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.
PharmAbcine | December 08, 2020
PharmAbcine Inc., a clinical-stage biotech organization focusing in on the improvement of completely human antibody therapeutics, declared today that the organization will introduce the refreshed break information from the continuous stage Ib trial of olinvacimab and pembrolizumab combination therapy in metastatic triple-negative breast cancer (mTNBC) patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) occurring for all intents and purposes over December 8-11, 2020.
Positive data from the progressing security and tolerability study will feature wellbeing and certain viability information including ORR (Overall Response Rate) and DCR (Disease Control Rate) from 11 patients diagnosed with mTNBC.
"We are excited to present highly encouraging data from our ongoing trial in the biggest breast cancer symposium. These data offer important insights into future development of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine.
TurtleTree | August 16, 2021
Solar Biotech, led by industrial biotech expert Alex Berlin, has become a significant piece of the puzzle for sustainable food tech companies taking products to market. TurtleTree knew from the beginning that one of the biggest challenges for food tech companies was developing the technologies required to scale up bio-manufacturing processes.
TurtleTree is a biotech company based in Singapore and the US. The company is focused on providing access to the best nutrients in milk using sustainable technologies. With so many food tech companies coming onto the scene, dedicated talent and resources needed to reach commercial scale are scarce.
Microbes like yeast and fungi are nature's perfect tools for bio-manufacturing. Precision fermentation uses microbial hosts as cell factories to produce specific beneficial ingredients in a controlled environment without having to go through animal agriculture.
What happens in the lab is just half the battle. Efficient precision fermentation and product recovery at an industrial scale demand agility, flexibility, decades of experience, unique multidisciplinary process and equipment engineering, and a well-connected network of bioprocessing and microbial biotech partners, all professionally taken care of by Solar Biotech.
Many startups and VC's believe major breakthroughs in the lab will result in the real-world commercialization of bioproducts. The reality is that many projects run into years of roadblocks and scale-up challenges making commercial viability difficult. There is a major difference between traditional fermentation methods, where the microbial biomass itself is the end product, and precision fermentation, where a highly technical skillset is required to obtain the specific desired bioproduct synthesized by the microbial host.
A key factor in reaching price parity with traditional food production methods is the availability of technologically advanced large-scale food-grade bioprocessing facilities, which combine precision fermentation and downstream processing lines that are customized for each player. Based on a Good Food Institute (GFI) report, available biomanufacturing facilities suitable for food precision fermentation is only 3% of the total manufacturing capacity. With the increasing demand for large-scale precision fermentation, we are already seeing the supply falling short.
Alex Berlin, Solar Biotech Founder, CEO & CTO, having built his extensive experience from his time at Novozymes and other industrial biotech companies, has a track record of developing and scaling up bioproducts that were quite challenging for many others. The TurtleTree team identified this value early on, built a strong collaboration model, and made an investment in Solar Biotech.
"TurtleTree's decision to back Alex Berlin and Solar Biotech's team from the early days has started to pay dividends. Our teams can focus on lab-scale R&D and go-to-market as we look to play a major role in the sustainable food supply chain, while Solar Biotech delivers the bioprocessing technologies required for production at scale," says Max Rye, co-founder and chief strategist of TurtleTree.
"My team and I are passionate about not only producing the food of the future but also about making a difference in the way these bioproducts are made. Industrial Biomanufacturing at scale has not evolved significantly for decades. We are committed to making a difference, in particular, with a focus on the deployment of unique cutting edge and sustainable bioprocessing technologies. We believe solar energy and a circular economy strategy will play a major role in how we produce novel bio-processed ingredients," says Alex Berlin.
TurtleTree is unlocking access to the natural ingredients found in milk using a host of cell-based technologies. Together with its valued partners, TurtleTree is able to achieve resource efficiency and provide millions with access to the beneficial nutrients found in milk. We aim to transform performance nutrition, food systems, and cellular agriculture with our cell-based technology platform.
About Solar Biotech
Founded in 2019 by Alex Berlin, Solar Biotech brings bioproducts from benchtop to industrial bioprocessing commercial scale. Its proprietary technology uses a combination of unique technologies, skills, and experience to swiftly adapt to the needs of each bioproduct. Solar Biotech customises modular plant architectures, called BioNodes, for specific bioproducts. Solar Biotech's 100% solar-powered platform and facility help precision fermentation companies scale up their operations sustainably and at a fraction of the cost.