Preclinical data with BBT001 demonstrate its best-in-disease potential for improved efficacy and dosing convenience compared to approved biologics in atopic dermatitis Interim safety and pharmacokinetic data from healthy volunteers anticipated in 2H 2025 BOSTON, Feb. 28, 2025 /PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biotechnology company developing novel biologics for inflammatory and immunological diseases, today announced the initiation of dosing in healthy volunteers (HV) in its first clinical trial for BBT001, a novel, multi-targeting, half-life extended bispecific antibody, which is being developed initially as a treatment for atopic dermatitis (AD). "The early initiation of the BBT001 Phase 1 clinical trial is a significant milestone for Bambusa as we continue to execute with excellence," said Shanshan Xu, M.D., Ph.D., Founder and Chief Executive Officer of Bambusa Therapeutics. "BBT001 represents a potential breakthrough in atopic dermatitis treatment by leveraging innovative antibody engineering to engage multiple, clinically validated, non-overlapping mechanisms of action. Our goal is to deliver faster onset of symptom relief, superior efficacy, and improved dosing convenience that could ultimately redefine the standard of care for AD patients." About the BBT001-001 Clinical Trial The Phase 1 clinical trial (BBT001-001; NCT06808477) is a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis. The trial will assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary clinical activity of BBT001 and is expected to enroll approximately 98 participants across multiple cohorts. Interim safety and pharmacokinetic data are anticipated in the second half of 2025. About BBT001 and Bambusa's pipeline BBT001 is a novel half-life extended bispecific antibody. Preclinical data with BBT001 demonstrate its best-in-disease potential, offering enhanced efficacy and improved dosing convenience compared to approved biologics in atopic dermatitis. Beyond BBT001, Bambusa is advancing BBT002, a bispecific antibody designed as a "platform in a molecule" with broad applications across respiratory, dermatology, and gastroenterology indications. The company's additional pipeline candidates, BBT003 and BBT004, are also being developed for inflammatory bowel disease and rheumatological conditions, each with best-in-disease potential. About Atopic Dermatitis Atopic dermatitis is a chronic inflammatory skin condition characterized by intense itching, dry skin, and recurrent eczematous lesions. It affects approximately 16.5 million adults in the United States alone and can have a significant impact on quality of life.[1] Despite recent therapeutic advances, including targeted biologics, a significant portion of patients continue to experience inadequate disease control, underscoring the need for novel treatment approaches. About Bambusa Therapeutics Bambusa Therapeutics is a clinical-stage biotechnology company specializing in developing transformative inflammatory and immunological therapeutics. Based in the vibrant Boston Seaport area, Bambusa's mission is to advance the field of immunology with cutting-edge solutions. For more information, visit www.bambusatx.com. [1] https://aafa.org/wp-content/uploads/2022/08/Atopic-Dermatitis-in-America-Study-Overview.pdf
SINGAPORE, Feb. 28, 2025 /PRNewswire/ -- This initiative aims to produce eco-friendly bio-based molecules from low-cost, eco-friendly sources. Key benefits include: Cost-parity with conventional methods: Unlike existing bio-based molecules production, this initiative aims to achieve cost-parity with conventional processes by utilising low-cost renewable sources like methanol. Wide-ranging industry applications: The sustainable bio-based molecules produced can be used for wide-ranging industrial applications in textiles, automotive, personal care, and coatings industries. Boosting Singapore's green economy: This effort strengthens Singapore's leadership in the global bioeconomy, which can lead to high-value job creation in sustainable biomanufacturing. SINGAPORE – MojiaBio, a leading innovator in green chemistry and sustainable biomanufacturing, will be developing an SGD 44.8 million state-of-the-art Sustainable Biomanufacturing Technology Platform (SBTP) with the Agency for Science, Technology and Research (A*STAR). By integrating advanced synthetic biology and bioprocessing innovations, the SBTP aims to position Singapore as a global leader in sustainable biomanufacturing, accelerating the transition to a circular bioeconomy and net-zero future. Unlike other existing bio-based molecules in the market, the SBTP aims to pioneer the production of a range of high-value bio-based molecules that are cost-competitive and serve the needs of various industries. This is made possible due to the innovative use of cost-effective sources like methanol and ethylene glycol, which enables the platform to produce scalable, sustainable alternatives to conventional chemical processes. This includes the production of 1,3-propanediol (PDO), a key ingredient for a broad array of industries such as skincare products, coatings and biodegradable plastics. Building Singapore's Capabilities in Green Biomanufacturing The global market for green chemicals is projected to reach USD 200 billion (around SGD 270 billion) by 2030, driven by increasing demand for sustainable alternatives to their fossil-based counterparts. This collaboration will help Singapore build up our synthetic biology capabilities, which will help position us to capture a share of this growing market and contribute to the development of new economic opportunities in the green economy. At the heart of the SBTP is MojiaBio's proprietary Cn+Bio™ pathway and OrthBio® bioconversion process, designed to convert low-cost, renewable sources into bio-based molecules. This will be developed in close collaboration with A*STAR Singapore Institute of Food and Biotechnology Innovation (A*STAR SIFBI)—which will provide expertise on enzyme engineering—to ensure a faster, more reliable, and higher-yield conversion. "The SBTP will not only produce bio-based molecules but also support downstream application research to synthesise high-value sustainable products for different industries," said Dr Ramon Gonzalez, MojiaBio CSO. "Through our partnership with A*STAR, we will be able to accelerate the commercialisation of green PDO to meet the growing demands and needs of the market." The SBTP leverages advanced synthetic biology and integrates the National University of Singapore (NUS)' computational modelling expertise to engineer enzymes and microbial strains, optimising them as biocatalysts. Unlike conventional fermentation methods, the platform operates independently of its host cell metabolism, which significantly enhances energy efficiency, scalability, and sustainability while reducing production costs. Professor Tan Sze Wee, Assistant Chief Executive from A*STAR Biomedical Research Council said, "The SBTP marks a significant step forward in sustainable biomanufacturing for Singapore, demonstrating how synthetic biology can unlock cost-effective productions of scalable value-added ingredient alternatives. By leveraging synthetic biology and enzyme engineering capabilities at A*STAR SIFBI and A*STAR Institute of Sustainability for Chemicals, Energy and Environment (A*STAR ISCE2) and forming strategic private-public partnerships, we are laying the foundation for further advancements in sustainable biomanufacturing across multiple industries. This collaboration will not only accelerate Singapore's bioeconomy growth but also underscore our commitment to advancing in value-added ingredient innovation and green technologies." Lim Wey-Len, Executive Vice President, Singapore Economic Development Board (EDB) said: "Singapore has been developing our capabilities in industrial biotechnology as part of a push for sustainable manufacturing. The SBTP demonstrates how leading companies can partner Singapore's research ecosystem to innovate and commercialise novel products that improve the quality of life, while meeting sustainability commitments. We welcome more like-minded companies to create solutions through Singapore that can further grow Asia's bioeconomy sector." Advancing Green Economy: Building a Sustainable Future Together The SBTP aligns with the Singapore Green Plan 2030 targets and global sustainability goals, such as reducing carbon emissions and promoting a circular economy. Compared to conventional methods, bio-based molecules produced through this platform offer significant environmental benefits over conventional processes, including: Reduced energy use: Renewable sources (e.g. methanol and ethylene glycol) require less energy to process. Lower carbon footprint: Bio-based production typically emits significantly less carbon dioxide than conventional chemical processes by around 60%. Fewer pollutants: Bio-based methods produce fewer harmful emissions, such as nitrogen oxides (NOx) and sulphur oxides (SOx). "This collaboration exemplifies our vision to create impactful, sustainable solutions for the future," said Dr Gonzalez. "MojiaBio is also making strides to establish our operational headquarters and a dedicated research laboratory in Singapore to accelerate commercialisation of other green chemicals to contribute to Singapore's bioeconomy and the global transition toward sustainability." 1 "Green Chemicals Market - Global Industry Assessment and Forecast." Vantage Market Research, 4 July 2023, www.vantagemarketresearch.com/industry-report/green-chemicals-market-1347. About the Agency for Science, Technology and Research (A*STAR) The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector R&D agency. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry. A*STAR's R&D activities span biomedical sciences to physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis. About A*STAR Singapore Institute of Food and Biotechnology Innovation (A*STAR SIFBI) A*STAR Singapore Institute of Food and Biotechnology Innovation (A*STAR SIFBI)'s vision is to be an innovation engine for health and well-being, focusing on the Asian phenotype. Our two strategic pillars are: 1) Developing sustainable, value-added ingredients for food and consumer care; and 2) Optimizing health and wellbeing within the Asian phenotype. We prioritize consumer acceptance, considering taste, texture, and nutrition, alongside sustainable and safe food production. Understanding sensory preferences and the Asian phenotype allows us to tailor food designs to meet consumer needs and improve population health and wellness. We directly impact food resilience, population health, economic growth, and talent development. We envision Singapore as a leading hub for Asian food and nutrition research, fostering industry partnerships and regional collaboration to advance this critical field. This is achieved through public-private partnerships locally and globally. Learn more about SIFBI. About MojiaBio MojiaBio is a pioneering leader in industrial biomanufacturing, revolutionizing the production of commodities, materials, and chemicals through sustainable and green processes. By leveraging cutting-edge technologies and demand-driven innovation, MojiaBio is committed to creating transformative solutions that shape the future of multiple industries. For more information on MojiaBio.
DONGGUAN, China, Feb. 28, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy. FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation. PD1 targeted antibodies drive the differentiation of effector CD8(+) T cells into terminally exhausted status. In the latest pre-clinical experiment conducted by Fapon Biopharma, FP008 effectively counteracted this process through IL-10M, significantly reducing the anti-PD-1 antibody-mediated exhaustion of CD8(+) T cells. In mouse experiments, FP008 exhibited potent anti-tumor effects, significantly increased the infiltration of intratumoral CD8(+) T cells, reduced their terminal exhaustion differentiation and enhanced the ability of terminally exhausted CD8(+) T cells to produce and secrete IFN-γ and GZMB. In addition, FP008 showed encouraging safety and pharmacokinetics profile in cynomolgus monkey, and demonstrated favorable developability. This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization. "Global collaboration is central to our vision," stated President Vincent Huo. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy." About Fapon Biopharma Fapon Biopharma specializes in discovering and developing biologics for treating cancers, autoimmune diseases and other diseases where there are unmet medical needs. Leveraging cutting-edge technologies, we have built advanced drug discovery platforms, including an antibody discovery platform based on the globally leading mammalian cell display technology, a platform for generating IL-10M fusion proteins, and a platform for developing multispecific antibodies using Fibody and nanobodies. With a differentiated pipeline of leading drug candidates, we have established capabilities that cover the entire drug development process from drug discovery, preclinical research, Chemistry, Manufacturing and Controls (CMC) to early clinical development. Committed to innovation, we strive to deliver safer, more efficacious, affordable, and accessible biologics for everyone. For more information about FP008 and partnership opportunities, please visit our website (https://en.faponbiopharma.com/) or contact our Business Development team.Max Wang: max.wang@fapon.com;Liyan Gao: liyan.gao@fapon.com
SHANGHAI, Feb. 28, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines, today announced that it will hold investor calls to discuss recent developments on its mRNA therapeutic vaccine programs. The English session of the conference call will be held at 9:00 pm on March 6, 2025 Beijing Time (8:00 am U.S. Eastern Time on March 6), and the Mandarin session of the conference call will be held at 9:00 am Beijing Time on March 7, 2025 (8:00 pm U.S. Eastern Time on March 6). The conference calls can be accessed by the following links: For English Session: Time: 9:00 pm Beijing Time, Thursday, March 6, 2025 (8:00 am U.S. Eastern Time, March 6) Pre-Registration Link: https://www.acecamptech.com/eventDetail/60522468 Webcast Link: https://www.acecamptech.com/meeting_live/70524462/787581?event_id=60522468 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: 798635 For Mandarin Session: Time: 9:00 am Beijing Time, Friday, March 7, 2025 (8:00 pm U.S. Eastern Time on March 6). Webcast Link: https://s.comein.cn/9y4tyiy1 Alternatively, participants may dial into the conference call using below dial-in information: United States: +1-646-3578788 +1-408-7093255 Chinese Mainland: 400-969-8928 400-806-3263 Hong Kong, China: +852-301-83602 Taiwan, China: +886-226563394 +886-277417882 Singapore: +65-64075649 +65-66220840 United Kingdom: +44-2070970018 International: +86-2362737123 Password: 185008 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.
SINGAPORE, Feb. 28, 2025 /PRNewswire/ -- KBP Biosciences Pte. Ltd. (the "Company") today issued a statement addressing a recent decision by the Singapore International Commercial Court ("SICC"), which granted an injunction sought by Novo Nordisk A/S ("Novo Nordisk") against the Company and its founder, Dr. Huang Zhenhua ("Dr. Huang") on February 14, 2025. The SICC decision was issued on an ex parte basis without the knowledge or participation of the Company and Dr. Huang. Novo Nordisk filed the application after it announced on June 26, 2024 that it was stopping CLARION-CKD trial for Ocedurenone, a drug for uncontrolled hypertension and advanced chronic kidney disease (CKD) that it acquired from the Company in 2023. "We are disappointed by Novo Nordisk's conduct in seeking the injunction without notice to us, which meant that we were not given the opportunity to defend ourselves in court. The serious allegations made by Novo Nordisk are completely unfounded and the truth will vindicate us in time to come. There is tremendous potential in Ocedurenone, and we remain committed to its cause," said Dr. Huang Zhenhua, founder and chairman of the Company. The Company and Dr. Huang will have an opportunity to be heard by the Singapore courts and have engaged legal counsel to vigorously defend their legal rights. All media inquiries can be directed to: info@kbpbiosciences.com About KBP Biosciences Pte. Ltd. KBP Biosciences is a global, clinical-stage biotechnology company, headquartered in Singapore, focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet medical needs. About Ocedurenone (KBP-5074) Ocedurenone is a third-generation, non-steroidal, mineralocorticoid receptor antagonist (MRA) with a unique pharmacokinetic (PK) profile characterised by a long half-life and high mineralocorticoid receptor (MR) affinity. Certain MRAs have shown benefits in people with hypertension or heart failure, as well as cardiorenal benefits in patients with chronic kidney disease (CKD) and type 2 diabetes [1]. [1] Kintscher U, et al. Br J Pharmacol. 2022 Jul;179(13):3220-3234. Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease - PubMed (nih.gov) For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/
SHANGHAI, Feb. 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that KJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, has administered at the starting dose specified in the clinical protocol to the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). KJ-C2219 is developed using THANK-u Plus™ platform. The company is currently evaluating the therapy in an IIT in China for B-cell malignancies and in another IIT for systemic lupus erythematosus and systemic sclerosis. About THANK-u Plus™ CARsgen has developed the THANK-u Plus™ platform as an enhanced version of its proprietary THANK-uCAR® allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus™ demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR®. Preclinical studies show that THANK-u Plus™ delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR®. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus™ has broad potential for developing diverse allogeneic CAR-T therapies. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.
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