Samsung Biologics | July 21, 2021
Kineta, Inc., a clinical-stage biotech firm developing novel immunotherapies in oncology, has signed a strategic partnership agreement with Samsung Biologics, one of the world's top contract development and manufacturing companies (CDMO). To support the IND filing for KVA12.1, Kineta's new anti-VISTA antibody under development to treat solid tumors, Samsung Biologics will offer end-through-end CDMO services ranging from cell line development to cell line development clinical drug substance and drug product manufacturing.
VISTA, which is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells, is a major driver of the immunosuppressive tumor microenvironment (TME) (Tregs). It is an important immune checkpoint in myeloid cells, and VISTA blockade can reprogram suppressive myeloid cells and restore anti-tumor immune function. Preclinical studies show that KVA12.1 has anti-tumor activity as a single agent and that targeting VISTA in combination with PD-1, PD-L1, or CTLA-4 can substantially enhance the anti-tumor efficacy of those checkpoint inhibitors. Thus, Kineta's KVA12.1 is intended to reprogram the TME in hard solid tumors.
The manufacturing cell line will be created with assistance from Samsung Biologics' R&D Center in San Francisco. The clinical trial materials will be manufactured in Samsung Biologics' headquarters in Incheon, South Korea.
Samsung Biologics provides one-stop CDMO research and development services from its headquarters in Incheon, South Korea, and its newly built R&D Center in San Francisco. Providing quality-driven development services at a faster pace, the company delivers cell line development to drug substance manufacturing in six months and drug product manufacturing in seven months, the industry's fastest pace. Samsung Biologics is currently building its fourth and largest facility in Incheon, Korea, which will have a biomanufacturing capacity of 620,000 liters upon completion in 2023.
About Kineta, Inc.
Kineta, Inc. is a clinical-stage biotechnology company dedicated to developing game-changing life science technologies that address unmet patient needs. We have used our immunology expertise to advance a focused pipeline of oncology investigational drugs. To develop our innovative products, we actively work with a diverse range of private, government, and industry partners.
About Samsung Biologics Co., Ltd.
Samsung Biologics is a fully integrated CDMO that provides state-of-the-art contract development, manufacturing, and laboratory testing. Samsung Biologics is an award-winning partner of choice, with proven regulatory approvals, the largest capacity, and the fastest throughput. As a result, it is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.
Research Solutions | October 12, 2020
Research Solutions/Reprints Desk (NASDAQ: RSSS), a pioneer in providing cloud-based workflow solutions for R&D driven organizations, today announced that it has partnered with BIO Business Solutions to help life sciences companies save time and money on scholarly literature access via its award-winning Article Galaxy research platform. Operated by the Biotechnology Innovation Organization (BIO), BIO Business Solutions is the industry's largest cost savings purchasing program. More than 4,500 member companies worldwide—including biotechnology and biopharmaceutical firms, medical device firms, academic institutions, state biotechnology centers, and related organizations—together save more than $511 million annually through the BIO Business Solutions® program.
GenScript | May 18, 2022
GenScript USA Inc., the world's leading life-science research tools and services provider, announced the availability of new GMP-grade GenExact™ single-stranded DNA (ssDNA) and GenWand™ closed-end linear double-stranded DNA (dsDNA) services. These services will enable next-generation gene and cell therapy R&D programs to advance to IND filing and clinical trials faster and more efficiently.
Today's announcement, made at the American Society of Gene & Cell Therapy (ASGCT) 25th annual meeting (booth #280), further establishes GenScript as the leading provider of non-viral homology-directed repair (HDR) template solutions for immune-cell engineering. GenScript now offers varying grades of non-viral HDR payload materials that support use cases across early discovery research, process development, and clinical studies.
CRISPR-based non-viral gene insertion methods have gained popularity among research teams with concerns about the FDA's recent draft guidance concerning the use of viruses for gene and cell therapy. Non-viral HDR templates, in combination with CRISPR technology, can accelerate cell engineering compared to traditional GMP virus-based engineering, delivering results faster than alternate techniques.
This new investment by GenScript demonstrates our commitment to non-viral delivery technology. We look forward to continuing to work with our partners and stakeholders in academia and industry to support their cell therapy R&D programs and further development of non-viral delivery platforms and workflows, We know this technology will be a more efficient and safer solution for cell engineering."
Ray Chen, PhD, president of GenScript USA Life Science Group.
GenScript's GMP ssDNA And dsDNA services enable faster CAR-T drug development:
GenExact™ ssDNA up to 5000nt in length, 100mg/batch production scale
GenWand™ closed-end, linear dsDNA up to 10,000nt in length, gram level/batch production scale
GenScript has been collaborating with several academic and industry partners in the development of CRISPR non-viral gene insertion. Recently, Dr. Alex Marson's lab at UCSF published a paper demonstrating how CRISPR RNP technology can both knock out endogenous T-cell receptors and integrate replacement anti-cancer receptors.
The UCSF team has been using GenScript's latest single-strand DNA to improve non-viral gene knock-in efficiency. Working in collaboration with GenScript, the team engineered modifications to the DNA payload to promote co-localization and delivery (or 'shuttle') to the nucleus.
About GenScript Biotech Corporation
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organization (CDMO) platform, the contract research organization (CRO) platform, and the industrial synthesis product platform.
GenScript was founded in New Jersey, USA in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript's business operation spans over 100 countries and regions worldwide, with legal entities located in the USA, mainland China, Hong Kong, Japan, Singapore, the Netherlands, and Ireland. GenScript has provided premium, convenient, and reliable products and services for over 100,000 customers.