Latest news with #TUS
Hamilton Spectator
4 days ago
- Business
- Hamilton Spectator
Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2025 EHA Congress
SAN DIEGO and TORONTO, June 12, 2025 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. ('Aptose' or the 'Company') (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, today announced data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) in an oral presentation at the European Hematology Association Congress (EHA 2025), being held June 12-15, 2025, in Milan, Italy. The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine, and an investigator in the TUSCANY study, reported safety and efficacy data from the first two dose cohorts at 40 mg of TUS or 80 mg of TUS in the TUS+VEN+AZA triplet. Dr. Mannis also noted three patients were rapidly enrolled on the third dose cohort of 120 mg TUS in the TUS+VEN+AZA triplet, and that no DLTs have been observed to date. The oral presentation at EHA included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up: Title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy Presenter: Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine Abstract #: S139 Key findings: 'The TUSCANY triplet trial is well under way, and we are observing exciting activity with the addition of TUS to the VEN+AZA standard treatment,' said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. 'The data presented today reveal complete responses across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients. TUS appears to have tremendous opportunity in the largest markets and the most challenging of AML cases.' Abstracts are available on the EHA2025 website here . The presentation is available on the Aptose website here . TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes. The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025. Data will be released as it becomes available. More information on the TUSCANY Phase 1/2 study can be found on ( here ). About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit . Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential and safety profile of tuspetinib (including the triplet therapy) and its clinical development, the anticipated enrollment rate in the TUSCANY trial and the timing thereof, as well as statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact: Aptose Biosciences Inc. Susan Pietropaolo Corporate Communications & Investor Relations 201-923-2049 spietropaolo@
Yahoo
4 days ago
- Business
- Yahoo
Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2025 EHA Congress
Addition of TUS to standard of care VEN+AZA creates a well-tolerated and mutation agnostic frontline triple drug therapy for newly diagnosed AML AML patients with diverse mutations, including TP53-mutated/CK and FLT3-wildtype, safely achieved complete remissions and MRD negativity Ten AML patients dosed across 40 mg, 80 mg, and 120 mg TUS with TUS+VEN+AZA triplet SAN DIEGO and TORONTO, June 12, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ('Aptose' or the 'Company') (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, today announced data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) in an oral presentation at the European Hematology Association Congress (EHA 2025), being held June 12-15, 2025, in Milan, Italy. The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine, and an investigator in the TUSCANY study, reported safety and efficacy data from the first two dose cohorts at 40 mg of TUS or 80 mg of TUS in the TUS+VEN+AZA triplet. Dr. Mannis also noted three patients were rapidly enrolled on the third dose cohort of 120 mg TUS in the TUS+VEN+AZA triplet, and that no DLTs have been observed to date. The oral presentation at EHA included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up: Title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy Presenter: Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine Abstract #: S139 Key findings: To date, ten newly diagnosed AML patients have received the TUS+VEN+AZA combination: Four received the 40 mg dose of TUS, three received the 80 mg dose of TUS, and three received the 120 mg dose of TUS At the initial dose of 40 mg TUS (n=4), with patients on longest duration of drug: Three subjects achieved CRs and were MRD-negative, including Patient with FLT3-ITD Patient with FLT3-WT Patient with TP53/CK At the 80 mg TUS dose level (n=3): All three patients (100%) already achieved composite complete remissions (CR and CRi) A TP53-mutated/CK AML patient achieved an early CRi Too early in treatment for final MRD assessment At the 120 mg TUS dose level (n=3): All three patients at the 120 mg TUS dose level remain on therapy Too early in treatment for formal response and MRD assessments Regardless of mutation status, TUS is active in newly diagnosed AML patients MRD-negative responses achieved across diverse genetic populations, including adverseTP53 mutations and CK Responses continue to evolve, and the triplet continues to be well tolerated with no DLTs TUS can be administered safely with standard-of-care dosing of VEN/AZA TUS PK properties not altered by VEN, AZA, antifungals or food No prolonged myelosuppression in Cycle 1 in the absence of AML No treatment-related deaths; all 10 subjects treated to date remain alive No treatment related QTc prolongation, CPK elevations, differentiation syndrome or non-hematologic SAEs 'The TUSCANY triplet trial is well under way, and we are observing exciting activity with the addition of TUS to the VEN+AZA standard treatment,' said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. 'The data presented today reveal complete responses across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients. TUS appears to have tremendous opportunity in the largest markets and the most challenging of AML cases.' Abstracts are available on the EHA2025 website here. The presentation is available on the Aptose website here. TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes. The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025. Data will be released as it becomes available. More information on the TUSCANY Phase 1/2 study can be found on (here). About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential and safety profile of tuspetinib (including the triplet therapy) and its clinical development, the anticipated enrollment rate in the TUSCANY trial and the timing thereof, as well as statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact: Aptose Biosciences Inc. Susan Pietropaolo Corporate Communications & Investor Relations 201-923-2049 spietropaolo@
Irish Times
6 days ago
- Sport
- Irish Times
Leaving Cert student diary: ‘Biology isn't my strongest subject - but that was a lovely paper'
Do as much as possible in as little time as I can: that's been my motto for the past few weeks. I really pulled the socks up to get these exams over the line. So far, the exams have been good. I enjoyed the first English paper, though the second was trickier. Same with maths: a good paper one followed by a more difficult paper two. Irish was good, and I liked the essay titles which were broad and easy to expand on, although I found the listening comprehension more challenging than previous years. And biology, not my strongest subject, was such a lovely paper today, and definitely the most accessible in years. READ MORE I hope to study athletic and rehabilitation at TUS (Technological University of the Shannon), and this degree would allow me to move into a masters in physiotherapy. I've considered studying abroad, as the Netherlands offers a similar course and it would be delivered through English. But I think I'd prefer to stay here – I'm from the area, TUS is a good university, and I could keep up my part-time job in the local Dunnes Stores. I love sports and I play for the Garrycastle GAA club, so I could keep that up if I stay local. Of course, the cost of living away from home is huge, and accommodation is so hard to find, so being at home would be so much more affordable. I'm doing all higher-level subjects, except for maths. I'm already at a disadvantage. At the start of fifth year, I did higher-level maths because I wanted the chance to get those 25 bonus points. But I quickly realised that I would have to neglect my other subjects, especially the ones that I'm strong in. It wasn't an easy decision to automatically drop to ordinary level and be 25 points down – just because I have strengths other than maths. I ultimately decided it made more sense to focus on the subjects I actually liked, but I know that so many do higher-level maths, struggle with it and fall behind in their other subjects. I just don't understand who this system serves. Still to come: Spanish, agricultural science and construction studies. For those last two, I've already done a significant chunk through project work. Nearly there. I'm aiming for as high as I can get – then it's time to put the feet up, relax and go on our Leaving Cert Albufeira trip. – Killian Keegan is a Leaving Cert student at Athlone Community College
Irish Times
06-06-2025
- Health
- Irish Times
Leaving Cert student diary: ‘I'm proof there's an alternative to incredibly stressful exams'
I'm only young, so it's fair to say I don't follow the ins and outs of education policy. But I do hear, from my friends and on the news, about how incredibly stressful the Leaving Cert is and how it needs to be reformed. I and the other 4,512 students sitting the Leaving Cert Applied [LCA] are living proof that there is a different way. The LCA means students like me, who prefer practical and vocational approaches, are not left behind. I know Ireland is trailing other European countries in terms of offering this vocational option, although the numbers sitting the LCA are growing every year. The LCA offers entry routes to college too. I am hoping to get into a post-Leaving Cert course: nursing studies at Moate ETB [education and training board]. It gives us a foundation in nursing, includes practical experience and a work placement, and is also linked to a general nursing course at TUS [Technological University of the Shannon]. READ MORE Over the past few years, I decided to learn sign language. I'm not doing it as an examined subject, but I felt that it would be a really useful skill for a nurse to have, as it means I can communicate with more people. I'm not fluent, but I can hold a basic conversation and I hope to improve. As for the exams? It's a case of so far, so good. I appreciated the layout of the papers and they haven't been as difficult as I expected. English and communications was probably my best so far, as a lot of the topics I studied appeared. Hotel catering and tourism, however, was probably the most challenging, although still achievable. In this subject, we learn about restaurants, tourist sites and we work on menus for parties and for people with food allergies and intolerances, such as coeliac disease. LCA students have already done a lot of projects and continuous assessment throughout the year, so that relieves the pressure of a single, high-stakes exam. [ Leaving Cert and Junior Cycle: Record 140,000 to sit State exams Opens in new window ] I can't believe the end is in sight, as I finish up on Tuesday with an exam on construction and graphics. I'll miss my classmates in school. There's only been eight of us in the entire LCA programme, so we became tight-knit. I currently commute for over an hour every day to and from school. This is because we moved a few years ago but I wanted to stay in the same school. I wish there was better public transport, particularly for rural areas, as there's currently only two buses a day. It's safe to say that I won't miss this commute. – Amy Cox is a Leaving Cert Applied student at Athlone Community College
Agriland
01-06-2025
- Science
- Agriland
Loop Head at forefront of agricultural sustainability research
Local community development group, Loop Head Together CLG, which is based in the Loop Head peninsula, Co. Clare, was recently awarded €1.75 million to conduct a soil carbon enhancement project aimed at determining the feasibility of restoring soil health in coastal farming regions of Ireland. The funding forms part of an overall investment of €17.8 m in eleven projects under the European Innovation Partnership (EIP), which forms part of the Common Agricultural Policy strategic plan. The announcement coincides with the current roll-out of Loop Head's involvement in Ireland mid-west's Living Lab, a European-funded project called Soilcrates. Loop Head The new project firmly places Loop Head at the forefront of this research around sustainability in agriculture, according to Margaret Cotter, chairperson of Loop Head Together CLG. The group – in collaboration with Technological University of the Shannon (TUS) through research fellow Dr Lena Madden, and assisted by consultants Laura Foley MSc and Michelle Cooney – submitted an EIP proposal to roll out a research project on the Loop Head peninsula, The project is dedicated to soil carbon enhancement, reducing nutrient run-offs and the need for chemical fertilisers, and exploring the potential for circular bio-economy solutions in agriculture. The project is co-funded by the Department of Agriculture, Food and the Marine (DAFM) and the EU. DAFM cited not only its support of the project as an extension of the department's overall mission to improve soil health, but also pointed out that the project is highly relevant and aligns with the department's priorities around promoting the circular and bio economy. According to Loop Head Together CLG, the most important part of this project is that it will be carried out in conjunction with farmers on the ground with the aim of improving not just the soil but also the long-term viability and sustainability of farming and agriculture generally, With soil management and soil health literally being the foundation of environmental sustainability, these learnings have the potential to have very positive impacts on both the environment and agriculture across the country, the CLG stated. With the Loop Head peninsula also already being the pilot decarbonising zone for Co. Clare, Loop Head Together CLG expressed its gratitude for the support of Clare County Council – in particular, Morgan Lahiffe and the wider climate action team – when it came to putting together this proposal for Loop Head. Dr. Lena Madden, research fellow at TUS. Image source: Longford County Council. The proposal will also see support from University College Dublin, Munster Technological University, Premier Green, Kracken Seeds, EIT Climate, Arigna Fuels, the ICOS, and agricultural consultants Damien Coyne Ltd. Minister of State at the DAFM, Timmy Dooley, cited the project as a 'way of exploring and demonstrating best practice across the country in terms of sustainable farming'. He described the economic impact of developing better systems for farmers in a way that does not damage the long-term viability of the farm or the soil. 'Research projects like these puts the farming community at the forefront of such findings, meaning that farming is protected going forward,' Minister Dooley said. Fine Gael Deputy, Joe Cooney commended the community on the Loop Head peninsula. 'I'm delighted to see the Loop Head Together organisation getting acknowledged at department level in this way, for the innovative and strategic approach it has taken in tackling some of the challenges that face coastal farming communities. 'I look forward to engaging with them as they progress the project,' Deputy Cooney said. This project, which is rolling out under the working title of SCEENE (Soil Carbon Enhancement for Excess Nutrient Elimination) is still pending final clarifications and signing of contracts, but it is hoped to move towards implementation in the coming months. Local community Margaret Cotter, chairperson of Loop Head Together CLG, said that the goal with the project as a group 'is to support our local farming community in finding solutions to the challenges presented by climate change'. 'The two principal economic drivers in Loop Head are tourism and agriculture and we are acutely aware as a community of the need to support both to ensure the sustainability of our locality into the future.' Cotter pointed out that the project would not have been possible without Loop Head Together's ongoing collaboration with TUS and in particular Dr. Lena Madden. 'Lena has brought with her the extensive expertise of her colleagues and friends who form the operational group for the project. We are also very grateful to the Department of Agriculture Food and the Marine for selecting us in this competitive process.' Loop Head Together CLG expressed thanks to its local community on Loop Head for supporting their efforts to work together towards protecting farms and the environment, and in promoting the potential for circular bioeconomy solutions that will help keep rural communities thriving into the future.
