SpectronRx to Showcase New Facility for the Global Supply of Actinium-225 at SNMMI 2022

On June 9, 2022 SpectronRx, a leading contract development and manufacturing organization (CDMO) for the life sciences industry that specializes in radiopharmaceuticals, reported that it will showcase its new Actinium-225 production facility during this year’s annual Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting being held June 11-14 in Vancouver, British Columbia, Canada (Press release, SpectronRx, JUN 9, 2022, View Source [SID1234615843]). SpectronRx has secured more than 10-acres in Bunker Hill, Indiana, where it is building a facility that will produce Actinium-225 for the clinical trial and commercial supply of cancer-fighting therapies.

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"Although there’s currently no Food and Drug Administration-approved treatment using Ac-225, it’s showing great promise when it comes to the treatment of certain types of cancer, including prostate, breast, colon, brain and neuroendocrine," said John Zehner, CEO of SpectronRx. "Researchers have been studying the radioisotope’s cancer-fighting potential for decades and are on the cusp of several new breakthroughs. Our goal is to support these new therapies as they are approved."

Actinium-225 is an exceptional cancer fighter. It can be attached to a molecule that delivers the radionuclide to a selectively targeted cancer site, where the Ac-225 alpha-emission can destroy the cancerous tissue with minimum damage to healthy cells. And the high-energy alpha particles Ac-225 releases can interrupt DNA processes, keeping cancer cells from replicating or even killing them altogether. This makes Ac-225 one of the most promising candidates for targeted alpha therapy.

"Unfortunately, there is a limited supply of the Ac-225 radionuclide globally," said Anwer Rizvi, president of SpectronRx. "This limits the ability of pharmaceutical companies to perform the drug trials needed in order to advance the use of this crucial radionuclide. That’s why building up production of Ac-225 is so important."

Currently, only small amounts of Ac-225 are being produced by various government entities. To enhance the available supply, SpectronRx will produce Ac-225 through methods including the use of particle accelerators. The company will invest several million dollars to install multiple particle accelerators at its new site near Grissom Air Reserve Base in Indiana, which will produce the much-needed medical isotopes to treat cancer. The project is expected to take two years to complete.

NEXT Molecular Analytics Receives Accreditation from the New York State Department of Health for its L-Asparaginase Enzyme Activity Assay Platform

On June 9, 2022 NEXT Bio Research Services LLC (www.nextmolecular.com), dba NEXT Molecular Analytics reported that the New York State Department of Health (NYSDOH) has accredited the Company’s L-Asparaginase enzyme activity assay platform (Press release, NEXT Molecular Analytics, JUN 9, 2022, View Source [SID1234615842]). This means that NEXT is now able to receive clinical test samples from New York State institutions without waiver and also means that NEXT is now accredited in all 50 states to process asparaginase test samples.

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Dr. Robert B Harris, the original developer of the Laboratory Derived Test for asparaginase, the holder of the Certificate of Quality from the NYSDOH, stated, "Reaching this milestone is a tremendous accomplishment for our Company and is testament to the diligent and precise work of our dedicated employees." He added, "The NYSDOH standards are among the most rigorous in the country for testing labs to meet, and we take great pride in the fact that NEXT has met these standards."

L-asparaginase chemotherapy is integral in the treatment of pediatric patients with acute lymphoblastic leukemia (ALL). Its incorporation as part of a multi-agent chemotherapy regimen has resulted in improved, event free survival in childhood ALL. NEXT’s test measures asparaginase levels in patients being treated with any of the current therapeutic biologics used in ALL patients including Oncaspar, Asparlas, Erwinaze, and Rylaze. NEXT has assayed more than 16000 patient samples from well over 250 institutions worldwide, including hospitals and clinics in Canada, Switzerland, Hong Kong, Singapore, and the United Arab Emirates. Assay results are returned by the close of business the same day that the sample is received, thereby providing the clinician real-time therapeutic monitoring of his patient with respect to asparaginase activity levels. In addition to providing results to ordering physicians, NEXT is also partnering with the different drug manufacturers of asparaginase to help propagate the usefulness of real time therapeutic monitoring of asparaginase levels, NEXT is actively using its assay to support several human pre-clinical and clinical trials.

Quanterix to Participate in Goldman Sachs 43rd Annual Global Healthcare Conference

On June 9, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that its Chief Executive Officer, Masoud Toloue, will join the Goldman Sachs 43rd Annual Global Healthcare Conference for a fireside chat on June 16, 2022 at 8:40 a.m., EST (Press release, Quanterix, JUN 9, 2022, View Source [SID1234615841]).

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To register for the live webcast, please visit: View Source

Toloue will also host one-on-one meetings with institutional investors on Thursday, June 16. A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

Healthcare Is Personal: GE Healthcare’s Total Molecular Imaging Solutions Enable Precision Health & Theranostics for Personalized Prostate Cancer Care

On June 9, 2022 GE Healthcare reported that cutting-edge molecular imaging solutions that enable and increase access to precision health and theranostics to help improve patient outcomes across care areas, including prostate cancer – the most prevalent cancer in men and the third most prevalent cancer overalli (Press release, GE Healthcare, JUN 9, 2022, View Source [SID1234615840]).

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Where most medical therapies are designed with the ‘average’ patient in mind, theranostics brings together diagnoses and treatment in one application, providing a more targeted and personalized therapy than ever before. Clinicians and patients are especially seeing much success with theranostics in prostate cancer – a highly manageable disease, but one that is difficult to treat when diagnosed at a late stage – claiming more than 1.4 million lives annuallyii.

During the COVID-19 pandemic, clinical adoption of theranostics slowed due to a delay in elective procedures and the increased risk posed to its often-immunocompromised patients. However, a surge in demand for theranostics infrastructureiii is now anticipated following the U.S. Federal Drug Administration’s (FDA) approval of several new drugs and therapies. This includes the diagnostic tracer Gallium-68 PSMA-11 and therapy drug Lutetium-177 PSMA-617, which are key to applying theranostics in prostate cancer.

"Healthcare is timely and personal – and its delivery should be too," explains Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE Healthcare. "Theranostics has the potential to transform care from a look at the ‘average’ patient to a precise look at ‘each’ individual. Already, it is providing hope to late-stage prostate cancer patients by aiding with the diagnosis of the disease, the accurate quantification of its progression, and the delivery of targeted, personalized therapies – all in the same session. And soon, we hope to see it adopted earlier in the disease care pathway and across oncology to benefit more patients around the world."

To prepare for the creation of dedicated theranostics centers, SNMMI and related international molecular imaging societies recently published a new guide for healthcare systems globallyiii. Focusing on safety protocols and operational procedures, the guide provides a framework that highlights best practices that can be applied across care areas.

"Nuclear medicine is entering a new age of precision theranostics, in which next-generation alpha- and beta-labeled radiotherapeutics are tailored to individual cancer patients using the latest diagnostic PET radiopharmaceuticals," explains Dr. Peter Scott, Associate Professor of Radiology, Division Director of Nuclear Medicine, University of Michigan. "With the FDA approval of a new PSMA-agent for treatment of prostate cancer, the future is here. Patients, their families and referring physicians are all demanding access to theranostics, creating an unprecedented demand for higher and higher amounts of radioactive metals. The only way to meet the global need for PET radionuclides like Gallium-68 and Copper-64 is through commercial solid-target solutions suitable for routine use."

As the industry prepares to usher in this new era of precision health and personalized medicine, GE Healthcare is proud to offer innovative molecular imaging solutions to healthcare systems around the world.

Discovery with the Molecule Journey: Enabling Precision Health: The enablement of theranostics in prostate cancer care begins with the production of radioisotopes for use in diagnostic tracers – namely Gallium-68 PSMA-11 – which is administered to the patient, attaches to specific cancer cells, and releases radioactive emissions to provide detailed molecular information unique to each patient.

However, shortages of the generators that produce Gallium-68 historically have created serious challenges for clinicians and limited patient access. In response, GE Healthcare is proud to introduce a new Solid Target Platform for its PETtrace cyclotron which – in combination with its FASTlab 2 New Edition platform – can produce 100x the amount of Gallium compared to a generator for increased theranostics capabilities and access in prostate cancer patient careiv.

While solid targets have been around for some time, they have traditionally been viewed as research tools and required complicated infrastructure and highly trained operators. Now, with GE Healthcare’s TRACERcenter Solutions and new PETtrace Solid Target Platform, healthcare systems can more easily access the equipment, tracers and staff training necessary to deliver a more cost-effective, personalized solution.

Diagnosis: Accurately Staging & Quantifying Disease: To read the emissions released by the Gallium-68 PSMA-11 tracer, the patient must be imaged using a highly sensitive PET/CT scanner. This technology provides the clinician detailed information that is used to better understand the structure and function of each patient’s tissue and disease state to help form personalized therapy recommendations. The more sensitive the PET/CT, the more accurate the images and quantification.

To this end, GE Healthcare is now shipping its Discovery MI Gen 2 premium digital PET/CT system, which provides next-level digital detection with an axial field of view (FOV) scalable up to 30 centimeters to achieve a 125 percent increase in sensitivityv. This helps translate to 33 percent improvement in scan times or dose amountsvi.

These capabilities are further supported by Q.Clear, which offers up to 2x improvement in both image quality (SNR) and quantitation accuracy (SUVvii), and MotionFree for up to 67 percent improvement in lesion volume measurements, helping inform clinicians’ prostate cancer therapy recommendationsviii.

Additionally, this scanner includes a CT that is designed to allow TrueFidelity deep-learning image reconstruction to enable image sharpness and improved noise textureix. Discovery MI Gen 2 proclaims up to a 41 percent increase in small lesion detectabilityx.

Treatment: Delivering & Monitoring Targeted Therapy: With regard to therapy, the FDA recently approved Lutetium-177 PSMA-617 – an exceptional therapy for advanced prostate cancer – in March 2022. It works by binding to and delivering a small amount of radiation to prostate cancer cells anywhere in the body to help patients with advanced prostate cancer live longer and maintain quality of lifexi.

To help clinicians evaluate the success of these therapies, GE Healthcare developed its breakthrough StarGuide SPECT/CT system with 12 cutting-edge CZT detectors that not only scan patients in 3D to provide more information to clinicians but are also optimized for Theranostics procedures – including imaging this latest Lutetium-177-based prostate cancer therapy.

Compared to conventional technologies, StarGuide’s Digital Focus CZT detectors offer improved volume sensitivity and SPECT resolutionxii, which is especially valuable for imaging both peaks of Lutetium-177 emissions, which in turn helps clinicians pinpoint the size, shape, and position of lesions with exceptional accuracy. Paired with GE Healthcare’s innovative Q.Clear solution for SPECT reconstruction, the resulting images provide outstanding quantification for the diagnosis and staging of disease and monitoring of treatment.

Increasing Accuracy & Efficiency: Artificial intelligence (AI) also offers new opportunities to streamline workflows, provide accurate data, and help expedite diagnoses across care areas – all valuable offerings in today’s resource constrained healthcare environment.

That’s why GE Healthcare also offers the Xeleris V image processing solution with a collection of AI-enabled clinical applications to help simplify and enhance workflows. This includes Q.Thera AIxiii, which is designed to leverage Q.Volumetrix MI to help clinicians automatically and accurately segment areas of interest – including AI-based kidney segmentation – for quantitation and dosimetry calculations, all with the goal to help reduce the time required for the user to process and calculate dose – enabling them to spend more time with patients.

The advancement of imaging technologies and continuous evolution and discovery of new tracers and targeted therapies is ushering in a new era in healthcare – one in which precision health and theranostics exist at its core. Prostate cancer is only the beginning, with many more applications under development for the future.

GE Healthcare is proud to offer clinicians unique opportunities to make personalized care decisions and treatment response assessments for the benefit of patients around the world. The company is uniquely positioned to advance these efforts as the only partner with solutions spanning from molecular imaging diagnostics, cyclotrons, chemistry synthesis, PET/CT, PET/MR, nuclear medicine, advanced digital solutions, and pharma partnerships to cover the breadth of steps from discovery to diagnosis to treatment.

Molecular Targeting Technologies, Inc. Features EBTATE Advances at The 2022 SNMMI Meeting In Vancouver, BC

On June 9, 2022 Molecular Targeting Technologies, Inc. (MTTI), a clinical stage oncology company, reported that it will highlight advances on its EvaTheraTM radiotheranostics platform at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting in Vancouver, BC, on June 11-15, 2022 (Exhibit booth #1715) (Press release, Molecular Targeting Technologies, JUN 9, 2022, View Source [SID1234615839]). The EvaThera platform includes EBTATETM (177Lu-DOTA-EB-TATE) for Neuroendocrine Neoplasms (NENs), Hürthle cell thyroid and nasopharyngeal cancers and EBRGDTM (177Lu-DOTA-EB-RGD) for glioblastoma multiforme and non-small cell lung cancer

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A video featuring the EBTATE story (see link below) will be released at the meeting.

View Source

In addition, two abstracts highlighting MTTI’s EBTATE & our PET imaging agent,18F-glucarate, were selected for oral and poster presentations:

(i) Evaluation of Safety, Biodistribution and Dosimetry of a long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE with and without Amino Acid Infusion by Qingxing Liu, Yuanyuan Jiang, Koon Pak, Guochang Wang, Jingjing Zhang, Xiaoyuan Chen and Zhaohui Zhu (oral presentation)

EBTATE treatment without amino acid infusion, normally used in current treatments to block drug impact on non-target organs, has acceptable, minor effects on the kidneys and does no harm to kidney function. EBTATE may significantly improve patient comfort vs. current treatments.

(ii) Assessment of 18F-glucarate as a potential PET tracer for cancer imaging by Junling Li, Huaiyu Zheng, Levi Beverly, Brian Gray, Koon Pak and Chin K. Ng (poster presentation)

18F-glucarate uptake in both in vitro and in vivo correlated well with the degree of cell death and shows early tumor response to chemotherapy, enabling faster assessment of treatment efficacy.