FUJIFILM Diosynth Biotechnologies to Support COVID-19 Vaccine Candidate Manufacturing

FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today that its College Station, Texas, site will support COVID-19 vaccine candidate manufacturing, as part of Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, issued a task order through the Texas A&M System (TAMUS) Center for Innovation in Advanced Development & Manufacturing (CIADM). The CIADM subcontracts manufacturing to the FUJIFILM Diosynth Biotechnologies owned and operated Flexible Biomanufacturing Facility (FBF) in College Station, Texas. The task order reserves manufacturing capacity in the FBF through the end of 2021. The FBF is one of three manufacturing facilities at FUJIFILM Diosynth Biotechnologies Texas campus.

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Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine

Capricor Therapeutics | January 24, 2024

Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study. “We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.” Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.” About Capricor’s StealthX™ Vaccine The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication. About Capricor Therapeutics Capricor Therapeutics, Inc. is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.

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Virica Expands Bioprocessing Capabilities with Carleton University Partnership

Virica Biotech | January 17, 2024

Virica Biotech Inc. (“Virica”), a leading developer of cell enhancers for scaling of viral vector as well as cell and gene therapy manufacturing will expand its bioprocessing services through a partnership with Carleton University. Slated to open this spring, Virica’s new facility at the university multiplies the Company’s capacity to provide high throughput virology services for customers looking to optimize production of their cell and gene therapies. “Carleton’s new Health Sciences Building provides us with greater access to modern infrastructure and analytical expertise,” said Jean Simon Diallo, Ph.D., CEO of Virica Biotech. “Their state-of-the-art analytical research facilities and world-class researchers across multiple disciplines open the door to exciting opportunities for partnering with Carleton University as we continue to invest to meet customer demand.” “We are very pleased to welcome Virica Biotech to the Carleton campus,” said Rafik Goubran, Ph.D., Vice-President (Research and International) and Chancellor’s Professor, Carleton University. “This multi-year, multi-million-dollar research and infrastructure partnership will help drive innovation and talent development in the Ottawa region for the creation and manufacturing of advanced therapies.” This partnership expands on Carleton’s history of supporting Ottawa biotechnology companies. The new open concept facility will include high throughput equipment to accelerate Virica’s bioprocess development and optimizations. In addition to expanded modern infrastructure, this new location enables the development and recruitment of world-class talent with experiential learning and training opportunities for Carleton students. Through this partnership, Carleton will coordinate the establishment of a scholarship fund designed to empower graduate students from traditionally underrepresented groups in science. About Virica Biotech Virica develops cell enhancers for viral vectors that improve the yield and quality of vaccines and cell and gene therapies, allowing developers to economically deploy their products at scale. Virica’s Viral Sensitizer (VSE™) platform reduces production inefficiencies caused by anti-viral defenses in manufacturing cells. Purpose formulated VSE combinations substantially increase manufacturing yields and reduce the cost of goods for a range of life-changing products, including vaccines, gene therapies, and cell therapies. About Carleton University Carleton University is a dynamic, research-intensive institution that engages in partnerships to address the world’s most pressing challenges. The university’s corporate collaborations bring together world-class companies, researchers and a new generation of talent with over 30,000 students to deliver innovations and results that are driving a more prosperous, sustainable future.

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Cell and Gene Therapy

Solvias to Perform Release Testing on World's First CRISPR-based Gene-Editing Therapy

Solvias | January 23, 2024

Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a long-term agreement with Vertex Pharmaceuticals for CASGEVY™ (exagamglogene autotemcel or exa-cel) which received U.S. Food & Drug Administration (FDA) approval for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises. Solvias and Vertex Pharmaceuticals have worked together for several years to develop and validate test methods that are critical for the final release of patients' own edited cells, so that they can be delivered back to patients. The companies' collaboration included establishing the testing methods that will be scaled for commercializing CASGEVY. Solvias also has invested significantly in preparing one of its global facilities to support the commercial release work for this transformative therapy. Archie Cullen, Chief Executive Officer, Solvias, stated "Solvias is honored to be playing a critical role in delivering this breakthrough therapy to patients. Our decades of experience offering comprehensive GMP analytical services uniquely positions us to partner with companies in bringing their therapies to market. This collaboration highlights our deep scientific knowledge and creative solutions serving to advance even the most cutting-edge therapies." In addition to gaining FDA approval, CASGEVY recently received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use for conditional approval of the treatment of severe SCD and transfusion-dependent beta thalassemia (TDT). About Solvias Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the pharmaceutical, biotech, material science, and cosmetic industries. Its team of scientists and regulatory experts have years of experience in small molecules, biologics, and cell and gene therapies. The company offers comprehensive solutions from raw materials to drug products to final release testing, as well as API development and manufacturing for small molecules. Headquartered near Basel, Switzerland, Solvias operates five facilities to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.

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Medical

CCM Biosciences Announces Launch of 5Prime Sciences Business Unit

CCM Biosciences | January 01, 2024

Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics. 5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biology: engineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis. Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing. In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias. 5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency. About CCM Biosciences CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs - including small molecules, gene therapies, biologics, and nanomedicines - as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.

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