On May 11, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, reported that it has achieved a major milestone in its efforts to expand U.S. production capacity for the important medical radioisotope, molybdenum-99 (Mo-99) (Press release, NorthStar Medical Radiostopes, MAY 11, 2021, View Source [SID1234579710]). The Company has received two custom-built IBA RhodotronTT 300-HE (High Energy) electron beam accelerators at its facility in Beloit, Wisconsin. The accelerators are critical components in a first-of-its-kind commercial-scale process to produce Mo-99, the parent radioisotope of technetium-99m, the most widely used medical imaging radioisotope, informing healthcare decisions for approximately 40,000 U.S. patients daily.

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NorthStar Medical Radioisotopes is the sole commercial U.S. producer of the important medical radioisotope Mo-99 and the only company in the world to use environmentally friendly Mo-99 production processes that are non-uranium based. For over two years, NorthStar has provided the United States with reliable Mo-99 supply, which is used in its RadioGenix System (technetium Tc 99m generator) to produce Tc-99m. NorthStar is aggressively expanding and establishing dual production and processing hubs for additional Mo-99 capacity to better meet customer demand and to ensure reliable, sustainable U.S. supply. Two facility expansion projects are nearing completion in Beloit, Wisconsin, to augment current Mo-99 production and processing in Columbia, Missouri, conducted in partnership with the University of Missouri Research Reactor (MURR). NorthStar’s Isotope Processing facility in Beloit will enable it to more than double its current Mo-99 processing and is nearing completion, with FDA approval anticipated in 2022. The Company’s Accelerator Production facility in Beloit will add significant Mo-99 capacity, enable flexible production scheduling and minimize customer supply risks.

"Delivery of these electron beam accelerators to advance Mo-99 production marks a tremendous milestone event for NorthStar, nuclear medicine and the patients who rely on diagnostic imaging studies for their health," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Using electron beam accelerators is one of the most efficient methods of producing Mo-99, and like other NorthStar processes, it is non-uranium based and environmentally friendly. This production method will increase capacity, provide additional production days, and minimize supply risks. Additionally, electron beam accelerators can be used to produce therapeutic radioisotopes such as actinium-225 and copper-67. We anticipate that testing of these accelerators will begin this year, with commercial accelerator production commencing in 2023, pending appropriate licensure and FDA approval."

Mr. Merrick continued, "We are extremely grateful to all our partners and stakeholders for their support in achieving this milestone: the U.S. Department of Energy’s National Nuclear Security Administration and National Laboratories, the U.S. Food and Drug Administration, the Wisconsin Department of Health Services, our private commercial investors, NorthStar’s dedicated and talented employees, our supply chain partners, and our customers. We would like to recognize the support that our partners at the University of Missouri Research Reactor (MURR), with whom we jointly produce Mo-99 in Columbia, Missouri, continue to provide to NorthStar."

Mr. Merrick also added, "IBA (Ion Beam Applications S.A., EURONEXT), a leading global supplier of accelerators that is focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer, continues to be a tremendous collaborator in this effort, and we look forward to additional projects with them in the United States and globally. We are also proud to help showcase Wisconsin as a pioneer and leader in technology innovation and sustainable radioisotope production. Our expansion activities are supported by Corporate Contractors Incorporated (CCI), the lead contractor, Springs ATG (Advanced Technology Group) and Von Gahlen, a leading global supplier of state-of-the-art shielding solutions for nuclear medicine and radiopharmacy."

"This is a very exciting time for NorthStar and those involved in nuclear medicine. We all share a vision to accelerate the future of patient health by providing innovative solutions to ensure reliable access to radioisotopes that can make a positive difference in healthcare for people around the world," he concluded.

In conjunction with the delivery, NorthStar hosted, "From Belgium to Beloit, Wisconsin" on April 20, 2021, an event recognizing the significance of the occasion. Speakers included Stephen Merrick, President and Chief Executive Officer, and James Harvey, Senior Vice President and Chief Science Officer, as well as Diane Hendricks, Chairperson of the NorthStar Board of Managers. They highlighted NorthStar’s progress in delivering innovative technology to better patient health, its future plans, the increasingly important role of accelerators in radioisotope production and the Company’s commitment to nuclear medicine. The presenters showcased the state of Wisconsin as a pioneering leader in technology innovation and sustainable radioisotope production. In addition to expressing appreciation to NorthStar’s government and corporate partners, local contractors for the Accelerator Production facility were also recognized.

About the RadioGenix System (Technetium Tc 99m Generator)
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP

The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION

Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Sodium Pertechnetate Tc 99m Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Use the lowest dose of Sodium Pertechnetate Tc 99m Injection necessary for imaging and ensure safe handling and preparation to protect the patient and health care worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier. Follow step-by-step instructions for use provided in the Operator’s Guide, RadioGenix System 1.2.

On May 11, 2021 Australian clinical-stage drug development company Noxopharm Limited (ASX:NOX) reported its CEP-2 study will begin shortly. CEP-2 is related to the Investigational New Drug (IND) approval of Veyonda by the FDA based on evidence that Veyonda may increase generally poor response rates of sarcoma cancers to chemotherapy in combination with common chemotherapy drug, doxorubicin, for patients with soft tissue sarcomas (Press release, Noxopharm, MAY 11, 2021, View Source [SID1234579709]). The announcement marks the Company’s commitment to act on this valuable opportunity with the appointment of a contract research organization to oversee the study.

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Sarcoma was deliberately selected as a rare cancer carrying important funding and regulatory approval benefits including seven-year exclusive marketing opportunities. Sarcomas have very limited treatment options with only an estimated 14% of soft tissue sarcomas responding to chemotherapy. The Company is confident that Veyonda, with its unique mix of immunotherapy actions, has the means to increase both survival and response rates significantly when combined with doxorubicin.

"Soft tissue sarcomas are in that basket of cancers where there has been remarkably little advance in survival statistics over the past few decades, and the horizon has appeared to hold little reason to think that would change," said Graham Kelly, CEO of Noxopharm. "What we have seen to date with Veyonda both pre-clinically and clinically gives us confidence that a combination of Veyonda and doxorubicin has the capacity to deliver that change."

On May 11, 2021 Ashvattha Therapeutics, a clinical stage biotech company focused on novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in neuro-oncology, neurology and ophthalmology, reported that it will present at the Sachs 7th Annual Immuno-Oncology Innovation Forum, held virtually, May 18-20, 2021 (Press release, Ashvattha Therapeutics, MAY 11, 2021, View Source [SID1234579708]).

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Jeffrey Cleland, Ph.D., Chairman, CEO and President of Ashvattha Therapeutics will provide an overview of the company, and its pipeline enabled by a proprietary hydroxyl dendrimer (HD) technology platform – a differentiated, superior approach to targeted intracellular therapy.

"We are excited to present our strategy in neuro-oncology therapeutics for the first time at the Sachs Immuno-Oncology Forum," said Jeffrey Cleland, Ph.D., Chairman, CEO & President at Ashvattha Therapeutics. "There remains a significant unmet need in treating primary and metastatic brain cancers with therapeutic agents that can cross the blood brain barrier and precisely target tumor associated macrophages. We are developing an HD imaging agent, D6-B483, to demonstrate uptake of HDs in gliomas and brain metastases. This agent will also be used as a radiotherapeutic. HDTs currently in preclinical studies are designed to manipulate the tumor microenvironment toward a pro-inflammatory state increasing innate immune responses to the tumor."

Ashvattha’s technology platform consists of HDs that selectively target regions of inflammation within the body. Current cancer treatments have dose-limiting toxicity reducing efficacy, and even precision medicine and targeted therapies lack sufficient specificity to tumors. Most cancer drugs do not cross the blood-brain barrier (BBB) to treat brain cancer. In addition, current immune therapies do not target tumor-associated macrophages (TAMs). Ashvattha’s HDTs widen the therapeutic window and increase the maximum tolerated dose, for better patient outcomes. Its proprietary compounds also target and treat brain tumors with durable effects inside TAMs for up to 30 days. Ashvattha is currently on track to initiate a D6-B483 Phase 1 study in patients with glioblastoma multiforme or brain metastases by end of 2021.

The 7th Annual Immuno-Oncology Innovation Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment. Members of the management team will be available for virtual meetings at the conference. For more information, visit the conference website: View Source

On May 11, 2021 Avenda Health reported that Breakthrough Device Designation for a male "lumpectomy" product in development designed to treat prostate cancer in-office while preserving quality of life (Press release, Avenda Health, MAY 11, 2021, View Source [SID1234579707]). Breakthrough Device Designation by FDA is reserved for devices that are potentially transformative, offering treatment for serious diseases that may be more effective than currently available treatments. Avenda Health is a California-based software and medical device company aiming to improve cancer outcomes through artificial intelligence (AI) and minimally invasive technologies.

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Prostate cancer is one of the most common cancers, with one in eight men developing it in their lifetime.1 Prostate cancer is traditionally treated by surgery or radiation, which have well-known side effects such as urinary, sexual or bowel dysfunction. The Avenda Health Focal Therapy System, which is designed to spare healthy tissue and minimize side effects, uses patient-specific information and AI to deliver a precise and personalized treatment, targeting only the tumor. This treatment can be performed in a physician’s office with just local anesthesia, minimizing the patient’s downtime and potentially reducing cost to the healthcare system.

"We are working to advance the treatment of prostate cancer by giving patients and their doctors more options. We see our approach as similar to that of a lumpectomy for breast cancer – if the cancerous tumor and appropriate treatment margins can be identified, the standard approach of removing the entire prostate gland and surrounding tissue may not be necessary," said Shyam Natarajan, co-founder and CEO of Avenda Health.

Under the FDA Breakthrough Device Program, the FDA will provide Avenda Health with priority review for clinical trial protocols and commercialization decisions. The designation may also facilitate Medicare reimbursement following FDA approval of the technology.

"The FDA has not approved a new device for the treatment of localized prostate cancer in more than 40 years. We look forward to working closely with the FDA to bring our product to market so that patients no longer need to choose between treating their prostate cancer and preserving their quality of life," said Brit Berry-Pusey, co-founder and COO of Avenda Health.

Avenda Health spun out of UCLA and was founded with support from a National Cancer Institute grant, which helped fund a Phase I study on 10 patients that recently completed enrollment. The study demonstrated safety and no decline in urinary or sexual function in patients over the follow-up period.

"Ten years ago, a group of dedicated clinical scientists at UCLA came together from urology, radiology, pathology and biomedical engineering with the goal of improving treatment for prostate cancer. Where we are today compared to when we started is remarkable," said Leonard S. Marks, M.D., co-founder and chief medical officer of Avenda Health and professor of urology at UCLA. "Avenda Health continues to advance in this mission, and the FDA’s recognition of the incredible impact that this technology could have on the field of urology in treating prostate cancer is encouraging."

About Avenda Health Focal Therapy System

The Avenda Health Focal Therapy System is the only artificial intelligence (AI)-enabled focal therapy system being developed to treat localized prostate cancer in a urologist’s office under local anesthesia. In conjunction with AI-based margin prediction algorithms that rely on a large database of imaging and pathology, it uses a laser and a proprietary optical and thermal sensor to precisely target and treat just the prostate tumor – not the entire prostate. The goal is for this targeted ablation to minimize the impact on healthy tissues, without compromising urinary or sexual function.

The device has 510(k) clearance from the FDA for ablation of soft tissue. It is not yet commercially available while the company is working to advance clinical trials in pursuit of a PMA for the technology and system as a Class III medical device for the treatment of localized prostate cancer.

On May 11, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, reported a publication in Breast Cancer Research that demonstrates how multiplex immunofluorescence (mIF) may be used to characterize the immunological activity of IRX-2 in early stage breast cancer (Press release, Brooklyn ImmunoTherapeutics, MAY 11, 2021, View Source [SID1234579706]). The publication, entitled "Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer," describes a methodology for mIF in conjunction with statistical modeling applied in a clinical trial collaboration between Providence Cancer Institute in Portland, Oregon, and Brooklyn.

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"Multiplex immunofluorescence combined with hierarchical linear modelling resulted in more precise estimates of treatment-related increases in stromal tumor infiltrating lymphocytes, PD-L1, and other metrics such as CD8+ tumor nest infiltration compared to conventional testing," said study principal investigator David Page, MD, medical oncologist and assistant member, Earle A. Chiles Research Institute, a division of Providence. "Hierarchical linear modeling can mitigate the effects of intratumoral heterogeneity on immune cell count estimations, allowing us to more efficiently detect treatment-related pharmocodynamic effects of an anticancer drug such as IRX-2. This may allow us to more effectively demonstrate treatment activity, and ultimately patient benefit, in the context of immunotherapy clinical trials."

IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system associated with activation of the entire tumor microenvironment. The paper illustrates that IRX-2 increases immune cell infiltration and PD-L1 expression, suggesting that IRX-2 may hold promise in combination of PD-L1-targeted therapy in early stage breast cancer.

"We are excited to receive this validation for IRX-2 from an unbiased detection technology," said Howard Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "We recently initiated a combination trial evaluating IRX-2 with an immunotherapy that targets PD-1, in triple negative breast cancer, and we hope to explore additional combination approaches in various indications."

About the Phase 2 Trial

The Phase 2 randomized, open-label trial is designed to assess the efficacy and safety of IRX-2 in patients with triple negative breast cancer (TNBC). Approximately 30 patients in total are expected to be enrolled. Patients with locally confirmed stage II-III TNBC are eligible. Patients will receive alternating regimens of the PD-1 inhibitor plus chemotherapy and subcutaneous IRX-2 injections twice a day for 10 days as neoadjuvant therapy prior to surgery. The primary efficacy endpoint is pathological complete response rate, evaluated at the time of definitive surgery. For additional clinical trial details, refer to www.clinicaltrials.gov (NCT04373031).

This study is being supported in part by a multinational pharmaceutical company.