Aptose Presents Highlights from ASH and Company Replace Occasion Nasdaq:APTO

SAN DIEGO and TORONTO, Dec. 06, 2020 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) right this moment launched highlights from a company replace occasion held on Sunday, December 6^th, at the side of participation on the 2020 American Society of Hematology (ASH) Annual Assembly. The Aptose administration crew reviewed the present scientific standing of CG-806, Aptose’s oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor presently in two Section 1 a/b trials, one trial in sufferers with relapsed or refractory acute myeloid leukemia (AML), and the opposite trial in sufferers with relapsed or refractory B cell malignancies; and the crew additionally reviewed the scientific standing of APTO-253, a first-in-class small molecule MYC inhibitor in a Section 1 a/b trial in sufferers with relapsed or refractory AML or excessive danger myelodysplastic syndrome (MDS).

The webcast of the presentation is on the market on Aptose’s web site right here.

Aptose supplied a recap on CG-806 and included the next key highlights:

B-cell malignancy trial

• Growing plasma publicity with elevated dose ranges, with sustained regular state focus (trough stage) above 2M within the newest cohort (750mg)
• Progressive accrual of main indicators of pharmacologic and scientific exercise up to now, together with sturdy inhibition of a number of key oncogenic goal pathways (together with BTK) on track lymphocytosis in basic CLL sufferers, and modest tumor reductions in numerous tumor varieties
• Newest cohort (750mg) presently beneath enlargement following a probably drug-related DLT, nonetheless subsequent knowledge and analyses counsel this occasion is unlikely associated to check drug
• Usually nicely tolerated with no toxicity tendencies up to now that might stop dose escalation
• Based mostly on scientific observations up to now, research enrollment now centered on sure forms of CLL sufferers

AML trial

• Initiated dosing with 450mg BID as probably lively dose based mostly on track engagement analyses
• Quickly enrolled 4 sufferers on research drug, together with each FLT3-ITD and FLT3-WT
• Preliminary PK knowledge according to exposures noticed with 450mg dose stage in CLL/NHL sufferers
• Noticed potential anti-leukemic exercise in a single closely pretreated FLT3+ AML affected person, together with discount within the proportion of peripheral blood blast depend from 93% to 10% in cycle one
• Usually nicely tolerated with no toxicity tendencies up to now that might stop dose escalation

Aptose additionally reviewed the present standing of APTO-253:

• Continued favorable security and tolerability in closely pretreated sufferers with relapsed or refractory AML and MDS
• Continued dose-related publicity, with sustained lively drug species within the 2-3µM vary on the fourth dose stage of 100mg/m²
• Noticed reductions in MYC expression in PBMCs in 24 hours following dosing in most sufferers
• Persevering with dosing of sufferers on the fifth dose stage of 150mg/m²

“The on-target lymphocytosis and modest nodal reductions we have observed in CLL patients being treated with CG-806 may be leading indicators of potential eventual responses, similar to what has been observed in the development of other successful BTK inhibitors,” mentioned William G. Rice, Ph.D., Chairman, President and Chief Government Officer. “We are encouraged by the continued increase in plasma exposure, and we hope the current and future dose levels will deliver formal responses to these deeply relapsed or refractory CLL patients. In AML, we are pleased by the observation of an anti-leukemic blast reduction from 93% to 10% in one of our first patients who was heavily pretreated with several consecutive FLT3 inhibitors. For APTO-253, we continue to escalate the dose and observe MYC repression, suggesting future potential for broad anti-cancer activity. We are pleased by such indicators of activity from both CG-806 and APTO-253, and we look forward to providing further updates in the first half of 2021 and at the Annual EHA Meeting 2021.”

As well as, early scientific knowledge, together with sure preclinical knowledge for CG-806 and APTO-253, had been introduced on the ASH Annual Assembly and Exposition. The posters at the moment are out there on the displays web page of Aptose web site right here.

About Aptose

Aptose Biosciences is a clinical-stage biotechnology firm dedicated to creating customized therapies addressing unmet medical wants in oncology, with an preliminary concentrate on hematology. The Firm’s small molecule most cancers therapeutics pipeline consists of merchandise designed to offer single agent efficacy and to reinforce the efficacy of different anti-cancer therapies and regimens with out overlapping toxicities. The Firm has two clinical-stage investigational merchandise for hematologic malignancies: CG-806, an oral, first-in-class mutation-agnostic FLT3/BTK kinase inhibitor, is in a Section 1 trial in sufferers with relapsed or refractory B cell malignancies, together with continual lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and non-Hodgkin lymphoma (NHL), who’ve failed or are illiberal to straightforward therapies, and is in a separate Section 1 trial in sufferers with relapsed or refractory acute myeloid leukemia (AML); APTO-253, the one identified scientific stage agent that instantly targets the MYC oncogene and suppresses its expression, is in a Section 1b scientific trial for the remedy of sufferers with relapsed or refractory AML or excessive danger myelodysplastic syndrome (MDS).

Ahead Trying Statements

This press launch comprises forward-looking statements inside the that means of Canadian and U.S. securities legal guidelines, together with, however not restricted to, the scientific growth plans, the scientific potential and favorable properties of APTO-253 and CG-806, the APTO-253 Section 1b ,the CG-806 Section 1 a/b B-cell malignancy, and Section 1 a/b AML scientific trials, and statements regarding the Firm’s plans, targets, expectations and intentions and different statements together with phrases comparable to “continue”, “expect”, “intend”, “will”, “hope”, “should”, “would”, “may”, “potential” and different comparable expressions. Such statements replicate our present views with respect to future occasions and are topic to dangers and uncertainties and are essentially based mostly upon plenty of estimates and assumptions that, whereas thought-about affordable by us, are inherently topic to important enterprise, financial, aggressive, political and social uncertainties and contingencies. Many elements might trigger our precise outcomes, efficiency or achievements to be materially completely different from any future outcomes, efficiency or achievements described on this press launch. Such elements might embody, amongst others: our potential to acquire the capital required for analysis and operations; the inherent dangers in early stage drug growth together with demonstrating efficacy; growth time/price and the regulatory approval course of; the progress of our scientific trials; our potential to search out and enter into agreements with potential companions; our potential to draw and retain key personnel; altering market and financial circumstances; lack of ability of latest producers to supply acceptable batches of GMP in ample portions; sudden manufacturing defects; the potential impression of the COVID-19 pandemic and different dangers detailed from time-to-time in our ongoing quarterly filings, annual data varieties, annual stories and annual filings with Canadian securities regulators and the USA Securities and Alternate Fee.

Ought to a number of of those dangers or uncertainties materialize, or ought to the assumptions set out within the part entitled “Danger Elements” in our filings with Canadian securities regulators and the USA Securities and Alternate Fee underlying these forward-looking statements show incorrect, precise outcomes may range materially from these described herein. These forward-looking statements are made as of the date of this press launch and we don’t intend, and don’t assume any obligation, to replace these forward-looking statements, besides as required by legislation. We can not guarantee you that such statements will show to be correct as precise outcomes and future occasions might differ materially from these anticipated in such statements. Buyers are cautioned that forward-looking statements usually are not ensures of future efficiency and accordingly traders are cautioned to not put undue reliance on forward-looking statements as a result of inherent uncertainty therein.

For additional data, please contact: