Chronic myelomonocytic leukemia

Immune-Onc Therapeutics Announces Orphan Drug Designation Granted by US FDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic Myelomonocytic Leukemia (CMML)

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수요일, 2월 21, 2024

Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML).

Key Points: 
  • Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML).
  • IO-202 received Fast Track Designation for treatment of relapsed or refractory CMML in 2023.
  • In addition, Fast Track and Orphan Drug Designations for IO-202 were granted by the FDA for the treatment of acute myeloid leukemia (AML) in 2022 and 2020, respectively.
  • “We are very proud that the FDA has granted IO-202 Orphan Drug Designation for the treatment of CMML.

Investigator-initiated Phase 1/2 Clinical Trial Using Salarius Pharmaceuticals’ Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment

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수요일, 1월 3, 2024

While these efforts are ongoing, the Company continues to support the continuation of its clinical programs, as appropriate.

Key Points: 
  • While these efforts are ongoing, the Company continues to support the continuation of its clinical programs, as appropriate.
  • In October 2022, the FDA placed the MDACC investigator-initiated trial under a partial clinical hold following a suspected unexpected serious adverse reaction (SUSAR) in the FET-rearranged arm of Salarius’ Phase 1/2 trial with seclidemstat in sarcomas.
  • In addition to the MDACC investigator-initiated clinical trial, seclidemstat has been studied in a company-sponsored Phase 1/2 clinical trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with TC as a treatment for relapsed and refractory Ewing sarcoma.

Treadwell Therapeutics Announces a Presentation at the 2023 ASH Annual Meeting and Advisory Board Meeting

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금요일, 12월 15, 2023

TORONTO and SAN MATEO, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Treadwell Therapeutics, a clinical-stage biotechnology company developing novel first-in-class medicines for unmet needs in cancer, today announced a presentation for the Company's lead program, CFI-400945, a first-in-class inhibitor of Polo-like Kinase 4 (PLK4) being advanced in relapsed/refractory AML, at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 9-12, 2023. Treadwell also conducted a clinical advisory board meeting on December 10th at ASH with experienced experts in the treatment of AML and in clinical trials of novel agents, which included current investigators and thought leaders new to the program.

Key Points: 
  • Treadwell also conducted a clinical advisory board meeting on December 10th at ASH with experienced experts in the treatment of AML and in clinical trials of novel agents, which included current investigators and thought leaders new to the program.
  • "CFI-400945 is demonstrating complete remissions as a single agent and in combination with azacitadine in relapsed, adverse risk AML, including those with TP53 mutant disease.
  • Three of 6 evaluable patients with AML achieved a response (MLFS=2, CRi=1 with MRD+) at the 96mg dose​.
  • PK characteristics support daily dosing of CFI-400945 and PD studies are ongoing​.

The Ehlers-Danlos Society Receives $6.7 Million from the Mike and Sofia Segal Foundation to Advance Cutting-Edge Research for Ehlers-Danlos Syndrome

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수요일, 12월 20, 2023

NEW YORK, Dec. 20, 2023 /PRNewswire/ -- The Ehlers-Danlos Society, the global non-profit dedicated to advancing and accelerating research in the Ehlers-Danlos syndromes (EDS) and hypermobility spectrum disorders (HSD), today announced it has received a $6.7 million funding commitment from the Mike and Sofia Segal Foundation (the "Foundation") to advance its groundbreaking research initiatives.

Key Points: 
  • The support from the Mike and Sofia Segal Foundation is invaluable in propelling our research towards earlier diagnosis.
  • In 1978, Mike and Sofia Segal arrived in the U.S. from present-day Ukraine with $120, a young child, and just two suitcases.
  • The partnership between the Ehlers-Danlos Society and the Foundation marks a significant leap forward in the quest for breakthroughs in EDS and HSD research.
  • The Ehlers-Danlos Society and the Foundation hope this investment will serve as a catalyst, inspiring related contributions and collaborations within the scientific community and beyond.

The Leukemia & Lymphoma Society Receives $17 Million from the Mike and Sofia Segal Family Foundation to Accelerate Progress in the Treatment of Chronic Myelomonocytic Leukemia

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수요일, 10월 25, 2023

RYE BROOK, N.Y., Oct. 25, 2023 /PRNewswire/ -- The Leukemia & Lymphoma Society® (LLS), the largest nonprofit funder of leading-edge research for every type of blood cancer to improve treatment options for patients, today announced it has received $17 million from the Mike and Sofia Segal Family Foundation to advance the treatment of chronic myelomonocytic leukemia (CMML), a rare type of blood cancer. The $17 million commitment is the largest-ever outright gift from an individual donor that LLS has received and brings attention to the remarkable power of transformative giving.

Key Points: 
  • CMML impacts approximately 1,100 people in the U.S. each year and in most cases cannot be cured.
  • This generous gift will fund research to accelerate the development of new treatments for those diagnosed with this rare disease.
  • Mike Segal and his wife, Sofia, emigrated from present-day Ukraine to the U.S. in 1978 with 120 dollars, a four-year-old child, and two suitcases.
  • Mike and Sofia Segal will leave a lasting mark when it comes to accelerating progress in CMML."

NextCure Presents Non-Clinical Data Defining the Mechanism of NC525 at the 2023 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting

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수요일, 6월 21, 2023

“Our pre-clinical models showed that NC525 specifically eradicates leukemic stem cells (LSCs) and blast cells, while preserving healthy hematopoietic cells,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer.

Key Points: 
  • “Our pre-clinical models showed that NC525 specifically eradicates leukemic stem cells (LSCs) and blast cells, while preserving healthy hematopoietic cells,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer.
  • “The data presented in the poster define the mechanism that leads to specific induction of apoptosis in leukemic cells, but not in healthy immune cells.
  • High expression of LAIR-1 is seen on leukemic stem cells and blast cells, where it plays a role in survival of these cancer cells.
  • The current Phase 1 study is an open-label, non-randomized, dose escalation trial to determine safety and tolerability of NC525 in adult patients with relapsed or refractory AML.

Immune-Onc Therapeutics Presents IO-202 Phase 1 Data in Patients with Relapsed or Refractory AML and CMML at the EHA Annual Meeting 2023

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목요일, 6월 8, 2023

Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.

Key Points: 
  • Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.
  • “AML is the most common form of acute leukemia in adults in the U.S. and is characterized by high rates of relapsed and refractory disease.
  • Monocytic AML is especially in need of break-through medicine as it is often resistant to standard-of-care treatment.
  • Poster presentation details are as follows:
    Title: A first-in-human Phase 1 study of IO-202 (anti-LILRB4 mAb) in Acute Myeloid Leukemia (AML) with monocytic differentiations and Chronic Myelomonocytic Leukemia (CMML) patients.

Salarius Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

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월요일, 3월 27, 2023

HOUSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and 12 months ended December 31, 2022 and provided a business update.

Key Points: 
  • Cash and cash equivalents were $12.1 million as of December 31, 2022, compared with $29.2 million as of December 31, 2021.
  • Research and development expenses were $4.7 million in the fourth quarter of 2022, compared with $2.7 million in the fourth quarter of 2021.
  • As of December 31, 2022, Salarius had cash, cash equivalents and restricted cash of $12.1 million, compared with $29.2 million as of December 31, 2021.
  • Current cash and cash equivalents are expected to fund the company’s planned operations into the fourth quarter of 2023.

Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor

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화요일, 12월 13, 2022

The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

Key Points: 
  • The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.
  • "CFI-400945 had previously shown single agent complete remissions in refractory high risk AML.
  • Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.
  • The Company's internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor).

Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor

Retrieved on: 
화요일, 12월 13, 2022

The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

Key Points: 
  • The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.
  • "CFI-400945 had previously shown single agent complete remissions in refractory high risk AML.
  • Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.
  • The Company's internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor).