CMML

Faron’s Financial Statement Release January 1 to December 31, 2023

Retrieved on: 
Wednesday, March 13, 2024
Head, Q&A, Survival, Immunotherapy, Patient, Medicine, Standard of care, CMML, Macrophage, Faron Pharmaceuticals, Neoplasm, EET, Rheumatology, PD-1, TME, PR, ASH, AML, Cancer, Johnson & Johnson, Safety, Azacitidine, MDS, BLA, Decitabine, Food, ODD, Nasdaq First North, PD, Tumor microenvironment, Manuscript, CRS, SICAV, MD, Interferon beta-1a, Haematopoietic system, GMT, FDA, AIM, Neurotoxicity, Infection, EUR, Sanofi, SOC, Metabolism, European Hematology Association, EDT, MBA, IPF, Facility, Treasury, Society, Cytokine release syndrome, CPA, Pharmaceutical industry

As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter.

Key Points: 
  • As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter.
  • Loss for the period for the financial year ended December 31, 2023, was EUR 30,9 million (2022: EUR 28,7 million).
  • In June 2023, Faron conducted a placement of 2,601,510 newly issued treasury shares to investors to raise EUR 6,6 million gross.
  • In October 2023, the Company successfully raised EUR 7,1 million gross through the issuance of 2,491,998 ordinary shares to investors.

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

Retrieved on: 
Wednesday, February 21, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, AZA, AML, LILRB4, Azacitidine, Marketing, Food, Inflammation, HMA, Therapy, Bone marrow, CMML, Patient, Autoimmunity, Chronic myelomonocytic leukemia, Diagnosis, Acute myeloid leukemia, Pharmaceutical industry

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.

Inside information: Faron Announces First HMA-failed MDS Patient Dosed with Bexmarilimab as part of Phase 2 of BEXMAB Trial

Retrieved on: 
Tuesday, January 9, 2024
Patient, Azacitidine, Risk, FDA, Nasdaq First North, HMA, Disease, Myelodysplastic syndrome, CMML, AIM, MDS, Standard of care, ASH, Myelocyte, Faron Pharmaceuticals, SOC, Safety, Phase II, Majesty of the Seas, Pharmaceutical industry

TURKU, Finland and BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announced that the first patient has been dosed in Phase 2 of the BEXMAB trial that evaluates the safety and efficacy of bexmarilimab, in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options.

Key Points: 
  • The ongoing, randomized parallel-assigned Phase 2 part is enrolling 32 HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose levels of bexmarilimab.
  • Patients are being randomized 1:1 between the doses before moving into a Phase 2/3 study expansion.
  • Post selection of final dosing, Faron intends to discuss a potential registrational study plan with the FDA.
  • The Company’s key focus is to pursue an accelerated path to approval in refractory higher risk MDS, where no treatment option exists.

Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised

Retrieved on: 
Saturday, January 6, 2024
Patient, RNA, Medical Subject Headings, Liver, Marketing, INN, Risk, Classification, Bone marrow, ATC, IPSS, International, WHO, B cell, Myeloid tissue, Azacitidine, Myelodysplastic syndrome, CMML, DNA, Nausea, Blood, Language, MDS, Cancer, Abdomen, Death, Myelocyte, European Medicines Agency, Syndrome, Monocyte, Thigh, Growth, Select, HSCT, Anatomy, AML, Pancreatic serous cystadenoma, Acute leukemia, IIA, Skin, Cytidine, Vomiting, Medical device

Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised

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

Retrieved on: 
Wednesday, January 3, 2024
DCR, LSD1, SUSAR, Database, Canaccord Genuity, Food, Survival, Learning, Cyclophosphamide, Chronic myelomonocytic leukemia, Probability, Bone marrow, FDA, TC, Progression-free survival, Myelodysplastic syndrome, CMML, MD, MDS, Clinical trial, Monroe Dunaway Anderson, University, Azacitidine, Effectiveness, MD Anderson Cancer Center, Sarcoma, Patient, Ewing sarcoma, Pharmaceutical industry

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.

Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Date of authorisation: 17/12/2008, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Marketing, INN, Risk, Leukopenia, Woman, Nausea, DNA, Cancer, Death, Anatomy, Pancreatic serous cystadenoma, IIA, CHMP, Skin, Bone marrow, ATC, IPSS, Myeloid tissue, European, Ageing, MDS, Abdomen, Kidney, Neutrophil, Blood, Syndrome, Thigh, Patient, RNA, Medical Subject Headings, European Commission, WHO, B cell, International, Neutropenia, Language, CMML, Myelodysplastic syndrome, Thrombocytopenia, Monocyte, Select, HSCT, Medicine, Vomiting, Cytidine, Survival, Classification, Stomach, Myelocyte, Growth, Committee, AML, Acute leukemia, Medical device

Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Date of authorisation: 17/12/2008, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Date of authorisation: 17/12/2008, Revision: 27, Status: Authorised

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

Retrieved on: 
Wednesday, December 20, 2023
Leukemia, Ehlers-Danlos Society, Quality of life, Partnership, Chronic myelomonocytic leukemia, Rupture, Research, Bone marrow, Pain, Blood, Tissue, CMML, Cardiovascular disease, EDS, Society, Subluxation, Ehlers–Danlos syndromes, Joint, Dislocation, HSD, Bruise, Diagnosis, Injury, Child

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.

Aptose Reports Results for the Third Quarter 2023

Retrieved on: 
Thursday, November 9, 2023
Apoptosis, ASH, University, Acute myeloid leukemia, APS, Patient, Poster, VEN, SYK, TUS, FLT3, ORR, KIT, CMML, Toxic leukoencephalopathy, AML, MD Anderson Cancer Center, Society, TSX, Cell, European School, Pharmaceutical industry, Airline, Venetoclax

“Investigator enthusiasm for our tuspetinib/venetoclax (TUS/VEN) doublet has led to brisk enrollment in the APTIVATE trial.

Key Points: 
  • “Investigator enthusiasm for our tuspetinib/venetoclax (TUS/VEN) doublet has led to brisk enrollment in the APTIVATE trial.
  • In the most recent data cut (October 23, 2023), the favorable safety profile remained consistent for TUS and TUS/VEN treated R/R AML patients.
  • Aptose researchers investigated the effects of TUS on key elements of the phospho-kinome and apoptotic proteome in both parental and TUS-resistant AML cells.
  • APTIVATE oral presentation at ASH 2023 by Dr.

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

Retrieved on: 
Wednesday, October 25, 2023
Child, Acute myeloid leukemia, Leukemia, Rare, Family, Mortality, Mike, Disease, Research, LLS, Life expectancy, Risk, Clinical trial, Chronic myelomonocytic leukemia, Bone marrow, Patient, Diagnosis, AML, Pharmaceutical industry, CMML

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

Retrieved on: 
Wednesday, June 21, 2023
CMML, Myelodysplastic syndrome, Survival, Chronic myelomonocytic leukemia, Cancer, Acute myeloid leukemia, AML, Federation, Patient, Apoptosis, Mab, Federation of Clinical Immunology Societies, Safety, Vaccine

“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.