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SHANGHAI, Dec. 9, 2024 /PRNewswire/ -- December 8, 2024, Abbisko Therapeutics (HKEX: 02256) announced the presentation of preliminary Phase 2 study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) who have either progressed or not responded to one or more prior lines of therapy. The presentation took place at the 66th ASH Annual Conference, held December 7-10, 2024, in San Diego, California. Despite most enrolled patients having not yet completed the 6-month treatment cycle required for cGvHD response evaluation, preliminary data from the subset of patients receiving 20mg QD shows that pimicotinib achieved an ORR of 64%. Prof. Xiaodong Mo, Chief Physician of the Department of Hematology, Peking University People's Hospital, reporting on the scene As of November 22, 2024, a preliminary 64% ORR was observed in the subset of patients receiving pimicotinib 20mg QD, with responses observed in all affected organs, including the gastrointestinal tract, oral cavity, eyes, liver, joints and fascia, esophagus, skin, and lungs. In many patients with cGvHD, pulmonary manifestations, such as shortness of breath and diminished lung function, can occur and finally be diagnosed as cGvHD-associated BOS (Bronchiolitis Obliterans Syndrome), which is one of the major challenges in the treatment of cGvHD urgently requiring new therapies. During the oral presentation, researchers highlighted specific lung response results in six subjects at the latest data cut-off: one subject achieved an 11% increase in FEV1 (forced expiratory volume in the first second), one subject's FEV1 recovered to more than 75% after treatment thereby returning to normal levels, and the remaining four subjects saw improvements in the NIH Lung score with significant improvements in shortness of breath. Together, data demonstrate the clinical efficacy of pimicotinib for the treatment of cGvHD-associated BOS. As of the November 22, 2024 data cut-off, the majority of enrolled patients have not yet completed the 6-month treatment cycle to determine the primary endpoint of the study, suggesting the possibility of improved outcomes with longer-term treatment with pimicotinib. The results show that pimicotinib demonstrated robust clinical efficacy and is well tolerated in heavily pre-treated patients with cGvHD. Rapid and durable responses were observed across both inflammation-dominated and fibrosis-dominated organs, accompanied by patient-reported reductions in organ-specific symptom burden. The majority of adverse events were Grade 1 and reversible. Based on latest clinical experience, pimicotinib represents a potentially promising and novel therapeutic option for the management of cGvHD. About Pimicotinib (ABSK021) Pimicotinib (ABSK021), which is being independently developed by Abbisko Therapeutics, is a novel, orally administered, highly selective, and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designations (BTD) by China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) and priority medicine (PRIME) designation from the European Medicines Agency (EMA) for the treatment of patients with TGCT that are not amenable to surgery. Pimicotinib is also currently being evaluated for the treatment of patients with chronic Graft-versus-Host Disease. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit www.abbisko.com for more information.
Lunit and Volpara revealed a unified Ecosystem at RSNA 2024, featuring AI-powered cancer risk prediction, autonomous report generation, and innovations to transform global cancer care SEOUL, South Korea, Dec. 5, 2024 /PRNewswire/ -- At this year's RSNA 2024 Annual Meeting, Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, and Volpara Health, a Lunit company and a global leader in mammography AI for the early detection of cancer, announced their unified vision, focusing on a comprehensive Ecosystem for early cancer detection, cancer risk prediction, and autonomous AI for enhanced clinical workflows. A Lunit representative demonstrates the Autonomous Chest X-Ray Report Generation prototype to booth visitors at RSNA 2024, showcasing how AI-driven automation is transforming diagnostic workflows. (Courtesy of Lunit) Lunit Booth at RSNA 2024 A Growing Ecosystem for Cancer Detection and Care At the core of Lunit and Volpara's unified strategy is a comprehensive Ecosystem designed to support clinicians and improve patient outcomes across the entire cancer journey. The Ecosystem delivers actionable insights that enhance care quality and efficiency by integrating AI-driven technologies for lesion detection, workflow optimization, and patient engagement, with decision-making insight through risk prediction and mammography quality control. Powered by world-class AI, including physics-based algorithms and access to over 130 million images for research and development, the Ecosystem drives accurate, efficient, and scalable solutions for cancer detection. Focusing on customer obsession, the Ecosystem also provides dedicated support, professional services, and fosters an exclusive online community to ensure clinical success and operational excellence. Additionally, future multipliers like autonomous AI, intelligent report generation, and image-based risk evaluation are set to redefine the standards of cancer care globally. Lunit INSIGHT Risk and Volpara Risk Pathways: Transforming Risk Assessment As part of their collaboration, Lunit and Volpara presented a powerful combination of Lunit INSIGHT Risk and Volpara Risk Pathways, offering a comprehensive approach to breast cancer risk management. Lunit INSIGHT Risk uses AI-driven imaging data to predict breast cancer risk within 1-5 years, providing actionable insights based on mammography images. Volpara Risk Pathways incorporates clinical and lifestyle data to deliver broader, personalized risk assessments. Together, these solutions enable clinicians to create tailored care plans, enhance early detection strategies, and ensure equitable care for diverse patient populations. Expanding AI Innovation: Autonomous Chest X-Ray Report Generation At RSNA 2024, Lunit also introduced its Autonomous AI Chest X-ray Report Generation prototype, showcasing its potential to revolutionize diagnostic workflows. Using advanced foundation models, the system automates chest X-ray interpretations and generates structured reports. By analyzing and categorizing findings based on severity, measurement, and location, the tool ensures precision and standardization in reporting. This innovation significantly reduces radiologist workloads, especially in high-volume clinical environments, while improving diagnostic efficiency. By automating time-consuming processes, it enables radiologists to focus on complex and critical cases, ensuring timely and accurate patient care. As an additional feature, the tool includes voice recognition capabilities, allowing radiologists to make edits and finalize reports seamlessly, further enhancing workflow flexibility and usability. Driving Global Market Expansion The collaboration between Lunit and Volpara underscores their shared commitment to conquering cancer together and leading the global fight against cancer. Together, they aim to expand their presence in key markets by leveraging the Ecosystem, advanced AI solutions like Lunit INSIGHT Risk, and innovative tools such as autonomous report generation. "This year's RSNA marks an important milestone in our collaboration with Volpara," said Brandon Suh, CEO of Lunit. "By integrating our complementary technologies, we are transforming the way clinicians detect cancer, predict risk, and manage workflows. This Ecosystem is more than a set of tools. It's a global solution designed to empower healthcare providers, reduce disparities, and ultimately save more lives; the next frontier in cancer care." "Our partnership with Lunit has allowed us to combine decades of expertise in AI and personalized care to create a truly unified Ecosystem," said Teri Thomas, CEO of Volpara Health and CBO of Lunit Cancer Screening Group. "Together, as part of the same family, we're addressing some of the most pressing challenges in cancer care—from empowering clinicians with actionable insights to improving outcomes for patients around the world. We're proud to showcase the tangible impact of this integration, which is already shaping the future of global cancer detection and care." 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. The FDA-cleared Lunit INSIGHT suite for cancer screening serves over 4,500 hospitals and medical institutions across 55+ countries. Lunit 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 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. About Volpara Health Volpara Health is on a mission to save families from cancer with AI-powered software that helps healthcare providers better understand cancer risk, guide personalized care decisions, and recommend additional imaging and interventions. Used in over 3,500 facilities by more than 9,500 technologists worldwide. Volpara's software impacts nearly 18M patients, supports over 3.6M annual cancer risk assessments, and integrates seamlessly with electronic health records and imaging systems. Volpara helps radiologists quantify dense breast tissue with precision and technologists produce mammograms with optimal positioning, compression, and dose. Volpara software also streamlines operations to ease compliance and accreditation. Volpara, a Lunit company, is headquartered in Wellington, New Zealand, and has an office in Seattle. Volpara is the trusted partner of leading healthcare institutions globally. For more information, visit www.volparahealth.com.
MELBOURNE, Australia, Dec. 5, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: "CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, has successfully completed its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU). Key Highlights The trial met its primary objective, with CYP-006TK found to be safe and well-tolerated – no participants withdrew from the trial due to adverse events, and no suspected serious adverse reactions were reported. Importantly, the trial also generated positive efficacy data, indicating improved wound healing for CYP-006TK compared to the standard of care control group. The mean[1] change from baseline in wound surface area was: After 12 weeks, a decrease (improvement) of 181 mm2 in the CYP-006TK group, and an increase (deterioration) of 355 mm2 in the standard of care control group. After 24 weeks (end of study), a decrease (improvement) of 261 mm2 in the CYP-006TK group, and an increase (deterioration) of 62 mm2 in the standard of care control group. The mean change from baseline in wound surface area expressed as a percentage was: After 12 weeks, a decrease (improvement) of 64.6% in the CYP-006TK group compared to a decrease of 22.0% in the standard of care control group. After 24 weeks, a decrease (improvement) of 83.6% in the CYP-006TK group compared to a decrease of 47.8% in the standard of care control group.[2] The study also indicates that larger wounds in particular healed to a greater extent in the CYP‑006TK group compared to the standard of care control group. Dr Jolanta Airey MD, Cynata's Chief Medical Officer said: "Diabetic foot ulcers represent a substantial unmet medical need; they are a very prevalent and challenging complication of diabetes worldwide due to high morbidity, high risks of lower extremity amputation and associated mortality. Patients have a high rate of recurrent hospitalisations with consequent cost to the healthcare system. There is a desperate need for more effective interventions to improve wound healing and thus reduce the risk of severe infection and amputation. The results from this clinical trial of Cynata's topical MSC product are very promising. If subsequent trials confirm similar effects, then we might be on the path to a therapy that promotes successful wound healing in this challenging condition. We look forward to working with Cynata to continue development of this innovative product." Dr Kilian Kelly, Cynata's Chief Executive Officer and Managing Director, said: "We are very pleased and encouraged by these results. First and foremost, the trial achieved its primary objective of safety. Furthermore, whilst the trial was not powered to show statistically significant efficacy, we believe there is a clear signal indicating improved wound healing compared to standard of care treatments in this trial. We will now turn our attention to the next steps for this exciting program, including our strategy for further clinical development, engagement with regulatory agencies (including the FDA) and engagement with potential commercial partners. Finally, today's results further exemplify the commercial attractiveness of the broader Cymerus™ platform, with the Company now having two distinct product candidates that have generated positive clinical data – CYP006-TK in DFU, and CYP-001 in graft versus host disease, which also previously demonstrated very encouraging safety and efficacy data.[3],[4] The Company eagerly awaits further results from three more clinical trials over the next ~18 months which could also further add to the commercial attractiveness of the Cymerus™ platform." About the Clinical Trial CYP-006TK is Cynata's Cymerus™ iPSC[5]-derived MSC[6] topical wound dressing product candidate, which comprises MSCs seeded onto a novel silicone dressing. Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet/lower limbs, which are also known as DFU. In addition to causing severe pain and discomfort, DFU pose a significant risk of infection, and if treatment is unsuccessful, amputation may be necessary – an outcome that occurs in ~20% of patients who develop DFU.[7] An estimated 38 million Americans have diabetes,[8] up to 34% of whom will develop DFU.[9] The annual costs to US public and private payers to treat DFU are estimated to be US$9-13 billion per year.[10] In this Phase 1 trial, which took place at a number of clinical centres around Australia, a total of 30 patients with DFU were randomised to receive either: (i) CYP 006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or (ii) standard of care treatment throughout the study. Follow-up visits in this trial continued until 24 weeks after the initiation of study treatment. At each follow-up visit, three-dimensional images of the study ulcer were taken using specialised camera equipment. Images were then analysed by a technician independent of the clinical centre and blind to treatment allocation. This facilitated calculation of the wound surface area, and consequently the change in size of the wound over time. Results of the Clinical Trial The primary objective of the trial was to assess the safety and tolerability of CYP-006TK. There were no suspected serious adverse reactions[11] reported, and no participants withdrew from the trial due to adverse events. The only adverse events considered to be at least possibly related to CYP-006TK treatment were non-serious, mild to moderate local administration site reactions, which occurred in seven participants. Change in wound surface area from baseline was assessed using the mixed-effects model for repeated measures, which is a standard statistical approach used to assess this type of outcome measure. The mean change from baseline in wound surface area expressed in terms of mm2 was: After 12 weeks, a decrease (improvement) of 181 mm2 in the CYP-006TK group, and an increase (deterioration) of 355 mm2 in the standard of care control group. After 24 weeks (end of study), a decrease (improvement) of 261 mm2 in the CYP-006TK group, and an increase (deterioration) of 62 mm2 in the standard of care control group. The mean change from baseline in wound surface area expressed as a percentage was: After 12 weeks, a decrease (improvement) of 64.6% in the CYP-006TK group compared to a decrease of 22.0% in the standard of care control group. After 24 weeks, a decrease (improvement) of 83.6% in the CYP-006TK group compared to a decrease of 47.8% in the standard of care control group.[2] Analysis of Larger Wounds (wounds measuring >200 mm2) The Company also conducted an analysis that segmented participants by wound size at baseline. This analysis indicates that CYP-006TK had a particularly pronounced benefit in larger wounds. A total of eleven participants had wounds measuring <200 mm2 at baseline (six in the CYP-006TK group; five in the control group). If wounds <200 mm2 are excluded, and the remaining larger wounds (>200 mm2) are analysed separately,[12] there are even greater differences in outcomes between groups: The mean change from baseline in wound surface area for larger wounds was: After 12 weeks, a decrease (improvement) of 262 mm2 in the CYP-006TK group, and an increase (deterioration) of 540 mm2 in the standard of care control group. After 24 weeks (end of study), a decrease (improvement) of 354 mm2 in the CYP-006TK group, and an increase of 135 mm2 in the standard of care control group. The mean change from baseline in wound surface area for larger wounds, expressed as a percentage was: After 12 weeks, a decrease (improvement) of 68.4% in the CYP-006TK group compared to an increase of 3.9% in the standard of care control group. After 24 weeks, a decrease (improvement) of 84.2% in the CYP-006TK group compared to a decrease of 32.2% in the standard of care control group. [2] This indicates that the potential wound healing benefit of CYP-006TK is even greater in larger wounds. This is especially encouraging as patients with larger wounds are more likely to experience an amputation.[13] Conclusion The trial met its primary objective of demonstrating safety and tolerability of CYP‑006TK in participants with DFU. Importantly, the trial also generated positive efficacy data, indicating improved wound healing in the CYP-006TK group compared to the standard of care control group. It is also encouraging that this study indicates that larger wounds healed to a greater extent in the CYP-006TK group compared to the standard of care control group. Continued Trading Halt The Company will remain in trading halt pending an announcement of a potential capital raising, which is expected no later than opening of trading on Friday, 6 December 2024. The Company is not aware of any reason why the halt should not continue, nor any other information necessary to inform the market about the trading halt. About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata has demonstrated positive safety and efficacy data for its Cymerus™ product candidates CYP-001 and CYP-006TK, in Phase 1 clinical trials in steroid-resistant acute graft versus host disease (GvHD), and diabetic foot ulcers (DFU), respectively. Further clinical trials are now ongoing: a Phase 2 trial of CYP-001 in GvHD under a cleared US FDA IND; a Phase 1/2 trial of CYP-001 in patients undergoing kidney transplant; and a Phase 3 trial of CYP-004 in osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus™ technology in preclinical models of numerous other diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group. [1] Mean calculated using the mixed-effects model for repeated measures; differences were not statistically significant, as expected given that the study was not powered to show efficacy. [2] For clarity, the Company confirms that the change from baseline in the control group at both 12 and 24 weeks was an increase when calculated as mean change in mm2, but a decrease when calculated as a percentage. While this may seem like a discrepancy, it is correct – it is a consequence of wound size at baseline varying between patients. For example, if there were two wounds, one measuring 100 mm2, and the second measuring 1,000 mm2 at baseline, and:- The surface area of the first wound reduced from 100 mm2 to 0 mm2 (i.e. reduction of 100 mm2 or 100%)- The surface area of the second wound increased from 1,000 mm2 to 1,500 mm2 (i.e. increase of 500 mm2 or 50%).- In this example the mean change from baseline in wound surface area is an increase of 200 mm2 (-100mm2 + 500mm2 / 2) but the mean percentage change from baseline is a decrease of 25% (-100% + 50% / 2). This demonstrates that when smaller wounds improve but larger wounds deteriorate, there can be an overall reduction in mean wound surface area when expressed as a percentage, despite the mean wound surface area increasing when expressed in mm2. [3] Bloor AJC, et al. Nat Med. 2020;26:1720–1725. [4] Kelly K, et al. Nat Med. 2024;30(6):1556-1558. [5] iPSC = induced pluripotent stem cell. [6] MSC = mesenchymal stem (or stromal) cell. [7] McDermott et al. Diabetes Care. 46:209–221 (2023). [8] American Diabetes Association: https://diabetes.org/about-diabetes/statistics/about-diabetes [9] McDermott et al. Diabetes Care. 46:209–221 (2023). [10] Raghav et al. Ther Adv Endocrinol Metab. 9(1) 29-31 (2018). [11] A suspected adverse reaction is when a causal relationship between the investigational product and an adverse event is at least a reasonable possibility. [12] Post-hoc analysis. [13] Pickwell K, et al. Diabetes Care. 2015;38(5):852-7.
HONG KONG, Dec. 4, 2024 /PRNewswire/ -- The Chinese University of Hong Kong's Faculty of Medicine (CU Medicine) has, for the first time, discovered novel microbial signatures associated with inflammation of the gastrointestinal (GI) tract and transformed such signatures into clinically applicable non-invasive tests for early diagnosis and timely intervention. This invention can effectively differentiate common chronic gut disorders and is expected to minimise the need for endoscopies. Utilising nearly 6,000 faecal samples from different regions and ethnicities, the researchers have developed the world's first ddPCR test targeting selected unique bacterial species. This novel non-invasive diagnostic test is a reliable tool to differentiate irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), and is expected to be ready for clinical use in 2027. The findings were published in Nature Medicine. CU Medicine has, for the first time, discovered novel microbial signatures associated with inflammation of the gastrointestinal tract and developed the world’s first droplet digital polymerase chain reaction (ddPCR) test targeting selected unique bacterial species. This invention can effectively differentiate common chronic gut disorders and is expected to minimise the need for endoscopies. (From left) Professor Siew Ng, Professor Francis KL Chan, Dr Zheng Jiaying and Professor Wendy Zhang. Lack of a reliable, accurate, non-invasive test for IBD diagnosis IBD, a growing GI disease in Asia, often shares similar symptoms such as recurrent abdominal pain and diarrhoea with IBS, a common functional GI disorder. Delayed IBD treatment can lead to chronic inflammation of and ulcers in the digestive tract. Severe cases may require the removal of a damaged intestine or the creation of a stoma. Professor Francis KL Chan, Choh-Ming Li Professor of Medicine and Therapeutics at CU Medicine, Director of the Centre for Gut Microbiota Research and Co-Director of Microbiota I-Center (MagIC), said: "Globally, over eight million people experience GI symptoms yearly and likely need endoscopies. Colonoscopy and histology with CT or MRI scans are commonly used for IBD diagnosis but there is not yet a reliable blood or stool test. Surging demand for colonoscopies may result in long waiting times and delayed treatment. There is an urgent need for a non-invasive, accurate diagnostic test for IBD." Discovery of microbiome biomarkers for IBD diagnosis CU Medicine researchers performed metagenomic sequencing of 5,979 faecal samples with or without IBD – ulcerative colitis or Crohn's disease – from 11 countries, featuring different ethnicities. They identified microbiota alterations in IBD and uncovered 10 unique bacteria species associated with UC and nine associated with Crohn's disease. Postdoctoral Fellow Dr Zheng Jiaying from the Department of Medicine and Therapeutics, said: "We found that IBD patients had more toxin-producing bacterial genes in the gut, such as Adherent-invasive E. coli and Proteus mirabilis, and they lacked a variety of bacterial species with anti-inflammatory functions." Assistant Professor Wendy Zhang Jingwan from the same department, added: "We constructed machine learning diagnostic models for IBD based on the novel bacterial markers and found that the models performed well in diagnosing ulcerative colitis and Crohn's disease with an area under the curve of over 0.94." Transforming bacterial markers into a rapid, effective, clinically applicable innovation for IBD diagnosis To transform findings into clinical applications, researchers developed multiplex ddPCR technology to facilitate rapid, effective IBD diagnosis. Validation in independent cohorts and a public dataset showed a sensitivity and specificity of nearly 90% for IBD diagnosis. The innovation has received the Silver medal in Geneva International Exhibition of Inventions 2024. Professor Siew Ng, Croucher Professor in Medical Sciences and Director of MagIC, said: "The incidence of IBD is rising rapidly in Asia, and it is expected that the number of patients in China will exceed 1.5 million by 2025. CU Medicine has been a pioneer in the research of IBD diagnosis, treatment and prevention. We have now developed a first-in-class, microbiome-based, next-generation diagnostic tool for chronic intestinal diseases. We are also conducting large scale transethnic, multicentre studies to further explore the potential of these biomarkers in disease monitoring, drug response prediction and patient stratification in IBD."
HONG KONG, Dec. 4, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the results from a prospective, open-label, single-arm, multi-center phase Ib/II clinical study (AK104-IIT-018) of cadonilimab (PD-1/CTLA-4 bispecific antibody) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had progressed after prior PD-(L)1 inhibitor treatment, were presented at the 2024 Asian Conference on Lung Cancer (ACLC). Professor Han Baohui from Shanghai Chest Hospital presented the initial positive results of the cadonilimab combination therapy for immune-resistant NSCLC at the conference. The treatment demonstrated a 6-month progression-free survival (PFS) rate of 56.9%, a median PFS of 6.5 months, a disease control rate (DCR) of 94.0%, and a median duration of response (DoR) of 5.0 months. Nearly all patients showed long-lasting tumor control, highlighting cadonilimab as a promising and effective second-line treatment for advanced immune-resistant NSCLC. The AK104-IIT-018 study is a prospective, open-label, single-arm, multicenter Phase Ib/II clinical trial (NCT05816499) conducted across four centers in China. The study was initated in February 2023, and this report presented the preliminary data analysis. The study enrolled patients with unresectable, incurable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC), who tested negative for driver mutations and had previously received PD-1/L1 inhibitors along with platinum-based doublet chemotherapy (either in combination or sequentially, regardless of sequence), with disease progression. Patients were treated with a combination regimen of cadonilimab (10 mg/kg every 3 weeks), anlotinib, and docetaxel (60 mg/m²). The primary endpoint of the study is the 6-month progression-free survival (PFS) rate. As of May 31, 2024, 46 patients had been enrolled in the study. Among these, 41.3% had non-squamous NSCLC and 58.7% had squamous NSCLC. Regarding PD-L1 expression, 10.9% of patients had levels <1%, 28.3% between 1-49%, and 15.2% had PD-L1 expression≥50%. Reflective of the real-world NSCLC patient population, 10.9% of patients had brain metastasis, 6.5% of the patients had liver metastasis, and 23.9% of the patients had bone metastasis. Progression-Free Survival (PFS): As of May 31, 2024, the maturity of PFS was 30.4%, with a 6-month PFS rate of 56.9% (compared to 30% for docetaxel monotherapy). The median PFS was 6.5 months (versus 4 months for docetaxel monotherapy). Tumor Response: Out of 33 patients, 10 achieved partial response (PR), and 21 had stable disease (SD). The overall objective response rate (ORR) was 30.3%, which is significantly higher than the 14% ORR observed in previous studies of docetaxel alone. Among the 10 patients with partial response, the median duration of response (DoR) was 5.0 months. Disease Control Rate (DCR): The DCR reached 94.0%, with nearly all patients experiencing effective tumor control. Safety: The combination of cadonilimab, anlotinib, and docetaxel for treating advanced, driver gene-negative, immune-resistant NSCLC was well-tolerated. The adverse events were manageable and controllable, and the safety profile was favorable. For patients with advanced, driver gene-negative NSCLC who progress after first-line immunotherapy combined with chemotherapy, treatment options are limited. The standard treatment recommended by the NCCN guidelines is single-agent chemotherapy, but its efficacy is limited, with an objective response rate (ORR) of 14%–17%, a 6-month progression-free survival (PFS) rate of approximately 30%, PFS of 4.0–5.4 months, and overall survival (OS) of 10.5–12 months. The cadonilimab regimen holds potential as a new treatment option for immune-resistant NSCLC. Cadonilimab is a bispecific antibody that targets both PD-1 and CTLA-4, and is independently developed by Akeso. It is a humanized immunoglobulin G1 (IgG1) bispecific antibody (BsAb). Cadonilimab promotes "immune normalization" in the tumor microenvironment through multiple mechanisms. Its unique tetravalent symmetric structure design and Fc modifications enable enhanced accumulation in tumor tissues. As a result of this study, cadonilimab demonstrated the potential to improve the efficacy of tumor immunotherapy while reducing adverse reactions. Akeso has conducted several clinical trials to evaluate cadonilimab in the treatment of immune-resistant or poorly responsive tumors. These include the registrational phase III trial (AK109-301) of cadonilimab combined with its VEGFR-2 monoclonal antibody for advanced gastric cancer progressing after PD-1/L1 inhibitors plus chemotherapy, and the phase III trial (AK104-307) comparing cadonilimab plus chemotherapy to tislelizumab plus chemotherapy as first-line treatment for PD-L1-negative NSCLC. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin, and X (formerly Twitter).
Patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission. In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved immunological complete remission by week 24. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. SHANGHAI, Dec. 4, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK,"Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced positive results in the ongoing Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor. In an analysis of the data available as of September 13th, 2024, results from the Phase 1b/2a clinical trial showed that for patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission1 and 10 out of 11 (91%) achieved immunological complete remission (ICR)2. In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24. EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. The Phase 1b/2a clinical trial of EVER001 for the treatment of pMN is an ongoing trial conducted in China. A total of 31 patients with biopsy-proven pMN who tested positive for anti-PLA2R autoantibodies were enrolled into two cohorts. The total treatment duration was 36 weeks. Based on the patient data collected by September 13th, 2024, in the low-dose cohort, the geometric least squares mean 24-hour proteinuria decreased by 78.3% at week 36 compared to baseline, while the high-dose cohort achieved a 73.8% reduction by week 24. EVER001 treatment induced greater than 90% reductions in anti-PLA2R antibody as early as week 24 in the low-dose cohort and week 12 in the high-dose cohort. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. "We are excited to see the encouraging results in this preliminary analysis of our Phase 1b/2a clinical proof-of-concept trial of EVER001. This demonstrates the potential of EVER001 as a next-generation BTK inhibitor for the treatment of various autoimmune renal diseases, including pMN." Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said："This data release marks the first time Everest Medicines has disclosed results from its global pipeline. We look forward to completing this trial and sharing detailed data in future conferences and publications. Moving forward, we will continue to drive the global clinical development of EVER001, to meet patients' urgent clinical needs." Membranous nephropathy is a common pathological type of nephrotic syndrome in adults, and its prevalence in China has been increasing, ranking second only to IgA nephropathy3. There are about 2 million patients with pMN in China, with an estimated 80,000 to 100,000 patients in the United States, 80,000 in Europe, and 40,000 in Japan. There are no approved drugs for this indication worldwide. The current treatment goal is to improve remission rates, reduce high relapse rates, and minimize the risk of chronic toxicity caused by currently available treatments. More than one-third of pMN patients still progress to end-stage renal disease under current standards of care. This Phase 1b/2a clinical trial was approved by the Center for Drug Evaluation of the National Medical Products Administration in September 2022 to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. The previously published results of a Phase 1 study conducted in healthy Chinese and Australian subjects conducted by SinoMab BioScience indicate that EVER001 has high selectivity, excellent pharmacokinetic properties, a good safety profile, and strong target binding. About EVER001 EVER001 (previously known as XNW1011) is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. BTK is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases. Based in part on results from a completed phase 1 trial with healthy subjects conducted by SinoMab in China, EVER001 exhibited high selectivity, excellent pharmacokinetics properties, strong target binding and a safety profile that supports continued clinical development. Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases. Investor Calls Information Everest Medicines will hold investor calls on the data results from EVER001 Phase 1b/2a clinical study in primary membranous nephropathy. EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, and Everest owns the global rights to develop EVER001 for the treatment of renal diseases. The English session of the conference call will be held at 9:00 AM on Dec. 4, 2024, Beijing Time (8:00 PM U.S. Eastern Time on Dec. 3, 2024) and the Mandarin session of the conference call will be held at 10:30 AM Beijing Time on the same day (9:30 PM U.S. Eastern Time on Dec. 3, 2024). The conference calls can be accessed by the following links: For English Session:Time: 9:00 AM Beijing Time, Wednesday, Dec. 4, 2024 (8:00 PM U.S. Eastern Time on Dec. 3, 2024)Pre-Registration Link: https://www.acecamptech.com/eventDetail/60510700 Webcast Link: https://www.acecamptech.com/meeting_live/70512679/774680?event_id=60510700 Alternatively, participants may dial in to the conference call using below dial-in information: United States: +1-646-2543594 (EN)Chinese Mainland: +86-10-58084166 (EN) +86-10-58084199 (CN)Hong Kong, China: +852-30051313 (EN) +852-30051355 (CN)United Kingdom: +44-12-1368-0466 (EN)International: +1-866-6363243 (EN)Password: 842080 For Mandarin Session:Time: 10:30 AM Beijing Time, Wednesday, Dec. 4, 2024 (9:30 PM U.S. Eastern Time on Dec. 3, 2024)Webcast Link: https://s.comein.cn/n3arj55s Alternatively, participants may dial into the conference call using below dial-in information: United States: +1-646-3578788 +1-408-7093255Chinese Mainland: 400-969-8928 400-806-3263Hong Kong, China: +852-301-83602Taiwan, China: +886-226563394 +886-277417882Singapore: +65-64075649 +65-66220840United Kingdom: +44-2070970018International: +86-2362737123Password: 377570 The replay of English session will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. References: Overall clinical remission (complete remission or partial remission): 24h proteinuria complete remission (CR): 24h proteinuria < 0.3g/24 h; 24h proteinuria partial remission (PR): 24h proteinuria < 3.5g/24h, but ≥0.3g/24 h, and reduction > 50%, regardless of eGFR or the serum albumin level from baseline. Immunological complete remission (ICR): anti-PLA2R titer < 20RU/ml (negative). Expert consensus on the application of rituximab in the treatment of membranous nephropathy, Chin J Intern Med, March 2022, Vol. 61, No. 3.
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Clinical Trials/Medical Discoveries
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