Curia | June 10, 2022
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), today announced that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics.
As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales.
“Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins,” said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. “This customization has important therapeutic. advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients.”
“The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases. Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach.”
Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia
Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com.
About Replicate Bioscience
Replicate Bioscience, an ATP company, is designing and delivering srRNA immunotherapies to revolutionize the practice of medicine and improve and save lives. Replicate applies advanced srRNA technology in its work to prevent drug resistance in cancers. The company is also developing srRNA injections for sustained therapeutic protein expression to treat autoimmune and inflammatory disorders and other conditions. Replicate believes that srRNA will bring about the next big breakthroughs in RNA therapeutics and is working to realize the promise of srRNA for all patients.
PostEra | May 19, 2022
PostEra, a biotechnology company specializing in machine learning for preclinical drug discovery, announced a multi-year collaboration with the National Institutes of Health to develop small molecule antiviral therapeutics to prevent pandemics. The center will receive initial funding of $68M. PostEra co-leads this initiative with the Drugs for Neglected Diseases Initiative, a global charity with expertise in drug development for global equitable access, and the Memorial Sloan Kettering Cancer Center.
As part of the National Institutes of Health's National Institute of Allergy and Infectious Diseases Antiviral Program for Pandemics, the AI-driven Structure-Enabled Antiviral Platform (ASAP) consortium aims to discover dozens of lead compounds against key viruses of significant pandemic concern, such as flaviviruses (responsible for endemic diseases such as Dengue and Zika), picornaviruses (including potentially debilitating enteroviruses as well as other cold-causing viruses), and coronaviruses. ASAP will further deliver three IND-ready candidates which can be immediately ready for clinical evaluation in the event of a viral outbreak, so that future pandemics can be halted before severe outbreaks occur. The consortium is committed to making resulting antivirals globally and equitably accessible, so that no patient population is left behind.
ASAP will use PostEra's end-to-end AI-first approach to accelerate the discovery process, generating molecules with optimised properties, designing rapid synthesis, and optimally prioritising experiments. In particular, AI approaches are tightly integrated into structural biology to realize next generation structure-based design. ASAP is built on the success of the COVID Moonshot project, a global open-science AI-driven initiative that began in March 2020 and rapidly identified antiviral drug candidates that target the main protease of the SARS-CoV-2 virus.
"We are honored to be co-leading this consortium. We believe that our AI platform will accelerate the discovery of therapeutics that will prevent pandemics."
Dr Alpha Lee, Chief Scientific Officer of PostEra, who co-founded COVID Moonshot
PostEra was founded in 2019 and its technology is built on pioneering academic research done by its founding scientists. PostEra's technology addresses some of the key challenges in drug discovery R&D by integrating molecular design with chemical synthesis. PostEra advances small molecule programs through partnerships with biopharma, working on its own internal pipeline, and also offering some of its synthesis technology via its Manifold web platform. PostEra also helped launch the world's largest open-science drug discovery effort; COVID Moonshot, along with an NIH-funded antiviral research center for the prevention of future pandemics.
House Rx | August 04, 2022
House Rx, the platform for medically integrated dispensing of specialty medications, announced it has partnered with three new rheumatology clinics to integrate in-house specialty drug dispensing – also known as medically integrated dispensing (MID) – into the clinics' operations. The three practices are: Arizona Arthritis & Rheumatology Associates (AARA), Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), and Arthritis Associates of Tennessee and represent an additional 68 providers that will dispense specialty medications through the House Rx platform, bringing the total number of providers on House Rx's platform to 137.
While MID has grown in oncology, House Rx's partnership with these practices is one of the first to bring the model to rheumatology care.
"It's very exciting to partner with key thought leaders in rheumatology to bring medically integrated dispensing to this specialty. Each one of these practices is a leader in their region, and we look forward to partnering very closely with them to define a new standard for a better patient experience and improved outcomes for patients living with rheumatic diseases."
Ogi Kavazovic, Co-Founder and CEO of House Rx
By bringing specialty dispensing into the physician's office, the partnership with House Rx aims to dramatically improve the specialty medication experience for patients. The MID care model provides a seamless and efficient way for patients to receive prescribed therapies directly from their doctor – which research has demonstrated improves outcomes, including quality of life and increased survivability, when contrasted with the Pharmacy Benefit Manager-controlled specialty pharmacy approach.
"This partnership will increase patient satisfaction by providing prescription medication in-house, and House Rx's technology and expertise will help us achieve this," said Prakash Viswanathan, CFO of AARA. "It is motivating to help trailblaze a new path in rheumatology and be one of the first practices to bring specialty medication dispensing under our roof, making it far easier and quicker for patients to get the medications they need."
"We couldn't be more excited about this partnership, which will bring immediate benefits for our patients," said Scott Gilomen, CEO of AOCC. "Having managed an oncology practice earlier in my career, I've seen first-hand the advantages of the MID model and look forward to how House Rx's approach to MID will propel the rheumatology field forward – with our practice at the forefront."
"The House Rx model will transform how rheumatology care is delivered, making it more coordinated and improving our patients' experience," said Beth Simpson, DO and managing physician partner at AATN. "We look forward to our patients not being on hold for hours on end waiting to speak with a specialty pharmacy. Instead, they'll speak immediately with House Rx's integrated team of pharmacy experts who understand their rheumatologic conditions."
While the concept of dispensing specialty medications in rheumatology is not new — a handful of clinics attempted dispensing in the past but ultimately were unsuccessful due to a lack of technological and operational support — House Rx's model approaches in-office dispensing in a new way. By providing clinics with specialized technology and operational support from pharmacists and pharmacy technicians who work integrated with the clinic, practices can keep the service under their roof while reducing the heavy lifting of implementing and maintaining a successful MID program. In addition, clinics can repurpose staff resources normally spent on prior authorizations and financial assistance for patients to focus on direct patient care or other activities critical to the viability and financial independence of community rheumatology clinics.
About House Rx
House Rx is a healthcare technology and services company focused on making specialty medication more accessible and affordable. The company partners with specialty clinics across the country to help these community clinics offer medically integrated dispensing, bringing together clinical and pharmacy expertise to better serve patients, lower the cost of care, and create a better experience for patients and their caregivers. Learn more at www.houserx.com.
About Arizona Arthritis & Rheumatology Associates
With 19 physicians, 30 advanced practice providers, and 10 clinics around the state of Arizona, AARA is one of the largest rheumatology practices in the country bringing world-class expertise to patients managing autoimmune conditions. A member of the American Rheumatology Network, and always at the forefront of rheumatology care, AARA has led the way in addressing the rheumatologist workforce shortage by integrating advanced practice providers into their practice, which has allowed the practice to scale clinical operations and meet the demand of a growing patient population.
About Arthritis & Osteoporosis Consultants of the Carolinas
Based in Charlotte, North Carolina, AOCC has 10 physicians and 5 advanced practice providers caring for patients across two clinics. Combining years of experience in private practice, academic teaching and clinical research, the clinic staff provides highly individualized and state-of-the-art care.
About Arthritis Associates
Founded in 1975, Arthritis Associates has been at the forefront of rheumatological care in Chattanooga, TN and is the only practice in the area treating both adult and pediatric patients. Arthritis Associates has an excellent, experienced and knowledgeable team including skilled nurses who can administer intravenous treatments onsite, supervised by a board-certified rheumatologist.