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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 has initiated dosing for the first patient in a continuous dosing regimen of the G3 formulation of luxeptinib for relapsed or refractory acute myeloid leukemia (AML). This Phase 1a/b clinical trial seeks to enhance drug bioavailability significantly, as the new formulation is expected to provide similar plasma exposure to the higher dose of the original formulation while reducing potential toxicity. The company is optimistic about the G3's efficacy and hopes it will yield better clinical responses in difficult-to-treat AML patients.
Aptose Biosciences Inc. (NASDAQ: APTO) announced the acceptance of clinical data for tuspetinib and luxeptinib for poster presentations at the 64th American Society of Hematology (ASH) Annual Meeting from December 10-13, 2022, in New Orleans, LA. The studies include a Phase 1/2 trial for tuspetinib in patients with relapsed or refractory acute myeloid leukemia and a Phase 1a/b trial for luxeptinib targeting similar patient groups. Furthermore, a clinical update webcast will be held during the ASH meeting.
Aptose Biosciences announced the completion of its Phase 1/2 trial for tuspetinib (HM43239), demonstrating a superior safety profile and clinical responses, including complete remissions in challenging r/r AML patients. The company reported a net loss of $9.8 million for Q3 2022, an improvement from $11.3 million in Q3 2021. Total cash as of September 30, 2022, was $55.4 million. Recruitment for an expansion trial will target enriched patient populations, with continuous dosing of the new luxeptinib G3 formulation commencing soon.
Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS) announced it will release its financial results for the quarter ending September 30, 2022, on November 1, 2022, after market close. The company will also provide a corporate update during a conference call scheduled for 5:00 PM ET that same day. This call can be accessed via an audio webcast, and a replay will be available for 30 days on the company's website. Relevant documents will be available on SEDAR and EDGAR.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) will participate in the Cantor Oncology, Hematology & HemeOnc Conference on September 28, 2022. Dr. Rafael Bejar, Chief Medical Officer, will join a panel discussion titled “Leukemia & MDS” and will conduct one-on-one meetings with attendees alongside CFO Fletcher Payne. The panel presentation is scheduled for 3:25 p.m. ET. Aptose is focused on developing oral kinase inhibitors for hematologic malignancies, boasting investigational products like HM43239 and luxeptinib aimed at improving treatment response.
Aptose Biosciences Inc. has appointed Dr. Bernd R. Seizinger to its Board of Directors. With over 25 years of experience in biotechnology and pharmaceuticals, including senior positions at Bristol-Myers Squibb, Dr. Seizinger strengthens Aptose's leadership. The board now consists of seven members with diverse expertise. Dr. Seizinger expressed excitement to contribute to Aptose's advancement in developing oral hematology drugs, which include HM43239 and luxeptinib, currently in clinical trials.
Aptose Biosciences Inc. (NASDAQ: APTO) announced a significant advancement in its G3 formulation of luxeptinib, which shows an 18-fold improvement in oral bioavailability compared to the previous G1 formulation. This enhancement supports Aptose's plans for continuous dosing trials in relapsed/refractory acute myeloid leukemia (AML) patients. The original G1 formulation led to limited effectiveness, whereas the new G3 formulation aims to provide better absorption and clinical outcomes. Aptose's lead compound, HM43239, continues to progress through clinical trials.
Aptose Biosciences announced participation in the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. Dr. William G. Rice, Chairman and CEO, will present on September 13 at 11:30 a.m. ET. Additionally, one-on-one meetings with management will be available. Aptose focuses on developing oral kinase inhibitors for hematologic malignancies, with two key investigational drugs in clinical trials. For more details, visit www.aptose.com.
Aptose Biosciences Inc. (NASDAQ: APTO) reported a net loss of $10.6 million for Q2 2022, down from $13.5 million in Q2 2021. Total cash and equivalents reached $62.4 million, sufficient to fund operations through Q1 2024. The company highlighted a promising 43% response rate for HM43239 in relapsed/refractory AML patients with FLT3 mutations, despite the challenges of achieving complete remissions. Aptose is also advancing its dual inhibitor, Luxeptinib, and aims for accelerated approval in high-need AML subpopulations.
Aptose Biosciences Inc. (NASDAQ: APTO) announced that Dr. William G. Rice and CFO Mr. Fletcher Payne will attend the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 3:30 p.m. ET. Dr. Rice will present at the conference, and the management team will also hold one-on-one meetings. Aptose is focused on developing innovative oral kinase inhibitors for treating hematologic malignancies, with investigational products HM43239 and luxeptinib in clinical trials for conditions such as acute myeloid leukemia and B-cell malignancies.
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