On June 9, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that China’s National Medical Products Administration (NMPA) has approved Trodelvy (sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, JUN 9, 2022, View Source [SID1234615844]). This is the first drug that Everest has obtained New Drug Application (NDA) approval to launch in China. In May 2021, the NMPA accepted Everest’s NDA for Trodelvy with Priority Review designation.

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"We are extremely excited for Trodelvy’s NDA approval in China as Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. This marks a significant milestone for Everest with our first drug approved in our home market, where we hope to continue to bring innovative therapies to people with urgent medical needs," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We want to extend our gratitude to the NMPA and the Center for Drug Evaluation for the Priority Review and fast approval."

"The NMPA approval of Trodelvy will provide an important and new treatment option for Chinese women with metastatic triple-negative breast cancer – a very aggressive and challenging to treat form of the disease. We would like to thank the investigators and patients who participated in the clinical trials for making this possible," said Yang Shi, Chief Medical Officer for Oncology/Immunology at Everest Medicines. "We will continue to work with our partner, Gilead, to advance clinical research of Trodelvy across multiple tumor types as well as earlier lines of therapy."

In November 2021, Everest announced topline results from its Phase 2b EVER-132-001 study of Trodelvy in 80 people, which met its primary endpoint with a 38.8% overall response rate (ORR). The results were consistent with those from the global Phase 3 ASCENT study, thus showing similar efficacy and safety in the Chinese population.

"Patients with triple-negative breast cancer are in urgent need of new and effective treatment options. I have witnessed the introduction of sacituzumab govitecan (Trodelvy) into China, and led the registrational clinical study in the nation," said Professor Binghe Xu, academician of the Chinese Academy of Engineering and director of the National New Drug (Anti-Cancer) Clinical Research Centre who is the principal investigator of Trodelvy’s registrational study in China. "I am glad that sacituzumab govitecan has shown similar positive results in the domestic clinical study as those from the global trial. As a clinician, I hope that this new drug can reach patients as early as possible to save more lives."

"There is a significant unmet need among metastatic triple-negative breast cancer patients in China who are waiting eagerly for a better treatment option to extend their lives," said Kevin Guo, Chief Commercial Officer at Everest Medicines. "With the Trodelvy approval in China, we will rapidly expand our sales team to launch this novel product in the fourth quarter this year and bring it to as many hospitals and patients in China as possible."

In addition to mainland China and Singapore where Trodelvy has been approved, Everest is closely coordinating with regulatory bodies in South Korea, Taiwan and Hong Kong to review its applications for Trodelvy for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
In December 2021, the Taiwan Food and Drug Administration accepted submission of NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
In January 2022, the Health Sciences Authority of Singapore approved the Company’s NDA for Trodelvy for the treatment of second-line and later-line metastatic TNBC.
In March 2022, an NDA was submitted to the Department of Health, the Hong Kong Special Administrative Region, China, for Trodelvy for the treatment of second-line metastatic TNBC.
Conference Call Information

A live conference call will be hosted on June 13, 2022 at 8:00 AM Beijing Time (June 12, 2022 at 8:00 PM U.S. Eastern Time).

The live webcast of the conference call will be available at View Source

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About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells do not have estrogen and progesterone hormone receptors and have limited or no human epidermal growth factor receptor 2 (HER2) expression. Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy (Sacituzumab Govitecan)

Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, Trodelvy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer and was also included in the updated 2022 Guidelines for Breast Cancer Diagnosis and Treatment of the Chinese Society of Clinical Oncology in April.

*The TRODELVY trademark is used under license from Gilead Sciences, Inc.

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.

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.

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.

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.