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Findings are the first, peer-reviewed evidence of gene-edited microbes supplying a material proportion of corn farmers' nitrogen in commercial production BERKELEY, Calif., Nov. 14, 2024 /PRNewswire/ -- Peer-reviewed research published today in Scientific Reports describes a new technology that could revolutionize a century-old approach to providing nitrogen to crops. The study, a collaboration of researchers from the University of Wisconsin-Madison, Purdue University, and Pivot Bio, a leading sustainable agriculture company, presented first-of-its-kind evidence showing how gene-editing enhances microbes' ability to fix atmospheric nitrogen and transfer it to cereal crops. A scientist at Pivot Bio scraping corn roots to measure the colonization of Pivot Bio's nitrogen producing microbe. Using isotopically labeled nitrogen, researchers traced nitrogen in the air to chlorophyll of corn leaves, providing evidence that it was fixed from the air by the gene-edited microbes. Field studies also showed that these microbes could fix and supply nitrogen comparable to up to 40 pounds of synthetic nitrogen fertilizer with similar yields. Improving the effectiveness of nitrogen fertilizers has been a long-standing challenge. "The core issue," explains Dr. Bruno Basso, a professor of environmental science at Michigan State University, who was not involved in the study, "is that the soil-plant-atmosphere system is extremely complex." Unpredictable weather makes it difficult to match nutrient supply to plants' demand, and to determine precisely how much nitrogen a crop will require and whether the nutrient will remain in the soil. "My research lab has spent years helping farmers, using advanced sensing technology and computer models to help them better understand their fields and use nitrogen fertilizer more efficiently to increase profit and reduce environmental impact, such as nutrient losses to groundwater and greenhouse gas emissions to the atmosphere." Diazotrophs, special types of bacteria that occur in nature, have a unique ability to turn atmospheric nitrogen gas into ammonium, the building block of amino acids and proteins. This process, commonly known as biological nitrogen fixation (BNF), was the main form of nitrogen nutrition for crops for thousands of years before synthetic nitrogen fertilizer was invented. "Native soil diazotrophs lose their ability to perform BNF when exposed to high concentrations of nitrogen in the soil for extended periods of time. This is an evolutionary response to conserve energy because BNF is a very energy-intensive process," explains Dr. Jean-Michel Ané, professor of bacteriology and plant and agroecosystem sciences at the University of Wisconsin-Madison, a co-author of the study. "We need to convince these bacteria to maintain high levels of BNF in environments with lots of nitrogen, such as synthetically fertilized soils." Researchers at Pivot Bio developed gene-edited microbes using non-transgenic methods to enable diazotrophs to continue providing nitrogen to the crop even under high nitrogen conditions. "With the gene edits, we blind microbes to the presence of nitrogen in their surroundings, so they continue to fix ammonium, delivering it directly on the root system," said Dr. Karsten Temme, chief innovation officer and co-founder at Pivot Bio and a co-author of the paper. "We also introduced other edits to ensure the bacteria can transfer the fixed nitrogen to the crop instead of keeping it for itself." The paper presents evidence of this process happening in the lab and field test plots. It is also the first peer-reviewed paper covering PROVEN® 40, Pivot Bio's second-generation commercial product for corn containing gene-edited nitrogen-fixing microbes. "Nitrogen fertilizer is arguably the most significant invention of the past century and will be essential to the world's development and food security for the foreseeable future. However, we believe it can be used better," said Dr. Temme. "Pivot Bio's focus is on improving the productivity of farming by increasing the efficiency of nitrogen with our gene-edited microbes and reducing losses of synthetic fertilizer to the environment." In the field, the researchers used a variety of isotopic experiments to again demonstrate nitrogen fixation, this time under real-world conditions, and quantify the nitrogen levels in the plant. They also collected hundreds of samples from farmers who reduced nitrogen fertilizer rate by 35 to 40 pounds of nitrogen per acre, replacing it with Pivot Bio's PROVEN 40. On average, researchers found plants treated with PROVEN 40 had higher nitrogen levels early in the season and no negative impacts on yield, even though they had received less synthetic fertilizer. "It is very hard to keep track of nitrogen as it moves from the air to the microbe and then to the plant. We rely on the isotopic signatures of nitrogen atoms coming from the air versus those in the soil," Dr. Ané explains. With these measurements, researchers detected isotopically labeled nitrogen in the chlorophyll of corn leaves in the lab, a sign that microbes supplied that nitrogen to the plant. "This extensive research is promising because it means that farmers can start reducing nitrogen fertilizer without compromising productivity: a win-win for the farmer and the environment," said Dr. Temme. "This is very exciting because the technology is highly scalable. Our products have already been used on over 13 million acres in the U.S. since their commercial launch five years ago, which translates into real impact." Dr. Basso agrees. "If this technology continues to improve and deliver more nitrogen to crops, and they show this translates to reductions of environmental pollution and the overall agricultural carbon footprint, it could be a game changer for nitrogen management. The more we replace synthetic fertilizer for more efficient and sustainable sources of nitrogen to support crop yield, the better is for farmers, communities and the environment." The full paper can be found in Scientific Reports. Founded in 2011, Scientific Reports is an open-access journal from the Nature Portfolio, publishing notable original research across the natural and clinical sciences and known for its rigorous peer review process. About Pivot BioPivot Bio is a leading sustainable agriculture company delivering to farmers patented crop nutrition technologies that harness the power of nature to reliably and productively grow the food the world needs in the face of increasing volatility. Currently available in North America, and soon in Brazil, the company's products are a breakthrough innovation. They are among the industry's most promising climate solutions. The company's nitrogen is weatherproof, safer to handle, and does not leach or contribute to nitrous oxide emissions. Pivot Bio has been recognized three times by Time magazine on its annual list of best inventions, by Fast Company on its World Changing Ideas and World's 50 Most Innovative Companies lists, by CNBC on its Disruptor 50 list of private companies, by Fortune on its Impact 20 list of startups driving social good and by MIT Tech Review as one of 15 climate tech companies to watch. For more information, visit PivotBio.com.
PISCATAWAY, N.J., Nov. 13, 2024 /PRNewswire/ -- The global cell and gene therapy (CGT) industry is poised for remarkable growth, driven by significant advances in life sciences and robust investments from capital markets. To strengthen this vital sector, GenScript is bringing together leading scientists, industry experts, investors, and regulatory authorities at the GenScript Biotech Global Forum. This series of conferences aims to address key industrial trends in cell therapy and gene therapy. Join the GenScript Biotech Global Forum in London to Navigate the Future of Cell and Gene Therapies. For more information, please visit the forum website.Scan QR code or click the link to register: https://bit.ly/477v0pa(Register using code GSOM to reserve your free pass.) Scan QR code or click the link to register: https://bit.ly/477v0pa In this November 20, GenScript Biotech Global Forum will take place in London during the Jefferies London Healthcare Conference. This year's forum will explore the theme "Unlock the Full Potential of Cell and Gene Therapies." This event aims to foster collaboration among industry leaders while tackling the challenges and opportunities in the CGT landscape. Highlights of the Agenda Include 3 keynote speeches and 4 panel discussions. Hot topics focusing on the innovation and breakthroughs of CGT and mRNA vaccine. Addressing CMC Challenges of CGT product development. Insights from Investors for the CGT investment opportunities. 20+ world-renowned scholars and industry leaders. Get an insider's look into the make-or-break opportunities in cell and gene therapy. 200+ experts. Get inspired, forge alliance and make an impact! 55% policy makers. The can't-miss gathering of cell and gene therapy luminaries during Jefferies London Healthcare Conference. Agenda Navigating Challenges: Insights into the Future of CGT and Multiple Cell Therapy Technologies in Development In recent years, cell and gene therapy has become a key player in biopharmaceuticals, with a growing number of approvals annually. CAR-T therapies are the most advanced, while innovations have led to a wider range of cell therapies, including CAR-NK, CAR-M, and TIL, addressing various challenging diseases. However, the diverse landscape of new therapies and technologies presents numerous challenges. The forum will feature keynote speeches from prominent figures in cell and gene therapy, including Dr. James M. Wilson, President and CEO of Gemma Biotherapeutics; Dr. Miguel Forte, President of the International Society for Cell & Gene Therapy (ISCT) and CEO of Kiji Therapeutics, and Tom Whitehead, co-founder of the Emily Whitehead Foundation will also give a speech to share the life-saving stories of CAR-T therapy. Keynote Speakers In-Depth Discussion on Gene Therapy, mRNA Vaccines and the CMC Challenges in Developing and Manufacturing CGT Product The development of gene therapy and mRNA vaccine technologies has been transformative, particularly during the COVID-19 pandemic, and holds immense promise for treating rare diseases and genetic disorders. As advancements in gene editing reshape clinical applications, emerging innovations in gene therapy and mRNA vaccines are poised to revolutionize medicine. However, the transition of these technologies from research and development to clinical application brings significant challenges. Throughout the development and production of cell and gene therapies, issues related to CMC are prevalent. The quality of raw materials and the stability of supply chains directly impact early development, while the complexity and consistency of manufacturing processes, from small-scale trials to large-scale commercialization, remain key obstacles. Further optimization is needed in process scaling and standardization, alongside the ongoing challenge of ensuring product quality and safety in compliance with stringent regulatory standards for successful market entry. The forum will explore these challenges, as well as emerging market trends and future opportunities for innovation, through in-depth panel discussions. Exploring the Investment Potential of CGT: A Future Outlook The cell and gene therapy (CGT) industry faces challenges in investment returns due to high development costs, regulatory hurdles, and manufacturing complexities. However, significant opportunities exist in gene editing and cell-based therapies, which offer promise for treating various diseases. Attracting funding requires understanding the potential impact of these therapies and their path to commercialization. This forum will feature a fireside chat with investment insights, helping attendees explore CGT's potential and how to secure long-term returns as therapies progress toward commercialization. Moderators and Panelists For more information, please visit the forum website.Scan QR code or click the link to register: https://bit.ly/477v0pa(Register using code GSOM to reserve your free pass.)
MELBOURNE, Australia and BERLIN, Germany, Nov. 13, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into a technology collaboration and licence agreement with Berlin-based Eckert & Ziegler SE (EZAG) for the use of EZAG's cyclotron-based systems to produce the alpha-emitting isotope, actinium-225 (225Ac). This provides Telix with both an additional commercial source of 225Ac and access to a platform technology that enables highly efficient, scalable isotope production for use in the development of next generation targeted alpha therapies (TATs), a strategic focus for Telix. EZAG is one of the world's largest providers of isotope technology for medical, scientific and industrial use and a long-term partner of Telix. By combining EZAG's technology with Telix's rapidly expanding global manufacturing footprint, the collaboration will enhance capacity to produce 225Ac, to accelerate the development of Telix's alpha therapy candidates and support eventual commercial demand. "This new collaboration is a significant step in the implementation of our actinium strategy," said Dr. Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler. "Eckert & Ziegler and Telix have a long-standing and multi-faceted business relationship. Combining the strengths of two leading players in radiopharmaceuticals and isotopes will create a collaboration for the supply of actinium-225-based radiotherapeutics, that are of high interest worldwide." Raphaël Ortiz, Chief Executive Officer, Telix International, added: "Targeted alpha therapy is regarded as the next frontier in the field of radiopharmaceuticals and is a priority R&D focus for Telix. This collaboration will enable us to unlock the early investment we have made in alpha therapy candidates and further leverage our manufacturing facilities worldwide, including in Brussels South, for the production of this important alpha emitting isotope." Alpha emitters such as 225Ac have the potential to deliver high amounts of energy to cancer tissue, while their short range can reduce the risk of damage to surrounding healthy cells, increasing the selectivity and potency of radiation treatment. In contrast, beta emitters such as lutetium-177 (177Lu) and iodine-131 (131I) have a longer penetration, which may suit bulky metastatic disease. The development of TATs is a priority research and development focus area for Telix and is highly complementary to the Company's existing late-stage therapeutic pipeline. Experts believe the demand for 225Ac will increase significantly over the next decade. Telix's R&D commitment to TAT is demonstrated in an extensive clinical-stage TAT pipeline: TLX592, a PSMA[1]-targeting prostate cancer therapy candidate based on the Company's proprietary RADmAb® engineered antibody technology; TLX252, a CAIX[2]-targeting radio antibody-drug conjugate (rADC) under development as a potential complement to the TLX250 (beta) program; TLX102[3], a LAT1[4]-targeting small molecule-based candidate under development as a potential complement to the TLX101 and TLX101-CDx brain cancer programs; and TLX300, a radiolabelled form of a naked antibody in-licensed from Eli Lilly & Company, under investigation in soft tissue sarcoma[5]. In addition, the completed OPALESCENCE[6] and PERTINENCE[7] investigator-initiated trials have demonstrated CAIX-targeting and dosimetry proof-of-concept for alpha therapy in triple-negative breast cancer, and non-muscle-invasive bladder cancer, respectively, using TLX250-CDx PET[8]. About Eckert & Ziegler SE Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse. For more information visit: www.ezag.com Contributing to saving lives. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix's lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[9], by the Australian Therapeutic Goods Administration (TGA) [10], and by Health Canada[11]. No other Telix product has received a marketing authorisation in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. [1] Prostate-specific membrane antigen. [2] Carbonic anhydrase IX. [3] TLX102 labelled with astatine-211. All other listed alpha therapies labelled with actinium-225. [4] Large amino acid transporter 1. [5] Telix ASX disclosure 17 April 2023. [6] ClinicalTrials.gov ID NCT04758780. Positive topline results presented at SABCS in December 2023, Telix media release 7 December 2023. [7] ClinicalTrials.gov ID NCT04897763. [8] Positron emission tomography. [9] Telix ASX disclosure 20 December 2021. [10] Telix ASX disclosure 2 November 2021. [11] Telix ASX disclosure 14 October 2022.
TAIPEI, Nov. 13, 2024 /PRNewswire/ -- Innovative Cultivation to Dominate the Raw Materials Market Cordyceps Sunshine Biotech Holdings Co., Ltd. 【C.S】Group has made a breakthrough by cultivating Taiwanofungus using innovative ceramic carriers, overcoming the industry-wide challenge of sourcing the rare Cinnamomum kanehirae Hayata tree. According to Vincent Liu, Director of 【C.S】Group, establishing Taiwanofungus as a premium brand requires control over the mushroom's genetic strains, cultivation facilities, brand channels, and international expansion. The market demand for Taiwanofungus raw materials has increased significantly, particularly in the health-conscious era accelerated by the COVID-19 pandemic. Following the acquisition of patents for "Cultivation Methods and Porous Carriers for Taiwanofungus" in Taiwan, China, and Japan, 【C.S】Group has achieved large-scale production. The company's technology has been officially designated in the Chinese government's "Taiwanofungus Production Technical Specifications" group standards announced on April 1, 2022, positioning 【C.S】Group as a leader in setting cultivation standards for Taiwanofungus across Greater China. The goal of becoming the largest supplier of Taiwanofungus raw materials is now within reach. Establishing the Leading Taiwanofungus Franchise: Leveraging Capital to Amplify Industry Growth Dalan Huang, CEO of 【C.S】Group, announced a strategic partnership with Guangzhou Baoquan Agricultural Biotechnology, the company's Greater China agent, leading to the establishment of the first large-scale Taiwanofungus cultivation base in China and marking the official entry into the Chinese market. In 2023, 【C.S】Group launched Taiwan's largest Taiwanofungus retail chain, setting up stores in key locations such as Taipei's Dihua Street, the bustling East District, and Kaohsiung's Sanfeng Central Street. The stores, branded as KASAER Taiwanofungus Specialty, offer a variety of Taiwanofungus health products, including unique items like Taiwanofungus dark chocolate and a blend of Taiwanofungus and agarwood. Recently, we collaborated with the champion chef of the 2023 Taipei International Beef Noodle Festival to launch a special beef noodle soup featuring Taiwanofungus. This year, we entered the competition with the Taiwanofungus beef noodle soup and won the championship. 【C.S】Group will continue to enhance customer loyalty and brand exposure, adding more creative marketing initiatives! On July 9, 2024, 【C.S】Group entered a strategic partnership with Yue Hwa Chinese Products Emporium Limited, a renowned Hong Kong-based department store chain. A full range of Taiwanofungus products will be distributed through Yue Hwa's retail channels in Hong Kong and Singapore, bringing this precious fungus to a broader audience. In the second half of 2024, we will officially set up counters in Taiwan's department stores, starting with Taipei's SOGO Tianmu Store and the Far Eastern Mall, along with expanding our flagship store in Taichung. By the end of the year, we plan to continue expanding in Taiwan's six major cities, opening more than ten directly operated stores. Over the next 12 to 18 months, 【C.S】Group will gradually recognize revenue from Taiwanofungus raw material supply and chain store sales, entering a period of exponential growth. This will create greater profitability for shareholders and support future stock value. (Left) Taipei SOGO Tianmu Store Counter; (Right) Taipei Far Eastern Mall Counter The Path Forward "The journey of every company includes overcoming challenges," says CEO Dalan Huang. "The key is resilience and adaptability. When a company's technology effectively addresses market needs, it drives performance, which in turn reflects in stock value. Now is a pivotal moment for 【C.S】Group to showcase its achievements—advancing technical upgrades and scaling production in the Taiwanofungus industry. By leveraging capital, we aim to enhance commercialization, broaden market influence, and drive steady market expansion."
IRVINE, Calif., Nov. 13, 2024 /PRNewswire/ -- Zymo Research Corporation (Zymo Research), a leader in innovative life science solutions, announced today that it has filed claims in the United District Court for the Central District of California against Qiagen GmbH (Qiagen) alleging that Qiagen has engaged in antitrust violations and improperly interfered with Zymo Research's contractual relations. These claims were filed as part of an amended response to a patent infringement lawsuit previously filed by Qiagen. In addition to asserting its claims for antitrust and interference, Zymo Research's amended response denies all of Qiagen's allegations of infringement. Zymo Research believes that Qiagen's lawsuit is part of a larger strategy to misuse litigation as a tool to stifle innovation and delay the adoption of groundbreaking technologies that benefit the scientific and medical communities. By bringing its counterclaims, Zymo Research not only intends to vindicate its position in the lawsuit against Qiagen, but to shed light on the misuse of litigation as a weapon against technological progress. "Qiagen's lawsuit was not brought in good faith and lacks merit. The scientific community deserves access to cutting-edge tools that foster growth and discovery, and we are committed to defending our breakthrough cfDNA technology and our contributions to the scientific community." said Dr. Marc Van Eden, VP of Corporate Development. About Zymo Research Corporation Zymo Research, a private biotech company established in 1994 and headquartered in Irvine, California, is a global leader in innovative molecular tools for life sciences. Driven by the principle "The Beauty of Science is to Make Things Simple," Zymo Research is dedicated to developing reliable solutions that address complex scientific challenges. Known also as The Epigenetics Company, Zymo Research offers a comprehensive range of technologies, including solutions for sample collection, DNA/RNA purification, NGS library preparation, microbiomics, transcriptomics, epigenomics, genomics, and Next-Generation Sequencing (NGS) services. Through scientific innovation, Zymo Research is committed to engineering sustainable biotech solutions that fundamentally change how life science research is conducted-- as demonstrated by their ambient temperature sample collection and transportation DNA/RNA Shield system, which eliminate cold chain logistics completely, thus reducing waste and the environmental footprint. For more information visit www.zymoresearch.com Note to Editors: Zymo Research's counterclaims in the legal proceedings allege that Qiagen's actions violate antitrust principles and interfere with Zymo Research's business relationships.
Encouraging findings with immunotherapy aiming at ART-free virological control A significant step towards functional cure of HIV infectionHONG KONG SAR - Media OutReach Newswire – 12 November 2024 - Immuno Cure BioTech ("Immuno Cure"), a clinical-stage biotechnology group based in Hong Kong Science Park, is pleased to announce the completion of a first-in-human novel therapeutic HIV vaccine, ICVAX, Phase I clinical trial with encouraging findings of exceptional safety and promising immunogenicity profiles. This represents a significant step of ICVAX towards achieving antiretroviral therapy ("ART") free virological control by ICVAX and ultimately accomplishing as a functional cure of HIV/AIDS. ICVAX is the result of the collaboration between Immuno Cure and Hong Kong AIDS Foundation, HKU AIDS Institute, Hong Kong Science & Technology Parks Corporation and the Shenzhen Third People’s Hospital. Globally, there are more than 39 million people living with HIV ("PLWH") and over 40 million deaths since HIV was discovered in 1981. The currently available ART, while highly efficacious, does not cure HIV/AIDS, highlighting the need for an effective immunotherapy to assist ART. Such immunotherapy can potentiate host immune response, aiming to achieve a state of ART-free virological control, and ultimately a complete suppression of virus to an undetectable level in blood for a prolonged period of time, and hence achieving functional cure. Immuno Cure's ICVAX aims to induce broadly reactive polyfunctional viral-specific T cells to achieve sustained HIV-1 virological control in the absence of ART. This Phase I clinical trial is a randomized, double-blinded, placebo-controlled, dose-escalation study, approved by the National Medical Products Administration ("NMPA") and carried out at The Shenzhen Third People's Hospital ("Shenzhen Third Hospital"), for the evaluation of the safety, maximal tolerating doses, and for the exploration of immunogenicity of ICVAX in clinically stable HIV-1-infected patients whose virus replication are well-suppressed by antiretroviral therapy (clinicaltrials.gov no. NCT06253533), ("Phase I Trial"). A total of 45 participants were recruited and randomly assigned into three dosing groups (1 mg, 2 mg, and 4 mg groups), with an ICVAX-to-placebo ratio of 12:3 in each cohort. ICVAX was delivered by electroporation using Immuno Cure's NMPA-approved Class II Teresa EP device ("Teresa EP"). All trial data were reviewed by the Data Safety Monitoring Board ("DSMB") and unblinded in late September 2024. ICVAX was well tolerated and had a favorable safety profile at all doses studied. All 45 participants completed the scheduled visits. All reported treatment-related adverse events were mild, and no treatment-related severe adverse events were reported. Overall, ICVAX vaccine recipients demonstrated promising T cell responses. In those receiving the optimal ICVAX dose, a large majority had more than 2-fold increase in T cell responses. Critically, ICVAX could enhance functional T cells previously found in Elite Controllers ("EC") for HIV-1 control. The primary and secondary endpoints of the Phase I trial have been met. Immuno Cure plans to share such promising findings from the Phase I Trial in scientific conferences and in a peer-reviewed scientific journal. The Phase I Trial data will be submitted to regulatory agencies for review for advancing the vaccine into a Phase II efficacy clinical trial. Dr. Hongzhou LU MD, PhD, President of Shenzhen Third Hospital and Co-Principal Investigator of the Phase I Trial, said "We are incredibly excited with these unprecedented results of the Phase I clinical trial of ICVAX upon unblinding after thorough review and clearance by the DSMB. These promising trial data laid a solid foundation for the upcoming Phase II clinical trial, and for ICVAX to ultimately achieve ART-free virological control in HIV-1 patients and potentially the long-awaited functional cure of HIV/AIDS for PLWH. We thank the volunteers for their selfless participation and commitment to finish the entire trial. I believe many patients are eager to join the next stage of clinical trials of the candidate HIV vaccine." HKU AIDS Institute has been leading a collaborative research initiative in association with Immuno Cure and other academic institutions on ICVAX, which was awarded significant grant funding twice under the Theme-based Research Scheme ("TRS") from the Research Grants Council ("RGC"), aggregating to some HK$ 113.8 million. In the first 5-year term of TRS 18/19 (8th round), HK$47.1 million was granted for basic research of ICVAX, studying PD-1-Enhanced DNA vaccine-based combination immunotherapy in monkey models and human subjects. Recently, in the second 5-year term of TRS 24/25 (14th round), HK$66.7 million was granted for carrying out of further translational research, including multicenter clinical trials in the coming five years. The collaborative research was also granted an aggregate amount of HK$ 5.99 million by the Innovation and Technology Commission ("ITC") for early-stage pre-clinical studies under the University and Industry Collaboration Program ("UICP"). Prof. Zhiwei CHEN PhD, Founding Director of HKU AIDS Institute, Tenured Professor and Chair of Immunology and Immunotherapy in the Department of Microbiology, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, the University of Hong Kong (HKU), and Suen Chi-Sun Professor in Clinical Science, inventor of the patented PD-1 Enhanced DNA vaccine technology and the Principal Scientific Advisor of Immuno Cure, said "The Phase I Trial preliminary data demonstrated satisfying safety and immunogenicity profiles of ICVAX in PLWH. It is encouraging to discover that ICVAX enhances functional T cells previously found in EC for HIV-1 suppression. Our team members are very grateful for the significant amount of funding from RGC and ITC, which have enabled us to accomplish our interim achievements at this stage and to further expand our translational research, including an upcoming Phase II clinical trial for the benefit of more and more PLWH." Immuno Cure was granted a maximum amount of ΗΚ$8 million funding for this Phase I Trial under the Clinical Translational Catalyst ("CTC") programme of the Institute for Translational Research ("ITR") of the Hong Kong Science and Technology Parks Corporation ("HKSTP"). The CTC program is a highly specialized platform to provide all-round support to biomedical companies in the pre-clinical and early clinical stages, aiming to transform Hong Kong and the Greater Bay Area to become the go-to destination for translational medicine in the region. Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients. Ms. Gracie Ng, Chief of Staff and Acting Chief Corporate Development Officer, HKSTP said, "The HKSTP team was thrilled to hear the news that Immuno Cure has completed Phase 1 clinical trial for ICVAX. This pioneering vaccine represents a major advancement in our fight against HIV/AIDS. The success highlights our role as one of the global leaders in translational development, producing innovative therapies to improve patients' quality of life." The Hong Kong AIDS Foundation, established in 1991, is a non-governmental social service organization with a mission to limit the spread of HIV infection in the community. Throughout the years, the Foundation has been actively engaged in the promotion of AIDS education, the provision of services, and the nurturing of a harmonious and caring environment for those infected with or affected by HIV/AIDS. Dr. Che Hung LEONG MD, PhD, GBM, GBS, JP, President of Hong Kong AIDS Foundation and the Chairman of the Advisory Board of Immuno Cure said: "It is exciting to see the positive results of ICVAX, Immuno Cure's therapeutic HIV vaccine, from its Phase I clinical trial. The trial data shows that ICVAX might potentially provide an alternative to ART which would alleviate the burden of drug compliance of patients. These results suggest that we may be on the brink of a breakthrough with a therapy that could enhance the quality of life for many PLWH and provide them a hope for functional cure in the longer term." Immuno Cure is communicating with the NMPA for the upcoming multi-centre, double-blinded, placebo-controlled, dose-finding Phase II clinical trial. The trial will aim to evaluate the immunogenicity and efficacy in controlling HIV viral load. It is anticipated to commence in mid-2025. Dr. Xia JIN MD PhD, CEO of Immuno Cure concludes, "The encouraging outcomes of the Phase I Trial are attributed by fruitful collaboration for over 8 years between Immuno Cure and Prof. Chen of HKU-AIDS Institute, representing a significant milestone of the development of ICVAX. Looking ahead, we shall move on with our BLA application under NMPA's breakthrough drug regulatory regime after meeting the expected end points of the Phase II clinical trial. The success of development of ICVAX will not only prove the novelty of our DNA vaccine technology platform, but also mark a giant step towards functional cure of HIV/AIDS, and to enable the relief of burden on PLWH and improvement of their quality of life. Lastly, we thank the volunteers for their participation and the doctors and nurses at the Shenzhen Third Hospital trial site, as well as other clinical trial collaborators, CRO, SMO, CMO and clinical laboratories, for their dedication and diligence, for they are the key elements of the smooth completion of this trial. Also, we would like to thank HKSTP, ITC, and RGC for their generous funding support. Next, we plan to launch a cross-border multi-centre Phase II clinical trial in mid-2025, including CUHK Phase 1 Clinical Trial Centre, Shenzhen Third People's Hospital, Guangzhou Eighth People's Hospital, etc. Through this trial, we look forward to cooperating with the Greater Bay Area International Clinical Trial Institute ("GBAICTI"), which will soon begin its service to promote advanced biomedical technology research, clinical trials, and applications in Hong Kong and the Greater Bay Area, aiming to jointly develop Hong Kong into an international medical innovation hub." Hashtag: #ImmunoCure #醫克生物 #医克生物https://www.immunocure.hk/The issuer is solely responsible for the content of this announcement.About Immuno CureImmuno Cure is a clinical stage biotechnology group based in the Hong Kong Science Park, focusing on research and development of immunotherapies for cancers, inflammatory and infectious diseases based on its patented PD-1-enhanced DNA vaccine and Anti-Δ42PD1 Antibody platforms. To learn more about Immuno Cure, please visit: www.immunocure.hk About The University of Hong Kong and AIDS Institute of HKUMedThe University of Hong Kong (HKU), founded in 1911, is the first and oldest institution of higher education in Hong Kong. HKU has an established worldwide reputation for being a research-led comprehensive university. The AIDS Institute of HKU was established in November 2007 to take HKU in a new strategic direction in fighting this global epidemic and help to make it a leader in the region in AIDS research, education and prevention. Scientists at the AIDS Institute are fully committed to conducting basic and applied research that facilitates the understanding of AIDS pathogenesis and the development of effective AIDS vaccines. Furtherance to the Hong Kong Theme-based Research Scheme entitled "Potentiating Host Immunity for HIV-1 Functional Cure", the institute is currently leading the second 5-year term research entitled "Sustained cART-free HIV-1 Control by Immunotherapeutic Interventions". To learn more about HKU and AIDS Institute of HKU, please visit https://www.hku.hk and https://www.med.hku.hk/aidsinstAbout The Shenzhen Third People's HospitalThe Shenzhen Third People's Hospital / The Second Affiliated Hospital of Southern University of Science and Technology was founded in 1985 by the Shenzhen municipal government. It is a grade A tertiary research-oriented hospital characterized by strong specialty and comprehensive medical services. The hospital covers an area of around 198,400 square meters with 223,000 square meters construction area and 2416 hospital beds, including 1008 in negative pressure wards in the emergency campus for infectious diseases. By far, the hospital has become a large, well-equipped clinical and research center of infectious diseases in the Guangdong-Hong Kong-Macau Greater Bay Area offering comprehensive services. Thus, it contributes to the control of infectious disease and major public health emergency and benefits patients in Shenzhen and adjacent areas. To learn more about Shenzhen Third People's Hospital, please visit http://www.szsdsrmyy.comAbout Hong Kong Science and Technology Parks CorporationHong Kong Science and Technology Parks Corporation (HKSTP) was established in 2001 to create a thriving I&T ecosystem grooming 13 unicorns, more than 15,000 research professionals and over 2,000 technology companies from 26 countries and regions focused on developing healthtech, AI and robotics, fintech and smart city technologies, etc. Our growing innovation ecosystem offers comprehensive support to attract and nurture talent, accelerate and commercialise innovation for technology ventures, with the I&T journey built around our key locations of Hong Kong Science Park in Pak Shek Kok, InnoCentre in Kowloon Tong and three modern InnoParks in Tai Po, Tseung Kwan O and Yuen Long realising a vision of new industrialisation for Hong Kong, where sectors including advanced manufacturing, micro-electronics and biotechnology are being reimagined. Hong Kong Science Park Shenzhen Branch in Futian, Shenzhen plays positive roles in connecting the world and the mainland with our proximity, strengthening cross-border exchange to bring advantages in attracting global talent and allowing possibilities for the development of technology companies in seven key areas: Medtech, big data and AI, robotics, new materials, microelectronics, fintech and sustainability, with both dry and wet laboratories, co-working space, conference and exhibition facilities, and more. Through our R&D infrastructure, startup support and enterprise services, commercialisation and investment expertise, partnership networks and talent traction, HKSTP continues contribute in establishing I&T as a pillar of growth for Hong Kong. More information about HKSTP is available at www.hkstp.org.About Hong Kong AIDS Foundation LimitedThe Hong Kong AIDS Foundation was established in 1991 and is a non-governmental social service organisation. The Foundation's mission is to limit the spread of HIV infection in the community. Throughout the years, the Foundation has been actively engaged in the promotion of AIDS education, the provision of services, and the nurturing of a harmonious and caring environment for those infected with or affected by HIV/AIDS. To learn more about Hong Kong AIDS Foundation, please visit https://aids.org.hk.
Biotechnology
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