Point-of-Care Tools in Pharmacy Take Off

Managed Healthcare Executive | March 02, 2020

New point-of-care (POC) tools that promote communication between providers and patients are establishing themselves as next generation shared decision-making solutions, especially when it comes to medications and issues of insurance coverage, price, and out-of-pocket costs. “When compared to traditional shared decision-making tools, there’s an increased emphasis not just on improving measures such as medication adherence by involving the patient in his or her own care but also on using this education and engagement to improve patient satisfaction,” says Chuck Lee, MD, senior director of clinical knowledge and Meducation at First Databank, a San Francisco company medical data company.

Spotlight

Knowing how someone thinks is crucial to understanding their behavior. With EEG (electroencephalography), you can get access to this hidden world, and reveal what’s really going on in someone’s mind. EEG offers many advantages, but it can be tricky to get your head around in the beginning. This infographic from iMotions is designed to give you a head start to this powerful technology.

Spotlight

Knowing how someone thinks is crucial to understanding their behavior. With EEG (electroencephalography), you can get access to this hidden world, and reveal what’s really going on in someone’s mind. EEG offers many advantages, but it can be tricky to get your head around in the beginning. This infographic from iMotions is designed to give you a head start to this powerful technology.

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PHARMACY MARKET

WuXi Biologics Launches First Commercial Drug Product Facility for Pre-Filled Syringes

WuXi Biologics | June 06, 2022

WuXi Biologics a global CRDMO service company, announced it has successfully launched the GMP operation of its new drug product facility DP5 located in Wuxi, China. The DP5 is the ninth operational drug product facility in the global network of WuXi Biologics. The DP5 facility features an advanced isolator filling line for continuous and steady filling services, which offers multiple volume delivery options for pre-filled syringes including 1 mL Long, 1 mL, 2.25 mL and 3 mL. The maximum filling speed can reach 400 PFS/min to support 17 million syringes of drug products manufacturing every year. The increased manufacturing capacity at DP5 allows WuXi Biologics to provide global partners with faster and more robust end-to-end drug product services for their innovative products at different scales and stages. Compared to a traditional drug product filling line, DP5's state-of-the-art design and layout, single-use technology and automated equipment, significantly decrease the risk of contamination and maintain aseptic control required in the filling process. This process supports clients' products scale up to commercial capability and reliably delivers to patients under the highest quality standards which WuXi Biologics represents. "Pre-filled syringes have emerged as one of the fastest-growing choices for biologics dosage form as our partners seek new and more convenient biologics delivery methods. The GMP operation of DP5, our first commercial drug product facility for pre-filled syringes, not only demonstrates our commitment to global partners, but also marks an important milestone for WuXi Biologics to become one of the global leaders in drug product CDMO services. We'll continue to enable our clients to advance innovative biologics towards clinical trials, regulatory approvals, and commercialization to benefit patients worldwide." Dr. Chris Chen, CEO of WuXi Biologics About WuXi Biologics WuXi Biologics is a global Contract Research, Development and Manufacturing Organization offering end-to-end solutions that enable partners to discover, develop, and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 10,000 skilled employees in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development, and manufacturing solutions. As of the end of 2021, WuXi Biologics is supporting over 480 integrated client projects, including nine in commercial manufacturing.

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PHARMA TECH

Antengene Announces Clinical Trial Collaboration with BeiGene to Evaluate Selinexor in Combination with Tislelizumab in T and NK-Cell Lymphoma

Antengene Corporation Limited | June 27, 2022

Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has entered into a clinical trial collaboration with BeiGene to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of selinexor in combination with BeiGene's anti-PD-1 checkpoint inhibitor, tislelizumab. This multi-center, open-label Phase I/II trial will evaluate the investigational combination as a potential treatment option for patients with T and NK-cell lymphoma. "We are delighted to partner with BeiGene, a company that strives for innovation and excellence, and is committed to developing best-in-class or first-in-class anti-cancer therapies for patients across the globe. These qualities are very similar to those of our vision at Antengene. We look forward to advancing the combination of selinexor and tislelizumab to clinical development. With good data we will be able to bring this treatment regimen to patients with T and NK-cell lymphoma, diseases that are endemic in Asia but underserved by current therapies." Dr. Jay Mei, Antengene's Founder, Chairman and CEO "At Antengene, we believe that the combinational use of immuno-oncology drugs and Selective Inhibitor of Nuclear Export compounds possesses huge potential as novel treatment regimens for cancer patients," said Dr. Kevin Lynch, Antengene's Chief Medical Officer. "The mechanism of action of selinexor in inhibiting the nuclear export protein XPO1 facilitates the intranuclear accumulation of tumor suppressors, making it a good partner in multiple combination treatment regimens. Preclinical research we conducted demonstrated that selinexor combined with a checkpoint inhibitor increased anti-tumor activity in multiple tumor models. In addition, deep and durable responses were also seen in multiple case reports of patients with T and NK-cell lymphoma treated with selinexor in combination with an anti-PD-1 checkpoint inhibitor. We hope to confirm that selinexor can synergize with tislelizumab to deliver an effective treatment regimen and help address the huge unmet medical needs in T and NK-cell lymphoma in the Asia Pacific regions and around the world." continued Dr. Lynch. Tislelizumab is a PD-1 inhibitor designed to help aid the body's immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. About T and NK-Cell Lymphoma T and NK-cell lymphoma is a set of heterogeneous diseases, accounting for 25-30% of Non-Hodgkin Lymphoma cases in China and only about 10% in USA and Europe. There has been little improvement in the past decade when compared to B-cell Non-Hodgkin Lymphoma (B-NHL) as 5-year overall survival rate was only 30% in most common subtypes[1]. The unmet medical needs remain as agents with new mechanism of action to be explored and possibility to improve the treatment paradigm for the disease. About the SINE Compounds Selective Inhibitor of Nuclear Export compounds are inhibitors of the major nuclear export protein Exportin 1 Currently, there are three oral SINE compounds, ATG-010 ATG-016 and ATG-527, under clinical development. Antengene has obtained exclusive development and commercialisation rights from Karyopharm Therapeutics Inc. to these three compounds in certain APAC markets. About XPOVIO® XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. XPOVIO® is approved in Australia for two indications In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody. XPOVIO® is approved in Singapore for three indications In combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy who are not eligible for haematopoietic cell transplant. About Antengene Antengene Corporation Limited is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". About BeiGene BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents.

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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.

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