Faron Pharmaceuticals

Faron Confirms Plans for the Coming Months Under New Leadership

Retrieved on: 
Tuesday, April 16, 2024
FDA, Science, Nasdaq First North, Myelodysplastic syndrome, Safety, Myelocyte, Food, SOC, Majesty of the Seas, AIM, Fårö, ASCO, Faron Pharmaceuticals, Patient, Society, Standard of care, MDS, Pharmaceutical industry

This data readout will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024.

Key Points: 
  • This data readout will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024.
  • “2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab,” said Dr. Juho Jalkanen, Faron’s incoming Chief Executive Officer.
  • “In my new role as CEO, I am excited to start executing on some of these key activities and accelerating important discussions with the FDA as we map our future plans for bexmarilimab together.
  • There is a tremendous need for an effective treatment in HMA-failed MDS patients, and so we are very keen to ensure we get this treatment option to patients as soon as we can.”
    For more information please contact:

Inside Information: Additional Positive Data from the Phase 1 Part of the BEXMAB Study in Both Higher-Risk HMA-Failed MDS and r/r AML

Retrieved on: 
Monday, March 18, 2024
Principal, Nasdaq First North, Survival, ASH, AML, Associate, Webcast, Patient, Acute myeloid leukemia, Doctor of Philosophy, MD, Quality of life, Myelodysplastic syndrome, Faron Pharmaceuticals, HMA, Myelocyte, Society, Helsinki University Central Hospital, Azacitidine, MDS, MCR, FDA, AIM, SAE, Pharmaceutical industry

TURKU, Finland and BOSTON, March 18, 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 provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA).

Key Points: 
  • Latest readout of the BEXMAB study shows more responding patients and good durability of remission amongst HR HMA-failed MDS patients.
  • 4/5 of the initial Phase 1 HR HMA-failed MDS patients were still alive after eight months of follow-up.
  • Faron will be hosting a virtual webinar to discuss the additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am GMT.
  • After the already reported 5 HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots.

Faron to Host Webcast to Discuss latest data from Phase 1 part of the BEXMAB Study of Bexmarilimab

Retrieved on: 
Thursday, March 14, 2024
Nasdaq First North, AML, Fårö, Associate, Webcast, Patient, Myeloid leukemia, Standard of care, Acute myeloid leukemia, University, Doctor of Philosophy, MD, Myelodysplastic syndrome, Faron Pharmaceuticals, Myelocyte, MDS, AIM

This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment.

Key Points: 
  • This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment.
  • Faron will also provide an update on bexmarilimab’s future development pathway and business opportunity.
  • There will be an opportunity to ask questions during the webcast.
  • To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at [email protected] .

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.

Detailed Analysis of BEXMAB Data Provides Insights into Patient Profiles of Responding HMA-Failed MDS Population

Retrieved on: 
Thursday, January 25, 2024
AIM, Patient, SOC, MDS, Decitabine, Standard of care, Survival, Faron Pharmaceuticals, PD, Quality of life, Azacitidine, Nasdaq First North, Safety, Majesty of the Seas, Myelodysplastic syndrome, Myelocyte, Pharmaceutical industry

The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.

Key Points: 
  • The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.
  • “Patients with high-risk MDS who have failed HMA therapy face a poor prognosis and median overall survival in refractory MDS is just 4-6 months with no viable treatment options.
  • Yet here we have data showing that patients are surpassing anticipated survival rates and maintaining remission.
  • It is remarkable to see patients going into remission with bexmarilimab/azacitidine after showing disease progression on all the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.

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.

Inside information: Faron Presents Phase 1 Data from BEXMAB in Myeloid Malignancies Trial at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Cellular, Transplant, PR, Efficacy, Principal, Helsinki University Central Hospital, TP53, Standard of care, Nasdaq First North, HMA, Myelodysplastic syndrome, MD Anderson Cancer Center, MD, AIM, Society, MDS, Haematopoietic system, Trial of the century, ASH, University, Faron Pharmaceuticals, University of Helsinki, Safety, Patient, AML, BLA, Vaccine

TURKU, Finland and BOSTON, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON) (“Faron” or the “Company”), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announced very positive Phase 1 data from the ongoing BEXMAB study in myeloid malignancies, being presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place until tomorrow, December 12, 2023, in San Diego, California, and virtually.

Key Points: 
  • “The BEXMAB results continue to improve over time showing remarkable overall response rate in both higher-risk frontline as well as hypomethylating agent (HMA)-failed myelodysplastic syndrome (MDS) patients,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron.
  • "The combination is well-tolerated and generates strong and durable leukemic blast eradication and immune responses.
  • This solidifies bexmarilimab’s unique and leading mechanism of action in the field of myeloid cell re-programming.
  • The data presented at ASH are promising, demonstrating a higher ORR and prolonged response duration in this trial compared to published historical benchmarks.

Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine

Retrieved on: 
Thursday, December 7, 2023
Immunotherapy, Survival, Immune system, Principal, PD-1, Nasdaq First North, AIM, Neoplasm, Faron Pharmaceuticals, Patient, Safety, Antigen presentation, Macrophage

TURKU, Finland and BOSTON, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces the publication of the full safety and anti-tumor efficacy results from the first-in-human Phase 1/2 MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors in Cell Reports Medicine.

Key Points: 
  • TURKU, Finland and BOSTON, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces the publication of the full safety and anti-tumor efficacy results from the first-in-human Phase 1/2 MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors in Cell Reports Medicine.
  • The publication, entitled, “Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: the phase I/II first-in-human MATINS trial” is available online at Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial: Cell Reports Medicine
    “Positive Phase 1/2 data published in Cell Reports Medicine highlights bexmarilimab’s potential to overcome cancer immune resistance by restoring macrophage immune function,” said Petri Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and Principal Investigator of the MATINS study.
  • "We are pleased to see that bexmarilimab was safe and very well-tolerated, achieving disease control and prolonged survival in a proportion of patients with very late-stage solid tumors who have exhausted all standard treatment options.
  • The Phase 1/2 first-in-human MATINS trial evaluated the safety and efficacy of CLEVER-1 blockade with bexmarilimab in patients with treatment-refractory solid tumors.

Insider information: Faron Initiates Phase 2 Part of BEXMAB Study of Bexmarilimab in HMA-failed MDS

Retrieved on: 
Monday, November 6, 2023
Principal, Patient, FDA, Helsinki University Central Hospital, Standard of care, AIM, Food, Trial of the century, MDS, Nasdaq First North, Associate professor, Bone marrow, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Syndrome, HMA, Quality of life, Optimus, Majesty of the Seas, RDE, Faron Pharmaceuticals, Immunotherapy, ORR, SOC, Safety, Pharmaceutical industry, Vaccine, Dietary supplement, Fårö

TURKU, Finland and BOSTON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that based on guidance from the U.S. Food and Drug Administration (FDA), hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS) has been selected as the initial indication to advance to Phase 2 in the BEXMAB study investigating bexmarilimab in combination with standard of care (SoC).

Key Points: 
  • The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with SoC in patients with aggressive myeloid leukemias.
  • The Phase 2 part of the BEXMAB trial will enroll a total of 32 patients with HMA-failed MDS.
  • Patients will be randomized 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/kg or 6 mg/kg bexmarilimab before moving into a Phase 2/3 extension of the study.
  • Post selection of final dosing Faron intends to discuss a potential registrational study plan with the FDA.

Faron to Present Phase 1/2 Data From BEXMAB Study of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies at the 65th American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Standard of care, Acute myeloid leukemia, AIM, MDS, Nasdaq First North, MD, Safety, Doctor of Philosophy, Poster, Syndrome, Society, ASH, Majesty of the Seas, Efficacy, Cancer, Faron Pharmaceuticals, University, SOC, Exposition, Cellular, MD Anderson Cancer Center, Patient, Transplant, Associate, AML, Pharmaceutical industry, Leukemia

The ASH Annual Meeting will take place from 9-12 December, 2023, in San Diego, California and virtually.

Key Points: 
  • The ASH Annual Meeting will take place from 9-12 December, 2023, in San Diego, California and virtually.
  • The poster will contain updated clinical data from the study.
  • Encouraging Efficacy Observed in BEXMAB Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies
    Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
    Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr.
  • Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center
    The full abstract, which contains data up to July 25, 2023, when the abstract was submitted, is available online on the ASH Annual Meeting & Exposition website: 65th ASH Annual Meeting & Exposition - Hematology.org