Scientists enter research collaboration to outsmart cancer

eurekalert | April 17, 2019

Cancer is a disease that afflicts an alarming number of people, with one in two being diagnosed with a type of cancer during their lifetime. The global cancer burden has risen to 18.1 million people in 2018, which makes cancer one of the leading causes of death worldwide. While clinical developments and advances in early detection and treatment have already changed the lives of many people suffering from this disease, there is still a tremendous need to develop new knowledge and make new breakthroughs in cancer drug discovery and development. Effective cancer research is unthinkable without collaboration. The field is immense and new developments are occurring all the time, so partnerships are key - whether internal, external or interdisciplinary. Today, Insilico Medicine, a biotech company developing the end-to-end drug discovery pipeline utilizing next-generation artificial intelligence, announces its partnership with Arctoris, the world's first fully automated cancer research laboratory providing robotic experimentation in the cloud, Science Entrepreneur Club, a life sciences network and Cluster Market, a leading online equipment sharing and booking platform enabling and accelerating science.

Spotlight

Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

Spotlight

Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

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RESEARCH

Nanoform and Celanese Explore Ways to Improve Drug Delivery

Nanoform, Celanese | May 26, 2021

Nanoform Finland Plc, an innovative nanoparticle medicine enabling company, and Celanese Corporation, a global specialty materials company, announced today plans to investigate potential synergies in the field of nanoparticle-enabled drug delivery. The objective of this research is to determine the utility of combining Nanoform's nanoparticle platform technologies with Celanese's VitalDose® EVA copolymer delivery technology for drug-eluting implants. The objectives are to enable the development of next-generation drug delivery systems that can handle an increased drug load and have better-sustained release properties. Nanoform and Celanese intend to collaborate on formulation development, using each company's formulation expertise. "We are excited to announce our collaboration with Celanese. One of Nanoform's primary goals is to allow next-generation drug therapies through the use of our nanoparticles. Given the inherent difficulty in loading an adequate amount of drug into many medical devices, we see a huge opportunity in employing our nanoparticles to overcome this fundamental challenge. We are excited about the potential to use the combination of these two technologies to provide new therapies to patients "said Nanoform CEO Edward Hggström. "Celanese has a good track record of developing drug-eluting implants for women's health, ophthalmology, and central nervous system disorders by integrating our VitalDose® EVA copolymer delivery technology with proteins, peptides, and small molecules. Exploring Nanoform's nanoparticle technologies offers up new possibilities for enhancing formulation performance with existing products and enabling future products. We are excited to collaborate with Nanoform and hope that our efforts will result in innovations that will benefit patients "Laura Brand, Celanese Vice President of Medical & Pharmaceuticals, said.

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PHARMACY MARKET

M-Pharma and Kyowa Kirin Sign Exclusive License Agreement for Commercialization of Ilofotase Alfa in Japan

AM-Pharma | September 08, 2021

AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, and Kyowa Kirin Co., Ltd, a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, today announced that they have entered into an exclusive license agreement under which Kyowa Kirin gains the rights to develop and commercialize ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase. Ilofotase alfa is currently being evaluated in the global pivotal REVIVAL Phase III clinical study as the potential first disease-altering treatment for sepsis-associated acute kidney injury (SA-AKI). In July of this year, AM-Pharma announced the enrollment of the first patient in Japan as part of the ongoing REVIVAL trial. “This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.” “Kyowa Kirin is a leading Japanese specialty pharmaceutical company deeply rooted in science that shares our commitment to addressing high unmet medical needs. Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialization of ilofotase alfa in Japan,” stated Erik van den Berg, Chief Executive Officer at AM-Pharma. “This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.” Under the terms of the agreement, AM-Pharma will receive EUR 20 million upfront payment, and EUR 30 million related to milestones prior to regulatory submission, and up to EUR 195 million upon submission, NHI price listing and sales milestone payments bringing the overall deal value to EUR 245 million. In addition, AM-Pharma is entitled to tiered double-digit royalties on sales and a drug supply fee. Kyowa Kirin will gain the exclusive right to develop and commercialize ilofotase alfa in Japan. AM-Pharma is responsible for the completion of the REVIVAL pivotal Phase III study, as well as a Phase I pharmacokinetics, safety and tolerability study in Japan and drug supply, whereas Kyowa Kirin will be responsible for the regulatory approval process and commercialization of ilofotase alfa in Japan. About REVIVAL The REVIVAL trial is a Phase III pivotal study evaluating AM-Pharma’s proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI. The primary endpoint of the study is all-cause mortality 28 days post-treatment start with ilofotase alfa at a dose of 1.6 mg/kg. In the Phase II study of ilofotase alfa, the patient group treated with this dose experienced a statistically significant 46% relative reduction in mortality compared to the group treated with placebo (p= 0.022). REVIVAL was initiated in November 2020 and is enrolling up to 1,600 patients in North America, Europe and Japan. As per the study protocol, four interim analyses for futility and/or efficacy will be conducted when enrollment hits certain levels and the first futility analysis will occur when 400 patients have been treated. Up to about 120 clinical sites worldwide, including as many as 11 sites in Japan, will enroll patients into the single global pivotal Phase III REVIVAL trial in SA-AKI patients. The U.S. Food and Drug Administration, European Medicines Agency and Japanese Pharmaceuticals and Medical Devices Agency have all approved the REVIVAL protocol. In addition to the REVIVAL study, the PMDA has approved enrollment into a Phase I pharmacokinetics (PK), safety and tolerability study in healthy Japanese subjects, which is being conducted in parallel to REVIVAL in Japan. About ilofotase alfa AM-Pharma’s therapeutic candidate is a proprietary recombinant human Alkaline Phosphatase (AP) constructed from two naturally occurring human isoforms of the AP enzyme. The Company’s compound is highly stable and active and has a dual mechanism of action. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as, ATP, ADP, lipopolysaccharide (LPS) and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway (A2aR). AM-Pharma has shown that treatment of patients with ilofotase alfa not only reduces local and systemic inflammation but also protects the kidney, and possibly other organs, against further damage. About AKI and Sepsis Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to complete loss of renal function. Hospital‐acquired AKI affects annually around 3 million patients in the US, Europe, and Japan, and is associated with mortality in roughly 700,000 patients. It occurs in 40-60% of critical care admissions. Depending on the severity and cause of renal injury, mortality occurs in up to 60% of the cases. In the US alone, hospitals spend around $10 billion each year on managing this major medical problem. Sepsis is a condition that is responsible for 1 out of 3 deaths in hospitals and is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. The kidney is the most commonly affected organ, resulting in SA-AKI and significantly increasing the risk for mortality and morbidity in sepsis. No singular effective therapy to alter the progression of these devastating conditions has been approved.4 About AM-Pharma AM-Pharma's purpose is to save and improve the lives of patients confronted with severe medical conditions. Our initial focus is sepsis-associated acute kidney injury, the cause of death for hundreds of thousands of people hospitalized each year. Our proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: www.am-pharma.com. About Kyowa Kirin Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity.

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BUSINESS INSIGHTS

Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA (srRNA)

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 About 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.

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