On October 11, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize health care, reported that The University of Tennessee Medical Center’s (UTMC) Cancer Institute has joined Caris’ Precision Oncology Alliance (POA) (Press release, Caris Life Sciences, OCT 11, 2022, View Source [SID1234621921]). The POA is a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

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UTMC, a Magnet recognized hospital, Level I Trauma Center and regional academic medical center, serves as a major referral center for East Tennessee, Southeast Kentucky and Western North Carolina. As the largest provider of cancer care in the region, the Cancer Institute offers the broadest spectrum of cancer specialists and services to care for the local adult population, with research as its cornerstone of knowledge.

"We are proud to join the Caris Precision Oncology Alliance," said John L. Bell, M.D., Director of the Cancer Institute at The University of Tennessee Medical Center. "As cancer treatments become more sophisticated and personalized, having access to the most recent, ever-changing molecular testing helps our providers choose the best cancer treatment for each patient. It is truly an honor to join this prestigious group of institutions and make this testing available to patients in East Tennessee and beyond through cutting-edge precision oncology research."

"We’re excited to welcome The University of Tennessee Medical Center’s Cancer Institute into the growing Caris Precision Oncology Alliance network and look forward to collaborating with its clinicians and investigators to advance clinical and translational research," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The University of Tennessee Medical Center’s addition to the POA advances our precision oncology research portfolio aiming to improve the outcomes of patients with cancer."

The Caris Precision Oncology Alliance includes 73 cancer centers and academic institutions. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and advance research in cancer precision medicine. By leveraging the comprehensive genomic, transcriptomic and proteomic profiling available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and clinical outcomes data for over 275,000 patients covering over 1 million data points per patient.

On October 11, 2022 HanAll Biopharma (KRX: 009420.KS), a global biopharmaceutical company developing innovative medicines, reported that its licensed partner in greater China, Harbour BioMed, has signed an exclusive sublicense agreement with CSPC NBP Pharmaceutical Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC, a RBM 28 billion 2021 sales company based in China, for HanAll’s FcRn inhibitor batoclimab (Press release, HanAll Biopharma, OCT 11, 2022, View Source [SID1234621920]). The deal grants NBP Pharma the exclusive rights to develop and commercialize batoclimab in Greater China including mainland of China, Hong Kong, Macau, and Taiwan. Under the agreement Harbour BioMed will receive a total of over RMB 1 billion, including the RMB 150 million worth upfront payment along with the potential milestone payments.

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"We are pleased to have reached this agreement with Harbour BioMed," said Cuilong Zhang, CEO of CSPC through the press release by Harbour BioMed. "Batoclimab is a promising innovative drug, and we hope to accelerate its clinical development, manufacturing, registration and commercialization in China, so as to benefit the patients in China better and earlier," he added.

"HanAll welcomes CSPC to join our journey to develop innovative medicines for patients in China. With its strong track records of R&D and commercialization, CSPC is expected to even further accelerate and expand the clinical development of batoclimab to contribute to autoimmune patients in China," said Sean Jeong, M.D., CEO of HanAll Biopharma.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.