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- The first tri-party executive roundtable was held in London to strengthen synergies for Seegene's vision of creating 'a world free from diseases' - Preliminary results of product development automation and statistical analysis of syndromic test results powered with Microsoft's AI technology were showcased - Global experts and scientists participated in building a diagnostic product development eco-system utilizing Springer Nature's scientific network - Companies fostered collaboration to drive collective impact towards next year's 'a world free from diseases' declaration ceremony SEOUL, South Korea, Oct. 24, 2024 /PRNewswire/ -- Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, held the first executive roundtable with Microsoft and Springer Nature to discuss advancing its technology-sharing initiative aimed at mitigating future pandemics and creating 'a world free from diseases', including the showcase of preliminary results from an automated diagnostic development system powered with Microsoft's artificial intelligence (AI) technology. This is the first official event that the three companies gathered to discuss the initiative. [Photo 1] ▲ From left: Marc Spenlé, COO of Springer Nature; Dr. Jong-Yoon Chun, CEO and Founder of Seegene; and Elena Bonfiglioli, Vice President of Global Business Leader Healthcare, Pharma and Life Science at Microsoft posed for a photo during Technology-Sharing Initiative Partner Roundtable in Springer Nature Campus, London, United Kingdom on October 23, 2024. On October 23, the three companies convened at Springer Nature London Campus Auditorium for the technology-sharing initiative partner roundtable to share initial achievements and explore strategies for further collaboration. Dr. Jong-Yoon Chun, CEO and founder of Seegene; Marc Spenlé, chief operating officer of Springer Nature; Steven Inchcoombe, president of research at Springer Nature; and Elena Bonfiglioli, vice president of global business leader healthcare, pharma and life science at Microsoft attended the meeting. "By integrating Seegene's proprietary syndromic real-time PCR technology, Microsoft's cutting-edge AI and cloud services, and Springer Nature's extensive reach in the global scientific community, we will create new avenues for collaboration with scientists and experts in this technology-sharing initiative," said Dr. Chun, CEO and founder of Seegene. The technology-sharing initiative aims to globally share Seegene's advanced diagnostic and data analysis technologies, including syndromic real-time PCR and an automated product development system (SGDDS), with a leading company partnered in each country. Partnering companies will collaborate with local scientists and experts to develop diagnostic tests tailored to the needs of their communities and fields, spanning a wide range of human and non-human diseases. Amidst the challenges of climate change and the anticipated rise in outbreaks, the initiative's ultimate vision is to create 'a world free from diseases'—a future where people no longer suffer from infectious diseases and cancer, and where animals and plants thrive without illness. Seegene's syndromic real-time PCR technology represents a breakthrough in molecular target detection, unparalleled by other PCR methods. It enables the simultaneous detection of up to 14 pathogens in a single reaction tube, with quantitative information for each target. Furthermore, multi-tube panel tests may be designed to cover an even more comprehensive set of pathogens with overlapping symptoms. As a powerful tool for mitigating the growing threat of multi-pandemics—exacerbated by climate change—Seegene's technology enhances the ability to monitor and respond to a diverse range of rapidly evolving pathogens. Companies participating in the technology-sharing initiative will gain access to Seegene's cutting-edge technology and expertise, enabling them to develop and manufacture syndromic real-time PCR products tailored to their countries' specific public health needs. Localization of such capabilities through this initiative will allow their communities to promptly respond to future outbreaks and multi-pathogen pandemics. Building on the momentum achieved during this year's roundtable, a declaration ceremony is expected to take place in the second half of next year, where strategies to maximize synergy amongst the three company's technology will be further discussed. At the meeting in London, Seegene and Microsoft showcased the preliminary results of integrating Microsoft's Azure Open AI into the research planning module of Seegene's automated product development system (SGDDS). The use of AI technology dramatically reduced the time needed to process and analyze relevant information from published scientific literature. Additionally, the two companies demonstrated a proof of concept for Seegene's syndromic-based statistical analysis system that leverages Fabric, Microsoft's AI-driven data integration platform, ultimately to discover statistical correlations between multiple pathogens causing similar symptoms, support accurate diagnosis and treatment, and predict future outbreaks. "Until now, scientists and experts have been confined to limited local data, usually generated by themselves. However, access to diagnostic information shared across the world powered with Microsoft's AI technology will enable swift response to any emerging diseases," said Dr. Chun at Seegene. "Seegene and Microsoft shared the vision of a new generation of diagnostic solutions, accessible at population level to help people stay healthier longer. Cloud and AI solutions help protect, manage and reason over the vast amounts of data needed to track diagnosis of global diseases in real time. Microsoft is the trusted partner to help realize Seegene's vision of building 'a world free from diseases,'" said Ms. Bonfiglioli from Microsoft. In January 2024, Seegene and Microsoft entered a strategic collaboration to integrate Microsoft's Azure Open AI services into numerous modules of Seegene's SGDDS. The goal of these collaborative projects is to empower global companies participating in the technology-sharing initiative with a streamlined product development system augmented by advanced IT system operations and AI-powered data analysis. Springer Nature was also present at the discussion. Since 2023, Seegene and Springer Nature have been running the Open Innovation Program (OIP) that invited scientists and experts around the world to participate in the development of clinically significant diagnostics assays. This year, the program was renewed by Springer Nature as the prestigious Nature Awards, MDx Impact Grants, calling for innovative proposals for PCR diagnostic assay development. Springer Nature will oversee key aspects of the process, including project submissions and evaluations, expecting to broaden interest and participation from the global scientific community. In May 2024, the two companies signed a strategic alliance agreement that included expansion of the OIP program scope. Springer Nature will encourage the global scientific community to participate in the ideation, design, and development of new PCR diagnostic products. "We have high expectations that the MDx Impact Grants will work synergistically with the technology-sharing initiative serving as a catalyst for greater adoption of PCR molecular diagnostics. Together we will build an ecosystem that promotes the development of accurate, rapid, accessible tests for underserved patient populations." said Mr. Spenlé, the COO of Springer Nature. An OIP Award ceremony was held, following the technology-sharing initiative partner roundtable to recognize the European winners. At the ceremony, eight scientists working in Europe among 17 awardees across the world were honored for their achievements. The awardees were as follows: Ulrich Eigner (Germany); Gian Maria Rossolini (Italy); Vismara Chiara Silvia (Italy); Davy Vanden Broeck (Belgium); Nicolas Yin (Belgium); Piet Cools (Belgium); Khoa Thai (Netherlands); Pedro Vieira-Baptista (Portugal). Prof. Dame Jenny Harries, Chief Executive of the UK Health Security Agency (UKHSA), attended the event as a keynote speaker. During her visit to South Korea in March this year, Prof. Harries met with Dr. Chun at Seegene's headquarters to discuss Seegene's response and achievements during the COVID-19 pandemic, as well as to exchange views on its technology-sharing initiatives and the Open Innovation Program (OIP). Companies participating in the technology-sharing initiative, such as Hy Laboratories Ltd. based in Israel and Werfen based in Spain, along with other business partners and bio-medical experts from Europe, attended the event to share the vision of the technology-sharing initiative. About Seegene Seegene has 24 years of dedicated experience in R&D, manufacturing, and business related to syndromic real-time PCR technologies. This expertise was particularly highlighted during the COVID-19 pandemic when Seegene provided over 340 million COVID-19 tests to more than 100 countries worldwide. The core feature of Seegene's syndromic real-time PCR technology is the ability to simultaneously test for 14 pathogens that cause similar symptoms in a single tube with quantitative information. Visit: Seegene.com and follow linkedin.com/company/seegene-inc [Photo 2] ▲ From Right: Dr. Jong-Yoon Chun, CEO and Founder of Seegene; Professor Dame Jenny Harries, Chief Executive of the UK Health Security Agency; Elena Bonfiglioli, Vice President of Global Business Leader Healthcare, Pharma and Life Science at Microsoft; and Marc Spenlé, COO of Springer Nature posed for a photo during Open Innovation Award ceremony in Springer Nature Campus, London, United Kingdom on October 23, 2024.
SEOUL, South Korea, Oct. 24, 2024 /PRNewswire/ -- J INTS BIO, a pioneering biopharmaceutical company, has unveiled promising interim results from the Phase 1/2 clinical trial of its novel 4th-generation EGFR Tyrosine Kinase Inhibitor (TKI), JIN-A02, aimed at EGFR-mutated non-small cell lung cancer (NSCLC) patients who developed resistance and progressive diseases despite treatments. The data was presented at this year's edition of ENA (EORTC-NCI-AACR) Symposium, held in Barcelona, Spain, from October 23-25, 2024, drawing significant attention from the global oncology community. Ethan Seah, Vice President of J INTS BIO, is giving a poster presentation on the Phase 1/2 study of its novel oral 4th generation EGFR-TKI ‘JIN-A02’ at the ENA (EORTC-NCI-AACR) Symposium. JIN-A02: A Next-Generation Therapeutic Targeting Resistance to 3rd-Generation EGFR-TKIs Mutations in the epidermal growth factor receptor (EGFR) is a key driver in the pathogenesis of NSCLC, with 3rd Generation EGFR-TKIs like osimertinib serving as the cornerstone of treatment. Unfortunately, eventually resistance to this treatment will occur, leading to cancer relapse and disease progression. JIN-A02, developed by J INTS BIO, is the 4th-generation EGFR-TKI specifically designed to address this. By targeting both the original mutations and those acquired subsequently as a result of cancer treatments, it offers a therapeutic solution for these patients. The ongoing Phase 1/2 clinical trial evaluates JIN-A02 in patients with advanced or metastatic NSCLC who have developed resistance and disease progression after 3rd-generation EGFR-TKIs use. The study consist of 3 parts: dose escalation (Part A), dose exploration (Part B), and dose expansion (Part C). The data generated so far in Part A has been encouraging with a good safety profile and early efficacy signals, underscoring JIN-A02's position as a novel treatment for EGFR-TKI-resistant NSCLC. J INTS BIO said, "New treatment are urgently needed for lung cancer patients whose disease has worsened or relapsed after treatment with 3rd-generation EGFR-TKI. JIN-A02 is potentially one such treatment option that can bring hope to patients world wide." Study Design and Interim Results: To date, the Part A of the study has enrolled 16 patients who received increasing doses of JIN-A02, starting with a low dose of 12.5mg daily to 150 mg daily, with the primary objective of determining the maximum tolerated dose (MTD). This Part also look at safety, pharmacokinetics, and anti-tumor activity as secondary objectives. Doses higher than 150mg are currently being studied in this Part. Key Interim Findings: Safety: JIN-A02 demonstrated a very favorable tolerability across all dose levels studied so far, with no dose-limiting toxicities (DLTs) observed up to 150mg daily. There has been no myelosuppression and more importantly, no adverse events commonly associated with EGFR TKI such as rash, diarrhea and cardiotoxicity and this despite tumor reduction already being observed. This is the reason higher doses are being studied. Efficacy: Tumor control were reported early in this study at lower doses. The first instance occurring at a relative low dose of 50mg. In this cohort, Partial Response of the lung lesions with stable disease in brain metastases was reported. Another Partial Response of the lung lesions was reported in the next cohort of 100mg, in a patient with similar primary EGFR mutation. These findings highlight JIN-A02's potency as a therapeutic agent, even in patients with progressive diseases and who were heavily treated prior to entering this study. Central Nervous System (CNS): Of interest is JIN-A02 activity against brain metastases, a potentially fatal complication of progressive lung disease. Reduction in the brain metastases was first reported with JIN-A02 in the 100mg Cohort, although stable disease was reported in the 50mg Cohort. These results points to JIN-A02 not only penetrating the tough Blood-Brain Barrier, but also exerting its anti-tumor effects. Progression to Subsequent Trial Phases: Once we have the final doses to be used in Phase 2, the dose-expansion part of the study (Part B) will begin, and two doses will be selected and studied in bigger groups of patient to verify its safety, pharmacokinetics, and anti-tumor activity. Part B is essential for the selection of the final dose level to be used in Phase 2 or Part C of this study. In this final part (Part C), we will investigate JIN-A02 in specific patient populations who are stratified by EGFR mutation subtypes and the presence of CNS metastases. Part C is critical for generating a bigger dataset on the drug's therapeutic potential across distinct NSCLC patient groups for regulatory approval purposes. Implications for Future Therapeutic Development Professor Byeong Cheol Cho of Severance Hospital's Division of Medical Oncology, South Korea, commented on the significance of these findings, stating, "JIN-A02's demonstrated efficacy against both lung and its associated CNS disease underscores its potential as a groundbreaking treatment for patients with EGFR-TKI-resistant NSCLC, including and especially those with brain metastases." JIN-A02's ability to effectively target CNS lesions represents a notable advancement and as a 4th generation EGFR-TKI, offers hope for patients with very limited options as a result of progression after 3rd-generation TKIs use. Next Steps in Clinical Development: J INTS BIO is fully committed to accelerating the clinical development of JIN-A02. And as the clinical study continues to enroll patients ahead of schedule, JIN-A02, is poised to shape the treatment landscape of NSCLC and to offer hope to lung cancer patients worldwide.
SEOUL, South Korea, Oct. 24, 2024 /PRNewswire/ -- J INTS BIO, a leader in oncology drug development, has revealed interim preclinical results of its second-generation synthetic HSP90 inhibitor, JIN-001, at the ENA (EORTC-NCI-AACR) Symposium held in Barcelona, Spain, from October 23-25, 2024. The findings demonstrate JIN-001's potential as a new therapeutic option for cancer patients who have developed drug resistance after treatment, representing a significant advancement in addressing this critical challenge. Ethan Seah, Vice President of J INTS BIO, is giving a poster presentation on the preclinical study of its novel oral 2nd generation HSP90 (heat shock protein 90) inhibitor ‘JIN-001’ at the ENA (EORTC-NCI-AACR) Symposium. JIN-001: A Novel Approach to Overcoming Chemotherapy Resistance in Ovarian Cancer Ovarian cancer remains one of the most aggressive and lethal gynecological malignancies, with approximately 70% of patients diagnosed at an advanced stage. While many patients initially respond to standard chemotherapy, drug resistance eventually develops, leading to disease progression and cancer relapse. JIN-001 was designed to address this issue and by targeting heat shock protein 90 (HSP90), a molecular chaperone that plays a crucial role in enabling cancer cells to adapt to therapeutic stress and survive. By inhibiting HSP90, JIN-001 disrupts the ability of cancer cell to evolve and acquire resistance to the chemotherapy, thereby maintaining the effectiveness of existing standard treatment options. The preclinical studies presented at the symposium specifically explored the drug's efficacy when used in combination with established chemotherapeutic agents, offering new hope for patients with drug-resistant cancer. A New Therapeutic Hope for Cancer Patients The preclinical study was designed to evaluate the efficacy of JIN-001 in ovarian cancer cell lines, including those resistant to common chemotherapies such as paclitaxel and cisplatin. Researchers treated both normal ovarian cancer cell lines and chemo resistant strains with various concentrations of JIN-001, either alone or in combination with paclitaxel (PTX) or cisplatin (Cis). Study Highlights: Cell Lines Tested: Ovarian cancer cell lines (OV90, TOV21G, OVCAR3) and chemo resistant cell lines (OV90/PTX200, TOV21G/PTX100, OVCAR3-CisR) were used to assess the drug's efficacy. Methods: The researchers measured cell viability, comparing outcomes between monotherapy with JIN-001 and combination therapy with standard chemotherapy agents. JIN-001: A Game-Changer in the Treatment of Cancer Combination Therapy with Chemotherapeutics: The most notable results emerged when JIN-001 was combined with conventional chemotherapy agents. When JIN-001 was used alongside paclitaxel, the IC50 value of paclitaxel in the resistant OV90/PTX200 cell line decreased from 0.204 μM to 0.043 μM, demonstrating a substantial improvement in therapeutic efficacy. Similarly, in the cisplatin-resistant OVCAR3-CisR cell line, the combination of JIN-001 with cisplatin reduced the IC50 of cisplatin from 9.643 μM to 0.142 μM. JIN-001: A Breakthrough for Treatment-Resistant Ovarian Cancer The interim results strongly suggest that JIN-001 has the potential to serve as a breakthrough companion therapy for patients with ovarian cancer. By inhibiting HSP90, JIN-001 enhances the efficacy of existing chemotherapies by limiting the adaptability and heterogeneity of cancer, thereby removing their ability to overcome the therapies. "The synergy observed between JIN-001 and standard chemotherapy agents is extremely promising. It represents a new treatment paradigm for cancer patients," commented the J INTS BIO research team. "We are committed to further clinical development of JIN-001 to validate its efficacy and safety, and we believe this drug could offer a transformative option in limiting chemotherapy resistance." JIN-001: Leading the Way in Innovative Cancer Therapies JIN-001 has shown considerable promise as a novel therapeutic agent, particularly for chemotherapy resistance. J INTS BIO is committed to accelerating the clinical development of JIN-001, with plans to advance its use not only in ovarian cancer but also in other cancers, such as glioblastoma. Collaborative research with MD Anderson Cancer Center on JIN-001's potential in glioblastoma has already yielded positive preclinical results, with a Phase 1 trial anticipated in 2025.
Designed to make next-generation sequencing accessible to more labs With room-temperature kit storage and shipping, Illumina's newest sequencers remove barriers to enable more insights and discoveries SAN DIEGO, Oct. 24, 2024 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today unveiled its MiSeq™ i100 Series of sequencing systems, delivering unparalleled benchtop speed and simplicity to advance next-generation sequencing (NGS) for labs. The two new benchtop instruments, MiSeq i100 and MiSeq i100 Plus Systems, will empower customers to unlock powerful insights through an affordable, comprehensive solution that is simple to understand and use, even for those with limited NGS expertise. Room-temperature storage and shipping enable labs to sequence on demand, with no delays for thaw time, and same-day sample-to-analysis. "Our customers told us they need a faster, smaller, and easy-to-use instrument, and that's what we're delivering with the MiSeq i100," said Jacob Thaysen, PhD, CEO of Illumina. "Whether you are an established next-generation sequencing lab, or looking to start sequencing for the first time, our latest benchtop instrument adds the plug-and-play flexibility that today's labs are seeking." The MiSeq i100 Series builds on the legacy of the original benchtop MiSeq System, which Illumina customers have used since 2011 to power a host of genomic discoveries. Completely redesigned and incorporating the groundbreaking technology and chemistry of the NovaSeq™ X Series, the MiSeq i100 will help to fuel the next era of genomics growth and discovery. Key technology enhancements The MiSeq i100 Series brings Illumina's powerful XLEAP-SBS™ chemistry innovation even further—for the first time, harnessing the potential of room-temperature storage and shipping, which provides customers greater flexibility in how they plan and execute their projects while reducing their environmental impact. It offers flexible output capabilities and comes in two configurations: the MiSeq i100 Plus System has the full 100 million single-end reads per run, and the MiSeq i100 System has a maximum of 25 million single-end reads per run. Key features include: Room-temperature shipping and storage for reagents: Eliminating the cold chain and allowing for greater flexibility to sequence on demand without the need to thaw reagents, which is critical for running urgent samples Sustainability: An 85% reduction in packaging waste compared to the MiSeq System supports a lower carbon footprint Speed: Dramatic reduction in run times: as fast as four hours, with same-day results (4× faster than MiSeq) Cost efficiency: Cost-effective consumables enable more affordable sequencing Turnkey workflows: 18 proven end-to-end workflows across 10 applications Simplicity: Simpler, streamlined operations for various levels of sequencing experience Push-button workflows on MiSeq i100 are available for small whole-genome sequencing for microbiology and targeted NGS panels for both infectious disease and oncology. Workflows provide metrics either directly on the instrument or via cloud-based DRAGEN™ genomic data analysis, minimizing the need for bioinformatics expertise. "The MiSeq i100 symbolizes Illumina's commitment to delivering total systems with complete workflows that allow our customers to accomplish more," said Steve Barnard, PhD, chief technology officer of Illumina. "With its enhanced speed, simplicity, scalability, and quality–and its intuitive user experience–the MiSeq i100 sets a new standard for benchtop sequencing." Customer reactions Illumina conducted early access testing of MiSeq i100 with customers around the world. Geneviève DonPierre, team leader of NGS Sequencing at Génome Québec, shared her lab's experience with the instrument, noting that most of the sequencing operations at the Center of Expertise and Services of Génome Québec are conducted on the NovaSeq X Plus. "With this new instrument, we are able to provide answers quickly for small projects or for researchers who need fast answers to determine whether or not they should pursue their project." Génome Québec is a nonprofit organization that provides genomic services for researchers in the academic and industrial fields of 45 countries. DonPierre noted the importance of room temperature storage for her lab: "It really helps the planning for the sequencing run. We don't have to think two days before to get a kit out of the freezer. So it really is a game changer to have kits stored at room temperature." Tim Roloff Handschin, PhD, co-leader of Microbial Genomics (NGS) at the Institute for Medical Microbiology at the University of Zurich, and his team conduct research on developing new diagnostic tests, antimicrobial resistance and antimicrobial drugs. In his lab's experience with MiSeq i100, the ease of use and being able to achieve a turnaround time from bacterial culture to results within 24 hours will be transformative. "We can start two runs on the same day and thereby increase our sample flow massively. And given that the reagents are shipped at room temperature, we don't need to wait for the cartridges to thaw," Roloff said. "We can just launch a run whenever we're ready with a new pool and there is no planning needed upfront. This gives us great flexibility, and this can provide new possibilities to develop new tests." The new instrument was unveiled during a virtual customer event; a replay may be viewed here. The MiSeq i100 will be available to ship globally in 2025. For more information, visit the website. Use of forward-looking statements This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services; (ii) our ability to manufacture robust instrumentation and consumables; (iii) customer uptake of, and satisfaction with new products and services; and (iv) the speed and scale of new product adoption by customers, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.
HMI-115 has demonstrated statistically significant improvement in endometriosis pain The mean dysmenorrhea pain score was reduced by 42% The mean non-menstrual pelvic pain score was reduced by 50% Most of the patients reported normal menstrual periods No typical peri-menopausal symptoms were reported There were no significant changes in bone mineral density or key sex hormone levels About 190 million women worldwide suffer from endometriosis, making up a market size of $200 billion SHANGHAI, Oct. 24, 2024 /PRNewswire/ -- Hope Medicine Inc. ('HopeMed'), a clinical-stage innovative biopharmaceutical company, announced positive results from an interim analysis of a global Phase 2 study, " A Randomized, Multicenter, Double-Blind, Placebo -Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women with Moderate to Severe Endometriosis Associated Pain Over a 12-Week Treatment Period". HMI-115 is a monoclonal antibody that blocks the prolactin receptor. It is a first-in-class treatment for endometriosis. Notably, HMI-115 has been granted Breakthrough Therapy Designation by the National Medical Products Administration ("NMPA") in China. Hope Medicine This Phase 2 study included 142 female patients with endometriosis in US, Poland and China. HMI-115 has demonstrated statistically significant improvement in endometriosis associated pain. HMI-115 was well-tolerated with no treatment-related serious adverse events. Specifically, in the first 102 patients included in the interim analysis, at the end of the study treatment, the mean dysmenorrhea pain score was reduced by 42% in the 240 mg q2w group, compared to the baseline. The mean non-menstrual pelvic pain score was reduced by 50%. These reductions were statistically significant compared to placebo. Most of the patients reported normal menstrual periods. No typical peri-menopausal symptoms were reported. There were no significant changes in bone mineral density and sex hormone levels including estradiol, LH, FSH and progesterone. "Endometriosis is a common and debilitating disease among women," said Dr. Hugh Taylor, Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology, at Yale School of Medicine, "for decades, patients and physicians have been seeking an endometriosis treatment that provides pain relief and does not alter sex-steroid hormones. HMI-115 has the potential to fulfill this unmet medical need." "The findings from this proof-of-concept study are exciting," said Dr. Jeffrey Jensen, Leon Speroff Professor of Obstetrics and Gynecology, at the School of Medicine, Oregon Health & Science University, "in contrast to existing treatments like GnRH blockers, HMI-115 does not disrupt the normal menstrual cycle and maintains physiologic levels of sex hormones to prevent menopausal symptoms and bone loss. Unlike hormonal therapies, the approach is not contraceptive and could offer particular benefit to women with endometriosis seeking pregnancy. I was very impressed to see a significant impact on both menstrual and non-menstrual pain." "HMI-115 is first-in-class," said Professor Rui-Ping Xiao, founder of Hope Medicine, "this study is the first ever to show that prolactin receptor blockade can treat patients suffering from endometriosis. For the last 40 years people have been calling for a new target that provides pain relief while bypassing sex hormones, we are answering that call." "We are very encouraged by the success of this proof-of-concept trial," said Nathan Chen, CEO of Hope Medicine," in the coming months, we plan to hold End-of-Phase 2 meetings with FDA, NMPA, and other key regulatory authorities to determine next steps for the development of HMI-115. We plan to move quickly towards global Phase 3 trials, so that patients can begin to benefit from HMI-115 as soon as possible. We are dedicated to improving women's health worldwide." About Endometriosis About 190 million women worldwide suffer from endometriosis, making up a global market size of approximately $200 billion dollars. Endometriosis affects about 10% women of childbearing age. Endometriosis is a common gynecological disease characterized by the implantation of endometrial cells in locations outside the endometrium, typically presenting as chronic inflammations. The endometrium is a mucosal layer within the uterine cavity that undergoes hormone dependent changes during the menstrual cycle. Endometriosis symptoms include lower abdominal and pelvic pain, dysmenorrhea, painful intercourse, and infertility. About half of the infertilities in women are associated with endometriosis. Endometriosis negatively impacts patients' quality of life and sex, psychology, and social behavior. About Hope Medicine Hope Medicine Inc. is a science-driven clinical-stage biopharmaceutical company with research laboratories and offices in Beijing, Shanghai, and Nanjing, China. HopeMed is established on the in-depth expertise in translational medicine and decades of research of Professor Rui-Ping Xiao's laboratory at the Institute of Molecular Medicine of Peking University. Based on excellent scientific research and to improve the quality of life, HopeMed is committed to the research, development, and commercialization of first-in-class medicines for common and major diseases that threaten human health. CONTACT: amber.chen@hopemedinc.com
Two new studies show Lunit INSIGHT MMG cuts radiologist workload by 50% in a double reading environment while maintaining or improving screening quality, and predicts cancer risk up to six years in advance SEOUL, South Korea, Oct. 23, 2024 /PRNewswire/ -- Amid rising demands and a global shortage of radiologists, Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced pivotal findings from two large-scale studies evaluating its AI-powered mammography solution, Lunit INSIGHT MMG. The studies conducted by researchers at the Cancer Registry of Norway and Odense University Hospital in Denmark demonstrate the technology's potential to significantly improve breast cancer screening programs. Lunit INSIGHT MMG, Lunit's AI-powered mammography analysis solution, showcased its ability to predict breast cancer risk and assist in streamlining radiologist workflows. The Norwegian study, published in JAMA Network Open, led by Professor Solveig Hofvind, evaluated how Lunit INSIGHT MMG could estimate the development of future cancer. The research analyzed data from 116,495 women aged 50-69 who underwent at least three consecutive biennial screening rounds at 9 breast centers in Norway. The research found that Lunit INSIGHT MMG can estimate future breast cancer risk up to 4 to 6 years before it becomes detectable. Lunit's AI assigns each breast a score from 0 to 100, with higher values indicating a greater likelihood of cancer being present on the current mammogram. The study found that the mean AI scores were consistently higher for breasts that developed cancer compared to those that remained cancer-free, even 4 to 6 years before detection. Over multiple screening rounds, the gap in these AI scores between breasts that developed cancer and those that did not grew larger, indicating the AI's ability to detect subtle signs of cancer earlier. Specifically, for women who developed screen-detected cancer, the mean absolute differences in AI scores between the two breasts were 21.3 in the first study round, 30.7 in the second, and 79.0 in the third. Additionally, Lunit's AI achieved an Area Under the Curve (AUC) for the absolute difference of 0.63, 0.72, and 0.96 across the three screening rounds for screen-detected cancer. These findings indicate that Lunit's AI can effectively identify early signs of cancer and offer a pathway for personalized screening approaches. The double reading of mammograms, though the standard of care in Denmark and other European regions, is resource-intensive and demands significant radiologist time. The Danish study, led by Dr. Mohammad T. Elhakim and published in Radiology: Artificial Intelligence, explored how Lunit INSIGHT MMG could enhance double reading without compromising screening performance. The research team evaluated three AI-integrated screening scenarios on 249,402 mammograms, demonstrating significant reductions in radiologist workload while either maintaining or improving accuracy (Scenario 1: AI replaced first reader; Scenario 2: AI replaced second reader; Scenario 3: AI replaced both for triaging of low and high-risk cases). Results showed that replacing the first, second, or both radiologists with Lunit's AI could reduce reading volume by 48.8%, 48.7%, and 49.7%, respectively, while maintaining or improving cancer detection accuracy. Most notably, the AI triage scenario (Scenario 3) achieved higher sensitivity, positive and negative predictive values with a lower arbitration rate when compared to standard double reading. This result highlights that by utilizing Lunit INSIGHT MMG, healthcare systems can significantly reduce radiologists' burden without compromising the screening program's diagnostic performance quality, allowing them to focus on more complex cases and improving overall efficiency. "These studies provide compelling evidence of our AI's potential to transform breast cancer screening," said Brandon Suh, CEO of Lunit. "In Norway, our AI identified future breast cancer risk up to 6 years ahead, providing women and healthcare providers valuable time for proactive interventions. The Danish study showed a 50% reduction in radiologist workload without sacrificing detection quality—a result that directly impacts radiology efficiency worldwide. These are not hypothetical improvements; they represent concrete benefits that healthcare providers and patients are experiencing today. Our focus is on ensuring these advancements translate directly to better outcomes for women undergoing breast cancer screening." About Lunit Founded in 2013, Lunit (KRX:328130.KQ) is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,500 hospitals and medical institutions across 50+ countries. Our clinical studies have been published in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as the ASCO and RSNA. In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies. Headquartered in Seoul, South Korea, with a network of offices worldwide, Lunit leads the global fight against cancer. Discover more at lunit.io.
Biotechnology
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