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.

On November 18, 2021 GT Medical Technologies, Inc. a company dedicated to improving the lives of patients with brain tumors, reported upcoming presentations related to its breakthrough GammaTile Therapy at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO) being held in Boston November 18-21, 2021 (Press release, GT Biopharma, NOV 18, 2021, View Source [SID1234595825]). In total, GammaTile will be showcased in seven clinical presentations as well as an Industry-Sponsored Symposium.

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"We look forward to sharing updated data, clinical experiences of GammaTile users, and ongoing trials evaluating GammaTile Therapy with our neuro-oncology colleagues at the SNO conference this week," said Matthew E. Likens, president and CEO of GT Medical Technologies, Inc. "These presentations add to the mounting clinical evidence supporting the use of GammaTile Therapy in patients with brain tumors."

A list of educational presentations and their respective authors are below. The full text of these presentations is available in the November supplement of Neuro-Oncology, the official journal of the Society for Neuro-Oncology.

Poster Session: Friday, November 19th, 7:30 PM – 9:30 PM, Exhibit Hall D
A Multicenter Observational Study Of Cs-131 Seeds Embedded In A Collagen Carrier Tile For Newly Diagnosed And Recurrent Operable Intracranial Neoplasms –Trial In Progress, Erin Dunbar, MD
Successful Safety And Efficacy Of GammaTile Intracranial Brachytherapy Implanted During Awake Craniotomy, Ulysses G. Gardner, Jr., MD, MBA
Phase III Multicenter RCT Of Post-Surgical Stereotactic Radiotherapy Versus Surgically Targeted Radiation Therapy For The Treatment Of Large Newly Diagnosed Brain Metastases – Trial In Progress, Jeffrey S. Weinberg, MD
Access To Specialty Radiation Care For Patients With Resectable Brain Tumors, Mehee Choi, MD
Lunch Independent Symposium Session: Saturday, November 20th, 12:45 PM – 1:45 PM
GammaTile Therapy: Surgically Targeted Radiation Therapy For Brain Tumors, David Brachman, MD, Clark C. Chen, MD, PhD, Erin Dunbar, MD, Brandon Imber, MD
Abstract Session: Sunday, November 21st, 10:10 AM – 10:15 AM, Room 208
First Experience With Maximal Safe Resection And GammaTile Brachytherapy As Treatment For Recurrent Glioblastoma, Clark C. Chen, MD, PhD
Concurrent Session: Sunday, November 21st, 11:50 AM – 12:10 PM, Ballroom C
Revisiting Brachytherapy In The Treatment Of Recurrent Glioblastoma, Peter Nakaji, MD
Published Abstract Available Online
Resection And Surgically Targeted Radiation Therapy For Treatment Of Locally Recurrent GBM In 28 Prospectively Treated Patients, Kris Smith, MD

On November 18, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that it has executed a definitive credit facility agreement with a syndicate of lenders for up to $750.0 million in financing (Press release, BridgeBio, NOV 18, 2021, View Source [SID1234595774]).

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This facility, combined with the Company’s existing cash balance as of September 30, 2021, provides access to over $1.2 billion to advance the Company’s pipeline programs, support commercialization efforts, and enable the Company to pursue strategic business development opportunities. As structured, this financing is expected to fully fund BridgeBio’s portfolio of more than 30 drug development and discovery programs into 2024, independent of near-term milestone readouts. It is a significant achievement in BridgeBio’s broader efforts to attract diverse sources of capital to fund life science innovation and is aligned with its long-term strategy of creating non-dilutive financing pathways that leverage portfolio readouts—in addition to cash balance on hand—to extend runway.

This financing announcement follows BridgeBio’s repurchase of approximately $150.0 million in its own common stock under its 2021 Share Repurchase Program, completing about $385.6 million of equity and capped call purchases in the aggregate since its initial public offering in 2019. In addition, today’s financing replaces the Company’s $100.0 million debt facility with Hercules. Collectively, these transactions represent a strategic recapitalization of the Company ahead of upcoming clinical data readouts.

"We are grateful to have the support of debt investors who are committed to helping us build the next great genetic medicine company and deliver meaningful therapies for patients in need. Since our founding, we have believed in the power and importance of innovative financing approaches to advance critical biomedical research and drug development, and we are grateful that our broad diversified pipeline enables us to do this. By bringing on this additional capital, we have the potential to help more people living with genetic diseases and cancers as quickly as possible," said Brian Stephenson, Ph.D., CFA, BridgeBio’s Chief Financial Officer.

"Potential breakthrough medicines should never languish on the shelf because of a lack of funding. By seizing inventive financing tools to fund its growing R&D pipeline, BridgeBio is working to ensure that promising medicines in development can advance into the clinic and toward potential commercial approval. The Company’s groundbreaking approach to science and finance has made it a leader within the biotech industry and we are hopeful there are new methods we can explore to more fully unlock the power of investors to help patients," said Andrew Lo, Ph.D., a BridgeBio co-founder and a member of the Company’s board of directors.

Key features of the credit facility include:

$450.0 million funded on November 17, 2021

An additional $300.0 million to be funded at the Company’s option following either 1) positive topline results from Part A of its Phase 3 ATTRibute-CM trial of TTR stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM), which is expected by the end of the year, OR 2) positive proof-of-concept data for various pipeline programs by year end 2022, with $100.0 million available upon each proof-of-concept, for up to three pipeline programs

Fixed interest rate of 9%, with 3% eligible at the Company’s discretion to be paid in kind and added to principal

Maturity date of November 17, 2026

Interest-only period for three years, which may be extended to four years upon success of the Part A readout

Substantial flexibility for future business development, M&A, share repurchases, and royalty transactions

No financial covenants

Morgan Stanley & Co. LLC acted as the sole placement agent to BridgeBio on this transaction.

Latham & Watkins LLP acted as counsel to BridgeBio.

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 Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, reported that it is giving notice of its intention to redeem the following Senior Notes (the "Redemption"), representing an aggregate total principal amount of approximately $2.2 billion, on December 3, 2021 (the "Redemption Date") (Press release, Thermo Fisher Scientific, NOV 18, 2021, View Source [SID1234595826]):

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$1.1 billion aggregate principal amount of 4.133% Senior Notes due 2025 (the "2025 Notes"); and
$1.1 billion aggregate principal amount of 4.497% Senior Notes due 2030 (the "2030 Notes" and, together with the 2025 Notes, the "Notes").
The Notes will be redeemed at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of the Notes to be redeemed discounted to the Redemption Date on a semi-annual basis at a comparable treasury rate plus 50 basis points in the case of both the 2025 Notes and the 2030 Notes, plus, in each case, accrued and unpaid interest on the Notes to be redeemed to, but excluding, the Redemption Date. Thermo Fisher intends to fund the Redemption using cash on hand.