Cell and Gene Therapy, Medical
prnewswire | August 25, 2023
Synthego, a leading provider of industrialized genome editing solutions that accelerate discovery to clinic journey, and bit.bio, the company coding human cells for novel cures, today announced a strategic partnership to build a platform centered on the implementation of synthetic circuitry in cells for therapeutic application.
bit.bio is building a pipeline of cell therapies focused on areas of unmet clinical need. The partnership will apply Synthego's expertise in gene editing to bit.bio's opti-oxTM precision cell programming technology, with the aim of discovering and developing advanced genetic engineering solutions for cell therapies.
Synthego will rapidly design, build, test and deliver an end-to-end optimized multiplexed genetic editing strategy. The implementation of the multiplexed opti-ox engineering approach will reduce the number of engineering steps required, with the potential of shortening clinical cell engineering and development timelines by up to 10 months.
"bit.bio is the leading synthetic biology company focussed on human cells. We are thrilled to deepen our partnership with bit.bio to facilitate a leap forward in the development of synthetic biology-based cell therapies," said Paul Dabrowski, CEO at Synthego. "By coordinating our respective technologies, expertise and resources, we will unlock new opportunities for addressing critical challenges in the field by advancing the R&D cycle of innovative cell therapies."
"Synthego are experts when it comes to industrialized cell engineering," stated Mark Kotter, CEO at bit.bio. "Teaming up with Synthego will boost our genetic engineering capabilities. We expect efficiency gains across bit.bio's platform which will allow us and our partners to deliver transformative therapies more rapidly to patients in need."
About Synthego
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health. The company leverages machine learning, automation, and gene editing to build platforms and products for science at scale. With its foundations in engineering disciplines, the company's platform technologies vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials. With its technologies cited in hundreds of 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.
About bit.bio
bit.bio is a synthetic biology company focused on human cells that is advancing medicine (UN SDG9) and enabling curative treatments (UN SDG3). The company does this by industrializing the manufacture of human cells and making them more accessible. The company was spun out of the University of Cambridge in 2016 and has since raised approximately $200m from investors such as Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, Verition Fund and Puhua Capital.
bit.bio's opti-ox™ precision cell programming and manufacturing technology enables conversion of induced pluripotent stem cells (iPSCs) into any desired human cell type in a single step. This can be achieved within days and at industrial scale, while maintaining exceptional purity and unparalleled consistency.
Our discovery platform extends this approach to any desired cell type by identifying the transcription factor combinations that define cell states (including identity, cell subtype identity, maturity) using high throughput screens and advanced data analysis. We believe that opti-ox can revolutionize regenerative medicine similarly to how CRISPR is unlocking gene therapy.
bit.bio's cell therapy pipeline is focused on serious diseases that currently lack effective treatments. Our preclinical research areas include liver, immunology and metabolic disease, and we have a collaboration with BlueRock Therapeutics (Bayer AG) to create therapeutics for autoimmune and inflammatory disorders. In addition, our extensive ioCells™ research cell product portfolio, which includes wild type and disease model cells, is opening up new possibilities for studying human biology and developing new medicines in both research and high throughput and high content drug discovery.
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Medical, Industry Outlook
PRNewswire | August 14, 2023
ERS Genomics Limited ('ERS') is pleased to announce a new license agreement with Santa Cruz Biotechnology Inc ('SCBT,'). This is a non-exclusive licensing agreement granting SCBT access to the ERS CRISPR/Cas9 patent portfolio.
ERS founder, Dr. Emmanuelle Charpentier, won the 2020 Nobel Prize for the discovery of CRISPR/Cas9. Consequently, the ERS patent portfolio is the most comprehensive collection of proprietary rights to this gene editing technology.
Santa Cruz Biotechnology, headquartered in Dallas, has earned its place as a world leader in the biomedical research market, boasting a remarkable thirty-year track record of relentless innovation. With a specific focus on research tools and reagents, including monoclonal antibodies, biochemicals, labware, and now CRISPR products, SCBT has consistently demonstrated its commitment to advancing scientific exploration.
Commenting on the deal with ERS, Santa Cruz Biotechnology representative Dr. John R. Stephenson, President and CEO, had the following statement 'CRISPR/Cas9 technology is an exciting advancement for the scientific community. This technology has greatly expanded the possibilities of research. Santa Cruz Biotechnology offers Knock-Out, Activator and Nickase CRISPR products to most human and mouse protein encoding genes. The CRISPR product line complements our well established monoclonal antibody product line.
Eric Rhodes, CEO, ERS Genomics was equally positive about the new relationship: 'Santa Cruz has an established and impressive reputation for making innovative solutions accessible to scientists. This fully aligns with our core mission of advancing scientific progress and unlocking the full potential of CRISPR/Cas9 in our industry.'
Financial details of the agreement are not being disclosed.
About Santa Cruz Biotechnology Inc
Santa Cruz Biotechnology is a world leader in the development of products for the biomedical research market. Over the past thirty years, the Company has focused on the ongoing development of research monoclonal antibodies, biochemicals, labware and CRISPR products. Santa Cruz Biotechnology has the highest commitment to quality and customer service.
About ERS Genomics
ERS Genomics is a biotechnology company based in Dublin, Ireland. The company was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property held by Dr. Emmanuelle Charpentier. Non-exclusive licenses are available for research and sale of products and services across multiple fields including research tools, kits, reagents; discovery of novel targets for therapeutic intervention; cell lines for discovery and screening of novel drug candidates; GMP production of healthcare products; companion animal and livestock health; production of industrial materials such as enzymes, biofuels and chemicals; and synthetic biology. ERS holds over 100 patents worldwide.
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Medical
Businesswire | July 11, 2023
Melinta Therapeutics, LLC a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications.
BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This partnership may enable BAXDELA® and VABOMERE® to be integrated into national preparedness efforts as well as pediatric care for multi−drug-resistant bacterial infections, enhancing sustained availability of the products, increasing end-user familiarity, and striving for availability for the US pediatric population.
"I am thrilled and honored that BARDA and Melinta have agreed to partner for this important research marking a significant milestone in our journey toward becoming legendary for providing innovative therapies to people impacted by acute and life-threatening illnesses,” said Christine Miller, Melinta President and CEO. “This contract fuels our excitement to explore expanded applications of BAXDELA® and VABOMERE® through innovative research. We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs. We will drive progress and redefine what is possible, paving the way for a healthier future.”
BAXDELA® (delafloxacin) is a novel fluoroquinolone (FQ), approved for adults in IV and oral tablet formulations to treat acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP). CABP remains a leading cause of pediatric hospitalization and mortality in the US, with the highest incidence and morbidity in children under 2 years of age. The partnership with BARDA will support the BAXDELA® pediatric development plan to extend the adult CABP indication to children aged 2 months to less than 18 years.
In addition, Melinta aims to advance BAXDELA® as a potential treatment option against biothreat pathogens for both adults and children. Given its broad spectrum of activity and availability in both IV and oral formulations, BAXDELA® can provide flexibility for use following a biothreat public health emergency, in varied care settings and across spectrums of disease severity.
VABOMERE® is an approved combination of the carbapenem, meropenem, and the novel ß-lactamase inhibitor (BLI), vaborbactam. VABOMERE® was specifically designed to address gram-negative bacteria that produce beta-lactamase enzymes, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the predominant form of carbapenem-resistant Enterobacterales (CRE) in the US. The CDC (Centers for Disease Control) classifies CRE as an “urgent” threat because there are few alternative antibiotics to treat CRE-infections. The VABOMERE® pediatric development plan will support the filing of sNDAs to extend the adult cUTI indication to children aged 3 months to less than 18 years and target the indication of late onset neonatal sepsis in children aged less than 90 days.
“The ability to partner with BARDA on these important programs is exactly the type of work that brought me to Melinta and what excites me about the work we do,” said Douglas Girgenti, MD, VP, Head of Development and Clinical Operations, Melinta. “Pediatric clinical development of BAXDELA® and VABOMERE® will help inform drug safety and tolerability as well as determine optimal antibiotic dosing, with the ultimate goal of enabling use in pediatric cases and expanding the arsenal of healthcare providers in their fight to save lives. The potential addition of BAXDELA® to the biodefense armamentarium will likewise provide a much-needed option for public health emergencies in both children and adults.”
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00022.
About Melinta Therapeutics
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam).
About BAXDELA® (delafloxacin)
BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
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