FUJIFILM Diosynth Biotechnologies to Support COVID-19 Vaccine Candidate Manufacturing

FUJIFILM Diosynth Biotechnologies | July 28, 2020

FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today that its College Station, Texas, site will support COVID-19 vaccine candidate manufacturing, as part of Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, issued a task order through the Texas A&M System (TAMUS) Center for Innovation in Advanced Development & Manufacturing (CIADM). The CIADM subcontracts manufacturing to the FUJIFILM Diosynth Biotechnologies owned and operated Flexible Biomanufacturing Facility (FBF) in College Station, Texas. The task order reserves manufacturing capacity in the FBF through the end of 2021. The FBF is one of three manufacturing facilities at FUJIFILM Diosynth Biotechnologies Texas campus.

Spotlight

Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywwide challenge, particularly within the context of global trials.

Spotlight

Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywwide challenge, particularly within the context of global trials.

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DIAGNOSTICS

Oxford BioTherapeutics Announces Research Collaboration with ImmunoGen to Develop Novel Antibody-Drug Conjugates

Oxford BioTherapeutics | June 14, 2022

Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, today announced a multi-year collaboration to research, develop and commercialize novel, first-in-class ADCs with ImmunoGen (IMGN), a leader in the expanding field of ADCs for the treatment of cancer. The companies will utilize ImmunoGen's linker-payload technology directed to novel targets identified via OBT's proprietary OGAP® discovery platform. The companies will support these R&D efforts through joint funding and by combining their respective proprietary technologies. "I am very enthusiastic about our new partnership with ImmunoGen, a leader in the development of ADCs," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "The company's expertise, in combination with the unique targets from our OGAP® database, provides potential to strengthen our respective drug pipelines with novel and highly differentiated ADCs for cancer patients in need of novel therapeutic options." As part of the agreement, OBT will receive an upfront payment from ImmunoGen, reflecting OBT's preclinical programs to be included in the partnership. In addition, once antibodies generated by OBT have been coupled with ImmunoGen's proprietary linker-payload technology, each company will have the opportunity to select one or more development programs to further develop on its own. Each company is eligible to receive milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones, as well as tiered royalties as a percentage of worldwide commercial sales, with respect to each program selected by the other company. Once a company has chosen a given program, it will be solely responsible for all R&D costs associated with the specific program. "OBT has demonstrated expertise in identifying novel targets for the development of specific antibodies – two key components to generating successful ADCs," said Stacy Coen, ImmunoGen's Senior Vice President and Chief Business Officer. "This expertise, combined with ImmunoGen's portfolio of cancer-killing payloads and linkers, will be instrumental as both companies work to develop novel ADCs designed to address cancers with high unmet need. We look forward to working with OBT as we expand and diversify our investment in ADC research capabilities, deepen our pipeline, and transition to a fully-integrated oncology company." ImmunoGen's portfolio is comprised of next-generation maytansinoid, DNA-acting, and novel camptothecin toxins and proprietary linkers. This collaboration will utilize novel targets identified by OBT combined with ImmunoGen's proprietary toxins and associated linkers. OBT has clinical experience with ImmunoGen's ADC platform and DM4 payload, which is utilized in OBT's lead program OBT076, an ADC currently in clinical trials as a monotherapy, as well as in combination with checkpoint inhibitors, in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian, and lung cancer. About Oxford BioTherapeutics Oxford BioTherapeutics is a clinical stage oncology company based in Oxford, UK; San Jose, CA and Morristown, NJ, USA; with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. OBT's lead clinical program, OBT076, an ADC utilizing an Immunogen toxin, initiated expansion in a U.S. Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers.

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INDUSTRIAL IMPACT

Gilead Sciences to Acquire MiroBio

Gilead Sciences, Inc. | August 05, 2022

Gilead Sciences, Inc. and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments. The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response. MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years. “The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.” “We are excited to be joining Gilead. MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.” Eliot Charles, Chairman of MiroBio Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. About MiroBio MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California

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MEDTECH

GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

Samsung Biologics | August 02, 2022

GreenLight Biosciences a biotechnology company dedicated to making ribonucleic acid products affordable and accessible for human health and agriculture, and Samsung Biologics a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies' mRNA production partnership. Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung's commercial facility was completed in seven months, demonstrating platform adaptability and scalability. GreenLight's process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight's mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA. The company's RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight's Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale. "This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic," John Rim, CEO and President at Samsung Biologics Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients. "One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production," said GreenLight CEO Andrey Zarur. "We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity." To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight's process to Samsung Biologics' Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale. About GreenLight Biosciences GreenLight Biosciences aims to address some of the world's biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company's platform is protected by numerous patents. GreenLight's human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq.

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