Drugs / bexmarilimab
bexmarilimab
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05171062 | Jun 2023 → Dec 2025 | non-small cell lung carcinoma | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07718243 | Aug 2026 → Jan 2030 expected | cutaneous melanoma, non-small cell lung carcinoma | Institute of Cancer Research, United Kingdom | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07460986 | Aug 2026 → Jul 2028 expected | soft tissue sarcoma | MedSIR | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05428969 | Jun 2022 → Mar 2027 expected | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Faron Pharmaceuticals Ltd | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05104905 | Oct 2021 → Jan 2022 | colon carcinoma, renal cell carcinoma | Faron Pharmaceuticals Ltd | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03733990 | Dec 2018 → Sep 2023 | cancer | Faron Pharmaceuticals Ltd | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07672769 | Oct 2026 → Nov 2027 expected | myelodysplastic syndrome | Faron Pharmaceuticals Ltd | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 60
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | Faron Pharmaceuticals Ltd | Results Inside Information: Faron announces encouraging first overall survival data from frontline higher-risk (HR) MDS patients in the BEXMAB phase 1/2 trial faron.com ↗
Other subgroups: monoallelic TP53 mutated and wildtype patients have still not reached their median OS. |
| 2026-06-15 | Faron Pharmaceuticals Ltd | Results Faron Presents Matured BEXMAB Data at EHA 2026 Confirming Durable Efficacy and Bone Marrow Reprogramming in HR-MDS faron.com ↗
Data from the treatment-naïve HR-MDS cohort continues to mature positively, reflecting an ORR of 85% and a CR rate of 45%. |
| 2025-12-08 | Faron Pharmaceuticals Ltd | Results Faron presents updated BEXMAB data at ASH 2025: Deep and durable responses in HR-MDS with favorable safety profile faron.com ↗
The data highlights significant improvement in survival outcome and new findings on hematopoietic recovery in patients with higher-risk Myelodysplastic Syndromes (HR-MDS) treated with bexmarilimab in combination with standard-of-care azacitidine. |
| 2025-10-20 | Faron Pharmaceuticals Ltd | Results Updated BEXMAB Phase I/II Data presented at ESMO 2025 shows further improvement, strengthening the clinical profile of bexmarilimab in treatment-naïve HR-MDS patients faron.com ↗
Turku, Finland– Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announced that updated data from the Phase I/II BEXMAB study continues to show significant clinical activity for bexmarilimab. |
| 2025-08-18 | Faron Pharmaceuticals Ltd | Regulatory Inside Information: Faron to advance bexmarilimab into a registrational Phase 2/3 study in treatment-naïve (frontline) HR-MDS after positive meeting with the FDA faron.com ↗
The FDA advised Faron to focus on frontline development since possible frontline approval enables use across the entire HR MDS indication. |
| 2025-08-06 | Faron Pharmaceuticals Ltd | Results Inside Information: Faron to present updated BEXMAB data in frontline HR-MDS to FDA; complete remission rate substantially increased to 43% faron.com ↗
According to the investigator-assessed response using IWG 2006 criteria, as per protocol, the CR rate (as explained below) has increased to 43% (9 out of 21 patients), a substantial improvement from the 28% rate, seen in the earlier data cut. |
| 2025-07-09 | Faron Pharmaceuticals Ltd | Results Faron announces acceptance of two studies involving bexmarilimab, one of them as an oral presentation, at the 19th International Congress of Immunology (IUIS) 2025 faron.com ↗
The second study, accepted as a poster, details the identification of secreted Clever-1 (sClever-1) as a key driver of immune suppression and immunotherapy resistance. |
| 2025-06-30 | Faron Pharmaceuticals Ltd | Results Faron-supported research in Theranostics identifies secreted Clever-1 (sClever-1) as an independent driver of immune evasion in cancer, deepening the understanding of bexmarilimab’s mode of action faron.com ↗
Importantly, the study demonstrated that bexmarilimab treatment significantly reduced the release of sClever-1 in cancer patients. |
| 2025-06-12 | Faron Pharmaceuticals Ltd | Results Faron Pharmaceuticals presents updated Phase II data from BEXMAB Study at EHA 2025 faron.com ↗
Strong efficacy and survival outcomes with bexmarilimab in high-risk MDS support Phase III advancement |
| 2025-06-02 | Faron Pharmaceuticals Ltd | Results Faron Pharmaceuticals presents Phase II data from BEXMAB Study at ASCO 2025 faron.com ↗
Median overall survival of 13.4 months in 32 r/r MDS patients treated with bexmarilimab + azacitidine |
| 2025-05-30 | Faron Pharmaceuticals Ltd | Results Faron announces publication of full Phase I BEXMAB study data in Lancet Haematology faron.com ↗
Bexmarilimab in combination with azacitidine showed ORR of 100% and 89% in treatment-naïve and HMA-failed HR-MDS patients, respectively |
| 2025-05-27 | Faron Pharmaceuticals Ltd | Results Faron’s Bexmarilimab demonstrates immune-activating and drug-sensitizing potential in myeloid malignancies faron.com ↗
Bexmarilimab, when combined with azacitidine or venetoclax, enhanced HLA-DR expression and in many samples, reduced the viability of leukemic blasts, particularly in venetoclax-resistant samples. |
| 2025-05-23 | Faron Pharmaceuticals Ltd | Results Faron announces new data that highlight patient populations with cancer that are most likely to benefit from first-in-class immunotherapy bexmarilimab faron.com ↗
Bexmarilimab stimulated response in immunologically-cold tumors and inhibited inflammation in treatment resistant tumors. |
| 2025-05-12 | Faron Pharmaceuticals Ltd | Results Faron Pharmaceuticals presents promising Phase 1/2 data from BEXMAB Study at MDS 2025 plenary session faron.com ↗
BEXMAB data highlights meaningful clinical benefit, with beneficial immunological and hematological impact in r/r MDS |
| 2025-04-15 | Faron Pharmaceuticals Ltd | Results Inside Information: Faron Announces Positive Phase II results in higher-risk myelodysplastic syndrome faron.com ↗
Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced positive topline results of the BEXMAB trial, which shows a high overall response rate (ORR) among both frontline as well as relapsed/refractory (r/r) HR MDS patients treated with a combination of bexmarilimab and azacitidine. |
| 2025-03-03 | Faron Pharmaceuticals Ltd | Regulatory Inside Information: FDA Grants Orphan Drug Designation for Bexmarilimab in MDS faron.com ↗
their lead candidate bexmarilimab has been granted Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS) by the USA Food and Drug Administration (the FDA). |
| 2025-02-27 | Faron Pharmaceuticals Ltd | Regulatory Inside Information: Faron Receives Positive EMA Opinion on Orphan Drug Designation for Bexmarilimab for the treatment of myelodysplastic syndrome (MDS) faron.com ↗
Given strong efficacy data of bexmarilimab in the treatment of MDS patients, the EU’s Committee for Orphan Medicinal Products (COMP) issued positive opinion on Orphan Drug Designation (ODD) for bexmarilimab |
| 2024-12-10 | Faron Pharmaceuticals Ltd | Results Faron presents BEXMAB data at ASH Annual Meeting faron.com ↗
“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. |
| 2024-12-02 | Faron Pharmaceuticals Ltd | Regulatory Interactions with UK Regulatory Authorities faron.com ↗
MHRA has awarded bexmarilimab an Innovation Passport for the treatment of relapsed/refractory Myelodysplastic Syndrome and given approval for the BEXMAB trial to be conducted in the UK |
| 2024-11-27 | Faron Pharmaceuticals Ltd | Results Positive Phase 2 Interim Results from BEXMAB Trial faron.com ↗
Interim Phase 2 read-out from the BEXMAB Trial confirms earlier positive Phase 1 & 2 findings in MDS patients with prior HMA failure |
| 2024-10-22 | Faron Pharmaceuticals Ltd | Results Faron’s Capital Markets Day 2024 faron.com ↗
The BEXMAB Phase I/II trial results have already indicated a high overall response rate (ORR) of 79% (11 out 14) amongst relapsed and refractory myelodysplastic syndrome (r/r MDS) patients treated with a combination of bexmarilimab + azacitidine. |
| 2024-08-27 | Faron Pharmaceuticals Ltd | Regulatory FDA Grants Fast Track Designation for Bexmarilimab faron.com ↗
Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been granted Fast Track Designation for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine by the USA Food and Drug Administration (the FDA). |
| 2024-05-20 | Faron Pharmaceuticals Ltd | Results Initial positive data from Phase 2 of BEXMAB faron.com ↗
In Phases 1 & 2, 14 MDS patients who are refractory or relapsed on HMA (r/r MDS) and have no effective treatment options, show an objective response rate (ORR) of 79% |
| 2024-03-18 | Faron Pharmaceuticals Ltd | Results Additional Positive Data from Phase 1 of BEXMAB faron.com ↗
3 additional HMA-failed HR MDS patients have been enrolled in Phase 1 part, leading to a total of 7 out of 8 patients responding, an overall response rate of 87.5%. |
| 2024-01-25 | Faron Pharmaceuticals Ltd | Results BEXMAB Insights into Patient Profiles faron.com ↗
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. |
| 2023-12-11 | Faron Pharmaceuticals Ltd | Results Phase 1 BEXMAB data presented at ASH faron.com ↗
“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. |
| 2023-12-07 | Faron Pharmaceuticals Ltd | Results MATINS Trial in Cell Reports Medicine faron.com ↗
Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine |
| 2023-10-11 | Faron Pharmaceuticals Ltd | Results Faron Announces Positive BEXMAB Study Update faron.com ↗
Eight of 11 patients achieved complete remission in the bone marrow with or without blood count recovery. |
| 2023-08-29 | Faron Pharmaceuticals Ltd | Regulatory FDA Orphan Drug Designation for Bexmarilimab faron.com ↗
Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its wholly owned asset bexmarilimab, for the treatment of acute myeloid leukemia (AML). |
| 2023-07-19 | Faron Pharmaceuticals Ltd | Results BEXMAB study Update faron.com ↗
Three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort achieved objective responses (CR and mCR) |
| 2023-06-09 | Faron Pharmaceuticals Ltd | Results New biomarker data from BEXMAB study at EHA2023 faron.com ↗
In BEXMAB patients, a high Clever-1 expression in leukemic blasts is associated with lower levels of antigen presentation. |
| 2023-04-24 | Faron Pharmaceuticals Ltd | Results Bexmarilimab Efficacy and Safety in MATINS Trial faron.com ↗
The manuscript, which is available here, indicates that macrophage conversion, and changes in the tumor microenvironment leading to disease control and prolonged survival in late-stage cancer, is achieved with bexmarilimab monotherapy, and that targeting CLEVER-1 with bexmarilimab is well-tolerated. |
| 2023-04-18 | Faron Pharmaceuticals Ltd | Results Poster Presentations at AACR 2023 faron.com ↗
The first poster indicates a PD-L1/CLEVER-1 IHC staining ratio may be used to predict bexmarilimab response, as responding patients have a low PD-L1 and high CLEVER-1 staining, as well as low inflammatory cytokine (IFNγ, TNFα, IL-6) levels as reported previously. |
| 2023-04-17 | Faron Pharmaceuticals Ltd | Results BEXMAB study update faron.com ↗
In the second doublet cohort (3mg/kg + azacytidine), two patients have objective responses thus far, including one complete response with incomplete blood count recovery (CRi) and one patient with hematological improvement in platelets (HI-P). |
| 2023-03-22 | Faron Pharmaceuticals Ltd | Regulatory Positive FDA Feedback to Progress Bexmarilimab faron.com ↗
Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, announces positive FDA feedback and recommendations for the future development of bexmarilimab as a monotherapy in multiple solid tumors. |
| 2023-01-16 | Faron Pharmaceuticals Ltd | Results BEXMAB study update faron.com ↗
Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces objective responses in 3 out of 5 patients dosed in the first doublet cohort of the Company’s Phase I/II BEXMAB study. |
| 2022-12-05 | Faron Pharmaceuticals Ltd | Results BEXMAB Study Update faron.com ↗
An azacytidine-refractory acute myeloid leukemia (AML) patient with partial responses as communicated on October 31, 2022, achieved a complete remission, with incomplete blood cell count recovery after four treatment cycles. |
| 2022-10-31 | Faron Pharmaceuticals Ltd | Results BEXMAB Study Update faron.com ↗
Early signs of efficacy with partial response observed in one patient after three dosing cycles |
| 2022-10-18 | Faron Pharmaceuticals Ltd | Results Faron Pharmaceuticals Presents Results from PD-1 Blockade Refractory Melanoma Cohort of MATINS Trial at 19th International Congress of The Society for Melanoma Research faron.com ↗
Patients with cold tumors, defined by low baseline levels of pro-inflammatory cytokines, were more likely to experience clinical benefit following treatment with bexmarilimab |
| 2022-09-20 | Faron Pharmaceuticals Ltd | Results Top-Line Data on Bexmarilimab Dose Variation faron.com ↗
Treatment induced significant systemic interferon (IFN) gamma increase – again showing the capacity of bexmarilimab to activate immune response in cancer patients, especially in patients with immunologically “cold” tumors |
| 2022-06-15 | Faron Pharmaceuticals Ltd | Results Faron Announces Top-Line 12-Month Survival Results faron.com ↗
65% of patients who benefited from treatment with bexmarilimab were alive at 12-months compared to 11% for patients who did not benefit from treatment |
| 2022-05-30 | Faron Pharmaceuticals Ltd | Results Presentation of Biomarker Analysis at ASCO faron.com ↗
Faron Announces Presentation of Biomarker Analysis at 2022 ASCO Annual Meeting Showing Promising Clinical Benefit of Bexmarilimab in Patients with Low PD-L1 and High Clever-1 Levels |
| 2022-05-16 | Faron Pharmaceuticals Ltd | Regulatory Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies faron.com ↗
today announces that both the U.S. Food and Drug Administration (FDA) and Finnish Medicines Agency (FIMEA) have cleared Faron’s Investigational New Drug (IND) application to begin the Company sponsored BEXMAB study. |
| 2022-05-12 | Faron Pharmaceuticals Ltd | Results Ex Vivo Data Presented at EHA2022 Congress faron.com ↗
Blocking Clever-1 with bexmarilimab in these patients induced immune activation as observed through increased antigen presenting molecule, human leucocyte antigen DR (HLA-DR) expression and declined PD-1 expression |
| 2022-04-21 | Faron Pharmaceuticals Ltd | Results Faron Presents Results from Melanoma Cohort of MATINS Trial at 18[th] Congress of the European Association of Dermato-Oncology (EADO) faron.com ↗
Compelling 30% clinical benefit rate seen following treatment with bexmarilimab in heavily pre-treated, checkpoint inhibitor refractory patient population |
| 2022-03-09 | Faron Pharmaceuticals Ltd | Results Presentation of Biomarker Data at AACR 2022 faron.com ↗
Patients with low baseline IFNy and TNFa levels found to experience significantly higher clinical benefit following bexmarilimab treatment |
| 2022-02-23 | Faron Pharmaceuticals Ltd | Results Faron Updates on Bexmarilimab Development Program faron.com ↗
Updated landmark analysis estimates nine-month overall survival rates were 70% for heavily pre-treated, late-stage cancer patients who benefited from treatment with bexmarilimab and 26% for patients who did not benefit from treatment |
| 2021-12-09 | Faron Pharmaceuticals Ltd | Results Faron Announces Topline MATINS Biomarker Analysis faron.com ↗
The initial biomarker data shows patients with low interferon gamma (IFNg) and tumor necrosis factor alpha (TNFa) levels experienced significantly higher clinical benefit (defined as partial response or stable disease) following treatment with bexmarilimab. |
| 2021-09-17 | Faron Pharmaceuticals Ltd | Results Presentation of Updated MATINS Data at ESMO faron.com ↗
Faron Announces Presentation of Updated MATINS Data at ESMO Showing Bexmarilimab Delivers Compelling Antitumour Activity Across Five Different Advanced Solid Tumors |
| 2021-06-22 | Faron Pharmaceuticals Ltd | Results Updated corporate presentation faron.com ↗
The previously reported DCR figure of 3/9 patients (33.3%) has, following the accumulation of new data, now increased to 4/11 patients (36.3%). |
| 2021-06-03 | Faron Pharmaceuticals Ltd | Results Bexmarilimab results published in CCR faron.com ↗
Bexmarilimab’s macrophage-targeting approach activates T-cells and drives anti-tumour immune responses in cold tumours that are not otherwise responsive to immunotherapy |
| 2021-05-17 | Faron Pharmaceuticals Ltd | Results Bexmarilimab shows promising anti-tumour activity faron.com ↗
TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces promising new data from its ongoing bexmarilimab MATINS study, reporting combined headline data from 141 evaluable patients enrolled in the completed Part I and ongoing Part II of the study. |
| 2021-03-22 | Faron Pharmaceuticals Ltd | Results Bexmarilimab (Clevegen) development update faron.com ↗
Gastric cancer becomes sixth tumour cohort to show early signs of clinical efficacy |
| 2021-01-20 | Faron Pharmaceuticals Ltd | Results Bexmarilimab (Clevegen) development update faron.com ↗
Cholangiocarcinoma becomes fifth tumour cohort to show early signs of efficacy |
| 2020-12-10 | Faron Pharmaceuticals Ltd | Results Presentations at ESMO Immuno-Oncology Virtual Congress build case for CLEVER-1 as a new immune checkpoint target faron.com ↗
Full data from Part I (dose ranging) of the MATINS trial, to be presented during an educational session by principal investigator Petri Bono, M.D., Ph.D., show bexmarilimab to be well tolerated and demonstrating immune activation and promising clinical anti-tumour activity. |
| 2020-09-18 | Faron Pharmaceuticals Ltd | Results MATINS trial data presented at ESMO faron.com ↗
Th1-weighted immune activation in all subjects measured following treatment with bexmarilimab. |
| 2020-06-01 | Faron Pharmaceuticals Ltd | Results MATINS Update faron.com ↗
Data were presented on all 30 patients in Part I of the trial, who had advanced solid tumours and had exhausted all standard therapeutic options. |
| 2019-11-28 | Faron Pharmaceuticals Ltd | Regulatory FDA has approved Faron’s Clevegen IND faron.com ↗
Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces that the US Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for Clevegen® (FP-1305), enabling expansion of its ongoing MATINS trial into the US. |
| 2019-10-09 | Faron Pharmaceuticals Ltd | Results Matins Trial Update faron.com ↗
A maximally tolerated dose (MTD) has not been reached. |
| 2019-09-30 | Faron Pharmaceuticals Ltd | Results MATINS poster presentation at ESMO Congress faron.com ↗
During the session Dr Petri Bono, principal investigator of the MATINS trial, presented data showing Clevegen’s potential early efficacy and good tolerability. |
All press releases naming this drug 86 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bexmarilimab | “In this study, we analyzed the mode of action of a humanized IgG4 anti-Clever-1 antibody, FP-1305 (bexmarilimab), both in vitro and in patients with heavily pretreated...” PMID 34078651 ↗ Jun 2021 |
| Known as | Clevegen | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594544 ↗ |
| Known as | FP-1305 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03733990 ↗ |
| Action | Inhibit | “This first-in-human trial investigates the safety and tolerability of Clever-1 blockade with bexmarilimab in patients with treatment-refractory solid tumors” PMID 38056464 ↗ Dec 2023 |
| Modality | Monoclonal antibody | “bexmarilimab, a humanized IgG4 antibody against human Clever-1” PMID 35500016 ↗ Jul 2022 |
| Route | Intravenous | “Bexmarilimab is a monoclonal antibody to common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1), administered by IV infusion every 3 weeks.” NCT05171062 ↗ |