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Aptose Biosciences, Inc. (NASDAQ: APTO, TSX: APS) is a clinical-stage biotechnology company dedicated to developing precision medicines for the treatment of life-threatening cancers. This science-driven organization is focused on advancing first-in-class agents targeting acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), and other hematologic malignancies. Based on a deep understanding of the genetic and epigenetic profiles of specific cancers and patient demographics, Aptose is building a robust pipeline of novel oncology therapies aimed at dysregulated processes and signaling pathways.
One of Aptose's pioneering agents, tuspetinib (TUS), is a highly potent, first-in-class pan-FLT3/BTK inhibitor. Developed as a small molecule therapeutic, tuspetinib targets various key kinases such as SYK, FLT3, JAK1/2, and mutant forms of KIT, RSK2, and TAK1-TAB1. This mechanism of action not only combats the proliferation of AML cells but also minimizes the typical cytotoxic side effects associated with conventional cancer treatments, thus enhancing the quality of life for patients.
Tuspetinib has shown significant promise in ongoing clinical trials. In the APTIVATE Phase 1/2 study, tuspetinib, both as a monotherapy and in combination with venetoclax (VEN), has demonstrated favorable safety profiles and robust efficacy in relapsed/refractory AML patients. This includes patients with various genetic mutations and those who have failed prior therapies. Notably, tuspetinib has demonstrated a 48% overall response rate when used in combination with venetoclax, making it a potential candidate for accelerated approval in difficult-to-treat VEN-resistant AML cases.
Aptose is also developing luxeptinib (CG-806), an oral, dual lymphoid and myeloid kinase inhibitor currently in Phase 1 a/b development. Luxeptinib targets relapsed or refractory hematologic malignancies and is being positioned for future clinical trials using its new generation 3 (G3) formulation, which has shown improved pharmacokinetics and tolerability.
Recently, Aptose has entered strategic financial transactions, including a public offering and private placement, to support the further development of tuspetinib and general corporate activities. With strong clinical data and robust financial backing, Aptose continues to make strides in the oncology field, aiming to bring life-saving treatments to patients in need.
Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS) announced it will release its Q2 2022 financial results on August 2, 2022, after market close, alongside a corporate update. A conference call is scheduled for the same day at 5:00 PM ET. Participants must preregister for dial-in details. The company focuses on developing oral kinase inhibitors for hematologic malignancies, currently advancing two candidates in clinical trials. More details will be available on SEDAR and EDGAR.
Aptose Biosciences has appointed Fletcher Payne as the new Senior Vice President and Chief Financial Officer (CFO). With over two decades of finance experience in the biotech sector, Payne previously held CFO roles at notable companies including Syapse and Catalyst Bioscience. His expertise will be pivotal as Aptose advances its clinical-stage products, HM43239 and luxeptinib, which target hematologic malignancies. Aptose aims to leverage his strategic insights to enhance its financial operations and strengthen its executive management team.
Aptose Biosciences (NASDAQ: APTO) announced significant developments during a recent KOL update event on June 2, 2022. Findings from clinical trials of HM43239, a promising oral myeloid kinome inhibitor, showed eight responses, including seven complete remissions (CRs) at three dose levels (80 mg, 120 mg, 160 mg). Additionally, the G3 formulation of luxeptinib displayed favorable pharmacokinetics, indicating improved absorption. Expansion trials for HM43239 and luxeptinib are set to commence in 2022 and 2023, respectively. These advancements enhance Aptose's potential in treating acute myeloid leukemia (AML).
Aptose Biosciences announced significant updates at a recent event, highlighting clinical data for two investigational products: HM43239 for AML and luxeptinib. HM43239 demonstrated new complete remission (CRi) at 160 mg in AML patients with wildtype FLT3. The drug has shown up to eight complete remissions across various doses. The G3 formulation of luxeptinib also showed promising pharmacokinetics, with rapid absorption and sustained exposure. Expansion trials for both drugs are expected to begin in late 2022 and 2023, respectively.
Aptose Biosciences Inc. (NASDAQ: APTO), a clinical-stage oncology company, held its annual and special meeting of shareholders on May 31, 2022. During the meeting, 53.46% of common shares were represented. All nominees from the April 19, 2022 proxy statement were elected as Directors, with votes for nominees ranging from 93.22% to 97.99%. Shareholders also approved the re-appointment of KPMG LLP as the public accounting firm, an amendment to the 2021 Stock Incentive Plan allowing an increase of 3 million shares, and a resolution on executive compensation.
Aptose Biosciences (NASDAQ: APTO) announced a webinar on its investigational therapies HM43239 and luxeptinib for treating acute myeloid leukemia (AML) on June 2, 2022. The event will feature leading hematology experts, including Dr. Brian Druker, discussing the treatment landscape and unmet needs in AML. Additionally, Aptose's leadership will provide updates on its two clinical-stage therapies aimed at addressing hematologic malignancies. The company focuses on personalized oncology therapies, with its pipeline including key candidates in clinical trials.
Aptose Biosciences Inc. (NASDAQ: APTO) announced a corporate update for investors on June 2nd at 4:30 PM ET. The session will cover clinical data from two investigational products: HM43239, targeting acute myeloid leukemia (AML), and luxeptinib, for relapsed B-cell malignancies and AML. Additionally, HM43239's preclinical data will be presented on June 10th at the EHA2022 Hybrid Congress in Vienna. Aptose focuses on developing personalized oncology therapies to address unmet medical needs in hematology.
Aptose Biosciences Inc. (NASDAQ: APTO) reported a net loss of $11.5 million for Q1 2022, down from $16.2 million in Q1 2021. As of March 31, 2022, cash and cash equivalents totaled $69.5 million, sufficient to fund operations into Q4 2023. The FDA granted Fast Track designation for its drug HM43239, aimed at treating relapsed acute myeloid leukemia (AML). The company is expanding its cohort for HM43239 and advancing luxeptinib in clinical trials. Additionally, Aptose appointed Dr. Philippe Ledru as Chief Commercial Officer to spearhead future product launches.
Aptose Biosciences announced the FDA granted Fast Track designation to HM43239, an oral kinase inhibitor for relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation. This designation aims to expedite HM43239's development, facilitating communication between the FDA and Aptose. Currently, HM43239 is in an ongoing Phase 1/2 clinical trial, showing promise in delivering complete remissions in R/R AML patients, including those resistant to prior FLT3 inhibitors. Aptose remains focused on developing targeted therapies for hematologic malignancies, enhancing treatment options for patients.
Aptose Biosciences announced that Dr. William G. Rice will participate in the 2022 RBC Capital Markets Global Healthcare Conference on May 17, 2022, from 3:30 to 4:00 p.m. ET. The event features a fireside chat moderated by Gregory J. Renza, M.D. The management team will also host 1x1 meetings during the conference. Aptose is a clinical-stage biotechnology company focused on developing targeted therapies for hematologic malignancies. Their pipeline includes two investigational products for treating acute myeloid leukemia and B-cell malignancies.
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