On October 11, 2022 ImpediMed Limited (ASX.IPD) reported the recent expansion of the use of its SOZO Digital Health Platform at leading cancer centers dedicated to reducing the impact of lymphedema on breast cancer patients (Press release, ImpediMed, OCT 11, 2022, View Source [SID1234621919]). Several key customers, including City of Hope, Mayo Clinic, University of Pittsburgh Medical Center, and US Oncology, added new SOZO devices or software licenses to expand access to SOZO testing for their breast cancer patients.

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In 2019, ImpediMed launched its comprehensive Lymphedema Prevention Program, with the goal of ending cancer-related lymphedema. Routine lymphedema testing of cancer survivors uses the company’s FDA-cleared SOZO Digital Health Platform with L-Dex technology, which helps detect lymphedema at the subclinical stage, before noticeable swelling.

We are excited that these prestigious organizations are expanding access to SOZO testing for breast cancer patients.

Since the launch of the Lymphedema Prevention Program, ImpediMed has announced multiple partnerships with leading institutions globally. Publication of ImpediMed’s PREVENT Trial three-year primary endpoint results, which demonstrated that routine monitoring with L-Dex combined with at-home intervention resulted in a 92% reduction in lymphedema progression, also contributed to further adoption of SOZO for lymphedema prevention.

"It is well established that early detection and intervention reduces the burden of lymphedema on breast cancer patients," commented Frank Vicini, MD, radiation oncologist and ImpediMed’s Chief Medical Officer. "ImpediMed’s L-Dex technology, which is available on SOZO, has the most extensive evidence of efficacy for early detection of breast cancer-related lymphedema. Continued improvement in breast cancer treatment has increased the focus on quality of life in survivorship."

"We are excited that these prestigious organizations are expanding access to SOZO testing for their patients," said David Anderson, Interim CEO of ImpediMed. "This is aligned with our commitment to the goal of ending cancer-related lymphedema by delivering research, technology, and workflows to guide clinicians in the use of SOZO for lymphedema prevention. Every day, our team works closely with our customers to ensure successful implementation of SOZO for the benefit of patients."

ImpediMed offers clinicians multiple channels for education about SOZO and lymphedema prevention including online resources at View Source, the ImpediMed Webinar Series, and in-person training. ImpediMed’s website, www.preventlymphedema.com, offers quick and easy access to extensive information about lymphedema prevention including videos and educational materials for surgeons, cancer centers, caregivers and patients.

About Lymphedema
Lymphedema is a side effect of cancer treatment. It currently affects about 1-in-3 patients who have undergone surgery, radiation, or chemotherapy, each of which may compromise the lymphatic system. Lymphedema is characterized by abnormal swelling that generally occurs in one of the arms or legs, and sometimes both arms and both legs. Patients with lymphedema also have a greater risk of getting infections. Cuts or small breaks in the skin can lead to serious complications and hospitalizations. Currently, no cure for lymphedema exists. By the time patients experience swelling, the condition is typically irreversible. However, extensive research indicates that prevention is possible if lymphedema is caught early and ImpediMed’s L-Dex technology, which is available on SOZO, has the most extensive evidence of efficacy for early detection. For more information, visit www.preventlymphedema.com.

On October 11, 2022 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and Toregem BioPharma, a biotech startup company from Kyoto University, reported that they have signed a Memorandum of Understanding (MOU) to form a strategic partnership in the development of TRG035, a monoclonal antibody targeting USAG-1 for the treatment of congenital adentia (Press release, WuXi Biologics, OCT 11, 2022, View Source [SID1234621918]).

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Within the partnership, Toregem BioPharma will have access to WuXi Biologics’ integrated CMC services in cell line development, cell banking and testing services, cell culture development, biologics GMP manufacturing, bioassay development, and related services. WuXi Biologics will support Toregem BioPharma on the TRG035 project for its Investigational New Drug (IND) application.

"We are glad to be collaborating with WuXi Biologics as they are experienced in enabling universities to turn advanced technologies into promising products," said Dr. Honoka Kiso, CEO of Toregem BioPharma. "By utilizing WuXi Biologics’ comprehensive IND-enabling capabilities and large global footprint with extensive GMP production capacities, Toregem BioPharma will be able to focus on realizing and maximizing the therapeutic potential of TRG035. WuXi Biologics is the best partner for us as we step forward to conduct the clinical trial and realize the eventual commercialization of our unique product. We look forward to bringing this tooth regeneration drug to the global market, treating patients across the world."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are very pleased to partner with Toregem BioPharma, and this is one of the first integrated CMC projects in Japan that we have supported – with our integrated services and experience – from early academic research phase all the way to clinical phase. WuXi Biologics is proud to support all kinds of global partners in bringing new biologics solutions to life for patients in multiple markets worldwide."

On October 11, 2022 Fujirebio Europe and Self-screen B.V. reported a commercial collaboration around the distribution of the PreCursor-M+ methylation-specific molecular IVD assay from Self-screen B.V (Press release, Fujirebio Diagnostics, OCT 11, 2022, View Source [SID1234621917]). The test is intended for the qualitative detection of elevated methylation levels of cervical cancer biomarkers and may be used as a triage follow-up test of human papillomavirus (HPV) positive women and women with ASCUS/ LSIL cytology results. It complements Fujirebio’s HPV-specific molecular test portfolio.

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Every year, more than 340,000 women across the world die from cervical cancer1, even though it is a preventable disease. Global efforts to eliminate cervical cancer focus on expanding coverage of HPV vaccination and improving cervical cancer screening. However, within (primary HPV) screening programs it is not possible to clearly distinguish within the positively tested women, those who have persistent and progressing cervical disease and those, for whom the disease might be regressing. The PreCursor-M+ methylation-specific molecular assay has been demonstrated as a sensitive follow-up test to identify HPV positive women with progressing cervical disease in direct need for colposcopy or other follow-up procedures2,3.

"Fujirebio has a long legacy in HPV testing, and it was important for us to bring new and complementary testing solutions to our many customers," says Christiaan De Wilde, CEO Fujirebio Europe "The methylation test from Self-screen, a well-respected pioneer in convenient and powerful HPV testing solutions, is a perfect example of quickly meeting customer demand with market-leading solutions and strategic partnerships."

"We are very happy that Fujirebio partners with us to transition into still necessary effective innovations. Both our companies share a long history in HPV diagnostics, so this partnership strengthens our joint ambitions in this field," says Michelle Meijer, Chief Commercial Officer at Self-screen B.V. "Our methylation test can improve triage with significantly less over-referrals to the gynecologist and unnecessary treatments, and is compatible with lab- and patient-friendly procedures such as self-sampling."

The PreCursor-M+ test is validated for samples taken by physicians as well as for samples collected by women (self-sampling), which can largely optimize the testing process and increase the participation rates in screening programs and follow up. Please contact Fujirebio for further information about the local availability of the test.

On October 11, 2022 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Eckert & Ziegler Isotope Technologies Dresden (ITD), a specialist for radiopharmaceutical plant engineering and fully owned subsidiary of Eckert & Ziegler AG (ISIN DE0005659700, SDAX), reported an agreement for the purchase of hot cells and related equipment for NorthStar’s dedicated non-carrier-added (n.c.a.) actinium-225 (Ac-225) production facility (Press release, NorthStar Medical Radiostopes, OCT 11, 2022, View Source [SID1234621916]). Hot cells are specially designed shielded enclosures that allow the safe handling of radioactive material. The equipment, worth several million USD, will be used by NorthStar in Beloit, Wisconsin, to produce commercial-scale quantities of n.c.a. Ac-225. Ac-225 is an emerging medical radioisotope for potential use in the treatment of cancer. The manufacturing process for these advanced radiopharmaceuticals requires innovative solutions and equipment to enable routine large-scale commercial production of Ac-225.

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"This agreement underlines our long-standing and extensive know-how in the construction of customized special plants, both because of its scope and with respect to the technological requirements," explained Felix Husmann, Managing Director of Eckert & Ziegler’s subsidiary Isotope Technologies Dresden GmbH. "We are proud that a leading radiopharmaceutical company like NorthStar is putting its trust in our expertise in process development."

"NorthStar is confident that we will be the first commercial-scale supplier of n.c.a. Ac-225 utilizing our environmentally preferable and non-uranium based electron accelerator technology," said Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. "From the preliminary stages of this project, we have had the full support of ITD’s technology team. We consider them the leading industry specialist in turnkey facilities for radiochemical and radiopharmaceutical processes, and anticipate that their technical solutions will enable us to make a significant contribution to the global supply of Ac-225 in the future."

On October 11, 2022 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, reported the dosing of the first patient in China in a Phase 1 study of AC0682, an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity (Press release, Accutar Biotechnology, OCT 11, 2022, View Source [SID1234621915]).

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"The initiation of this study marks the first program from our chimeric degrader portfolio to enter the clinic in China, after the initiation of AC0682 Phase 1 study in the US late last year and the IND clearance by the China National Medical Products Administration (NMPA) earlier this year," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "Breast cancer is the most common cancer type among Chinese women. We look forward to accelerating the development of AC0682 globally with the goal of bringing transformative medicines to patients worldwide."

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in Chinese patients with ER-positive breast cancer. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05489679).

About AC0682

AC0682 is an investigational orally bioavailable, chimeric degrader of ERα for the potential treatment of ER-positive breast cancers. ERα is a hormone-regulated transcription factor that plays a critical role in breast cancer initiation and proliferation, and nearly 80% of breast cancers express ERα. In preclinical studies, AC0682 demonstrated potent and selective ERα protein degradation with favorable pharmacological properties, as well as promising anti-tumor activity in ER-positive animal tumor models.