC128 is advancing to the GMP production stage following the successful completion of the initial R&D stage of drug product development and manufacturing, conducted by Biose Industrie (Aurillac, France). Biomica's immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128  in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity. Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

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CELL AND GENE THERAPY

Dyadic Announces a NIIMBL Coronavirus Grant Under the White House’s American Rescue Plan

Dyadic International, Inc. | December 23, 2021

Dyadic International, Inc. a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, announced it is the recipient of one of thirty-two project grants awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals funded through the White House’s American Rescue Plan. Under the NIIMBL grant, Dyadic will receive up to $690,000 in funding to engineer the Company’s proprietary and patented C1 thermophilic fungal protein production platform to produce two different antibodies. “We are honored to have been selected by NIIMBL to receive this grant and to further leverage Dyadic’s C1-cell protein production platform to help the nation prevent, prepare for, and respond to coronavirus and other public health threats. The grant provides us with the opportunity, among other attributes, to further demonstrate to academia, industry, and governmental agencies the rapid speed at which we can develop stable C1 expressing cell lines to produce antibodies as compared to traditional cell lines, such as Chinese Hamster Ovary cells. We look forward to moving this project forward in the new year,” Mark Emalfarb, Dyadic’s President and Chief Executive Officer NIIMBL members include large and small companies, academic institutions, non-profits, and federal agency partners who are well-equipped to significantly strengthen the nation’s preparedness and response to public health crises. Through the ARP funding, NIIMBL has selected projects that will Provide testbeds for process development, for next generation manufacturing approaches, and for drug product manufacturing approaches that provide access to industrially relevant equipment and facilities for pre-competitive manufacturing innovation Support the development of significantly improved methods for vaccine production, quality, and distribution, including mRNA and other vaccine platforms Demonstrate rapid scaling for production of coronavirus antigens and medical countermeasures for variants of concern Train a diverse biopharmaceutical manufacturing workforce Demonstrate the concept of mobile Good Manufacturing Practices capabilities to support mRNA vaccine and gene therapy production Dyadic’s project grant is intended to benchmark the speed that the C1 manufacturing platform will have when compared to current state of the art methods, which could lead to a rapid ability to produce medical countermeasures and vaccines in response to future pandemics. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology in the U.S. Department of Commerce with significant additional support from its members. Visit NIIMBL.org to view a summary of these projects and to learn more about NIIMBL. About Dyadic International, Inc. Dyadic International, Inc. is a global biotechnology company that is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica, named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales.

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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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CELL AND GENE THERAPY

Gracell Biotechnologies Unveils Innovation Center in U.S.

Gracell Biotechnologies Inc | January 13, 2022

Gracell Biotechnologies Inc. a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that its newly established research facility, the Innovation Center, is scheduled to open in San Diego, California, during the first quarter of 2022. As a pivotal part of Gracell's global strategy, the company is fully committed to expanding its operations in the U.S. to enhance and diversify its in-house drug discovery, pre-clinical research, and translational capabilities to further complement its proprietary platforms and extensive early-stage pipeline. After a thorough nationwide search, Gracell chose to establish its Innovation Center within the Cornerstone Research Center in San Diego. The new hub includes a state-of-the-art laboratory, along with office space. Gracell is also expanding its R&D team through the recruitment of high-caliber biotech talent in the San Diego area. "We are delighted to start 2022 with the opening of our U.S. Innovation Center in San Diego, which will strengthen our R&D capabilities and further expand our presence in the U.S. market. This marks another solid step in Gracell's journey of becoming a leading global cell therapy company. By innovating and expanding upon our proprietary FasTCAR and TruUCAR platforms, we remain focused on solving the challenges of conventional CAR-T cell therapies and advancing innovative, highly differentiated programs from our robust pipeline to benefit cancer patients all around the world." Dr. William (Wei) Cao, Founder, Chairman and Chief Executive Officer of Gracell About Gracell Gracell Biotechnologies Inc. is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR, TruUCAR and SMART CARTTM technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

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RESEARCH

Institute for Bioscience and Biotechnology Research Receives $16.8 M Investment from the National Institute of Standards and Technology

Institute for Bioscience and Biotechnology Research | January 14, 2022

The Institute for Bioscience and Biotechnology Research announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges. IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines. This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers. "Trusting in and funding research makes it possible to find solutions to address major health and scientific challenges, and to prepare for the unknown. UMB has invested heavily in operational support and high-end instruments for IBBR in support of the NIST relationship. I am very pleased to see that the long-standing NIST collaboration will continue." Bruce E. Jarrell, MD, FACS, President of the University of Maryland, Baltimore As part of the new agreement, NIST provided state-of-the-art equipment for the "IBBR Commons"—a highly sophisticated research space shared with researchers throughout Maryland and the nation. For example, NIST recently partnered with Maryland to establish the Maryland Center for Advanced Molecular Analysis (M-CAMA) that established new cryo-electron (cryoEM) instruments and facilities to be used by NIST and researchers in Maryland for the timely development of new therapies and vaccines. "IBBR has long provided the critical link necessary to bring together researchers across disciplines to address major health challenges and help strengthen the state's economic base in bioscience and biotechnology," said Darryll J. Pines, Ph.D., President of the University of Maryland, College Park. "I am so pleased this collaboration between NIST and the University of Maryland, Baltimore and the University of Maryland, College Park remains strong, and I look forward to seeing the innovations it will lead to in the future." IBBR was established by the University System of Maryland Board of Regents in 2010, building on and integrating previous partnerships between the University of Maryland and NIST that date back to 1984. The institute connects dozens of experts from interrelated fields of study with the common goal of accomplishing world-class interdisciplinary research that can lead to real-world advances like drug discovery, more effective vaccines, and disease prevention and treatment. "Achieving truly groundbreaking results in fields like bioscience and biotechnology requires a wide array of resources, perspectives and expertise—from pharmaceutical and biotech companies to academic and government institutions, to foundations and NGOs," said Jennifer King Rice, Ph.D., Senior Vice President and Provost of the University of Maryland, College Park. "What makes IBBR so unique and impactful is its ability to stand in the center of this circle of voices as the catalyst for collaborative and impactful work." "Having this important cooperative agreement with NIST enables us to develop and share the most sophisticated and advanced instrumentation for use in the discovery, development and manufacturing of safe and effective new medicines to treat human disease—including, most recently, for COVID19," said E. Albert Reece, MD, Ph.D., MBA, Executive Vice President for Medical Affairs at the University of Maryland, Baltimore and the John Z. and Akiko K. Bowers Distinguished Professor and Dean of the University of Maryland School of Medicine. About IBBR IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore, and the National Institute of Standards and Technology. IBBR brings together critical elements necessary to inspire transformative discoveries in the field of bioscience and biotechnology and provides innovative solutions to major scientific and engineering challenges important to society. IBBR researchers seek to advance the fields of biomedical research, therapeutic development, biomedical manufacturing, and state-of-the-art measurement technologies, to support accelerated delivery of safe and effective medicines to the public. IBBR is financially supported in part by the University of Maryland Strategic Partnership: MPowering the State, an initiative designed to achieve innovation and impact through collaboration.

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