Latest news with #STS
Yahoo
27-05-2025
- Business
- Yahoo
Immutep's Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma
Novel combination with efti has met the trial's primary endpoint of tumour hyalinization/fibrosis in the neoadjuvant setting for patients with resectable soft tissue sarcoma Detailed results are planned for presentation at a future medical meeting SYDNEY, AUSTRALIA, May 27, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ('Immutep' or 'the Company'), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS). Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial's investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial's principal investigators, said: 'It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial's primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti's activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year.' As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3 For more information on EFTISARC-NEO, visit (NCT06128863). About Eftilagimod Alfa (efti)Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit 1. Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/ Epub 2017 Feb 24. PMID: 28463157.2. Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.3. American Cancer Society statistics: KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Catherine Strong, Sodali & Co.+61 (0)406 759 268; U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-05-2025
- Business
- Yahoo
Immutep's Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma
Novel combination with efti has met the trial's primary endpoint of tumour hyalinization/fibrosis in the neoadjuvant setting for patients with resectable soft tissue sarcoma Detailed results are planned for presentation at a future medical meeting SYDNEY, AUSTRALIA, May 27, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ('Immutep' or 'the Company'), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS). Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial's investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial's principal investigators, said: 'It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial's primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti's activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year.' As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3 For more information on EFTISARC-NEO, visit (NCT06128863). About Eftilagimod Alfa (efti)Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit 1. Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/ Epub 2017 Feb 24. PMID: 28463157.2. Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.3. American Cancer Society statistics: KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Catherine Strong, Sodali & Co.+61 (0)406 759 268; U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
21-05-2025
- Business
- Yahoo
US Ports Warn of $6.7B Bill if 100% Tariff on China-Made Cranes Kicks in
U.S. ports are urging the U.S. Trade Representative (USTR) to reconsider a new 100-percent tariff on Chinese-manufactured ship-to-shore (STS) cranes, citing billions in extra costs. At a hearing in Washington on Monday, American Association of Port Authorities (AAPA) president and CEO Cary Davis testified that public port authorities would have to pay total tariffs, if imposed, of a combined $6.7 billion over the next decade. More from Sourcing Journal NRF VP: Retailers 'Need Clarity' on New China Tariff Deadline India Ends Land Port Entry for Bangladeshi Garment Imports Walmart Says It Will Increase Prices on Some Goods Because of Tariffs 'Applying a new 100 percent tariff to Chinese STS cranes will not create a domestic crane manufacturing industry out of thin air,' stated Davis, in official comments submitted to the Federal Register. 'It will only increase costs for public port authorities.' The 100-percent tariffs would expand on prior 25-percent tariffs slapped on the equipment in 2024 under the Biden administration. At the time, the 81-port AAPA also pushed back against those duties, but to no avail. American ports currently have 55 cranes on order and another 151 are expected to be needed in six to 10 years, according to Davis' testimony. For example, Port Houston has eight STS cranes contracted for delivery by spring 2026 for $14 million each. But under the tariffs, the port would be spending an extra $302.4 million in added costs—potentially preventing the hub from investing in infrastructure elsewhere. The port association suggested that the 'logical first step' toward reshoring STS crane production would be for Congress to establish a tax credit for domestic production. 'USTR should forgo any further tariffs on STS cranes until such legislation is passed,' Davis said. From there, the association recommended the USTR to forgo applying the 100-percent tariff to cranes that were ordered and contracted prior to the publication of the proposal on April 17. Davis also called for the USTR to delay imposition of the 100-percent tariff for one or two years, saying that ports' decisions on equipment and infrastructure investments are made years in advance. 'If a port authority needs a new STS crane to either replace aging equipment, expand the capacity of an existing terminal, or outfit a new terminal, altering procurement plans is complicated,' said Davis. 'Adding millions of dollars in tariffs to a project's budget can get the project scaled back, delayed, or cancelled entirely. Even with these tariffs, manufacturers cannot stand up production facilities in the U.S. and start producing cranes for several years.' Finally, he asked USTR to clarify that the Section 301 tariffs are not additive to the 125-percent reciprocal and 20-percent fentanyl tariffs on China—both of which were responsible for most of the added hypothetical tariff costs. American retailers and brands shared their own individual concerns with the USTR's Section 301 punitive measures. The American Apparel & Footwear Association (AAFA) is concerned that imposing tariffs on cranes, chassis and shipping containers without the availability of competitive alternatives will significantly raise shipping costs. 'Many companies have already increased prices in response to existing tariffs and cannot absorb further cost burdens,' said Nate Herman, senior vice president of policy at the AAFA, in a letter. 'We strongly urge you not to raise the duty rates on the proposed products.' If tariffs are deemed necessary, the AAFA requested that the duties be phased in gradually to allow businesses adequate time to adapt and plan for the resulting expenses. The Retail Industry Leaders Association (RILA) had a more specific worry regarding the office's 'country of origin' test set forth in the proposal, in which tariffs would be placed on cranes manufactured by any company's owned or controlled by a Chinese citizen rather than a state-owned enterprise. 'Here, USTR proposes to change well-established origin tests and adopt an expansive definition that requires importers of ship-to-shore cranes to exclude from its sourcing operations any business that may be owned by a Chinese national,' said Blake Harden, vice president of international trade at RILA. 'This would create additional burdens and administrative challenges for businesses trying to make sourcing determinations around the globe, as well as create confusion and impede their ability to meet other customs obligations.' RILA urged USTR to reconsider the expanded country of origin test. Shanghai Zhenhua Heavy Industries (ZPMC), which manufactured 80 percent of cranes currently used at U.S. ports, denied it was a threat to U.S. national security interests and requested its removal from the list of items proposed under Section 301 tariffs. 'The proposed tariffs on STS cranes will undermine the U.S. economy and national security by negatively disrupting essential U.S. supply chains,' ZPMC said in a filing to the USTR Monday. 'China's STS cranes pose no alleged cybersecurity risk, and the proposed tariffs are not a legitimate remedy; and the proposed tariffs would negatively impact the global STS crane industry, including the United States, and would harm, rather than help, the U.S. economy and national security.' The USTR Office and Ambassador Jamieson Greer have shown to be flexible in amending potential Section 301 penalties against China in the wake of public commentary. When the office unveiled the crane proposal in April, it also revealed a finalized, pared back version of the previously criticized port docking fees levied on Chinese ships. The latest measures were more lenient on container shipping giants than originally expected, with ocean carriers like Maersk and CMA CGM already saying they won't deal with any cost impact.
Korea Herald
21-05-2025
- Business
- Korea Herald
Korean port cranes emerge as bargaining chip in US tariff talks
HD Hyundai, Doosan Enerbility, and HJ Heavy Industries gain traction as US seeks alternatives to Chinese port cranes Port cranes have surfaced as Korea's next bargaining chip in tariff negotiations with the United States in the wake of the Trump administration's efforts to phase out made-in-China cranes at US ports. The US Trade Representative announced a plan last month to impose tariffs of up to 100 percent on ship-to-shore, or STS, cranes and cargo handling equipment made in China or built using Chinese parts, emphasizing the need to reduce America's reliance on Chinese maritime infrastructure and address national security concerns. According to a report by the US Select Committee on the Chinese Communist Party, Shanghai Zhenhua Heavy Industry, or ZPMC, the world's largest STS crane manufacturer, run by the Chinese government, accounts for almost 80 percent of the STS cranes used at US ports. The report added that there were no domestic manufacturing alternatives for STS cranes in the US. The US has openly mentioned Korea's shipbuilding sector as an area where it seeks cooperation while it continues to push for the revitalization of its own shipbuilding industry. On top of the shipbuilding sector, Korea is poised to support the Trump administration's 'Make America Great Again' agenda with US domestic port crane manufacturers. To this end, HD Hyundai, which operates the world's largest single shipyard at its HD Hyundai Heavy Industries' Ulsan site and boasts significant crane manufacturing capacity, has emerged as a key player. HD Hyundai Vice Chairman Chung Ki-sun discussed affiliate HD Hyundai Samho's crane manufacturing capabilities with US Trade Representative Jamieson Greer on Korea's Jeju Island last week. According to HD Hyundai, Chung specifically talked about the dominance of Chinese port cranes in the US and proposed strengthening cooperation between Korea and the US to expand related supply chains in the US. 'The US certainly appears to be interested in Korea's crane manufacturing capabilities,' said an industry official. 'We think there is a good chance of port cranes being on the table for the tariff negotiations.' In addition to the STS cranes, HD Hyundai Samho is capable of producing rubber-tired and rail-mounted gantry cranes. The crane manufacturer has scored a series of crane orders at Korean ports, including a 179.6 billion won ($129.5 million) deal in Busan last year and a 206 billion won contract in Gwangyang this year. HD Hyundai Samho, which accounted for about 3.6 percent of the global port crane market share in 2023, is considering expanding production capacities in the future to bolster its global presence. Doosan Enerbility has been ramping up its port crane business activities in Vietnam through its local office, Doosan Vina. As of May last year, Doosan Vina had produced 132 cranes for various port operators in India, Indonesia, Singapore and Vietnam. HJ Heavy Industries scored a 187 billion won contract to supply 34 cranes to the Busan New Port last year. The shipbuilder and crane manufacturer is also exploring entry into the US market. Industry watchers have raised the possibility of Korean companies setting up a complete knockdown, or CKD, site in the US to deliver unassembled parts and make the final product there, as establishing a new manufacturing plant in the US might be too costly in the beginning. Paceco, a US subsidiary of Japanese manufacturing conglomerate Mitsui E&S, secured an order to supply eight cranes for the Port of Long Beach in California last year.
Business Wire
20-05-2025
- Business
- Business Wire
Instem Announces Acquisition of Strong Tower Solutions, Strengthening its Clinical SCE Solutions
BOSTON & DOWNINGTOWN, Pa. & STAFFORDSHIRE, England--(BUSINESS WIRE)--Instem is excited to announce that it has closed on an acquisition of Strong Tower Solutions, a technology-enabled service provider with nearly 20 years of configuring and installing qualified, validated, and compliant statistical computing environment (SCE) systems. Strong Tower Solutions is a Pennsylvania-based company that provides technology solutions and services to life sciences customers proceeding through clinical trials. 'Our mission is to help our customers make discoveries, and to accelerate and advance their research programs. By joining forces with Strong Tower Solutions, we're enabling faster, more effective decision-making with reduced risk in clinical development. As the regulatory landscape evolves, Instem's end-to-end platform, and our growing leadership in SCE, becomes even more critical to our customers' success.' Vik Krishnan, CEO, Instem Bringing Instem and Strong Tower Solutions together allows Instem to better serve the clinical market and expands product offerings to small and large life sciences customers. Clients choose Instem and STS because they stay current on best practices and thought leadership in SCE, deploying environments according to their specific needs. These SCE solutions provide customers with the ability to focus on bringing drugs to market while remaining compliant with regulators. 'Instem is at the forefront of SCE modernization. This acquisition of Strong Tower Solutions is a testament to our unwavering commitment to innovation in clinical computing. By integrating STS's expertise with our own, we are accelerating the transformation towards open systems that enhance cloud-based analysis and reporting. This strategic move not only complements our previous acquisition of d-wise but also solidifies Instem's position as a leader in the field. Instem's thought leadership and SCE are increasingly synonymous. Together, we are empowering our clients to simplify and modernize their Statistical Computing Environments, driving faster, compliant drug development.' Stephen Baker, General Manager of Instem's Clinical division. 'Our team at Strong Tower Solutions has always been dedicated to delivering precisely configured, fully compliant computing environments. By joining Instem, customers will benefit from access to additional resources, cloud native technologies, and cross disciplinary expertise. We look forward to combining our deep domain knowledge and services with Instem's offerings to drive more value for customers and be ahead of industry shifts.' John Norton. Director of Customer Success, Strong Tower Solutions. The Instem clinical segment focuses on being the pre-eminent thought leader in SCE innovation with software, services, and advice for life sciences customers. It offers flexibility and supports the evolution of the market towards next-gen SCE. Strong Tower Solutions complements Instem as another trusted advisor to clients undergoing clinical trials. About Instem Instem is a leading supplier of SaaS platforms across Discovery, Study Management, Regulatory Submission and Clinical Trial Analytics. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products. Founded in the United Kingdom in 1969, Instem has deep roots internationally across North America, EMEA and APAC. Instem maintain a commercial and technical presence throughout these regions and pride ourselves on localized support for our diverse client base. About Strong Tower Solutions Strong Tower Solutions brings decades of unwavering dedication to navigating the complexities of data management and business analytics. We stand as a beacon of reliability and innovation in the realm of statistical computing and data management, empowering organizations to unlock new opportunities and redefine their potential for success. We help life sciences companies in all stages of the clinical lifecycle navigate their data and statistical computing demands in a way that is scalable, validated, and compliant. Learn more about Strong Tower Solutions here:
