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.
Synchronizing sales and marketing improves outcomes, yet 65% of field engagements are not SINGAPORE, Dec. 5, 2024 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today released its latest Veeva Pulse Field Trends Report, showing connected sales and marketing engagement helps biopharmas balance healthcare professionals' (HCP) need for deep scientific information on complex medicines as they become more time constrained. Data reveals synchronizing in-person engagements with promotional touchpoints improves education and increases treatment adoption. While HCPs have expectations that companies provide deeper scientific information and more engagement, they are more time-constrained than ever. Even for biopharmas with access, in-person meetings are down 7% per HCP since last year. Coordinating sales and marketing activities can help offset limited in-person meetings, but the majority (65%) of HCP engagements remain unsynchronized, slowing treatment adoption. "Physicians have limited time and don't need repetitive information. The transfer must be efficient, with scientifically trusted information through the right channel. Every interaction should inform the next communication," said Dr. Vital Hevia, urologist and robotic surgeon at ROC Clinic and HM Hospitals. New data from Veeva Pulse shows: 65% of HCP engagements are not synchronized Disconnected sales and marketing activities don't optimize limited HCP time: Today, 65% of HCP engagements are not synchronized. Amidst decreasing time and attention from HCPs, sales and marketing cannot coordinate effective HCP conversations without a connected view. Synchronized in-person and promotional touchpoints improve outcomes: Within 10 days, a rep meeting followed by a digital exposure is 30% more likely to result in a prescription, and HCPs exposed to digital ads after a speaker program are 25% more likely to prescribe. HCPs who also visit a brand website following a rep visit are 60% more likely to prescribe. An omnichannel commercial model meets HCP needs: Companies connecting data, systems, and KPIs can drive more effective scientific understanding. This coordination better meets HCPs' need for in-depth information in the face of growing therapeutic complexity. "In Asia, HCP engagement efforts are still not fully integrated, and challenges remain in aligning sales and marketing functions. It is also a highly diverse region with distinct markets, each presenting unique challenges and opportunities. Leveraging connected tools and advanced data analytics will help biopharmas streamline and enhance their coordination and engagement with HCPs in this complex landscape," said Shafi Hussain, vice president, business consulting lead, APAC, Veeva. About the Veeva Pulse Field Trends Report Analyzing over 600 million HCP interactions and activities annually from more than 80% of commercial biopharma field teams worldwide, the Veeva Pulse Field Trends Report is the largest industry benchmark of its kind on HCP engagement. The analysis compiles real-time transactional data recorded in Veeva CRM and Veeva data products to deliver a view of engagement activity across life sciences. Indexed by Veeva quarterly, the data will help companies effectively and accurately benchmark performance to set the right, actionable goals for continued growth and impact. Additional Information For more on the Veeva Pulse Field Trends Report, visit: veeva.com/FieldTrendsLearn more about Veeva Business Consulting: veeva.com/BusinessConsultingConnect with Veeva on LinkedIn: linkedin.com/company/veeva-systems About Veeva Systems Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world's largest biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com. Veeva Forward-Looking Statements This release contains forward-looking statements regarding Veeva's products and services and the expected results or benefits from use of our products and services. These statements are based on our current expectations. Actual results could differ materially from those provided in this release and we have no obligation to update such statements. There are numerous risks that have the potential to negatively impact our results, including the risks and uncertainties disclosed in our filing on Form 10-Q for the period ended July 31, 2024, which you can find here (a summary of risks which may impact our business can be found on pages 36 and 37), and in our subsequent SEC filings, which you can access at sec.gov.
Establishing sepsis diagnostic InfectID™ as the new standard of care BRISBANE, Australia, Dec. 5, 2024 /PRNewswire/ -- Microbio Ltd, the Australian pathogen diagnostics company specialising in innovative molecular diagnostic solutions, has today announced the appointment of Paul Perreault as a strategic advisor. Mr Perreault is the former CEO of CSL and considered a pre-eminent global biotech leader. He was Chief Executive Officer and Managing Director of CSL Limited from 2013 to 2023, leading the organisation to become the fifth largest biotechnology company in the world bringing lifesaving medicines to people in more than 100 countries. Microbio is commercialising InfectID™ BSI (Bloodstream Infection) as the new gold standard in the diagnosis of sepsis. InfectID™-BSI is currently CE-marked cleared for sale in Europe, United Kingdom, and India, with an advanced regulatory program underway for FDA and TGA approval pathing the way for a global market expansion in the coming years. The InfectID™-BSI diagnostic test delivers actionable intelligence to clinicians, enabling them to deliver targeted antimicrobial treatment – improving patient outcomes and reducing the emergence of antimicrobial resistant organisms. The assay detects 26 pathogens associated with more than 94% of sepsis cases in less than 3 hours. Sepsis is a life-threatening condition caused by the body's reaction to a bloodstream infection. The only effective treatment is the prompt administration of antimicrobials to eliminate the pathogen causing the infection. For every hour of delay in administering appropriate antimicrobial treatment, mortality rates increase by 7.6%1, underscoring the urgent need for rapid diagnosis. The current 'gold standard' method involves a slow, multi-step blood culturing and identification process. This approach takes 11 hours-21 hours for bacterial species and 48 hours for Candida species and has limited sensitivity. Microbio's InfectID™ is therefore considered a game changer in improving patient outcomes of sepsis through earlier detection. This latest appointment bolsters Microbio's executive team and advisors in supporting the rapid commercialisation and expanded market access for InfectID™. With over 40 years' experience in the global healthcare industry, Mr Perreault has held senior leadership roles with CSL, Wyeth, Centeon, Aventis Bioservices and Aventis Behring. He previously served on the board of directors for the Pharmaceutical Research and Manufacturers of America (PhRMA), Wall Street Journal's CEO Council, Penn State Provost's Global Advisory Council, and the Global Board for the Plasma Protein Therapeutics Association. Commenting on his appointment Mr Perreault said: "Microbio is an exciting biotechnology company on the cusp of positively disrupting the devastating impact of sepsis on patients with a diagnostic test that can more rapidly detect the majority of pathogens responsible for sepsis, which supports much earlier clinical intervention and treatment to ultimately safe lives and improve patient outcomes. I'm pleased to be working with a company at the forefront of innovation in this critical area of healthcare." Microbio's Chief Executive Offer Mr Colin Keating said: "We have a growing number of clinical, and key opinion leaders working with us to bring InfectID™ to market as our clinical data continues to support the profound benefits of our diagnostic of sepsis. We welcome Paul to our advisory board and the opportunity to draw upon his exceptional leadership and capabilities in supporting our ongoing global expansion." [End] Further information https://microbio.com.au/
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).
PRINCETON, N.J., SHANGHAI and SUZHOU, China, Dec. 4, 2024 /PRNewswire/ -- Duality Biologics ("DualityBio"), a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (ADC) therapeutics, today announced that it has entered into an exclusive option agreement with GSK for a potentially best-in-class ADC candidate, DB-1324. Under the agreement, DualityBio will grant GSK an exclusive option to obtain a license to develop and commercialize DB-1324 worldwide (excluding mainland China, Hong Kong, and Macau) (the "Option"). DB-1324 is an ADC candidate built with DualityBio's proprietary and clinically validated Duality Immune Toxin Antibody Conjugate (DITAC) platform. The molecule, currently in preclinical development, leverages DualityBio's DITAC platform against a gastrointestinal (GI) cancer target. There is high unmet medical need for patients with GI cancer as it represents 35% of all cancer-related deaths and approximately 26% of the global cancer incidence.[1] This ADC molecule has the potential to unlock multiple combination therapy opportunities to strategically complement GSK's oncology portfolio. Under the terms of the agreement, GSK will pay $30 million upfront and additional pre-option milestone payments to obtain an exclusive option for exclusive worldwide rights for DualityBio's ADC (excluding China's mainland, Hong Kong, and Macau). Upon GSK exercising the Option, DualityBio will receive an option exercise fee as well as potential development, regulatory and commercial milestone payments totalling up to $975 million. Upon commercialisation, GSK will pay tiered royalties on DB-1324's global net sales outside mainland China, Hong Kong, and Macau. GSK will receive royalties on net sales in mainland China, Hong Kong and Macau. Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: "GSK has built a portfolio of novel antibody-drug conjugates underpinned by our deep expertise in tumour cell-targeting mechanisms. Given the unique ability of ADCs to address certain targets on tumour cells while sparing healthy ones, we are confident in our strategic focus on this modality as it could advance new therapeutic treatments for the most challenging tumour types." John Zhu, Chief Executive Officer of Duality Biologics, said: "DualityBio is dedicated to becoming a leading global next-generation ADC company. We are very glad to have entered into this agreement with GSK. Through this collaboration, we will work together to advance our innovative ADC program in gastrointestinal cancer to address unmet medical needs. DualityBio's unique and validated ADC technology platform can continue to empower more partners around the world and provide innovative treatment options for global patients." About Duality Biologics Duality Biologics ("DualityBio") is a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (ADC) therapeutics to treat cancer, autoimmune diseases, and beyond. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Based on deep understanding of diseases, DualityBio has built a robust pipeline of ADCs, including several candidates in clinical stage. DualityBio has multiple ongoing global multi-regional clinical trials (MRCTs) across 17 countries with over 1,000 patients enrolled. In addition, DualityBio is leveraging its novel protein engineering and unique ADC technologies to develop the next generation of "Super ADCs", such as bispecific ADCs, ADCs with novel MOA payload and antibody-immune modulator-conjugates. DualityBio Enquiries Media/Investor Relations: IR@dualitybiologics.com References [1] Arnold M, Abnet CC, Neale RE, Vignat J, Giovannucci EL, McGlynn KA, et al.Global burden of 5 major types of gastrointestinal cancer. Gastroenterology, 159(1):335–349.e15.
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