Nucleus Biologics Unveils World's First Online Portal for Instantaneous Custom cGMP Cell Culture Media Configuration

Nucleus Biologics | May 27, 2020

Nucleus Biologics, a leader in precision cell culture, today announced the availability of NB-Lux™, an online configuration and ordering platform for cell culture media. Designed for developers of cell therapies, NB-Lux™ speeds formulation development by providing real time pricing for cGMP grade media in lot sizes from two liters to 2000 liters. Media is a critical component in the production of cell therapies. During development, companies iteratively test multiple formulations to identify an optimal medium for cGMP manufacturing. Some therapy developers utilize proprietary, off-the-shelf formulations for perceived streamlining in regulatory processes. However, unknown formulations are difficult to tailor to specific therapies, are not part of a therapy company's intellectual property portfolio and are vulnerable to supply chain issues due to sole sourcing. Equally undesirable, custom media currently takes up to six months to manufacture after it has been formulated. "Our mission is to speed the time from discovery to cure. We listened to the frustration of our cell therapy customers and reimagined the cell culture media configuration and ordering experience. No longer must a scientist guess what to add to proprietary, sole sourced medias or wait almost half a year to receive custom media," said David Sheehan, Founder, President and CEO of Nucleus Biologics. "NB-Lux™, a first-of-its-kind portal, empowers a scientist to create their own formulas, get real time quotes, and, in some situations, have cGMP media manufactured in as little as 9 weeks. This is the first step in our plan to reshape the media market. My sense is the COVID-19 pandemic has punctuated the need for the scientific community and industry to create new paradigms that expedite delivery of proven therapies." Nucleus Biologics developed the patent-pending NB-Lux™ to provide real time quotes for cGMP cell culture media. Users can input and manipulate different formulations online, receive real time pricing, and track order progress. NB-Lux™ is powered by one of the largest repositories of over 400 publicly available formulations. Users can optimize each individual chemical component, testing requirements, and packaging. By customizing a media to the unique critical attributes of each therapy, developers can take control of formulations, rapidly progress from small- to large-scale production, and move therapies to the clinic faster.

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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

Amnio Technology Launches Two New Dual-Layer Allografts, FDA Recognizes Products as Minimally Manipulated, Homologous Use HCT/Ps

Amnio Technology | February 15, 2022

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane. The new allografts, like the entire family of PalinGen® membrane products, are minimally manipulated, homologous use and chorion-free. The dual-layered nature of the allografts allow for unidirectional application with two outward facing epithelial sides. The proprietary Advantek® process used to manufacture PalinGen® membranes preserves the extracellular matrix components and regulatory proteins present in amniotic tissues. Preserving the characteristics of the natural tissue aids in wound management. PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are indicated for patients suffering from non-healing acute and chronic wounds as well as complex and/or open surgical wounds and burns. Senior Director of New Product Development, Robert Diller, PhD, shared his insight into the motivation for developing a multilayered amniotic product, "The PalinGen® Dual layer membranes have increased durability and slower resorption, which makes them ideal for use in robotic and other surgical applications" "With the application of single-layer PalinGen® membrane products, patients already experience improved clinical outcomes compared to treatment with standard of care. Cytokines, growth factors, and extracellular matrix proteins have been identified in amnion membranes and contribute to the complex wound healing process. Compared to single layer allografts, PalinGen® Dual Layer membranes deliver twice as many of these components to the wound area," lead Research Scientist on the development project, Sarah West The FDA recognized PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane as being minimally manipulated, homologous use human cell, tissue, and cellular and tissue-based products or HCT/Ps. In letters received from the Tissue Reference Group (TRG) within the Office of Tissues and Advanced Therapies (OTAT) on September 30, 2021, and February 8, 2022, respectively, FDA confirmed that PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane would be regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271. Amnio Technology has a long history of Good Tissue Practices (GTP) experience and compliance. In recent years, the FDA has issued final guidance on its Framework for the Regulation of Regenerative Medicine Products, making the confirmation of the regulatory status of amniotic products critical for business continuity in the amniotic tissue space. William Brown, Managing Director of Operations at Amnio Technology, recognized the efforts of the entire Amnio Technology Team, "We continue to be successful in the development and launch of new Products in our pipeline, which meet the Regulatory framework of the FDA and other Agencies. With a Team dedicated to compliance from the first step, we continue to expedite new product availability to clinicians for implementation into their practice and, ultimately, the ability to improve quality of life for the patient." Both PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are available in a variety of sizes suited for the patient's needs. About Amnio Technology Amnio Technology is a clinical stage biotechnology company dedicated to advancing the science of regenerative medicine. Established in 2013, Amnio Technology has developed core competencies in Good Tissue Practice and HCT/P Safety becoming a global leader in the development and distribution of amniotic tissue allografts. The Company has a robust pipeline of products and its liquid allograft for the treatment of chronic ulcers, PalinGen® Flow, is currently in a Phase 2 clinical trial.

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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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MEDTECH

Sorrento Announces COVISTIX COVID-19 Virus Rapid Antigen Detection Test Detects the Omicron Variant

Sorrento Therapeutics, Inc. | December 28, 2021

Sorrento Therapeutics, Inc. announced that initial testing of COVISTIX on recombinant N proteins demonstrated its ability to detect the Omicron variant, in addition to detecting the original SARS-CoV-2 virus and its other major VoCs such as the delta and delta-plus strains. The COVISTIX detection levels were similar for all variants. The ease of use and timely detection of Omicron infection was demonstrated by a recent case report of a Mexico patient infected with the Omicron variant detected first with COVISTIX in about 15-minutes test time. This result was confirmed a day later by RT-PCR and sequence verified a few days later to be Omicron infection. In a laboratory setting, Sorrento has also studied the ability of COVISTIX to detect the Omicron variant compared to other Emergency Use Authorization approved, commercially available COVID-19 virus rapid antigen tests. Initial lab results demonstrate that COVISTIX was able to detect the Omicron N protein at a significantly lower level than other commercially available tests. With a difficulty to detect the Omicron N protein at low levels, some of the EUA-approved and marketed rapid tests may have a tough time detecting the Omicron infection at a reasonable sensitivity. False negative readings for infected asymptomatic patients could lead to a false sense of security and the inability to control outbreaks and achieve normal social and business routines. Sorrento currently has the capacity to produce 30,000,000 COVISTIX tests a month and is currently building up its manufacturing capacity in the US. The company anticipates having a fully automated assembly line capable of producing 6,000,000 COVISTIX units per month up and running in Q1 2022. Pending US and global demand, this capacity could potentially be increased to over 100 million monthly in 2022. About Sorrento Therapeutics, Inc. Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain, autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies, immuno-cellular therapies , antibody-drug conjugates, and oncolytic virus. Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class non-opioid pain management small molecule, resiniferatoxin, and SP-102 corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

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