CD135

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 Reports Third Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, October 30, 2023

Both studies are now open for enrollment more than a quarter ahead of schedule.

Key Points: 
  • Both studies are now open for enrollment more than a quarter ahead of schedule.
  • Finally in this quarter, we also initiated the clinical study of our second, Biomea-discovered investigational covalent inhibitor, BMF-500, a novel FLT3 inhibitor.
  • Continued to advance development candidates derived from Biomea’s proprietary FUSION™ System platform to discover novel covalently binding small molecules.
  • G&A expenses were $17.1 million for the nine months ended September 30, 2023 compared to $15.2 million for the same period in 2022.

Biomea Fusion Reports Second Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, July 31, 2023

Our goal at Biomea is to develop a treatment that can halt or reverse disease progression in patients with type 1 and type 2 diabetes.

Key Points: 
  • Our goal at Biomea is to develop a treatment that can halt or reverse disease progression in patients with type 1 and type 2 diabetes.
  • We look forward to continuing to evaluate BMF-219’s proposed mechanism of action and its potential therapeutic impact as this study progresses.
  • BMF-500 is an investigational oral covalent inhibitor of FLT3, designed and developed in-house, and the second investigational compound discovered by Biomea’s FUSION™ System.
  • G&A expenses were $11.4 million for the six months ended June 30, 2023 compared to $9.9 million for the same period in 2022.

Biomea Fusion Reports First Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Tuesday, May 2, 2023

We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss.

Key Points: 
  • We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss.
  • With its intended disease-modifying mechanism of action, BMF-219 could potentially represent a monumental shift for the treatment of patients with diabetes.
  • Reported initial clinical data in March 2023 from the first two cohorts of the Phase II portion of COVALENT-111.
  • Report initial clinical data of AML/ALL patients (including those with MLLr rearrangement and NPM1 mutations) dosed in the COVALENT-101 study in the second quarter of 2023.

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.

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.

Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Retrieved on: 
Monday, October 24, 2022

The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.

Key Points: 
  • The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.
  • The FDAs prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
  • Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens.
  • Eligible patients, including those who underwent hematopoietic stem cell transplant (HSCT), continued with quizartinib or placebo for up to 36 cycles.

Quizartinib Marketing Authorization Application Validated by EMA for Treatment of Adult Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Retrieved on: 
Tuesday, August 23, 2022

We look forward to working with the EMA to support their review of quizartinib as a potential option for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.

Key Points: 
  • We look forward to working with the EMA to support their review of quizartinib as a potential option for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
  • The application is based on data from the QuANTUM-First phase 3 trial recently presented at the European Hematology Association (#EHA2022) Congress.
  • Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens.
  • Quizartinib is currently approved for use in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test.

CTI BioPharma Announces Presentation at the 2022 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Tuesday, May 10, 2022

SEATTLE, May 10, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced one poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2021.

Key Points: 
  • SEATTLE, May 10, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced one poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2021.
  • Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.
  • CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.
  • VONJOTM is a trademark of CTI BioPharma Corp.

ORYZON Announces FDA Approval of IND for FRIDA, a Phase Ib Trial With Iadademstat in R/R AML FLT3mut+ Patients

Retrieved on: 
Monday, March 21, 2022

FRIDA is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3mutations.

Key Points: 
  • FRIDA is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3mutations.
  • Dr. Carlos Buesa, President and CEO of Oryzon, said: FDAs clearance to start FRIDA is a relevant corporate milestone for Oryzon and the patients we hope to serve.
  • Iadademstat, a uniquely potent and selective LSD1 inhibitor, has already shown a safe profile and high and prolonged responses in AML patients in combination with azacitidine.
  • In an ongoing Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2021 poster).