Biotech

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, is releasing highlights from a corporate update event being held today, Friday, June 11, 2021, at 8:00 a.m. ET, in concurrence with participation at the EHA2021 Virtual Congress (EHA). The event is focused on the current clinical status of luxeptinib, Aptose's oral, first-in-class FLT3 and BTK kinase inhibitor currently in two Phase 1 ab trials, one trial in patients with relapsed or refractory acute myeloid leukemia (AML), and the other trial in patients with relapsed or refractory B cell malignancies. The live and archived webcast of the presentation is available on Aptose's website here .

"Our recent clinical experience has confirmed that luxeptinib is an active drug in several indications across both myeloid and lymphoid malignancies, which is consistent with our hypotheses from our broad portfolio of preclinical work," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We are especially encouraged to see this anti-tumor activity -- including meaningful blast reductions -- emerging even in heavily pretreated and clinically challenging patients, and we now look forward to continuing dosing at higher exposures for longer periods in order to explore fully the potential of this singular drug."

Aptose's presentation provides a recap on luxeptinib, including the following key highlights:

Luxeptinib clinical program in AML

  • In the ongoing Phase 1a/b study in patients with relapsed or refractory AML, we completed the first two dose cohorts (450mg and 600mg) and have escalated to the third cohort (750mg). We plan to dose escalate further and have observed no safety trends likely to prevent continued escalation.
  • We achieved anticipated steady state PK levels and PD inhibition of target kinases, in line with our parallel study in different patient populations.
  • The first two dose cohorts delivered encouraging anti-leukemic activity in multiple patients, including a durable MRD-negative complete response in a FLT3-ITD AML patient who had relapsed after two allogeneic stem cell transplants, multiple lines of chemotherapy, and prior FLT3 inhibitor therapy.
  • Based on the totality of our preclinical and clinical observations to date, we expect to select an expansion dose and expansion cohort strategy for AML during 2H21 and aim to explore select disease genotypes under monotherapy and combination therapy programs.

Luxeptinib clinical program in B-cell malignancies

  • In the ongoing Phase 1a/b study in B-cell malignancies, intermediate dose levels to date have delivered all leading indicators of clinical activity, including target engagement with dose-dependent inhibition of phospho-BTK, treatment-related lymphocytosis in patients presenting with classic CLL, and tumor reductions across different B-cell malignancies (FL, CLL, SLL, WM).
  • We continue to observe cases of clear reversal of aggressively growing disease upon intra-patient dose-escalation and longer times on drug, suggesting that even aggressive disease may be successfully challenged with higher exposure levels and extended dosing duration of luxeptinib.
  • We currently are treating patients at 750mg BID, and we plan to continue further escalation to higher dose levels and for extended duration to tackle an increasingly treatment refractory presenting population.
  • We plan to continue exploring the spectrum of B-cell malignancies in line with the preliminary anti-tumor activity observed in the study to date.

In addition, clinical data for luxeptinib and APTO-253 were presented at EHA this morning. The APTO-253 poster presentation contained a full update of the clinical status of APTO-253, a first-in-class small molecule MYC inhibitor in a Phase 1a/b trial in patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (MDS). The posters are now available on the presentations page of Aptose's website here .

Key highlights from the APTO-253 poster:

  • In the ongoing Phase 1a/b study in patients with relapsed or refractory AML and high-risk MDS, APTO-253 has been well-tolerated in the patients treated at 20, 40, 66, 100 and 150 mg/m 2 over multiple cycles.
  • In the peripheral blood of patients, APTO-253 monomer rapidly transforms to and co-exists with the mechanistically active Fe(253) 3 conjugate, and the serum levels of APTO-253 and the Fe(253) 3 conjugate are dose proportional with significantly higher concentrations of Fe(253) 3 conjugate that are sustained for longer periods of time compared to monomer, suggesting that further dose escalations may provide more sustained pressure on the MYC target gene and alter the biology of the tumor cells.
  • Collectively, the findings from the ongoing Phase 1a/b study support continued dose escalation of APTO-253. The study is current enrolling patients with AML and MDS at the sixth dose level of 210 mg/m 2 , and subsequent dose escalations are anticipated.

About Aptose

Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company has two clinical-stage investigational products for hematologic malignancies. The first investigational product, luxeptinib, an oral, first-in-class mutation-agnostic FLT3/BTK kinase inhibitor, is in a Phase 1a/b trial in patients with relapsed or refractory B cell malignancies, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and non-Hodgkin lymphoma (NHL), who have failed or are intolerant to standard therapies, and in a separate Phase 1a/b trial in patients with relapsed or refractory acute myeloid leukemia (AML). The second investigational product, APTO-253, the only known clinical stage agent that directly targets the MYC oncogene and suppresses its expression, is in a Phase 1a/b clinical trial for the treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (MDS).

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, the clinical development plans and timelines, the clinical potential and favorable properties of luxeptinib and APTO-253, the CG-806 Phase 1 a/b B-cell malignancy and Phase 1 a/b AML clinical trials, the APTO-253 Phase 1b clinical trial, and statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as "continue", "expect", "intend", "will", "hope", "should", "would", "may", "potential" 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; 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 and economic conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; the potential impact of the COVID-19 pandemic 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
Investor Relations
201-923-2049
spietropaolo@aptose.com
LifeSci Advisors, LLC
Dan Ferry, Managing Director
617-535-7746
Daniel@LifeSciAdvisors.com

Primary Logo

News Provided by GlobeNewswire via QuoteMedia

Gilead Joins First-of-its-Kind Public-Private Initiative to Improve Management of Viral Hepatitis in Vietnam and the Philippines

- Public-Private Effort to Shift Traditional Model of Hepatitis Management to Primary Care and Help to Expand Care to More People in Need -

Gilead Sciences, Inc. today announced a new public-private initiative with the Partnership for Health Advancement in Vietnam (HAIVN), a collaboration between Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year initiative will have a phased approach to help address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in Vietnam and the Philippines, two countries with high burdens of hepatitis B and C.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

The Forces of Beauty® Report from The DREAM Initiative® Reveals Demand for New Standards of Beauty and Imagery

--Initiative Creates Groundbreaking New, Royalty Free Inclusive Image Gallery In Strategic Partnership with Shutterstock Studios--

Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), and skinbetter science ® announce a new report from their DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative ® along with a long-term partnership with Shutterstock Studios. The report, titled Forces of Beauty ® provides a new understanding of what inclusive and representative beauty looks like today by shedding light on how narrowly defined Eurocentric ideals continue to impact women of color. By surveying over 4,000 women aged 21-65, from multiple geographic locations and backgrounds, the report explores what defines beauty, how beauty impacts women's lives, and the interplay between beauty and race. Some key insights include:

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
The Gummy Project Expands in US After Receiving Purchase Order from 5-Star Luxury Four Seasons Hotel San Francisco to Become Supplier of Gummy Products for Guest Room Mini-Bars

The Gummy Project Expands in US After Receiving Purchase Order from 5-Star Luxury Four Seasons Hotel San Francisco to Become Supplier of Gummy Products for Guest Room Mini-Bars

  • The Gummy Project's Peachy Bees and Watermelon Sharks expected to be featured for sale in all 277 guest rooms at the 5-star luxury Four Seasons Hotel San Francisco
  • Purchase order from world class hotel marks the achievement of another milestone in The Gummy Project's ongoing multi-channel sales strategy

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the 5-star luxury Four Seasons Hotel San Francisco to become a supplier of gummies for each of the hotel's 277 guest room mini-bars.

"We are thrilled to continue our strategic expansion in the US and honoured to have been selected by the luxury 5-star Four Seasons Hotel San Francisco to be a supplier of Peachy Bees and Watermelon sharks for hotel guest rooms," said Charlie Lamb, President & CEO of GUMY. "We very much look forward to developing a long-term relationship with The Four Seasons Hotel San Francisco, who not only are a world class hotel but who also share our commitment to a more sustainable future for everyone."

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Komo Plant Based Foods Expands Distribution through Quality Foods Grocery Chain

Komo Plant Based Foods Expands Distribution through Quality Foods Grocery Chain

Komo Plant Based Foods Inc. (CSE:YUM) (OTCQB:KOMOF) (FRA:9HB) ("Komo") is pleased to announce Quality Foods will be carrying Komo's 2 serving Lasagna, Shepherd's Pie and Mac & Greens as well as both Meal Helpers (Bolognese and Taco Filling) at all Quality Foods locations

Quality Foods is a British Columbia owned, award-winning leader in the Canadian grocery industry with brick and mortar stores in 13 locations in B.C. including Qualicum Foods in Qualicam Beach, Quality Foods in Parksville, Nanoose Bay, Nanaimo (Harewood), Nanaimo (Northridge Village), Port Alberni, Comox, Courtenay, Campbell River, Powell River, Victoria (Langford) and Victoria (View Royal).

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Gilead Sciences Completes Acquisition of MiroBio

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash. The acquisition provides Gilead with MiroBio's proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio's lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Aurinia Pharmaceuticals Announces Presentations at American College of Rheumatology Convergence 2022

Five abstracts underscore the long-term safety and efficacy of voclosporin, including in Latino patients and patients with Class V lupus nephritis

Data presentation on pre-clinical asset AUR200 reinforces Aurinia's commitment to autoimmune disease

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×