On November 18, 2021 Onco360, the nation’s leading independent Specialty Pharmacy, reported that has been selected by PharmaEssentia to be a specialty pharmacy partner for BESREMi (ropeginterferon alfa-2b-njft) which is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with polycythemia vera (Press release, Onco360, NOV 18, 2021, View Source [SID1234595811]).

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"Onco360 is honored to become a specialty pharmacy provider for BESREMi patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of polycythemia vera patients and their physicians across the United States."

According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of Myeloproliferative Neoplasms, polycythemia vera is one of several disorders of the hematopoietic system under a broader classification known as Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs). The prevalence of polycythemia in the United States is approximately 148,000 cases.1 Polycythemia vera results from abnormal red blood cell proliferation due to genetic mutations involving the Janus Kinase 2 (JAK2) gene. Due to over-production of red blood cells, patients with polycythemia vera have blood which is thicker than normal, potentially resulting in increased risks for thrombosis and reduction in blood flow.2 The average age at initial polycythemia vera diagnosis is 60-65 years old. The median overall survival for patients diagnosed with polycythemia vera is approximately 20 years.3

BESREMi is manufactured by PharmaEssentia, a growing biopharmaceutical innovator based in Taiwan. The FDA’s approval of BESREMi is based upon the results of the PEGINVERA study, a prospective, multicenter, single-arm trial of 7.5 years duration. This study demonstrated that BESREMi administration resulted in 61% of patients achieving a complete hematological response (CHR) during the treatment period defined as hematocrit <45% and no phlebotomy in the preceding 2 months, platelets < 400 x 109/L and leukocytes < 10 x 109/L, normal spleen size assessed by ultrasound and absence of thromboembolic events.4

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see accompanying full Prescribing Information, including Boxed Warning. For more information, visit www.BESREMi.com.

On November 18, 2021 City of Hope, a world-renowned research and treatment organization for cancer, diabetes and other life-threatening diseases, reported the opening of a first-in-human clinical trial evaluating the use of a cancer-killing oncolytic virus to treat patients with metastatic triple-negative breast cancer (Press release, City of Hope, NOV 18, 2021, View Source [SID1234595810]).

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The City of Hope-developed therapy, CF33-hNIS-antiPDL1, is genetically engineered from a naturally occurring virus (chimeric oncolytic orthopoxvirus). The patents covering CF33-hNIS-antiPDL1 have been licensed to Imugene Limited (ASX:IMU), a company developing immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. CF33-hNIS-antiPDL1 is designed to infect, replicate in and kill cancer cells while sparing healthy cells.

"The study is designed to determine the safety and optimal biological dose that may induce an immune response in triple-negative breast cancer tumors," said Yuan Yuan, M.D., Ph.D., associate professor in City of Hope’s Department of Medical Oncology & Therapeutics Research and principal investigator of the Phase 1 clinical trial. "Current approved therapies do not offer a cure for this aggressive type of breast cancer, which often becomes resistant to chemotherapy. Clinical trials like this one seek durable responses and better quality of life for patients."

The researchers seek to determine the appropriate dose of CF33-hNIS-antiPDL1 and ascertain if it is a safe and potentially effective treatment for patients with triple-negative breast cancer that is advanced or has spread to other places in the body. It will be tested in patients whose cancer has progressed through standard-of-care chemotherapy.

Triple-negative breast cancer affects about 15-20% of all breast cancer patients. It is a challenging disease to treat — most Food and Drug Administration-approved therapies prolong survival for a median of two years, Yuan said. Despite the recent FDA approval of targeted therapy for BRCA gene mutation (that is, immune checkpoint inhibitor pembrolizumab and Trop-2 antibody drug conjugate), the majority of patients continue to progress after the first two lines of therapy. There is an unmet need for patients whose triple-negative breast cancer has progressed despite previous treatment regimens.

The cancer killing effects of CF33 have been observed for the following cancer cell types in the preclinical setting: pancreatic, stomach, lung, ovarian and colon. Published preclinical data show that the CF33 oncolytic virus can increase the presence of immune checkpoint inhibitors, which can help enhance the immune system’s ability to do its job.

"It is an exciting time in immuno-oncology. Preclinical research has shown that this oncolytic virus can direct the killing of cancers and stimulate the immune system to enable further killing of cancers," said Yuman Fong, M.D., the Sangiacomo Family Chair in Surgical Oncology at City of Hope who developed CF33. "This trial is an important step forward."

The three-year trial seeks to enroll patients who have been diagnosed with recurrent metastatic triple-negative breast cancer who experienced disease progression after standard-of-care therapies. Study participants may receive a total of three cycles of six doses of the treatment through direct injection into the tumor.

Scientists will be able to say that the oncolytic virus activated the immune system against breast cancer if they note increased expression of checkpoint targets PD-1, PD-L1 or CTLA-4 and increased CD8+ immune cells. When there are more of these checkpoint targets, current approved and experimental therapies are better able to grab onto and unlock cancer cells to destroy them from the inside.

More information about the clinical trial can be found at CityofHope.org/research/find-a-clinical-trial or clinicaltrials.gov.

On November 18, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported that it is working with Epic to offer providers in-workflow integrations at scale (Press release, Tempus, NOV 18, 2021, View Source [SID1234595809]). Since its founding, Tempus has strived to provide physicians seamless access to next-generation sequencing and the accompanying data to support them in providing personalized patient care.

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Through Epic’s Genomics module, Tempus has been paving the way with live EHR integrations that embed test ordering and discrete genomic data delivery into the existing clinical workflow, with 8 institutions already live and a number underway. Tempus’ initial work with Epic made it the first somatic sequencing lab in the country creating these types of integrations.

"Tempus understands our need for efficient, streamlined ordering and reliable discrete results all in one place so that we can promptly implement the actionable results for our patients," said Karen Huelsman, MS, LGC, Precision Oncology Lead at TriHealth Precision Oncology. "More than that, Tempus continually works with our precision oncology team to optimize the integration and apply Epic’s Genomics module components to fit our specific, changing needs."

Tempus is building on that existing work to accelerate and scale this endeavor. In 2022, Epic and Tempus expect to support large-panel genomic sequencing testing across the Epic network. This new capability is designed to reduce integration timelines from months to weeks and make it significantly easier for health systems to enable Tempus testing options within their Epic EHR.

"We realized that we could significantly reduce the amount of time physicians spend ordering Tempus’ smart diagnostics and viewing results at the point of care, ultimately freeing up more time for them to spend with their patients," said Terron Bruner, Chief Commercial Officer of Tempus. "Epic introduced the technology we needed to make these kinds of integrations not only possible, but also seamless for providers, like TriHealth, seeking these solutions."

"Our work with Tempus presents a tremendous opportunity to advance precision medicine by empowering providers and patients with insights from integrated genomic data," said Alan Hutchison, Vice President of Population Health at Epic. "Together we can deliver on the promise of precision medicine and positively impact early detection, treatment, and survival."

On November 18, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient was dosed in the global TROPION-Breast01 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN), in patients with hormone receptor (HR) positive, human epidermal growth factor 2 receptor (HER2) negative inoperable or metastatic breast cancer previously treated with chemotherapy (Press release, Daiichi Sankyo, NOV 18, 2021, View Source [SID1234595808]).

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Breast cancer is the most common cancer worldwide with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 70% of all breast cancers are considered HR positive, HER2 negative.2 For patients with HR positive, HER2 negative metastatic breast cancer that progresses on or is not suitable for hormone therapy-based regimens, current standard of care is single-agent chemotherapy, which demonstrates diminishing efficacy with each subsequent line of treatment.3

"There are no TROP2 directed therapies currently approved for HR positive, HER2 negative breast cancer and we are encouraged by the emerging clinical profile of datopotamab deruxtecan in patients with breast cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer."

"Most patients with HR positive, HER2 negative metastatic breast cancer will inevitably progress on available treatments, including hormonal therapy and standard of care chemotherapy. In this setting, the unmet need is high, and new therapeutic approaches are necessary to delay disease progression and extend survival," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "The TROPION-Breast01 trial will evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients with previously treated HR positive, HER2 negative advanced breast cancer previously treated with one to two lines of chemotherapy."

About TROPION-Breast01
TROPION-Breast01 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator’s choice of chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in patients with inoperable or metastatic HR positive, HER2 negative breast cancer (per ASCO (Free ASCO Whitepaper)/CAP guidelines, on local laboratory results) who have progressed on or were not suitable for endocrine therapy and previously treated with one or two prior lines of systemic chemotherapy in the inoperable or metastatic setting.

The dual primary endpoints of TROPION-Breast01 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, and patient reported outcomes, as well as safety and pharmacokinetics.

TROPION-Breast01 will enroll approximately 700 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About HR Positive, HER2 Negative Breast Cancer
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 5% to 10% of women diagnosed with breast cancer have metastatic disease at diagnosis, and up to 30% of women with early-stage breast cancer will develop metastatic disease.4

Approximately 70% of all breast cancers are considered HR positive, HER2 negative, meaning tumors test positive for estrogen and/or progesterone hormone receptors and negative for HER2.2 Current standard of care treatment for patients with HR positive, HER2 negative metastatic breast cancer that progresses on hormone therapy-based regimens is sequential single-agent chemotherapy. However, response rates are low with PFS ranging from 4 to 6.3 months with second-line chemotherapy, and 2.4 to 5.5 months with third-line chemotherapy.5,6,7,8 Data in subsequent lines of treatment show decreasing median PFS and OS with each further line of chemotherapy. There remains a need to improve outcomes including survival for patients living with advanced HR positive, HER2 negative breast cancer.9

About TROP2
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein overexpressed in several types of solid tumors, including breast cancer.10 TROP2 expression has been detected in a wide range of breast cancer subtypes, including the HR positive, HER2 negative subtype.11,12 High TROP2 expression is an unfavorable prognostic factor for overall survival in all types of breast cancer.13 There are currently no TROP2 directed therapies approved for treatment of HR positive, HER2 negative breast cancer.

About Datopotamab Deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.14

A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), HR positive/HER2 negative breast cancer, small cell lung cancer (SCLC), urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

About Daiichi Sankyo in Oncology
The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

On November 18, 2021 NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, reported a new contract in which NorthStar will purchase a third Rhodotron TT300 HE electron beam accelerator from IBA (Press release, NorthStar Medical Radiostopes, NOV 18, 2021, View Source [SID1234595806]).

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The accelerator will be exclusively used for the production of no-carrier added (n.c.a.) actinium-225 (Ac-225), an important therapeutic radioisotope that is in highly limited supply and for which no commercial-scale production technology currently exists. NorthStar previously purchased two Rhodotron accelerators from IBA for its newly completed molybdenum-99 (Mo-99) production facility.

"We look forward to continuing to work with IBA, who have shown extensive commercial expertise and excellent performance in delivering electron beam accelerators for our Mo-99 production expansion project," said Stephen Merrick, President and Chief Executive Officer of NorthStar. "NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). We are applying that same development expertise to rapidly advance large-scale availability of the therapeutic radioisotope Ac-225 for use in oncology and other indications, and we are excited about its potential in these disease areas."

Olivier Legrain, Chief Executive Officer of IBA commented, "We are delighted to sign this latest contract with NorthStar Medical Radioisotopes and to continue to deliver innovative solutions for reliable radioisotope supply. IBA’s Rhodotron accelerators provide the most advanced electron accelerator technology in the world, and we are excited for the opportunity to create new therapeutic radioisotopes such as Ac-225. With its radiotheranostic capabilities, combining targeted diagnosis and therapy, we believe that this radioisotope has significant potential in the treatment of cancer."

The final stage of facility design is underway for NorthStar’s state-of-the-art Therapeutic Radioisotope production facility, which will be exclusively dedicated to Ac-225 production, with construction scheduled to begin in early 2022. Initial production of Ac-225 is planned for late 2023, and a Drug Master File will be submitted to the FDA in 2024. NorthStar’s proprietary process for the production of Ac-225 will use IBA’s Rhodotron to enable commercial-scale n.c.a. Ac-225 production that is free of long-life radioactive byproducts associated with other production methods.

About Actinium-225 (Ac-225) and Therapeutic Radiopharmaceuticals

Ac-225 is a high energy alpha-emitting radioisotope of significant interest by the medical community for extensive use in clinical studies of targeted radiopharmaceutical therapy (RPT). RPT combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while minimizing undesired dose to adjacent cells in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar’s electron accelerator technology will produce high purity, no-carrier added (n.c.a.) Ac-225, free of long-lived radioactive byproducts. NorthStar is positioned to be the first commercial-scale producer of therapeutic radioisotopes Ac-225 and copper-67 (Cu-67) by applying its production technology expertise to provide reliable supply for advancing clinical research and supplying commercial radiopharmaceutical products.