TKD

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

Retrieved on: 
Thursday, November 2, 2023

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia

Retrieved on: 
Monday, May 1, 2023

Phase I study (COVALENT-103) of BMF-500 will examine its safety and efficacy in patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr / NPM1 mutations.

Key Points: 
  • Phase I study (COVALENT-103) of BMF-500 will examine its safety and efficacy in patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr / NPM1 mutations.
  • BMF-500 has demonstrated approximately 20-fold greater potency compared to Gilteritinib in acute myeloid leukemia (AML) cell lines, MV-4-11 and MOLM-13.
  • BMF-219 and BMF-500 preclinical combination shows greater than additive cell killing in acute leukemia cell lines and patient samples.
  • These data provide preclinical evidence for combining pathway-specific inhibitors as a promising therapeutic strategy for further investigation in acute leukemia.

MaxQ @ Kirtland & Northrop Grumman Unveil New Facility

Retrieved on: 
Thursday, April 13, 2023

Albuquerque, NM, April 13, 2023 (GLOBE NEWSWIRE) -- MaxQ at Kirtland, a new mixed-use development located on Kirtland Air Force Base (AFB), held a ribbon cutting with Northrop Grumman on its first phase.

Key Points: 
  • Albuquerque, NM, April 13, 2023 (GLOBE NEWSWIRE) -- MaxQ at Kirtland, a new mixed-use development located on Kirtland Air Force Base (AFB), held a ribbon cutting with Northrop Grumman on its first phase.
  • While technically on Kirtland AFB, MaxQ will not be behind the security fence, and tenants will be accessible to the public.
  • Northrop Grumman unveiled its new 27,000-square-foot facility to expand capacity to support space systems engineering, integrated mission operations and cybersecurity services for Kirtland Air Force Base and other U.S. military customers.
  • Northrop Grumman is the first organization to occupy a stand-alone building at MaxQ.

Aptose Reports Results for the Fourth Quarter and Full Year 2022

Retrieved on: 
Thursday, March 23, 2023

SAN DIEGO and TORONTO, March 23, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced financial results for the fourth quarter and year ended December 31, 2022, and provided a corporate update.

Key Points: 
  • The net loss for the quarter ended December 31, 2022, was $10.0 million ($0.11 per share) compared with $24.3 million ($0.27 per share) for the quarter ended December 31, 2021.
  • Total cash and cash equivalents and investments as of December 31, 2022, were $47.0 million.
  • Aptose Appoints VP, Controller – During the fourth quarter, Aptose appointed Brooks Ensign, Vice President and Controller.
  • A summary of the results of operations for the years ended December 31, 2022 and 2021 is presented below:

Aptose Initiates Dosing of Tuspetinib in APTIVATE Expansion Trial in Patients with Acute Myeloid Leukemia

Retrieved on: 
Monday, January 30, 2023

SAN DIEGO and TORONTO, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib (formerly HM43239), an oral, mutation agnostic tyrosine kinase inhibitor (TKI) being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML). In parallel, another clinical response has been achieved by a R/R AML patient receiving 40 mg tuspetinib once daily orally in the original dose exploration trial, the second response at the recently launched low-dose 40 mg cohort.

Key Points: 
  • SAN DIEGO and TORONTO, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib (formerly HM43239), an oral, mutation agnostic tyrosine kinase inhibitor (TKI) being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML).
  • Importantly, Aptose has elucidated a rationale for the superior safety profile of tuspetinib.
  • In the APTIVATE expansion trial, tuspetinib also will be tested in combination with venetoclax.
  • “We are pleased to have dosing underway in our APTIVATE clinical trial of tuspetinib in a very ill R/R AML population,” said William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer.

Aptose Announces Updated Clinical Responses, Breadth of Activity, and Safety Across Four Dose Levels of Tuspetinib in Difficult-to-Treat Acute Myeloid Leukemia Populations

Retrieved on: 
Sunday, December 11, 2022

“The welcome blend of safety and breadth of activity seen with tuspetinib in AML patients makes this an ideal candidate for combination therapy,” remarked Dr. Daver.

Key Points: 
  • “The welcome blend of safety and breadth of activity seen with tuspetinib in AML patients makes this an ideal candidate for combination therapy,” remarked Dr. Daver.
  • Prior to Aptose licensing tuspetinib, Hanmi Pharmaceutical Company demonstrated complete remissions at the 80 mg dose level.
  • As of January 1, 2022, Aptose assumed control of clinical trial activities and has demonstrated additional complete remissions at the 120 mg, 160 mg, and now the 40 mg dose levels.
  • Vignettes of patient experiences highlight the potency and breadth of tuspetinib to deliver complete remissions among several mutationally-defined populations with a diversity of adverse mutations.

Infinite Electronics, Inc. Expands Position in European Market with Agreement to Acquire Cable Connectivity Group

Retrieved on: 
Tuesday, November 8, 2022

CCG is a leader in the production, distribution and assembly of specialty cables and cable connectivity solutions.

Key Points: 
  • CCG is a leader in the production, distribution and assembly of specialty cables and cable connectivity solutions.
  • The company operates across Europe with offices and production and distribution facilities in the Netherlands, Belgium, Germany, Poland, Italy and China.
  • We are very excited to welcome CCG and the team to Infinite Electronics and our portfolio of high-performing brands.
  • Cable Connectivity Group (CCG) is active in the production, distribution and assembly of specialty cables and cable connectivity solutions.

Infinite Electronics, Inc. Expands Position in European Market with Agreement to Acquire Cable Connectivity Group

Retrieved on: 
Tuesday, November 8, 2022

IRVINE, Calif., Nov. 8, 2022 /PRNewswire-PRWeb/ -- Infinite Electronics, Inc., a leading global supplier of electronic components serving the needs of customers through a family of highly recognized and trusted brands, has announced today that it signed a definitive agreement to acquire Cable Connectivity Group (CCG) from Torqx Capital Partners (Torqx) and TKH Group NV (TKH). The transaction is subject to customary regulatory approval and is expected to close in Q1 2023.

Key Points: 
  • The transaction is subject to customary regulatory approval and is expected to close in Q1 2023.
  • CCG is a leader in the production, distribution and assembly of specialty cables and cable connectivity solutions.
  • We are very excited to welcome CCG and the team to Infinite Electronics and our portfolio of high-performing brands.
  • Cable Connectivity Group (CCG) is active in the production, distribution and assembly of specialty cables and cable connectivity solutions.

Biomea Fusion to Present Preclinical Data for BMF-500, an Investigational Oral Covalent FLT3 Inhibitor, at the 64th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 3, 2022

We believe the preclinical data we will present at ASH has the potential to establish BMF-500 as the most potent and selective FLT3 inhibitor reported to date.

Key Points: 
  • We believe the preclinical data we will present at ASH has the potential to establish BMF-500 as the most potent and selective FLT3 inhibitor reported to date.
  • The potent covalent inhibition of FLT3 by BMF-500 manifested in effective and durable cellular response that was improved over gilteritinib.
  • In cells harboring FLT3 activating mutations, BMF-500 induced dose-dependent inhibition of FLT3 phosphorylation and downstream signaling, including phospho-STAT5 and phospho-ERK.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Monday, October 24, 2022

The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the FLT3-ITD mutation.

Key Points: 
  • The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the FLT3-ITD mutation.
  • Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select relapsed and refractory AML patients eligible for quizartinib in Japan.
  • "Invivoscribe's filing with the FDA for the use of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for quizartinib is an important milestone.
  • This submission to the FDA further solidifies the LeukoStrat CDxFLT3Mutation Assay as the international benchmark for FLT3 mutationassessments.