Biocytogen | January 15, 2024
Biocytogen Pharmaceuticals Co., Ltd. a global biotech company focusing on the discovery of novel antibody therapeutics, announces that it has entered into an Exclusive Option and License Agreement with Radiance Biopharma Inc. a biotechnology company specializing in developing next generation Antibody Drug Conjugates.
The agreement grants Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate (BsADC) for therapeutic product development, manufacturing and commercialization for all human indications worldwide. HER2 and TROP2 are two tumor-associated antigens (TAAs) that have been found to be commonly expressed and co-expressed by multiple tumor types, including breast, gastric, colorectal, bladder, pancreatic, and non-small-cell lung cancer.
Under the terms of the agreement, upon the option exercised, Biocytogen will be entitled to receive an option fee, licensing fee, development and commercialization milestone payments, as well as single-digit royalties on net sales. In addition, Biocytogen has the right to collect the sharing of sublicensing fee, if any, between Radiance and third party.
Dr. Yuelei Shen, President and CEO of Biocytogen, said: “We are excited to collaborate with Radiance, a strong team with extensive experience in drug development, to develop a leading proprietary fully human bispecfic antibody drug conjugate. We are optimistic that the combination of our strength in BsADC discovery and the extensive experience of Radiance’s team will help expedite the commercialization of this dual-targeting BsADC.”
Marc Lippman, MD, Chairman of the Board of Radiance said: “We are excited to enter into this Exclusive Option and License Agreement with Biocytogen for a novel human anti- HER2 and Trop2 Bispecific Antibody Drug Conjugate. Preclinical data from in vitro and in vivo assays of this BsADC shows promising high potency of anti-tumor activities in leading tumor indications. We are eager to work with Biocytogen to move the product to the clinic to benefit patients.”
Biocytogen is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMab™/RenLite®/RenNano®/RenTCR-mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established an off-the-shelf library of over 400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg).
About Radiance Biopharma
Radiance is focused on developing a pipeline of antibody-based cancer therapeutics including mono and bispecific Antibody Drug Conjugates (ADCs) for the treatment of cancer and to address other unmet medical needs. Marc Lippman, MD, a co-founder and Chairman of the Board of Radiance is a renowned oncologist and former founding board member of Seagen, a leader in the field of ADCs, recently acquired by Pfizer. Based in Boston, Massachusetts, Radiance has a world class, proven leadership team that brings together the best of ADC engineering, clinical, managerial expertise and track record. Radiance is an affiliated company to Alphageneron Pharmaceuticals Inc., a clinical-stage biotechnology company developing unique targeted cell and gene therapies for treating cancer and other unmet medical needs.
Stevanato Group | January 25, 2024
Stevanato Group S.p.A. a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC).
In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases.
The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration.
Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier. As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024.
Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy.
“In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner," says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group. "Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.”
About Stevanato Group
Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.
Twist Bioscience Corporation | January 30, 2024
Twist Bioscience Corporation a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced the expansion of Twist Express Genes, a new leading gene synthesis service with an order to shipping turnaround starting at five business days1, to include larger DNA preparations up to 1 milligram.
The Express Genes offering, initially launched in November 2023, now extends to larger midiprep (10μg to 100 μg) and maxiprep (100μg to 1mg) DNA preparations. As with Twist standard speed Clonal Genes, all Twist Express Genes are NGS-verified as clonally perfect.
“Since the initial launch of our Express Genes service in November, we have received positive and enthusiastic feedback from existing customers on our consistent and rapid turnaround time. By expanding Express Genes to include midiprep and maxiprep, we can now offer rapid gene synthesis at all gene prep scales, enabling large scale experimentation for pharmaceutical, biotechnology, academic and industrial chemical researchers,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “With the expanded offering of Twist Express Genes, more researchers can gain access to Twist genes fast and at scale, including those using alternative providers and those cloning their own genes. The ability to order and receive synthetic DNA fast and at scale means more time for cutting-edge research, more make-test-learn cycles, and an accelerated journey to game-changing discoveries.”
Twist leverages its ability to miniaturize the chemical reaction to create DNA using its silicon-based DNA synthesis platform along with expertise, software, optimized processes and the expanded layout of its Wilsonville facility to deliver Clonal Genes and Gene Fragments at scale and with rapid turnaround times. Twist’s Express Genes are offered with dynamic pricing, which reflects market demand and manufacturing capacity in a responsive premium price. Customers are able to quickly and easily place orders for Express Genes through Twist’s ecommerce platform.
Twist Express Genes
Twist Express Genes are 0.3kb to 5.0kb in length. Due to scale enabled by Twist’s platform, orders of any size both small and large can be filled, and as with standard speed Twist Clonal Genes, Twist Express Genes are NGS sequence-verified as one hundred percent accurate. Twist Express Genes can be cloned into catalog vectors or custom vectors so that customers can move right to experimentation. They can also be shipped in customers’ preferred delivery formats, including tubes and plates. For more information and product specifications click here.
Current turnaround times for some Twist Bioscience products
Express Genes1 (50ng-10µg): starting at 5 business days, now for up to 10µg
Standard Clonal Genes (50ng-10µg): starting at 10 business days
Express Genes1 (10µg-1mg): starting at 8 business days
Standard Clonal Genes (10µg-1mg): starting at 13 business days
1 Express Clonal Genes ship in 5-7 business days. DNA prep sizes including 10 μg - 100 μg, and 100 μg - 1 mg may incur an additional 3-5 days for synthesis. Orders placed outside of the US will incur additional delivery turnaround time. Express Genes orders that require new custom vector onboarding will incur an additional 1-2 weeks for processing.
About Twist Bioscience Corporation
Twist Bioscience is a leading and rapidly growing synthetic biology and genomics company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology. The core of the platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by “writing” DNA on a silicon chip. Twist is leveraging its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologics drug discovery. Twist makes products for use across many industries including healthcare, industrial chemicals, agriculture and academic research.