tuspetinib (TUS)

Search documents
Aptose Biosciences Announces Results of Reconvened Annual and Special Shareholders Meeting and Appointment of Ernst & Young LLP as New Auditor
GlobeNewswire News Roomยท 2025-08-22 21:01
Core Insights - Aptose Biosciences Inc. is a clinical-stage precision oncology company focused on developing tuspetinib (TUS) as a frontline therapy for newly diagnosed acute myeloid leukemia (AML) [1][4] Group 1: Shareholder Meeting Outcomes - Shareholders voted to appoint Ernst & Young LLP as the independent registered public accounting firm for the Company [2] - The appointment of EY is expected to enhance the Company's growth and commitment to transparency due to their expertise in the life sciences sector [2] Group 2: Funding and Financial Updates - Aptose has received an additional US$1.5 million in funding from Hanmi Pharmaceutical Co. Ltd. as part of an US$8.5 million loan facility agreement [3] - To date, the Company has received a total of US$7.1 million under the Loan Agreement to support the clinical development of tuspetinib [3]
Aptose Reports Second Quarter 2025 Results
Globenewswireยท 2025-08-13 20:30
Core Insights - Aptose Biosciences Inc. reported financial results for Q2 2025, highlighting progress in the TUSCANY triplet trial for treating newly diagnosed acute myeloid leukemia (AML) with tuspetinib-based therapy [1][2] Financial Performance - The net loss for Q2 2025 was $7.0 million, a decrease from $7.3 million in Q2 2024. For the first half of 2025, the net loss was $12.6 million, down from $16.9 million in the same period of 2024 [11][12] - Research and development expenses for Q2 2025 were $3.3 million, down from $4.4 million in Q2 2024. For the first half of 2025, these expenses totaled $5.7 million, compared to $10.9 million in the first half of 2024 [14][17] Clinical Development - The TUSCANY trial is advancing with promising safety and efficacy results for the tuspetinib (TUS) combination therapy, showing complete responses (CRs) across various genetic backgrounds in AML patients [4][5] - The Cohort Safety Review Committee (CSRC) recommended escalating the tuspetinib dose from 120 mg to 160 mg based on positive safety data [4][5] - Data from the TUSCANY trial was presented at the European Hematology Association (EHA) 2025 Congress, indicating that TUS can be safely combined with standard treatments [5][6] Corporate Developments - Aptose entered a loan agreement with Hanmi Pharmaceutical for up to $8.5 million to support the development of tuspetinib [6][9] - The company has been upgraded to trade on the OTCQB Market, enhancing its visibility among investors [9] - Aptose selected Ernst & Young as its new independent auditor and will hold a reconvened shareholder meeting on August 22, 2025 [9][10] Research and Development Focus - The company is focusing on the development of precision oncology therapies, particularly for hematological malignancies, with tuspetinib as a lead candidate [17][19] - Program costs for tuspetinib were $2.2 million for Q2 2025, down from $2.7 million in Q2 2024, attributed to reduced clinical trial activities [18]
Aptose Enrollment is Open for 160 mg Dosing Cohort of Tuspetinib in Phase 1/2 TUSCANY Trial of Frontline Triple Drug Therapy
GlobeNewswire News Roomยท 2025-08-06 20:30
Core Insights - Aptose Biosciences is advancing its clinical-stage precision oncology drug, tuspetinib (TUS), in a Phase 1/2 trial called TUSCANY, focusing on a triplet therapy for newly diagnosed acute myeloid leukemia (AML) patients [1][6][10] - The Cohort Safety Review Committee has approved an increase in the TUS dosage from 120 mg to 160 mg based on positive safety and efficacy data [1][9] - The triplet therapy (TUS+VEN+AZA) aims to provide a safe and effective treatment for a diverse population of AML patients who cannot undergo induction chemotherapy [3][6] Financial Updates - Aptose has received an additional advance of US$1.1 million from Hanmi Pharmaceutical as part of an US$8.5 million loan facility agreement, totaling US$5.6 million received to date [2][9] Clinical Trial Details - The TUSCANY trial is designed to evaluate the safety and efficacy of TUS in combination with standard doses of venetoclax (VEN) and azacitidine (AZA) [7][9] - The trial is being conducted at 10 leading U.S. clinical sites, with an expected enrollment of 18-24 patients by late 2025 [7][9] - Initial cohorts at 40 mg, 80 mg, and 120 mg doses have shown no significant safety concerns or dose-limiting toxicities, with patients achieving complete remissions and minimal residual disease negativity [3][4][5] Therapeutic Potential - The TUS+VEN+AZA triplet therapy is positioned as a unique, mutation-agnostic frontline treatment for newly diagnosed AML patients, particularly those with adverse mutations [5][6] - Data from the trial indicate that patients with challenging mutations, such as biallelic TP53 or FLT3-ITD, have achieved complete remissions safely [5][9]
Aptose Selects Ernst & Young Global Limited as its New Independent Auditor and Calls Reconvened Meeting of its Shareholders
Globenewswireยท 2025-08-01 11:30
Group 1 - Aptose Biosciences Inc. will hold a reconvened shareholder meeting on August 22, 2025, to vote on the appointment of Ernst & Young LLP as the new independent auditor [1][2] - The selection of Ernst & Young was based on their expertise, capabilities, and understanding of the company's industry [2] - The original meeting held on May 27, 2025, was adjourned to complete the search for a successor independent auditor [1] Group 2 - Only registered shareholders and duly appointed proxyholders as of April 22, 2025, will be entitled to vote and ask questions at the reconvened meeting [3] - Proxies from the original meeting will remain effective unless properly revoked, and new forms of proxies are not being distributed [4] - Registered shareholders who have not previously deposited a form of proxy may do so no later than 48 hours before the reconvened meeting [4] Group 3 - Aptose is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [5] - The company's lead product, tuspetinib (TUS), is being developed as a frontline triplet therapy for newly diagnosed acute myeloid leukemia (AML) [5]
Aptose Receives Second Advance under the Loan Agreement with Hanmi Pharmaceutical to Continue Development of Tuspetinib in Triplet Therapy for AML
GlobeNewswire News Roomยท 2025-07-15 21:00
Core Insights - Aptose Biosciences Inc. has received an additional US$2.0 million from Hanmi Pharmaceutical as part of an US$8.5 million loan facility agreement, bringing the total received to US$4.5 million [1] - The company is developing tuspetinib (TUS) as a frontline therapy for newly diagnosed acute myeloid leukemia (AML), demonstrating promising antileukemic activity and safety across diverse patient populations [2] - Tuspetinib is a once-daily oral agent that inhibits multiple kinases associated with AML, maintaining a favorable safety profile compared to other treatments [2] - The ongoing TUSCANY Phase 1/2 study is evaluating TUS in combination with azacitidine and venetoclax for patients ineligible for induction chemotherapy [2] Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [3] - The company's pipeline includes small molecule cancer therapeutics aimed at providing efficacy without overlapping toxicities [3] - Tuspetinib is the lead compound, showing activity as both a monotherapy and in combination therapy for relapsed or refractory AML, and is being developed for newly diagnosed patients [3]
Aptose Upgraded to Trade on OTCQB Market
Globenewswireยท 2025-07-01 12:00
Group 1 - Aptose Biosciences Inc. has been upgraded to trade on the OTCQB Market under the ticker symbol "APTOF" starting July 1, 2025, while continuing its listing on the Toronto Stock Exchange (TSX) under "APS" [1] - The OTCQB Venture Market is designed for early-stage and developing companies that are current in their reporting and undergo an annual verification process [2] - Aptose is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology, with its lead product being the oral kinase inhibitor tuspetinib (TUS) [3]
Aptose Announces Deferral of Interest Payment
Globenewswireยท 2025-06-30 21:00
Core Insights - Aptose Biosciences Inc. has entered into an Interest Deferral Agreement with Hanmi Pharmaceutical Co., Ltd. to defer interest payments on a loan facility agreement [1] - The deferral period for the interest payments extends from December 21, 2024, to March 31, 2025, and from June 27, 2025, to December 31, 2025 [1] Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [2] - The company's lead compound, tuspetinib (TUS), is an oral kinase inhibitor showing efficacy as both a monotherapy and in combination therapy for relapsed or refractory acute myeloid leukemia (AML) [2] - Tuspetinib is being developed as a frontline triplet therapy for newly diagnosed AML patients [2]
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
Globenewswireยท 2025-06-12 16:00
Core Insights - Aptose Biosciences Inc. presented data from its Phase 1/2 TUSCANY trial for newly diagnosed AML patients treated with tuspetinib in combination with venetoclax and azacitidine at the EHA 2025 Congress [1][3] Group 1: Study Overview - The TUS+VEN+AZA triplet is being developed as a mutation-agnostic frontline therapy for newly diagnosed AML patients who cannot receive induction chemotherapy [2][8] - The TUSCANY trial is designed to test various doses of tuspetinib in combination with standard dosing of azacitidine and venetoclax [9] Group 2: Key Findings - The addition of tuspetinib to standard care creates a well-tolerated and mutation-agnostic frontline therapy for newly diagnosed AML [5] - Ten AML patients have been treated with the TUS+VEN+AZA combination, with complete remissions and minimal residual disease negativity observed across diverse mutations [6][7] - At the 40 mg dose level, three out of four patients achieved complete remissions and were MRD-negative, while at the 80 mg dose level, all three patients achieved composite complete remissions [6] Group 3: Safety and Efficacy - No dose-limiting toxicities (DLTs) have been observed to date, and all ten subjects treated remain alive [6][7] - TUS demonstrated activity across diverse genetic populations, including those with adverse TP53 mutations [6][8] - The triplet therapy continues to be well tolerated, with no treatment-related deaths or significant adverse events reported [6][7]
Aptose Announces Dosing of First Patient with 120 mg of Tuspetinib in Phase 1/2 Tuscany Trial of Frontline Triple Drug Therapy after Dose Escalation Decision by Safety Review Committee
Globenewswireยท 2025-05-20 11:30
Core Viewpoint - Aptose Biosciences Inc. is advancing its clinical-stage precision oncology therapy, tuspetinib (TUS), in a Phase 1/2 trial (TUSCANY) for newly diagnosed acute myeloid leukemia (AML) patients, with recent approval to escalate dosing based on positive safety and efficacy data [1][2][3]. Group 1: Clinical Trial Progress - The Cohort Safety Review Committee has approved the escalation of the TUS dose from 80 mg to 120 mg due to favorable safety and efficacy data [1][3]. - The first patient has been dosed at the 120 mg level, and enrollment for this cohort is ongoing [1][7]. - No significant safety concerns or dose-limiting toxicities have been reported in the trial, including no prolonged myelosuppression in subjects [2][7]. Group 2: Efficacy and Safety Data - Data from the initial cohorts (40 mg and 80 mg) show promising clinical safety and antileukemic activity, even in difficult-to-treat AML populations [3][4]. - The TUS+VEN+AZA triplet therapy has achieved complete remissions (CRs) and minimal residual disease (MRD) negativity with favorable safety profiles [7]. Group 3: Future Presentations and Data - Updated data will be presented at the European Hematology Association Congress (EHA 2025) in Milan, Italy, including safety, CRs, MRD, and pharmacokinetic findings [2][4]. - The TUSCANY trial is being conducted at 10 leading U.S. clinical sites, with an anticipated enrollment of 18-24 patients by mid-late 2025 [5].
Aptose Selected for Prestigious Oral Presentation of Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2025 EHA Congress
Globenewswireยท 2025-05-14 17:07
Core Insights - Aptose Biosciences Inc. announced that data from its Phase 1/2 TUSCANY trial will be presented at the European Hematology Association Congress in June 2025, focusing on the TUS+VEN+AZA triplet therapy for newly diagnosed AML patients [1][2] Group 1: TUSCANY Trial Overview - The TUS+VEN+AZA triplet is being developed as a safe and mutation-agnostic frontline therapy for newly diagnosed AML patients who cannot receive induction chemotherapy [2][4] - Initial dose cohorts of the TUS+VEN+AZA triplet have shown safety, complete remissions, and minimal residual disease (MRD) negativity across diverse mutation profiles, including TP53 and FLT3 [2][4] - The TUSCANY trial is being conducted at 10 leading U.S. clinical sites, with an expected enrollment of 18-24 patients by mid to late 2025 [5] Group 2: Presentation Details - The oral presentation at EHA will include updated safety data, complete remission rates, and MRD findings, along with longer follow-up duration [2][3] - The presentation is scheduled for June 12, 2025, and will be led by Dr. Gabriel Mannis from Stanford University [3] Group 3: Company Background - Aptose Biosciences is focused on developing precision medicines for unmet medical needs in oncology, particularly in hematology [7] - The lead clinical-stage oral kinase inhibitor, tuspetinib (TUS), has shown activity as both a monotherapy and in combination therapy for relapsed or refractory AML [7]