INDUSTRIAL IMPACT

ProPhase Labs to Announce Formation of a Subsidiary ProPhase BioPharma, Inc.

ProPhase Labs, Inc. | June 29, 2022

ProPhase Labs
ProPhase Labs, Inc., a diversified biotech, genomics, and diagnostics company manufacturing homeopathic and health products, announced the formation of a new wholly-owned subsidiary, ProPhase BioPharma, Inc. (PBIO), for the development and licensing of new therapeutic compounds, drugs, and biotechnology. The subsidiary will be focused on advancements in technology across the biochemical industry and creating and developing new solutions that can transform the outcomes of healthcare.

The company has also entered into a license agreement with a wholly-owned subsidiary of DSS, Inc., Global BioLife, Inc. (Global BioLife), for Equivir G and Equivir, proprietary compounds that were developed by Global Research and Discovery Group (GRDG). According to the terms of the contract, ProPhase Labs will be the only company that can develop and sell Equivir G and Equivir, globally.

We are thrilled to announce the formation of ProPhase BioPharma, our new wholly-owned subsidiary tasked with licensing and developing novel drugs, compounds, and biotechnology. We are equally pleased with our first licensing agreement for Equivir and Equivir G, which we believe have significant potential to improve human health outcomes worldwide.”

Ted Karkus, ProPhase Lab’s Chief Executive Officer

He further added, “We plan to pursue commercialization of Equivir as an OTC supplement, leveraging our distribution in over 40,000 Food Drug and Mass retail stores and online direct to consumer. We also look forward to applying to the FDA for an IND for Equivir G as a prescription antiviral.”

Frank. D. Heuszel, Chief Executive Officer of DSS, said “We are excited to team up with ProPhase Labs, which will apply its nearly three decades of experience enhancing the health of the public to Equivir, which we believe to be a ground-breaking treatment that will positively impact health in the U.S. and globally.”

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MEDTECH

Synthego Launches Engineered Cell Libraries to Validate Targets with Speed and Accelerate Drug Discovery

SYNTHEGO | August 03, 2022

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As the newest addition to Synthego's Engineered Cells product line, the offering is a custom arrayed library of multi-guide™ knockout cell pools (immortalized or iPSC) delivered ready-made to researchers, efficiently enabling them to bypass the need for equipment and reagent sourcing, transfection, generation of an extensive CRISPR library, and hiring and training of staff. This allows researchers to overcome common hurdles associated with CRISPR-based target discovery and focus specifically on the science. “Arrayed screening approaches are more sensitive, compatible with a broader assortment of downstream assays, and can yield data that is more readily interpretable than the more commonly used pooled approach but are underutilized due to lack of infrastructure and limited bandwidth. With Engineered Cell Libraries, Synthego continues to provide transformative solutions for accelerated drug discovery which ultimately can bring a wider range of therapeutics to market faster.” Travis Maures, Synthego’s Chief Technology Officer With Engineered Cell Libraries, scientists specify the human or mouse cell type (Immortalized or iPSC available at launch) and gene targets they desire to knockout to generate a custom “Knockout Cell Library.” The cells are then edited on Synthego’s Eclipse Platform, which handles guide design, cell line optimization, editing through transfection, and assessment of editing efficiencies, so cells are ready to screen upon arrival. Engineered Cell Libraries on the Eclipse Platform additionally benefit customers with Scalability and flexibility - Engineered Cell Libraries allow researchers to maximize their screening power and identify more targets earlier in the screening process. Predictability and transparency - Synthego’s multi-guide™ technology achieves reliably high knockout efficiencies so researchers can confidently proceed with their screens. Cell engineering expertise and support - Synthego uses its expertise to bring automation innovation that provides greater consistency in outcomes and scalability. Synthego’s Eclipse Platform and Engineered Cell Libraries enable a wide range of applications in research and development across various disease areas and research disciplines such as oncology and neurology. Engineered Cell Libraries were employed in a recent study that used genetic screening to identify host factors that either facilitate or inhibit infection by SARS-CoV-2 and that could potentially be targeted with existing drugs that have been approved for other indications. “We were able to quickly combine our proteomic expertise with Synthego's genome engineering capabilities in a matter of weeks,” said Nevan J. Krogan, Director, Quantitative Biosciences Institute, University of California, San Francisco. “Normally, work such as this would take many years. We were able to quickly pinpoint which human genes are important for infection, and that allowed us to jump to which ones if we were able to drug them, could have a positive pharmacological effect on SARS-CoV-2 infection. That whole pipeline allowed us to identify several potential drug candidates, several of which we're still looking at.” Ultimately, Synthego’s goal is to enable scientists to spend less time thinking about method development and more time running their functional assays. The addition of Engineered Cell Libraries is driving impact in biopharma research and development. ABOUT SYNTHEGO Synthego was founded to revolutionize genome engineering technology, helping translate genomics into the clinic and ultimately making engineered biological therapies accessible to all patients. The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance both basic research and therapeutic development programs. With its technologies cited in more than a thousand peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation enabling the next generation of medicines by delivering genome editing at an unprecedented scale.

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INDUSTRIAL IMPACT

Biocytogen and LiberoThera Achieve Milestone Progress in Co-Development of Fully Human GPCR Antibody Drugs

Biocytogen | July 21, 2022

Biocytogen Pharmaceuticals Co., Ltd. entered a strategic collaboration with LiberoThera Co., Ltd to co-develop fully human GPCR antibodies using Biocytogen’s advanced antibody discovery platform based on fully human antibody RenMabTM mice combined with LiberoThera’s outstanding membrane antigen preparation technology. In around a year since the collaboration was established, the two parties have screened out a number of fully human therapeutic antibody clones with excellent anti-tumor activity in vitro and in vivo against the first mutually selected GPCR target, CCR8, which has the potential to become a best-in-class product. These antibody clones exhibit high affinity binding to human CCR8 with species cross-reactivity and good manufacturability. Mechanistically, these clones can deplete Tregs from the tumor micro-environment through enhanced ADCC activity, and can also inhibit the activities of Tregs in the tumor micro-environment by inhibiting CCR8 signaling mediated by its ligand CCL1, thereby enhancing the anti-tumor immune response. In the future, the collaborations between two parties will also be extended to other GPCR targets. GPCRs are seven-transmembrane proteins with short extracellular domains and high homology among them which make it difficult to find antibodies against them with high specificity and desired functions. However, both the success rate and the speed of GPCR antibody discovery have greatly increased by combining Biocytogen’s target knocked-out fully human antibody mice RenMab KO, various immunization and antibody discovery technologies, high-throughput in vitro and in vivo screening platform and LiberoThera’s deep understanding of GPCR target structures plus membrane antigen preparation technologies. “We are very pleased that with the joint efforts of us and LiberoThera, the drug development of CCR8, a potential target for tumor immunotherapy, is progressing smoothly. This undoubtedly validates that LiberoThera's advanced antigen preparation technology synergizes with our RenMice KO platform to generate diverse fully human antibodies. Furthermore, our high-throughput in vivo and in vitro screening capabilities ensured that antibodies against GPCRs can be efficiently obtained. We look forward to advancing our CCR8 antibodies into the clinic soon and we also look forward to continue working with LiberoThera to tackle more GPCR targets.” Dr. Yuelei Shen, Founder, Chairman and CEO of Biocytogen “Many GPCRs are important drug targets for a variety of indications. However, due to the special structure of such targets, the development of antibody drugs against them has always been challenging,” said Dr. Toru Kanke, CEO of LiberoThera. “The structural GPCR antigens prepared with LiberoThera’s proprietary cell-free membrane synthesis technologies together with non-natural amino acid incorporation methods can provide a solution for generating quality antibodies against the challenging targets. Biocytogen’s streamlined fully human antibody development platform greatly accelerates the translation of GPCR research. We are very happy to see the rapid progress and discovery of the best-in-class therapeutic antibodies against CCR8 under the collaboration of both parties. We also look forward to the collaborations in the future with Biocytogen to work on more GPCR targets so that to benefit more patients around the world.” About Biocytogen Biocytogen Pharmaceuticals Co., Ltd. is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM /RenLite® mice platforms for fully human monoclonal and bispecific antibody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs for more than 1000 targets, known as Project Integrum, and has entered ongoing collaborations with dozens of partners worldwide to produce a variety of first-in-class and/or best-in-class antibody drugs. At present, many GPCR projects from Project Integrum are under development that are important for treating cancer, metabolic diseases and beyond. In the future, Project Integrum will continue producing more fully human antibodies against GPCRs and other difficult targets. Biocytogen wishes to collaborate with partners around the world to discover, develop and deliver new medicines through innovative technologies that benefit human health. The company's pipeline includes 12 core products, among which two products are in phase II multi-regional clinical trials and two products are in phase I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany. About LiberoThera LiberoThera is a drug discovery company targeting membrane proteins including GPCRs. Founded on the revolutionary research by Prof. Shigeyuki Yokoyama, Emeritus Professor at The University of Tokyo and Distinguished Senior Scientist at RIKEN, LiberoThera utilizes its cutting-edge cell-free protein expression system and non-natural amino acid technology which enable complexed membrane proteins to be prepared in natural forms with structural and functional integrity. LiberoThera is developing novel therapeutic candidates targeting physiologically important membrane proteins, such as GPCRs, in collaboration with multiple partners.

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MEDICAL

Be Bio and Resilience Announce Strategic Collaboration to Manufacture Engineered B Cells, a New Class of Cellular Medicines

Be Bio | May 20, 2022

Be Biopharma, Inc. (“Be Bio”) and National Resilience, Inc. (Resilience) today announced a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning. The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties. Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner, Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs.” Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio. Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work. This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies, By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. About B Cells – A New Class of Cellular Medicines Imagine what could “Be?” In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas. About Be Biopharma Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. About Resilience Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.

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