MEDICAL

Sesen Bio Partners with Hikma Pharmaceuticals for the Registration and Commercialization of Vicineum

Sesen Bio | December 02, 2020

Sesen Bio, a late-stage clinical organization creating focused on combination protein therapeutics for the therapy of patients with cancer, and Hikma Pharmaceuticals, a worldwide pharmaceutical organization and driving permitting partner in the Middle East and North Africa ("MENA") area spend significant time in the turn of events and commercialization of an expansive scope of great medicines, today declared that the organizations have gone into exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and different sorts of cancer in MENA. Vicineum, a privately managed combination protein, is Sesen Bio's lead product competitor presently in the subsequent phase of a Phase 3 enrollment preliminary for the treatment of high-hazard, BCG-unresponsive NMIBC. In December 2019, the Company started the BLA submission for Vicineum to the FDA under Rolling Review.

Under the details of the understanding, Sesen Bio granted Hikma a exclusive license to register and commercialize Vicineum in all of the 19 MENA markets in a course of action foreseen to convey equivalent worth offer to the two players. Monetary terms of the arrangement are secret and incorporate a forthright installment to Sesen Bio, deals related achievement installments, and eminences on net deals in the locale for the term of the understanding. Sesen Bio holds full turn of events and commercialization rights for Vicineum for the treatment of NMIBC in the US and the remainder of the world barring Greater China and MENA.

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DIAGNOSTICS

Oncode Institute and ArgoBio Launch Laigo Bio, a Targeted Protein Degradation Biotech With Programs in Oncology and Neurological Disorders

ArgoBio and Oncode Institute | February 08, 2022

ArgoBio and Oncode Institute have teamed up with Oncode Investigator Madelon Maurice, researcher and group leader at UMC Utrecht, to launch Laigo Bio, a new company in the emerging field of target protein degradation. The company has additionally secured funding from Oncode Bridge Fund and ArgoBio to further develop its proprietary pipeline of targeted immunotherapies SureTACsR. The SureTACsR technology platform is a novel approach in membrane protein degradation, applicable to a broad scope of disease applications. The primary focus lies in the area of oncology, but with parallel programs in neuro-inflammation and neuro degenerative diseases. In contrast to other small molecule approaches, this results in an efficient and sustained degradation of target receptors, potentially resulting in superior efficacy in the clinic than modalities currently being employed by other emerging protein degradation technologies. Initially driven by Madelon Maurice, who will join as the Principal Investigator, Laigo Bio is gearing up for preclinical lead development in the coming months, generating proprietary biologics for a selection of targets to showcase its potential. Laigo Bio receives strong support from seasoned entrepreneurs Neill Moray Mackenzie at ArgoBio and Emil Pot at Oncode, who will prepare the company for a Series A investment round as it aims to initiate its first clinical studies in 2025. Dr. Neill Moray Mackenzie at ArgoBio is a veteran of the IO field and Mr Emil Pot is an IP & business development expert at Oncode with 25 years of experience in life sciences. Chris De Jonghe, Valorization Director of Oncode Institute, said: “SureTACsR is building on the innovative ideas that Dr. Maurice has initially validated with the support of Oncode’s Technology Development Fund. With the foundation of Laigo Bio, another exciting step forward is made towards the translation of Dr. Maurice’s innovations into effective, and tailored therapies for cancer patients. We are thrilled to join forces with ArgoBio in this initial seed round and consider it as a token of great confidence in the potential of this platform technology.” Madelon Maurice of the UMC Utrecht, said:“We are extremely happy that ArgoBio is supporting my long-standing research here at the UMC Utrecht on how to interfere with signalling alterations that drive oncogenesis and bringing a team of experienced scientists and entrepreneurs to help with its translation to the clinic.” Dr. Neill Moray Mackenzie of ArgoBio, said: “This is exactly why we put ArgoBio together last year – to fund these early-stage opportunities. I am especially pleased that Madelon Maurice, a renowned KOL in the field, is leading this novel approach to protein degradation which has great potential to open up a completely new biology in the field of cancer therapy.” “Targeted protein degradation is an exciting space and has gained validation in clinical studies with many players now entering the field. One key differentiator here is sustained degradation of cell membrane bound proteins with a biologic, which is a very novel approach, and we believe holds a lot of promise in oncology and many neurological indications. We look forward to supporting Madelon, Neill and Emil in their journey at Laigo Bio.” Shobhit Dhawan of Oncode Bridge Fund About Argobio Argobio is a start-up studio based in Paris, France, dedicated to turning cutting-edge innovations into breakthrough biotech companies. Argobio sources innovative early-stage projects on therapeutics from renowned European academic research institutions with a focus on rare diseases, neurological disorders, oncology, and immunology. Argobio selects and incubates these projects with the goal to create biotech companies and develop them up to a significant Series A financing. Argobio provides broad expertise in the discovery and development of novel drugs with a team of highly experienced Biotech entrepreneurs. About Oncode Institute Oncode Institute unites more than 900 excellent fundamental cancer researchers in the Netherlands. Our mission is to stimulate innovations in the diagnosis and treatment of cancer. The ultimate goal is to help patients survive, improve the quality of life for those affected and contribute to a more affordable healthcare system. Oncode Institute translates fundamental insights into the biology of cancer into new diagnostics, new drugs and innovative treatments. Oncode’s three strategic pillars to improve patient outcomes are Excellent Science, Collaboration and Valorization. Oncode is funded by The Dutch Cancer Society, together with the Ministries of Economic Affairs & Climate, Education Culture & Science and Health, Welfare & Sport, and Health~Holland, with a total amount of €120 million until 2022. About Oncode Bridge Fund The Oncode Oncology Bridge Fund provides early-stage financing to help the creation and growth of new enterprises based on the science of Oncode Investigators. The Bridge Fund aims to accelerate the translation of innovative cancer research of the Oncode labs into treatment options, diagnostic methods and research tools that benefit patients and society as a whole. About UMC Utrecht UMC Utrecht is one of the top-ranked academic medical centers in Europe with the core tasks of care, research and education. With more than 12,000 employees, UMC Utrecht, of which the Wilhelmina Children's Hospital is a part, is one of the largest public healthcare institutions in the Netherlands and the largest employer in the Utrecht region. Our mission: together we improve the health of people and create the care of tomorrow. Together we create more value, because we believe that every person counts. About Laigo Bio Laigo Bio is based on the research from the laboratory of Professor Madelon Maurice, known internationally for her contributions to the understanding of Wnt signaling, a key pathway for stem cell maintenance and tissue renewal. A main focus of her work is to uncover the mode-of-action of membrane-bound E3 ligases that control Wnt receptor turnover and are frequently mutated in cancer.

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INDUSTRIAL IMPACT

Nexeo Plastics and Earth Renewable Technologies Sign Agreement to Distribute BioCompounds in North America

Nexeo Plastics | March 02, 2022

Nexeo Plastics, a leading global thermoplastics resin distributor, has announced an agreement with Earth Renewable Technologies, Inc. (ERT), a biotechnology company, to distribute ERT’s BioCompounds in Canada and the United States. “We are extremely pleased to collaborate with ERT to increase the slate of sustainable products we offer our customers. ERT’s BioCompounds complement the products we already carry and help us close the gap in our renewable solutions line card.” Arturo Hoyo, Nexeo Plastics’ Vice President of Product Line Management Compostable, biobased and/or biodegradable, ERT’s plant-based BioCompounds perform like conventional plastics and are often ideal for a wide range of uses, including single-use and one-time niche applications, such as bags, bottles and cutlery. “We want to make the world more sustainable by improving the availability of sustainable materials that can perform like plastic,” said ERT President Kim Fabri. “Nexeo Plastics’ reach in North America, their understanding of the value of sustainable material, and their growing portfolio of sustainable products makes them an ideal partner for us.” About Nexeo Plastics Nexeo Plastics is a leading global thermoplastic resins distributor, representing quality products from world-class suppliers, and serving a diverse customer base across North America, Latin America, Europe, Middle East, Africa and Asia. From material selection assistance to identifying supply chain and inventory solutions, we go beyond traditional logistics to provide value-added services across many industries, including automotive, healthcare, packaging, wire and cable, 3D printing and more. About Earth Renewable Technologies Earth Renewable Technologies, Inc. (ERT) was founded in 2009 with the mission of replacing plastic packaging with biodegradable materials. ERT patented SFRP (Short Fiber Reinforced Polymer), a pioneering technology capable of drastically modifying the performance of biopolymers and delivering previously unknown applications for these materials. Since then, the company has been introducing new technologies to the market, revolutionizing the biopolymer market and allowing companies to truly move towards a circular economy.

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MEDICAL

PacBio transforms access to the epigenome and streamlines workflows

PacBio | April 23, 2022

PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced the release of a transformative capability to detect DNA methylation using the Sequel IIe and Sequel II Systems. This extends PacBio’s unique and highly capable HiFi sequencing technology to now include access to the epigenome, a second layer of genomic information often left unexplored due to fundamental limitations of common sequencing technologies. PacBio’s single-molecule approach provides a much more holistic view of molecular behavior during sequencing. Subtle patterns in this rich information allow detection of modified bases in native DNA during standard HiFi sequencing. As a result, scientists gain access to the epigenome with zero additional cost, effort, or complexity. This advance will unlock important new opportunities across a broad range of applications in fundamental and applied biological science. This update also includes a wide range of workflow improvements to enhance customer experience, such as simplified, unified, and accelerated library preparation workflows and consumables, live instrument performance monitoring, and on-instrument analysis support for recombinant adeno-associated virus (rAAV) genome sequencing, a rapidly growing biopharmaceutical application relevant to gene therapy and vaccine development research. With each product release we continue to improve the utility and value of the Sequel II and IIe platform, providing researchers with unique capabilities that differentiate PacBio HiFi sequencing from all other sequencing technologies, Our latest enhancements to the Sequel II and IIe platform, including 5-base sequencing and improved workflows are expected to both simplify the ability to generate high quality data and enable deeper insights into the complexity of the genome.” Christian Henry, President and Chief Executive Officer of PacBio. Multiple tests are currently required to evaluate rare disease cases for sequencing and methylation variation. HiFi sequencing has the potential to change that by measuring both genetic and epigenetic variation across the full genome in a single experiment. We have had success using 5-base HiFi sequencing at Children’s Mercy Kansas City to identify abnormal methylation in repeat expansion cases, and we plan to apply it to all the future genomes we sequence. It is exciting to access another aspect of the genome without needing to change sample handling or sequencing procedures.” Emily Farrow, PhD, CGC, Director of Laboratory Operations at Children’s Mercy Kansas City and Associate Professor of Pediatrics at University of Missouri Kansas City School of Medicine. We found that the CpG methylation patterns detected in tomato and maize genomes using HiFi sequencing are highly concordant to standard bisulfite sequencing but bring power to resolve transposable elements and other sequences that are out of reach with short reads. When combined with the incredible capabilities of HiFi sequencing for genome assembly and variation analysis, this creates an unmatched opportunity for ultra-high-quality genome and epigenome analysis of plant and vertebrate genomes from a single datatype.” Michael Schatz, PhD, Bloomberg Distinguished Professor of Computer Science and Biology at Johns Hopkins University. PacBio’s HiFi sequencing technology offers a comprehensive view of genomes and transcriptomes. But DNA contains much more information subtly encoded as “epigenetic” modifications to DNA bases. This epigenome influences how genes are expressed and plays a major role in determining biological function in both health and disease. Historically, access to the epigenome has been difficult and required sacrifices in read lengths, accuracy, and completeness while adding workflow complexity. By including automatic detection of the key modified base in humans and many other species (5mC in CpG motifs) PacBio sequencing technology provides access to the combined genome and epigenome without sacrificing read lengths, accuracy, or completeness, and without requiring additional workflow steps. Streamlining workflows is a key focus for PacBio, and this latest update makes it easier to perform HiFi sequencing. The company’s new SMRTbell prep kit 3.0 is capable of reducing workflow time for whole-genome sequencing applications by 50 percent or more and reducing required DNA inputs by 40 percent (to three micrograms per human genome). SMRTbell prep kit 3.0 is suitable for a wide range of applications and supports automation and batch processing of samples. PacBio also introduced a new single-reaction sequencing plate and SMRT Cell 8M tray that better enables customers to run samples at their convenience. About PacBio Pacific Biosciences of California, Inc. (NASDAQ: PACB) is empowering life scientists with highly accurate sequencing platforms. The company’s innovative instruments are based on Single Molecule, Real-Time (SMRT®) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio® sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology.

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CELL AND GENE THERAPY

c-LEcta Continues Its Growth in 2021 and Sees Itself Excellently Positioned for the Future With the ENESYZ Technology Platform

c-LEcta | December 20, 2021

c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, continued its growth in 2021. The high expectations for the fiscal year have been fully met and were even significantly exceeded. Thus, the management expects annual revenue in the range of EUR 20 million, which equates to a doubling of last year’s result. With an expanded team, further investments in the product range and the ENESYZ technology platform are expected to keep up the pace of growth in the coming year. The continued growth confirms the Leipzig-based company’s strategy of placing its development on a solid foundation with a broad range of specialized enzymes for the pharmaceutical and food industries. With average revenue growth of 56% from 2018 to 2020 and further growth expected to reach around EUR 20 million in 2021, even during the Covid-19 pandemic, the business performance illustrates the strength and resilience of this strategy. “We are very proud of our performance in recent years. Our products provide good growth momentum and also great resilience due to the diverse application fields and this has supported us over the last two years. To continue to drive this growth in the long term, we have continued to build our team again this year and now employ 108 people. Moving forward, we plan to continue to invest in additional staff and equipment,” Thomas Pfaadt, CFO of c-LEcta GmbH c-LEcta managed to launch its new product NuCLEANase in October 2021. NuCLEANase is an enzyme that is used to remove unwanted DNA residues, in the food industry, for example, but also helps to dissolve deposits on machines and manufacturing equipment. The high demand from customers already at its launch confirms the high market potential for this product. “NuCLEANnase is an incredibly versatile product that holds great potential. However, the development also demonstrates the versatility of our ENESYZ technology platform, which allows enzyme developments based on different production systems for a wide range of applications. ENESYZ is constantly being further developed. For example, this year we were able to integrate an additional expression host, Bacillus, into our enzyme engineering platform,” explained Dr. Marc Struhalla, founder and CEO of c-LEcta. The company also made significant progress in the area of machine learning and artificial intelligence in 2021. “We were recently able to achieve some very promising results in this innovative area. The topic is a very important building block for future product developments and we are extremely motivated to rapidly expand our expertise in this area,” Dr. Struhalla added. Many new customers were once again acquired over the course of 2021. There was strong demand for the products from the DENARASE family, which also address the gene and cell therapy market. A total of more than 500 mailings were sent out to more than 200 customers from nearly 30 countries. The largest sales market was the USA. The ELISA kit launched in 2020 was also a particular success, with very significant growth in demand in 2021. c-LEcta’s most important markets, the food and pharmaceutical industries, are subject to strict regulations worldwide. An enzyme dossier submitted by c-LEcta facilitates the approval of its products for customers from the food industry. With the filing of a master file with the FDA, c-LEcta supports its customers in terms of regulatory compliance and demonstrates the quality of its manufacturing processes and products. In October, c-LEcta secured itself its own building complex with more than 10,000 m2 of space in the new biotechnology campus that spans a total area of 27,000m2 and is to be built at the “Alte Messe” site in Leipzig starting in the second quarter of 2022. “We want to and will indeed continue to grow. Great new space is being built at Alte Messe, which will allow us to set up state-of-the-art office and laboratory areas for our growing team. This will provide us with the space to continue our growth,” Dr. Struhalla concluded. About c-LEcta c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. The company is based in Leipzig, Germany, and has established itself as a leading player in the realization of high-value biotech products, either in the form of in-house developments or in close cooperation with industry. The company currently employs more than 100 people.

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