Endomag: New Technique Renders Underarm Surgery Unnecessary for 80% of Women With Early Breast Cancer, Reducing Risk of Lymphedema

On September 8, 2021 Endomag repored that A pioneering new technique known as ‘delayed’ sentinel lymph node biopsy could spare as many as four in five Americans diagnosed with high-risk ductal carcinoma in-situ (DCIS) from an unnecessary additional underarm surgical procedure (Press release, Endomag, SEP 8, 2021, View Source [SID1234587433]).1

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Ductal carcinoma in-situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast, and accounts for one in every five new breast cancer diagnoses.2 It is considered the earliest form of breast cancer and is non-invasive, meaning that the cancer has not spread beyond the milk duct and has a low risk of becoming invasive. If left untreated, DCIS can break down and become invasive, where the cancer spreads through the lymphatic system.

A common treatment for DCIS is a mastectomy, where the patient will undergo surgery to remove the entire breast. Until now, doctors would also remove the majority of lymph nodes in the underarm on the side of the affected breast tissue during the mastectomy, to assess whether the cancer has spread. This procedure is known as a sentinel lymph node biopsy. Every year over 50,000 American women with the earliest form of breast cancer receive this node surgery.3 Yet, 70-80% of women diagnosed with DCIS do not have invasive cancer,3,4 rendering this additional surgery unnecessary.

The new procedure, known as a ‘delayed’ sentinel lymph node biopsy, involves the use of the Magtrace lymphatic tracer, a magnetic lymphatic tracer used in axilla staging. It is the only tracer that will be retained long enough in the lymph nodes to enable this pioneering treatment. In the procedure:

The Magtrace lymphatic tracer is injected at the time of the mastectomy and DCIS surgery, naturally migrating to the nodes that the cancer is most likely to spread to, if the disease is invasive.
It remains in place for up to 30 days after it has been injected and will provide a magnetic signal to help the surgeon return to the nodes, if they need to.
This means that doctors can wait for pathologic analysis of the DCIS to confirm if it is invasive. This information can then determine whether a sentinel lymph node biopsy is necessary. In up to 80% of cases it will not be. 1
If pathology confirms that the DCIS is invasive, the long-lasting signal of Magtrace allows for the sentinel lymph node biopsy to still be performed to understand the extent of cancer migration to the lymph nodes.
"The delayed sentinel lymph node biopsy has really revolutionized our ability to maintain lymphatic integrity in women who have DCIS", explained Dr Kandace McGuire, Chief, Section of Breast Surgery Surgical Leader of the Multidisciplinary Breast Cancer Program at Massey Cancer Center, Virginia. "So, what we do is we inject the Magtrace lymphatic tracer at the time of the initial mastectomy. The great thing about this is that the tracer will stay in the lymph nodes for up to six weeks so that we have time to get pathology back. If there’s no invasive cancer, there’s no need to do a sentinel lymph node biopsy."

By preventing surgery, the new ‘delayed’ sentinel lymph node biopsy spares women’s lymph nodes and leaves the lymphatic system undamaged, reducing the risk of life-altering complications connected with lymph node surgery. One of these is lymphedema, a condition affecting over 10 million Americans,5 caused by a build-up of lymphatic fluid that escapes into the body when the system is disrupted. Lymphedema, while manageable, is largely incurable,6 and causes lifelong swelling, altered sensation, pain and limitations in range of motion.7

"It felt wonderful to know that I would only have a sentinel lymph node biopsy if I truly needed it," explained Theresa Poon, who benefitted from the delayed Sentinel Lymph Node Biopsy procedure. "I was very scared of lymphedema. The swelling can just happen at any time, and even though it’s very rare, it’s always in the back of your mind. To be offered the possibility of not having any lymph nodes removed if I didn’t have invasive cancer was great."

Research from Uppsala University Hospital in Sweden and University Hospitals Cleveland has shown that the delayed Sentinel Lymph Node Biopsy procedure has reduced surgical interventions in 78.3% and 87% of cases respectively, and reduced costs to the healthcare system by 24.5% for women without invasive breast cancer.1,7 In total, over 160,000 women across more than 700 hospitals in over 45 countries have already been able to access more precise and less invasive breast cancer treatment thanks to Magtrace and Endomag’s other breast cancer treatment technologies.

"Women with breast cancer face so many difficult choices, so it’s gratifying to know that for high-risk DCIS patients, we can take one away without compromising their care and offer a real chance of avoiding unnecessary surgery," said Mathew Stephens, Chief Marketing Officer at Endomag. "Our new campaign, #SaveOurNodes, seeks to ensure that all women with high-risk DCIS are aware of this new surgical option. With advice from expert breast surgical oncologists who offer the technique and other patients who have had the procedure, we hope this campaign helps to provide more clarity on the best treatment approach for them."

Find out more about the campaign and the ‘delayed’ sentinel lymph node biopsy technique by visiting www.saveournodes.com, which features more information and resources about the procedure. There is now an ever-growing number of hospitals across the US practicing ‘delayed’ sentinel lymph node biopsy and Endomag will continue to work to improve access for all breast cancer patients.

NorthStar Medical Radioisotopes and POINT Biopharma Announce Supply Agreement for Therapeutic Medical Radioisotope Actinium-225

On September 8, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, reported the signing of a supply agreement for the therapeutic medical radioisotope actinium-225 (Ac-225) (Press release, NorthStar Medical Radiostopes, SEP 8, 2021, View Source [SID1234587432]).

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Ac-225 is a high energy alpha-emitting radioisotope that is a mainstay for studies in targeted radiopharmaceutical therapy (RPT), which 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 its half-life limits unwanted radioactivity 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 is positioned to be the first commercial-scale producer of Ac-225, applying its radioisotope production technology expertise to provide reliable supply for advancing clinical research and commercial radiopharmaceutical products.

Under the terms of the agreement, NorthStar will provide POINT with its electron accelerator-produced Ac-225 and POINT will use NorthStar’s Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) for non-metastatic castrate-sensitive prostate cancer (nmCSPC); PNT2004, a Fibroblast Activation Protein-α candidate with potential pan-cancer applications; and to advance its novel Tumor Microenvironment (TME) tumor-targeting technology platform.

"NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99), and we are applying that same development expertise to rapidly advance large-scale availability of Ac-225," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Our Ac-225 process uses highly efficient electron accelerator production technology that provides increased capacity and scheduling flexibility. Like all NorthStar processes, it is environmentally friendly, non-uranium based and uses highly advanced technology. We are very pleased to enter this Ac-225 supply agreement with an industry leader such as POINT, with whom we share a vision to progress research and clinical availability of targeted radiotherapies for cancer patients as a potential treatment option."

"A resilient radioisotope supply chain is key to advancing our next-generation pipeline of targeted radiopharmaceuticals," said Dr. Joe McCann, Chief Executive Officer of POINT. "NorthStar’s deep experience and commercial competencies in radioisotope production make them an ideal partner, and we believe that their accelerator production technology will provide us with a differentiated and highly efficient supply route for the therapeutic radioisotope Ac-225."

Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) at Upcoming American Urological Association’s 2021 Annual Meeting

On September 8, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) at the upcoming 2021 AUA Annual Meeting (AUA2021), to be held in a virtual format from September 10 to 13, 2021 (Press release, Blue Earth Diagnostics, SEP 8, 2021, View Source [SID1234587431]). Details of selected moderated poster presentations are listed below.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Blue Earth Diagnostics invites participants at AUA2021 to attend the presentations above and to learn more about the Company in the AUA2021 Virtual Science & Technology Hall. For full session details and scientific presentation listings, please see the AUA online program here.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Jasper Therapeutics Initiates New Clinical Trial with National Cancer Institute to Evaluate JSP191 in GATA2-related Myelodysplastic Syndromes

On September 8, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported the initiation of a Phase 1/2 clinical trial to evaluate JSP191, the company’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent prior to allogeneic transplant in patients with GATA2-related myelodysplastic syndromes (MDS) (Press release, Jasper Therapeutics, SEP 8, 2021, View Source [SID1234587429]). Jasper Therapeutics and the National Cancer Institute (NCI), part of the National Institutes of Health, have entered into a clinical trial agreement in which NCI will serve as the Investigational New Drug (IND) sponsor for this study.

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"As we seek to make stem cell transplants safer and expand the indications for which JSP191 could be used as a less toxic, more effective conditioning regimen in patients undergoing curative transplant, we look forward to collaborating with the NCI on this Phase 1/2 clinical trial in patients with GATA2-related MDS," said Wendy Pang, M.D., Ph.D., vice president, research and translational medicine, of Jasper Therapeutics. "The results may provide us with key insights about the use of JSP191, a highly differentiated anti-CD117 monoclonal antibody, as a conditioning agent for this patient population."

MDS are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i Some patients with MDS have mutations in the GATA2 gene, which plays a role in the production and maintenance of hematopoietic stem cells, which give rise to all blood and immune cells.ii Each year, about 2,500 patients with MDS in the G7 countries receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) are currently enrolling. Enrollment in four additional studies is expected to begin in 2021 in patients with severe autoimmune disease, sickle cell disease, chronic granulomatous disease or Fanconi anemia who are undergoing hematopoietic cell transplantation.

NorthStar Medical Radioisotopes to Present at Upcoming H.C. Wainwright 23rd Annual Global Investment Conference

On September 8, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, reported that Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes, will present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held in a virtual format September 13 – 15, 2021 (Press release, NorthStar Medical Radiostopes, SEP 8, 2021, View Source [SID1234587428]). Additionally, Company management will host one-on-one meetings during the conference.

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A pre-recorded presentation will be available to registered attendees for on-demand viewing beginning Monday, September 13, 2021, at 7:00 a.m. ET on the conference website.

"NorthStar is expanding its leadership position in the rapidly growing area of therapeutic radioisotopes, used in targeted precision radiopharmaceuticals for the treatment of cancer, respiratory and other diseases," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "In addition, NorthStar continues its successful commercialization of our lead SPECT diagnostic imaging radioisotope, which has informed critical healthcare decisions for hundreds of thousands of patients since launch. Our presentation and meetings will focus on the Company’s robust development portfolio of game-changing therapeutic and diagnostic products, and the ways in which NorthStar is strongly positioned for continued rapid growth and industry leadership. We look forward to sharing our success with the investor community at H.C. Wainwright’s 23rd Annual Global Investment Conference."