Report scope. This 2026 Drug Asset Due Diligence Report evaluates Bexmarilimab as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: CONDITIONAL GO
Bexmarilimab is a Monoclonal antibody associated with STAB1 and a global highest development stage of Phase 2. The lead disclosed indication is High Risk Myelodysplastic Syndrome. The current evidence supports a CONDITIONAL GO posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Bexmarilimab
- Target: STAB1
- Lead indication: High Risk Myelodysplastic Syndrome
- Highest phase: Phase 2
- Matched trials: 4
- Matched result records: 17
- Matched asset deals: 0
Use PatSnap Life Sciences MCP servers to validate the Bexmarilimab diligence evidence.
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Bexmarilimab, the MCP profile identifies STAB1 as the primary target context and High Risk Myelodysplastic Syndrome as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
Use PatSnap Life Sciences MCP servers to validate the Bexmarilimab diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07718243 | Phase 1/2 | Recruiting | Not disclosed | Not disclosed |
| NCT07672769 | Phase 2 | Not yet recruiting | Not disclosed | Not disclosed |
| NCT07460986 | Phase 1/2 | Recruiting | Not disclosed | Not disclosed |
| NCT05428969 | Phase 1/2 | Active, not recruiting | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
Use PatSnap Life Sciences MCP servers to validate the Bexmarilimab diligence evidence.
3. Clinical readouts: what is known
TRANSLATIONAL INSIGHTS AND CLINICAL EFFICACY WITH BEXMARILIMAB AND AZACITIDINE IN HR-MDS IN THE BEXMAB PHASE 1/2 STUDY
Study: NCT05428969 (BEXMAB, EHA2026). Phase: Phase 1/2. Enrollment: 55. Published: 2026-05-12.
CR = 45.0 %
1249MO - Macrophage reprogrammer bexmarilimab plus azacitidine in myelodysplastic syndrome: PK/PD and biomarker results from the phase I/II BEXMAB study
Study: NCT05428969 (BEXMAB, ESMO2025). Phase: Phase 1/2. Enrollment: 52. Published: 2025-10-17.
CD8+ T cells = 25% increase of BM CD8+ T cells, already after cycle 1 | CD8+ T cells = 25% increase of BM CD8+ T cells, already after cycle 1
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
Study: NCT05428969 (Pubmed | Lancet Haematol). Phase: Phase 1/2. Enrollment: 33. Published: 2025-07-01.
Adverse Event: anemia = anemia (n=7 [21%])
EFFICACY OF MACROPHAGE CHECKPOINT CLEVER-1 INHIBITION WITH BEXMARILIMAB PLUS AZACITIDINE IN MYELODYSPLASTIC SYNDROME: RESULTS FROM THE PH1/2 BEXMAB STUDY
Study: BEXMAB (EHA2025). Phase: Phase 1/2. Enrollment: 55. Published: 2025-05-14.
ORR = 100 % | ORR = 80 %
A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours
Study: NCT03733990 (MATINS, CTgov). Phase: Phase 1/2. Enrollment: 216. Published: 2025-04-02.
Dose Limiting Toxicities (DLT) in the Trial Subjects. = 0 DLT | Dose Limiting Toxicities (DLT) in the Trial Subjects. = 0 DLT
4265 Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study
Study: NCT05428969 (BEXMAB, ASH2024). Phase: Phase 1/2. Enrollment: 14. Published: 2024-12-09.
ORR = 79 %
Inside information: Faron Presents Phase 1 Data from BEXMAB in Myeloid Malignancies Trial at the 65th American Society of Hematology (ASH) Annual Meeting
Study: NCT05428969 (BEXMAB, Biospace). Phase: Phase 1. Enrollment: 28. Published: 2023-12-11.
ORR = 48 % | ORR = 100 %
Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial
Study: NCT03733990 (MATINS, Pubmed | Cell Rep Med). Phase: Phase 1/2. Enrollment: Not disclosed. Published: 2023-12-01.
DC = 25 % | DC = 40 %
752 Developing biomarkers for bexmarilimab, a novel macrophage-guided immunotherapy, in advanced solid tumors to select patients and confirm mechanism of action
Study: NCT03733990 (MATINS, SITC2023). Phase: Phase 1/2. Enrollment: Not disclosed. Published: 2023-11-02.
Immune activation = 30 %
Full efficacy analysis of phase I/II trial investigating bexmarilimab, a novel macrophage-guided immunotherapy in refractory solid tumors
Study: NCT03733990 (MATINS, ESMO2023). Phase: Phase 1/2. Enrollment: 216. Published: 2023-10-23.
Fatigue = 15.9% of the patients experiencing grade 3-4 TRAE
Inside information: Faron Announces Positive BEXMAB Study Update in Relapsed/Refractory AML and HMA-Refractory MDS Patients
Study: NCT05428969 (BEXMAB, GlobeNewswire). Phase: Phase 1/2. Enrollment: 22. Published: 2023-10-11.
ORR = 50 % | ORR = 80 %
Faron Updates Positive Clinical Data from Phase I/II BEXMAB Study of Bexmarilimab in Relapsed/Refractory AML and MDS BEXMAB Study Update
Study: NCT05428969 (BEXMAB, GlobeNewswire). Phase: Phase 1/2. Enrollment: 21. Published: 2023-07-19.
ORR = 53.3 % | ORR = 66.7 %
Abstract 2767: Low baseline serum IFNg and TNFa are predictive of response to bexmarilimab
Study: NCT03733990 (MATINS, AACR2022). Phase: Phase 1/2. Enrollment: 30. Published: 2022-06-15.
Serum IFNg levels(baseline) = 5.11 pg/mL (SD, +/ - 4.99) | Serum IFNg levels(baseline) = 13.07 pg/mL (SD, +/ - 13.26)
Promising clinical benefit rates in advanced cancers alongside potential biomarker correlation in a phase I/II trial investigating bexmarilimab, a novel macrophage-guided immunotherapy.
Study: NCT03733990 (MATINS, ASCO2022). Phase: Phase 1/2. Enrollment: 193. Published: 2022-06-02.
mPFS = 2.0 Month (95%CI, 1.9 - 2.0)
LBA38 - Bexmarilimab, a novel macrophage re-programmer shows promising anti-tumour activity in phase I/II trial in several last line solid tumour types
Study: NCT03733990 (MATINS, ESMO 12021 | ESMO 22021). Phase: Phase 1/2. Enrollment: 159. Published: 2021-09-17.
DCR = 17.3 % | TESAE = 185 Event
1024MO - A phase I/II MATINS trial: Part 1 pharmacokinetic, safety and efficacy results of Clever-1 blockade in advanced cancer
Study: NCT03733990 (MATINS, ESMO2020). Phase: Phase 1/2. Enrollment: 30. Published: 2020-09-18.
TEAE = 28.9 % of the treatment emergent adverse events were related to the study drug
6587 - Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumors
Study: NCT03733990 (MATINS, ESMO2019). Phase: Phase 1/2. Enrollment: 11. Published: 2019-09-28.
B cells = 143 % | B cells = 143 %
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
Use PatSnap Life Sciences MCP servers to validate the Bexmarilimab diligence evidence.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Bexmarilimab against approved therapies and clinical competitors in High Risk Myelodysplastic Syndrome, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
Use PatSnap Life Sciences MCP servers to validate the Bexmarilimab diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| No exact asset-specific transaction was returned. Use target-level precedents only as comparables and do not present them as asset transactions. | ||||
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
Use PatSnap Life Sciences MCP servers to validate the Bexmarilimab diligence evidence.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
CONDITIONAL GO
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-15. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
