Cobra Biologics and Symbiosis Complete Viral Vector Collaboration

Genengnews | July 10, 2019

Cobra Biologics, a CDMO focused on viral vector drug substance production, and Symbiosis Pharmaceutical Services, a CMO specializing in the sterile manufacture of injectable viral vector drug products, reported the successful completion of their collaboration to develop synergistic capabilities. Intended to accelerate the clinical and commercial production of viral vectors, which represent part of the burgeoning Advanced Therapeutics Medicinal Product (ATMP) drug development space and the growth of personalized medicine, the 18-month joint project saw a combined investment of £4.8m including significant support from a grant received under the U.K. government’s Innovate UK Health and Life Sciences Program. The collaboration significantly increases both companies’ existing commercial capacity and simplifies the supply chain process for the manufacture of viral vectors for use in gene therapy and immunotherapy, said Peter Coleman, CEO of Cobra. By aligning the technical expertise and manufacturing capabilities of Cobra and Symbiosis, the complexity, time, and risk of viral vector manufacturing projects will be greatly reduced meaning that customer companies developing viral vector ATMPs can derive their own competitive value from accelerating their progression along the drug development critical path, he added.

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INDUSTRIAL IMPACT

n-Lorem Foundation Partners with Argonaut to Manufacture ASO Medicines for Patients with Nano-rare Diseases

Argonaut Manufacturing Services | February 02, 2022

Argonaut Manufacturing Services, a leading contract manufacturing organization, and n-Lorem, a nonprofit foundation, today announced a new partnership that supports and reduces the cost of manufacturing of n-Lorem’s experimental antisense oligonucleotide medicines developed for nano-rare disease patients for free, for life. “Providing nano-rare patients, who would otherwise be largely ignored by our current drug discovery paradigm, with a personalized approach for free is a remarkable undertaking and one that requires the commitment of many people and organizations. We are pleased to add Argonaut to our growing list of the industry’s best to support the highest-quality drug discovery, development, and manufacturing for our patients. Reducing the cost of manufacturing translates into lower per-patient costs, which is important for our non-profit and important for our patients who depend upon us and our partners. At n-Lorem, we are fortunate that our partners can integrate seamlessly and efficiently with us and together we work toward making a difference for our nano-rare patient today and tomorrow.” Stanley T. Crooke, M.D., Ph.D., Founder, CEO and Chairman of n-Lorem Foundation “At Argonaut, we are incredibly proud to be working with this distinguished group of experts at the n-Lorem Foundation. We are focused on delivering the best contract manufacturing support to the innovators and creators, in the biopharma industry. Partnering with the n-Lorem Foundation provides us with the unique opportunity to apply our leading aseptic drug product manufacturing technology in support of nano-rare patients,” said Wayne Woodard, Founder and CEO of Argonaut. “I have been impressed with Stan’s vision and leadership with n-Lorem's charitable approach, and the overall progress of the foundation in such a short time. We are committed strategic partners as we understand that there are > 7,000 known rare to nano-rare diseases. Stan and I share a vision that these patient groups will have access to the life improving or lifesaving drugs that need to be developed. As such, we are honored to work with n-Lorem.” “For decades, patient care for rare disease and now nano-rare patients has improved with technological advancement. n-lorem has established the best partners in rare disease research, and we at Argonaut will be the final step in the sterile fill finish of these life-saving therapies. Our world class platform and expertise in drug product manufacturing were designed specifically for small batch drug product manufacturing that is specifically valuable for rare and orphan disease. This expertise and leadership is what we bring together with n-Lorem,” said Eric Blair, Chief Commercial Officer at Argonaut. About Argonaut Manufacturing Services, Inc. Argonaut Manufacturing Services is an FDA registered, FDB approved, ISO 13485:2016 cGMP contract manufacturing organization dedicated to providing custom manufacturing and supply chain solutions for life science, molecular diagnostics, and biopharmaceutical companies. Life sciences and molecular diagnostics services include formulation, filling, lyophilization, and kitting, while biopharmaceutical services feature state-of-the-art automated aseptic fill-finish equipment for sterile injectable drugs. All projects are supported by a senior project management group, full analytical quality control service offering and global shipping logistics. From procurement through distribution, Argonaut provides a wide range of flexible solutions for diverse outsourcing needs. About n-Lorem n-Lorem Foundation is a non-profit organization established to apply the efficiency, versatility, and specificity of antisense technology to charitably provide experimental antisense oligonucleotide (ASO) medicines to treat nano-rare patients diagnosed with diseases that are the result of a single genetic defect unique to only one or very few individuals. Nano-rare patients describe a very small group of patients who, because of their small numbers, have few if any treatment options. n-Lorem Foundation was created to provide hope to these nano-rare patients by developing individualized ASO medicines, which are short strands of modified DNA that can specifically target the transcripts of a defective gene to correct the abnormality. The advantage of experimental ASO medicines is that they can be developed rapidly, inexpensively and are highly specific. To date, n-Lorem has assisted in the development and treatment of 14 nano-rare patients and received over 100 applications for treatment with more than 50 nano-rare patients approved. n-Lorem was founded by Stanley T. Crooke, M.D., Ph.D., former chairman and CEO of Ionis Pharmaceuticals, who founded Ionis Pharmaceuticals in 1989 and, through his vision and leadership, established the company as the leader in RNA-targeted therapeutics.

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MEDTECH

IBM Research and Arctoris accelerate closed loop drug discovery with AI and Cloud

Arctoris | September 14, 2021

IBM Research and Arctoris announced they are investigating the application of AI and automation to accelerate closed loop molecule discovery. IBM Research has developed RXN for Chemistry, an online platform leveraging state-of-the-art Natural Language Processing (NLP) architectures to automate synthetic chemistry. Representing chemical reactions via SMILES (Simplified Molecular Input Line Entry System), the system is able to perform highly accurate reaction predictions using its powerful AI. Optimised synthetic routes are then used as input for RoboRXN, an automated platform for molecule synthesis. Arctoris has developed Ulysses, an end-to-end automated platform for drug discovery research. The platform ensures accuracy, precision, and reproducibility by leveraging robotic experiment execution and digital data capture technologies across cell and molecular biology and biochemistry/biophysics. Experiments conducted with Ulysses generate more than 100 times more datapoints per assay compared to industry standard, leading to deeper insights and accelerated progress compared to manual methods. The two platforms are now being combined for the first time in a research collaboration that will see new small molecule inhibitors for undisclosed targets being designed, made, tested, and analysed (DMTA) in an autonomous, closed loop approach. Concretely, IBM Research will design and synthesize novel chemical matter (Design, Make), to be profiled and evaluated by Arctoris (Test, Analyze), with the resulting data informing the subsequent iteration of the DMTA cycle. The collaboration is currently on-going; financial terms were not disclosed. About IBM Research For more than seven decades, IBM Research has defined the future of information technology with more than 3,000 researchers in 16 locations across five continents. Scientists from IBM Research have produced six Nobel Laureates, 10 U.S. National Medals of Technology, five U.S. National Medals of Science, six Turing Awards, 19 inductees in the National Academy of Sciences and 20 inductees into the U.S. National Inventors Hall of Fame. About Arctoris Arctoris is a biotechnology company founded and headquartered in Oxford with additional operations in Boston and Singapore. Ulysses, the unique technology platform developed by Arctoris, enables the company to conduct its R&D – from target via hit and lead to candidate – significantly faster, and with considerably improved data quality and depth. With its robotics, Arctoris generates richer, more reliable data, enabling better decisions both in human-driven and computational drug discovery, leading to higher success rates and an accelerated progression of programs towards the clinic. Led by an experienced team, Arctoris pursues its internal pipeline of small molecule inhibitors in different indications, and also partners with other biotech and pharma companies for small molecule and biologics discovery, with partners in the US, UK, Germany, Australia, Korea, China, and several other countries.

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MEDICAL

Felix Biotechnology Announces Initiation of CYPHY Phase 1/2 study at Yale for Lead Asset

Felix Biotechnology | January 08, 2021

Felix Biotechnology reported the inception of CYPHY, a Phase 1/2 examiner started single focus preliminary at Yale University for focused phage treatment YPT-01 in the therapy of constant P. aeruginosa diseases in cystic fibrosis. This twofold visually impaired, fake treatment controlled study (NCT 04684641) will evaluate the wellbeing and adequacy of YPT-01 added to standard antimicrobial treatment in 36 patients. CYPHY will likewise evaluate the capacity of YPT-01 to lessen the harmfulness and anti-infection obstruction of P. aeruginosa, improving patient results and re-empowering utilization of conventional anti-infection agents against multi-drug safe strains. The lead specialist for this investigation, Dr. Jon Koff, Associate Professor and Director of Yale's Adult Cystic Fibrosis Program, is supported by an academic grant from the Cystic Fibrosis Foundation. "This is a fantastic opportunity to show how effective phage therapy can be when deployed in an evolutionary framework. We know that pathogens evolve resistance to any antibiotic or therapy we use, so our approach turns that to our advantage," said Dr. Paul Turner, Professor of Ecology and Evolutionary Biology, co-inventor of YPT-01, and co-founder of Felix Biotechnology. "By targeting phage to mechanisms of virulence, we ensure that if pathogens evolve resistance to phage, they lose traits that make them effective pathogens, putting them in an evolutionary Catch-22."

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