This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1). Treating with an antiCLEVER-1 antibody, such as bexmarilimab, could lead to immune system activation, which, in turn, may lead to cancer elimination.

Start Date01 Jun 2023

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

[+1]

NCT05428969

/ Active, not recruitingPhase 1/2

A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination With Standard of Care Therapy in Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia

This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1.

Start Date02 Jun 2022

Sponsor / Collaborator

Faron Pharmaceuticals Oy

NCT05104905

/ WithdrawnPhase 1/2

A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma (Macrophage Antibody To Inhibit Immune Suppression in RENAl Cell and COLon Carcinomas)

Bexmarilimab treatment has demonstrated tolerable safety profile and anticancer efficacy in some subjects with advanced malignancies. This is the first study to investigate the effect of single neoadjuvant dose of anti-CLEVER-1 antibody bexmarilimab prior to radical surgery of renal cell and colon cancers. We expect that the single dose will demonstrate measurable effects on the tumour immunological microenvironment as well as systemic effects on subject´s immunological status and that this evidence may be used to guide future neoadjuvant studies. There will be a dose escalation to investigate the effect of different doses of bexmarilimab. In addition to subjects receiving single neoadjuvant dose of bexmarilimab, there will be an observational cohort without Investigational Medicinal Product (IMP) for either cancer. All patients participating in the study (whether in investigational or observational cohort) will attend each visit and are assessed for the same endpoints.

Start Date07 Oct 2021

Sponsor / Collaborator

Faron Pharmaceuticals Oy

100 Clinical Results associated with Bexmarilimab

100 Translational Medicine associated with Bexmarilimab

100 Patents (Medical) associated with Bexmarilimab

Literatures (Medical) associated with Bexmarilimab

01 Jul 2025·Lancet Haematology

Bexmarilimab plus azacitidine for high-risk myelodysplastic syndrome and relapsed or refractory acute myeloid leukaemia: results from the dose-escalation part of a multicentre, single-arm, phase 1/2 trial

Article

Author: Ylitalo, Arno ; Stein, Anthony Selwyn ; Rimpiläinen, Johanna ; Daver, Naval ; Fjällskog, Marie-Louise ; Aakko, Sofia ; Kontro, Mika ; Pyörälä, Marja ; Hollmén, Maija ; Jalkanen, Juho ; Pawlitzky, Inka ; Siitonen, Timo

BACKGROUND:

Bexmarilimab blocks Clever-1 on macrophages to enhance antigen presentation and T cell activation. Because Clever-1 is expressed by myeloid leukaemia cells, bexmarilimab may combat leukaemia and influence the tumour microenvironment to augment the effectiveness of standard-of-care therapy in patients with myelodysplastic syndrome and acute myeloid leukaemia. The aim of this study was to determine the safety of bexmarilimab in combination with standard-of-care treatment in myelodysplastic syndrome and acute myeloid leukaemia and to identify the recommended dose for expansion of bexmarilimab in combination with standard of care.

METHODS:

The phase 1 dose-escalation part of this multicentre, single-arm, phase 1/2 study was done at six centres in Finland and the USA. Patients aged 18 years or older (Eastern Cooperative Oncology Group performance status of 2 or less) with myelodysplastic syndrome (2016 WHO) with a Revised International Prognostic Scoring System (IPPS-R) score of 3·5 or more for USA (3·0 for the European Union), chronic myelomonocytic leukaemia (2016 WHO) with 10-19% marrow blasts, myelodysplastic syndrome or chronic myelomonocytic leukaemia with no response to or disease progression during hypomethylating agent treatment, or relapsed or refractory acute myeloid leukaemia were treated with escalating doses of bexmarilimab (1·0 mg/kg, 3·0 mg/kg, and 6·0 mg/kg, intravenous, once weekly, 28-day cycle) in combination with azacitidine, administered as per label. Here we report the phase 1 part of the study, for which the primary outcome was safety (the incidence and frequency of dose limiting toxicities and the frequency and severity of adverse events) as well as the determination of the maximum tolerated dose and recommended expansion dose for the phase 2 part using a Bayesian optimal interval design. All patients receiving at least one dose of bexmarilimab were included in safety analyses, and those with a post-baseline activity assessment were included in activity analyses. This trial is registered with ClinicalTrials.gov (NCT05428969) and EudraCT (2021-002104-12) databases. Phase 2 of the study is ongoing in patients with myelodysplastic syndrome with no response to hypomethylating agent.

FINDINGS:

Between June 2, 2022, and Dec 7, 2023, 33 patients (14 with myelodysplastic syndrome, 19 with relapsed or refractory acute myeloid leukaemia) were enrolled in phase 1; no patients with chronic myelomonocytic leukaemia were identified. 19 (58%) patients were male and 14 (42%) were female, and 24 (73%) patients were non-Hispanic ethnicity, and eight (24%) were White. Median follow-up time for all patients was 6·2 months (IQR 3·5-10·7). The maximum tolerated dose was not reached, and the recommended expansion dose for phase 2 was established as 6·0 mg/kg in patients with myelodysplastic syndrome with no response to hypomethylating agents. There were no dose-limiting toxicities. The most common grade 3-4 treatment-emergent adverse events were febrile neutropenia (n=8 [24%]), anemia (n=7 [21%]), and thrombocytopenia (n=5 [15%]). Treatment-emergent deaths occurred as a result of sepsis (n=1 [3%]), neutropenic infection (n=1 [3%]), and haemophagocytic lymphohistiocytosis (n=1 [3%]). Four patients presented treatment-related serious adverse events, one patient in the 1·0 mg/kg group, two in the 3·0 mg/kg group and one in the 6·0 mg/kg group. These included rash (grade 3), capillary leak syndrome (grade 3), cryptogenic organising pneumonia (grade 3) and haemophagocytic lymphohistiocytosis (grade 5) which led to one death. The objective response rate was 45% (15 of 33; 95% CI 28-62) across all doses.

INTERPRETATION:

Bexmarilimab in combination with azacitidine has a manageable safety profile, consistent with azacitidine, and shows promising clinical activity in patients with high-risk myelodysplastic syndrome.

FUNDING:

Faron Pharmaceuticals.

23 Jun 2025·Theranostics

Secreted Clever-1 modulates T cell responses and impacts cancer immunotherapy efficacy

Article

Author: Turpin, Rita ; Shetty, Shishir ; di Benedetto, Ilaria ; Bendes, Ábris Á ; Figueiredo, Carlos R ; Ylitalo, Arno ; Sjöroos, Riikka ; Salminen, Tiina A ; Rannikko, Jenna H ; Patten, Daniel A ; Viitala, Miro ; Boström, Pia ; Hollmén, Maija ; Prince, Stuart ; Koskivuo, Ilkka ; Tyni, Laura

Rationale: Clever-1 is a multifunctional scavenger receptor that promotes immunosuppressive activity in macrophages, contributing to tumor immune evasion. Its high expression correlates with resistance to immune checkpoint inhibitors, and co-targeting Clever-1 with anti-PD-1 enhances therapeutic efficacy in refractory tumor models. The humanized anti-Clever-1 IgG4 antibody, bexmarilimab, is under clinical investigation for treating solid tumors (NCT03733990) and hematological malignancies (NCT05428969). Methods: To assess the impact of Clever-1 in cancer, we analyzed plasma samples from breast cancer patients (n=139) and bexmarilimab-treated clinical trial participants (n=193) using TRFIA-based ELISA to quantify secreted Clever-1 (sClever-1). A recombinant sClever-1 protein was produced and characterized biophysically. Functional assays, including flow cytometry, Western blotting, T cell activation, and Jurkat reporter systems, were used to assess interactions with T cells. Mechanistic studies involved extracellular vesicle isolation, pulldown assays, and mass spectrometry. Inhibitor studies and patient-derived tumor explants were used to evaluate the immunomodulatory impact of sClever-1 and its effect on anti-PD-1 responses. Results: sClever-1 was significantly enriched in the plasma of cancer patients and reduced following bexmarilimab treatment. Its release was induced by IFNγ/LPS via serine protease-dependent cleavage. The recombinant sClever-1 bound selectively to activated T cells via mannose-6-phosphate-mediated interaction with IGF2R, impairing TCR signaling and Th1 expansion. sClever-1 was also associated with macrophage-derived extracellular vesicles and contributed to T cell tolerance and reduced anti-PD-1 efficacy. In tumor explants, sClever-1 bound to activated CD4⁺ and CD8⁺ T cells and increased TGFβ secretion. Conclusions: These findings identify sClever-1 as a previously unrecognized, immunosuppressive mediator in cancer that operates independently of cellular Clever-1 expression. sClever-1 may serve as both a therapeutic target and biomarker to guide immunotherapy strategies.

01 May 2025·Journal for ImmunoTherapy of Cancer

Macrophage sensitivity to bexmarilimab-induced reprogramming is shaped by the tumor microenvironment

Article

Author: Tamminen, Anselm ; Harth, Chantal ; Rannikko, Jenna H ; Koskivuo, Ilkka ; Turpin, Rita ; Boström, Pia ; Virtakoivu, Reetta ; Hollmén, Maija ; Takeda, Akira

Background:

Tumor-associated macrophages (TAMs) adapt to the tumor microenvironment (TME), either aiding cancer eradication or promoting tumor growth and immune evasion. To manipulate TAMs therapeutically, a deep understanding of their interaction with the TME is essential. This study explores the responsiveness of TMEs to bexmarilimab, a macrophage reprogramming therapy showing clinical benefit in various solid tumors.

Methods:

We exploited a breast cancer patient-derived explant culture (PDEC) model to characterize bexmarilimab responses in both tumor and adjacent cancer-free tissues by RNA sequencing and multiplex cytokine profiling. Using single-cell RNA sequencing, spatial transcriptomics, and conditioned media treatment, we further investigated the effects of Clever-1+ macrophages and TME features on bexmarilimab sensitivity.

Results:

The PDEC model captured key aspects of bexmarilimab’s mode of action and validated a gene signature for determining treatment sensitivity. We identified three distinct responses to bexmarilimab in tumors and adjacent cancer-free tissues, shaped by the local microenvironment and macrophage phenotype, origin, and localization. The inflammatory state of the TME emerged as the primary determinant of response. Immune activation occurred in immunologically cold TMEs lacking late-stage activated TAMs, whereas interferon-regulated TMEs exhibited suppressed inflammation. In cancer-free breast tissue, bexmarilimab activated B cell responses.

Conclusions:

These findings reveal the complexity of TAM targeting in cancer and emphasize the need for patient selection to maximize bexmarilimab’s efficacy.

News (Medical) associated with Bexmarilimab

20 May 2025

·www.einpresswire.com

New Study Advances Cancer Precision Therapies by Identifying Patients Who Benefit from Bexmarilimab treatment

Researchers have identified the conditions under which the antibody-drug bexmarilimab can activate the body's own defense system against cancer. Our findings suggest that by better understanding the tumor microenvironment, we can tailor immunotherapies to the patients who are most likely to benefit.” — Associate Professor Maija Hollmén TURKU, FINLAND, May 20, 2025 / EINPresswire.com / -- Researchers at the University of Turku , Finland, have taken a step towards more personalized and effective cancer treatments. A new study has identified the conditions under which the antibody-drug bexmarilimab can activate the body's own defense system against cancer, and how to identify patients who will benefit from the drug. Bexmarilimab has the ability to “wake up” macrophages, a type of immune cell, to act against cancer. The study found that this activation occurs especially when the tumor microenvironment is immunologically silent. Moreover, in the healthy tissue adjacent to the tumor, bexmarilimab was shown to trigger B cell-mediated immune responses, regardless of how sensitive the neighboring tumor was to the treatment. This suggests that the drug may have immunological effects beyond the tumor itself. New Tool for Patient Selection By utilizing previous knowledge about the changes bexmarilimab causes in tumors, researchers were able to demonstrate the benefit of bexmarilimab by measuring the upregulation of five different genes (gene signature). In the future, this could enable more accurate patient selection and improved treatment outcomes. “This gene signature gives us a tool to identify patients whose tumors are likely to respond to bexmarilimab. Supporting treatment decisions with gene signatures measured from the tumor may help target therapies to those who are most likely to benefit. The next step is clinical validation of the signature, which could enable its use in more precise patient profiling”, explains Jenna Rannikko, Doctoral Researcher and lead author of the study. The study utilized patient-derived tissue samples that closely mimic the interaction between tumors and the immune system. By measuring treatment response in these tissues, the researchers observed similar patterns to those seen in clinical trials of bexmarilimab. Promising Future for Finnish Immunotherapy Bexmarilimab, developed in Finland, has shown promising results in several types of solid tumors. This new study adds important insights into how bexmarilimab can be used most effectively in the future. “Our findings suggest that by better understanding the tumor microenvironment, we can tailor immunotherapies to the patients who are most likely to benefit”, says Associate Professor Maija Hollmén, the study’s principal investigator. “In addition, understanding the factors that influence treatment efficacy may help expand its use to new patient groups in the future.” The study was published in the Journal for ImmunoTherapy of Cancer on 15 May 2025. Maija Hollmén is a group leader in the InFLAMES Flagship which is a joint initiative of the University of Turku and Åbo Akademi University, located in Turku, Finland. The goal of the Flagship is to integrate the immunological and immunology-related research activities to develop and exploit new diagnostic and therapeutic tools for personalized medicine. InFLAMES is part of the Research Council of Finland´s Flagship Programme. Associate Professor Maija Hollmén University of Turku maija.hollmen@utu.fi Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Immunotherapy

10 Dec 2024

·pipelinereview.com

Faron Presents Full Analysis of Positive Phase 2 Interim Data from BEXMAB Trial at the 66th American Society of Hematology (ASH) Annual Meeting

Poster highlights TURKU, Finland I December 10, 2024 I Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announced full analysis of the positive Phase 2 interim readout presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. “The BEXMAB results continue to improve over time showing a remarkable 80% ORR in r/r MDS patients,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron . “The combination is well-tolerated and generates strong and durable cancer blast reduction and hematological improvements. This solidifies bexmarilimab’s unique and leading mechanism of action for the treatment of MDS and in the field of myeloid cell re-programming. With this compelling evidence, we are well positioned to advance to the full Phase 2 efficacy readout and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing.” Dr. Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said : “Addressing MDS remains a considerable therapeutic challenge due to the limited efficacy of the current standard of care, particularly in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH are highly promising, showing notable improvements in overall response rate and overall survival. These findings highlight the meaningful strides Faron is making in improving treatment outcomes for r/r MDS.” The BEXMAB study is a multicenter study, taking place in Finland, UK and the U.S., evaluating the safety and efficacy of bexmarilimab , a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias. Faron will host a virtual webinar to discuss the full analysis of data today, 10 December 2024 at 16.00 EET/9am ET/6am PT. To register for the event visit: BEXMAB Study Update The ASH Annual Meeting takes place from 7-10 December 2024, in San Diego, California and virtually. ASH Poster presentation details: Title: Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study Session Time : Monday, 9 December 2024, 6:00 PM – 8:00 PM PT Session Title: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III Location: San Diego Convention Center, Halls G-H Lead Authors: 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 Abstract Number: 4265 The full Poster is available on the Company’s website at https://www.faron.com/investors and contains updated clinical data from the BEXMAB trial. About BEXMAB The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. About bexmarilimab Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care. About Faron Pharmaceuticals Ltd Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab , a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com . SOURCE: Faron Pharmaceuticals

ImmunotherapyPhase 2ASH

10 Dec 2024

·www.prnewswire.com

Faron presents BEXMAB data at ASH Annual Meeting

Faron Pharmaceuticals Ltd. ("Faron" or "the Company") Faron Presents Full Analysis of Positive Phase 2 Interim Data from BEXMAB Trial at the 66th American Society of Hematology (ASH) Annual Meeting Poster highlights Overall response rate of 80% (16 out of 20) in refractory or relapsed HMA failed MDS patient population (r/r MDS) Observed responses were primarily deep and durable with 70% (14 out of 20) r/r MDS patients achieving complete response (CR) / marrow complete remission (mCR) / partial response (PR). Four patients have moved on to receive a bone marrow transplant Estimated median overall survival (mOS) of approximately 13.4 months in r/r MDS population The combination of bexmarilimab and azacitidine remains well tolerated Clever-1 target engagement and expression in the bone marrow with an increased antigen presentation capacity and presence of CD8 T and NK cells supports bexmarilimab mechanism-of-action Webinar scheduled today at 16.00 EET/9am ET/6am PT (please see link to register below) TURKU, Finland, Dec. 10, 2024 /PRNewswire/ -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announced full analysis of the positive Phase 2 interim readout presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. "The BEXMAB results continue to improve over time showing a remarkable 80% ORR in r/r MDS patients," said Dr. Juho Jalkanen, Chief Executive Officer of Faron. "The combination is well-tolerated and generates strong and durable cancer blast reduction and hematological improvements. This solidifies bexmarilimab's unique and leading mechanism of action for the treatment of MDS and in the field of myeloid cell re-programming. With this compelling evidence, we are well positioned to advance to the full Phase 2 efficacy readout and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing." Dr. Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said: "Addressing MDS remains a considerable therapeutic challenge due to the limited efficacy of the current standard of care, particularly in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH are highly promising, showing notable improvements in overall response rate and overall survival. These findings highlight the meaningful strides Faron is making in improving treatment outcomes for r/r MDS." The BEXMAB study is a multicenter study, taking place in Finland, UK and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias. Faron will host a virtual webinar to discuss the full analysis of data today, 10 December 2024 at 16.00 EET/9am ET/6am PT. To register for the event visit: BEXMAB Study Update The ASH Annual Meeting takes place from 7-10 December 2024, in San Diego, California and virtually. ASH Poster presentation details: Title: Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study Session Time: Monday, 9 December 2024, 6:00 PM - 8:00 PM PT Session Title: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III Location: San Diego Convention Center, Halls G-H Lead Authors: 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 Abstract Number: 4265 The full Poster is available on the Company's website at and contains updated clinical data from the BEXMAB trial. For more information please contact: ICR Healthcare Mary-Jane Elliott, David Daley, Lindsey Neville Phone: +44 (0)20 3709 5700 E-mail: [email protected] Cairn Financial Advisers LLP, Nomad Sandy Jamieson, Jo Turner Phone: +44 (0) 207 213 0880 Peel Hunt LLP, Broker Christopher Golden, James Steel Phone: +44 (0) 20 7418 8900 Sisu Partners Oy, Certified Adviser on Nasdaq First North Juha Karttunen Phone: +358 (0)40 555 4727 Jukka Järvelä Phone: +358 (0)50 553 8990 About BEXMAB The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. About bexmarilimab Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care. About Faron Pharmaceuticals Ltd Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at . Forward-Looking Statements Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should", "expect", "hope", "seek", ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors. A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based. This information was brought to you by Cision . The following files are available for download: SOURCE Faron Pharmaceuticals Oy WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2ImmunotherapyASHClinical Result

100 Deals associated with Bexmarilimab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Myelomonocytic Leukemia	Phase 2	United States	Faron Pharmaceuticals Oy	02 Jun 2022
Chronic Myelomonocytic Leukemia	Phase 2	Finland	Faron Pharmaceuticals Oy	02 Jun 2022
Chronic Myelomonocytic Leukemia	Phase 2	United Kingdom	Faron Pharmaceuticals Oy	02 Jun 2022
Refractory acute myeloid leukemia	Phase 2	United States	Faron Pharmaceuticals Oy	02 Jun 2022
Refractory acute myeloid leukemia	Phase 2	Finland	Faron Pharmaceuticals Oy	02 Jun 2022
Refractory acute myeloid leukemia	Phase 2	United Kingdom	Faron Pharmaceuticals Oy	02 Jun 2022
Myelodysplastic Syndromes	Phase 2	United States	Faron Pharmaceuticals Oy	02 Jun 2022
Myelodysplastic Syndromes	Phase 2	Finland	Faron Pharmaceuticals Oy	02 Jun 2022
Myelodysplastic Syndromes	Phase 2	United Kingdom	Faron Pharmaceuticals Oy	02 Jun 2022
Colonic Cancer	Phase 2	Finland	Faron Pharmaceuticals Oy	07 Oct 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05428969 (BEXMAB, ESMO2025)	Phase 1/2	Myelodysplastic Syndromes First line	52	bexmarilimab + azacitidine (frontline HR MDS)	bsaeqkvevc(syoowslfgb) = 25% increase of BM CD8+ T cells, already after cycle 1 tjbgcbawfa (xopjcjavxp ) View more	Positive	17 Oct 2025
				bexmarilimab + azacitidine (relapsed/refractory (r/r) MDS)
NCT05428969 (Pubmed \| Lancet Haematol)	Phase 1/2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	33	Bexmarilimab + Azacitidine	nzaxpjukur(dndlvecjzo) = anemia (n=7 [21%]) sgquwrqrru (elkjfjqyjc ) View more	Positive	01 Jul 2025
BEXMAB (EHA2025)	Phase 1/2	Myelodysplastic Syndromes	55	Bexmarilimab 1mg/kg	ojtkdadcck(bqvlerjlpi) = hnshxgaxjt ywrmhinjhh (nqdllqdoin )	Positive	14 May 2025
				Bexmarilimab 3mg/kg	ojtkdadcck(bqvlerjlpi) = sczkbtobfa ywrmhinjhh (nqdllqdoin )
NCT03733990 (MATINS, CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm	216	FP-1305 (bexmarilimab) (FP-1305 (Bexmarilimab) 0.3 mg/kg)	xdurzddxwi = hfmfcixcaq torrcrltjr (ycnnnrkgid, pdobfvdqqk - ftahkfmsnc) View more	-	02 Apr 2025
				FP-1305 (bexmarilimab) (FP-1305 (Bexmarilimab) 1 mg/kg)	xdurzddxwi = sjbxubmtjf torrcrltjr (ycnnnrkgid, zoehlughse - unuzpfrpat) View more
NCT05428969 (BEXMAB, ASH2024) Manual	Phase 1/2	Myelodysplastic Syndromes TP53 Mutation	14	Bexmarilimab+Azacitidine	fsoiurldnw(jlvsduywud) = ddfbichpyg fnptqsibko (olujnizluc ) View more	Positive	09 Dec 2024
NCT05428969 (BEXMAB, Biospace) Manual	Phase 1	Myeloid Leukemia Second line \| First line TP53 Mutation	28	bexmarilimab + azacitidine	bvxqeoqxvo(ccjdewvbjp) = bcyinmtwjl gytxhwidoi (zoxgjeicpd )	Positive	11 Dec 2023
				bexmarilimab + azacitidine (previously HMA-failed)	bvxqeoqxvo(ccjdewvbjp) = ubvusnfdzf gytxhwidoi (zoxgjeicpd )
NCT03733990 (MATINS, Pubmed \| Cell Rep Med)	Phase 1/2	Solid tumor Clever-1 \| interferon γ (IFNγ)	-	Bexmarilimab	kxgfrhbnug(ywyijcnzvo) = okoldvuxdh jhjigtcfat (bguyhpvuxe )	Positive	01 Dec 2023
				Placebo	kxgfrhbnug(ywyijcnzvo) = urqmmjrlch jhjigtcfat (bguyhpvuxe )
NCT03733990 (MATINS, SITC2023)	Phase 1/2	Advanced Malignant Solid Neoplasm Clever-1 \| IFNg \| proinflammatory cytokines ... View more	-	Bexmarilimab (FP-1305, Bex)	hexgjmtjoq(udzluxtgvq) = cxoaefnfzf hpwtlpjhut (wdmimspucv )	-	02 Nov 2023
NCT03733990 (MATINS, ESMO2023)	Phase 1/2	Refractory Malignant Solid Neoplasm	216	Bexmarilimab	jfypzanodz(xnfiibgzze) = 15.9% of the patients experiencing grade 3-4 TRAE pujtvpjqek (tfmheqodnu ) View more	Positive	23 Oct 2023
NCT05428969 (BEXMAB, GlobeNewswire) Manual	Phase 1/2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	22	Bexmarilimab+standard of care	hsjxmvwbus(rvtdfijlpk) = dnynogpbkm rwipakbcii (htjssbuogq ) View more	Positive	11 Oct 2023
				Bexmarilimab+standard of care (HMA-failed MDS patients)	hsjxmvwbus(rvtdfijlpk) = dezsngvuhg rwipakbcii (htjssbuogq )

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