FDA Breakthrough granted for Roche’s Gazyva

PharmaTimes | September 19, 2019

Roche has announced that Gazyva (obinutuzumab) has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for adults with lupus nephritis. The designation was based on the Phase II NOBILITY study, in which the drug in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo and standard of care alone in achieving complete renal response at one year. The trial also met its secondary endpoints, showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo. Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Sandra Horning, Roche’s chief medical officer and head of global product development, reminded that “new treatment options are needed for lupus nephritis”, and explained that the company is “committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase III trial next year.”

Spotlight

With telemedicine interest on the rise and mHealth and wellness device regulation in the news, patients and providers alike are interested in what medical innovations are up next. Moreover, everyone wants to know what medical devices, procedures, and technology will make life - and health - easier in 2015 and beyond.

Spotlight

With telemedicine interest on the rise and mHealth and wellness device regulation in the news, patients and providers alike are interested in what medical innovations are up next. Moreover, everyone wants to know what medical devices, procedures, and technology will make life - and health - easier in 2015 and beyond.

Related News

PHARMACY MARKET

Vipergen and LEO Pharma Partner for DNA Encoded Library (DEL)-Based Drug Discovery for Dermatology Indications

Vipergen | June 20, 2022

Vipergen, a leading provider of small-molecule drug discovery services based on DNA-encoded library technologies, announced a multi-target drug discovery partnership with LEO Pharma focused on novel treatments for dermatology indications. Under the terms of the agreement, Vipergen will apply its high-fidelity DNA-encoded library (DEL) screening technologies, including its new in-living-cell DEL platform, to discover novel small-molecule compounds that bind to selected LEO Pharma targets. LEO Pharma will select hits for potential development into innovative drugs for dermatology applications. LEO Pharma will retain exclusive rights to globally commercialize any products resulting from the collaboration. Financial details of the agreement were not disclosed. "Driving our mission to rapidly bring better treatments to people with skin conditions, we continue to explore ways to discover novel small-molecule compounds for innovative and challenging targets while shortening development timelines. Partnering with Vipergen gives us access to the only technology capable of screening DEL libraries inside living cells, under physiologically relevant conditions. We look forward to a productive partnership." Thorsten Thormann, Vice President of Research & Early Development at LEO Pharma "We are very pleased to partner with LEO Pharma in its mission to develop first-in-class and best-in-class treatments for the millions of patients around the world suffering with psoriasis, eczema, acne, skin infections, and other serious skin conditions," said Nils Hansen, PhD, Chief Executive Officer of Vipergen. "We look forward to applying our full suite of DEL screening technologies to accelerate and advance LEO Pharma's efforts to discover novel, high-quality small molecules for development into innovative new treatments." About Vipergen ApS Vipergen is a world-leading provider of small-molecule drug discovery services based on DNA-encoded library technologies and is the first and only company capable of screening DELs inside a living cell. Vipergen provides its proprietary suite of leading-edge DEL technologies through funded discovery partnerships with leading pharmaceutical and biotechnology companies, including top pharmaceutical companies in the U.S., EU, and Japan.

Read More

BUSINESS INSIGHTS

Fusion Pharmaceuticals and Niowave Announce Actinium-225 Collaboration and Supply Agreement

Fusion Pharmaceuticals Inc. | June 13, 2022

Fusion Pharmaceuticals Inc. a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs. "As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies. We continue to prioritize manufacturing and access to actinium as a critical component of Fusion's platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic." Fusion Chief Executive Officer John Valliant, Ph.D "The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion's progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey." Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. About Niowave Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and is using that expertise to produce various radioisotopes for nuclear medicine. Niowave is a Cooperative Agreement partner with the National Nuclear Security Administration to develop a domestic supply of molybdenum-99 and currently produces yttrium-90 for use in cancer therapy. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on production and purification of radioisotopes for use in cancer therapy. By using radium targets and electron beams, Niowave is able to produce ultra pure and carrier-free actinium-225. Niowave's R&D facility is currently supplying actinium-225 samples to partners. Production-scale operations are ramping up at a second, FDA-compliant facility capable of meeting the growing actinium-225 market.

Read More

BUSINESS INSIGHTS

Labcorp Plans Laboratory Expansion in Japan Through BML Collaboration

Labcorp | July 04, 2022

Labcorp a leading global life sciences company, announced that it is enhancing its central laboratory presence and drug development capabilities in Japan through an expansion of CB Trial Laboratory, the central laboratory co-managed by Labcorp Drug Development and BML, a leading Japanese provider of clinical laboratory testing services. Extending their strategic relationship that dates back more than a decade, Labcorp Drug Development and BML will begin work on a new laboratory facility in the city of Kawagoe, Saitama, expanding capacity and services for pharmaceutical and biotechnology clients. This will bolster Labcorp Drug Development’s central laboratory services offerings in Japan and sets the stage for a continued acceleration of companion diagnostic capabilities. “Labcorp Drug Development remains committed to growing its Japanese operations and services through continued expansion and partnerships. Broadening our work with BML and increasing our laboratory footprint means we will be able to offer shorter turnaround times, superior in-country sample management and full lab testing services for global clinical trials in Japan. This will benefit patients, clients and health care providers by providing them with the information needed to make key decisions.” Honggang Bi, senior vice president and head of Asia-Pacific for Labcorp Drug Development The new facility will be located near BML’s General Laboratory in Kawagoe where the current CB Trial Laboratory is located, providing over 4,000 square meters of dedicated space for global clinical trials managed by Labcorp Drug Development. The new space will be greater than five times the size of the current facility, with additional capabilities such as genomics, microbiology and companion diagnostics in addition to expanded offerings in current lab capabilities including flow cytometry, immunology, and anatomical pathology and histology. Completion of the expanded laboratory is expected by early 2025. Through the planned laboratory expansion, Labcorp will advance biomarker and esoteric testing services, expand its companion diagnostics portfolio and deepen the integration with its clinical development services. In addition, the company will be able to intensify its focus on cell and gene therapy research and development, part of a broader commitment to precision medicine and fortifying the company’s position as an oncology leader. “In collaborating with Labcorp, we are able to offer our pharmaceutical and biotechnology clients access to both comprehensive clinical laboratory testing and drug development opportunities,” said Dr. Kensuke Kondo, president of BML. “The laboratory expansion provides additional capabilities and capacity and opens the door to enriched services, more resources and better outcomes for our clients and patients.” Labcorp and BML have successfully provided central laboratory services for global clinical trials in Japan since 2010 through kit production, sample logistics and laboratory operations at CB Trial Laboratory. Their partnership agreement was renewed in 2020. About Labcorp Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $16 billion in FY2021.

Read More