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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
GenScript ProBio | February 24, 2023
GenScript ProBio, a renowned Contract Development and Manufacturing Organization (CDMO), has recently entered a strategic partnership agreement with RVAC Medicines Pte. Ltd., a biotech company specializing in the development and commercialization of mRNA vaccines and therapeutics. The collaboration is aimed at manufacturing GMP-grade plasmid DNA (pDNA) for the RVM-V001 mRNA COVID-19 vaccine candidate, as well as supporting future therapeutic pipelines.
GenScript ProBio will offer GMP plasmid manufacturing service for RVAC Medicines' program, RVM-V001. By collaborating with GenScript ProBio, RVAC Medicines will be able to accelerate the clinical manufacturing of mRNA-based COVID-19 vaccines, as well as future mRNA-based vaccines designed to target other infectious diseases such as Clostriodioides difficile infection (CDI) and Respiratory syncytial virus (RSV).
As RVAC proceeds with the development of its mRNA candidates, GenScript ProBio continues to offer high-quality GMP materials crucial to the objective, including plasmid DNA and the development of ancillary materials to support mRNA manufacturing processes. GenScript ProBio also provides consultative and expert guidance regarding regulatory and quality expectations of agencies worldwide.
RVAC Medicines and GenScript ProBio will continue collaborating to support mRNA initiatives for both clinical and commercial stage development.
Dr. Brian Min, CEO of GenScript ProBio said, "We are delighted to enter into this strategic partnership with RVAC Medicines. This collaboration will enable us to utilize our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based COVID-19 vaccine and its therapeutic candidates."
(Source – PR Newswire)
About GenScript ProBio
GenScript ProBio is a Contract Development and Manufacturing Organization (CDMO) that provides end-to-end drug discovery and commercialization services. The company's services are designed to accelerate drug development for its clients in various areas, including CGT, vaccines, biologics discovery, and antibody protein drugs. GenScript ProBio has a global presence, with subsidiaries in the Netherlands, the United States, South Korea, and China. Since October 2017, the company has helped clients in different regions, such as the United States, Europe, and Asia Pacific, to obtain over 40 IND approvals. Its goal is to drive innovation and speed up the biologics development process from target to market.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Sana Biotechnology | January 30, 2023
Sana Biotechnology, Inc., a firm focused on producing and delivering engineered cells as medicines, recently announced that the FDA has approved the company's Investigational New Drug (IND) application to begin a first-in-human trial of SC291 in patients with different types of B-cell malignancies.
SC291 is an allogeneic CAR T cell therapy that targets CD19. It is developed by Sana using its hypoimmune platform. The hypoimmune platform's objective is to overcome the allogeneic cells' immunologic rejection, which, if valid for SC291, could lead to prolonged CAR T cell persistence and increased rates of durable complete responses in patients with B-cell lymphomas or leukemias.
The hypoimmune platform includes disruption of the major histocompatibility (MHC) class I and class II expression to conceal cells from the adaptive immune system, which consists of antibody and T cell responses and overexpression of CD47 to inhibit activation of the innate immune cell system, especially macrophages and natural killer (NK) cells. The company has provided evidence from numerous preclinical models demonstrating the potential of this platform to cloak cells from immune detection and the therapeutic potential of SC291 for patients with B-cell malignancies.
About Sana Biotechnology
Founded in 2018, Sana Biotechnology is a firm focused on utilizing engineered cells as medicines for patients. It is constructing differentiated capabilities across the spectrum of cell and gene therapy. The company is motivated by three goals as it seeks solutions for people with poor outcomes or diseases that are currently incurable. The first is the ability to repair and control the genes in any cell in the body. It is developing innovative delivery technologies in order to deliver any payload to any cell in a precise, predictable, and repeatable manner, paving the way for next-generation in vivo gene therapy. Next comes the ability to develop pluripotent stem cells ex vivo into immune-cloaked functional cells, to replace any missing or damaged cells in the body. Finally, it believes that it can also enable broader access to its therapies by focusing on scalable manufacturing solutions, the manufacturing costs, and aligning with key stakeholders.
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MEDTECH, INDUSTRIAL IMPACT
MaxCyte | January 04, 2023
MaxCyte, a leading commercial cell-engineering company, announced the signing of a strategic platform license (SPL) with Catamaran Bio, a biotechnology enterprise creating off-the-shelf chimeric antigen receptor (CAR)-NK cell therapeutics to cure a wide range of cancers.
While Catamaran acquires non-exclusive clinical and commercial rights to use MaxCyte's Flow Electroporation® technology and ExPERT™ platform per the terms of the agreement, in exchange, MaxCyte will receive platform licensing fees and revenue related to its programs.
Catamaran is actively developing highly potent allogeneic, cryopreserved CAR-NK cell therapeutics using synthetic biology and non-viral cell engineering capable of treating challenging cancers, including solid tumors, by integrating new functional features with the inherent cancer-fighting properties of NK cells. In addition, the company created the TAILWIND® platform, an integrated set of technologies, to engineer, expand, and process NK cells into safe and effective off-the-shelf cell therapy products for numerous cancer types.
The MaxCyte ExPERT™ instrument portfolio is the next generation of clinically verified electroporation technology for complicated and scalable cell creation. The ExPERT™ platform provides the high-end performance required to enable the next era of biological and cellular treatments by delivering high transfection efficiency, seamless scaling, and expanded functionality. MaxCyte's Catamaran agreement is the company's 19th overall SPL.
About MaxCyte
MaxCyte is a prominent commercial cell-engineering firm dedicated to advancing breakthrough cell-based research and next-generation cell therapy discovery, development, and commercialization. Over the years, it has been developing and commercializing its unique Flow Electroporation® platform, which allows for the intricate creation of a wide range of cells. In addition, its ExPERT™ platform, based on its Flow Electroporation technology, has been created to assist the rapidly increasing cell therapy market and can be used across the high-growth cell therapy sector, from discovery and development to commercialization of next-generation cell-based therapies.
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