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CSF-GM (Leucogen)

✓ Approved

LG Chem Ltd. · CSF2RA · Recombinant Proteins

What is CSF-GM?

CSF-GM is a recombinant proteins developed by LG Chem Ltd.. It is approved for therapeutic indications via injectable (others).

Drug Profile

Brand NamesLeucogen
CompanyLG Chem Ltd.
Drug ClassRecombinant Proteins
Molecular TargetCSF2RA
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, LG Chem Ltd.

Mechanism of Action

Molecular Targets

CSF-GM acts on 1 molecular target:

CSF2RAcolony stimulating factor 2 receptor subunit alpha (CD116, CSF2RX)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

CSF-GM is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Leukaemia✓ Approved
Blood and lymphatic system disordersMyelosuppression✓ Approved

Related Research Articles

PubMedJournal of Alzheimer's disease : JAD2026-10-16

Immunoglobulin GM (γ marker) allotypes as potential genetic markers of efficacy of lecanemab therapy in Alzheimer's disease.

Pandey Janardan P JP

Lecanemab is a humanized IgG1 monoclonal antibody that targets amyloid-β (Aβ) aggregates, a pathological hallmark of Alzheimer's disease (AD). In the largest clinical trial of its kind to date, lecanemab slowed cognitive decline by 27% in patients with early-stage AD. Lecanemab has also been shown to reduce cerebral Aβ deposition. Lecanemab expresses the immunoglobulin GM 3 allotype, which is defined by an arginine residue in the CH1 region of the γ1 chain and is potentially immunogenic in individuals who lack this allotype. I hypothesize that anti-GM 3 antibodies, generated either following lecanemab administration or acquired previously through maternal-fetal incompatibility or transfusion of allotype-incompatible blood products, may form immune complexes with the therapeutic antibody. These immune complexes could be cleared by phagocytic cells, including microglia, thereby reducing the availability and efficacy of lecanemab and contributing to therapeutic nonresponsiveness. If validated, GM allotypes could serve as genetic markers for predicting response to lecanemab therapy and may help guide personalized treatment strategies in AD.

PMID 42885677
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PubMedNature neuroscience2026-10-16

Periventricular gradient pathology is linked to ependymal reactivity and cell adhesion disruption in multiple sclerosis.

Groh Adam M R AMR, Afanasiev Elia E, Thevakumaran Risavarshni R, Creeggan Finn F et al.

Cerebrospinal fluid (CSF)-adjacent brain areas are especially vulnerable to diffuse degeneration in multiple sclerosis (MS). Surface-in gradients arising from CSF-borne cytotoxic factors have been proposed to predict disease relapses independent of white matter lesions. Yet, whether such factors disrupt ependymal cells to penetrate the ventricular border in MS remains unknown. Here, using ultra-high-field magnetic resonance imaging-guided histology, electron microscopy and single-nucleus multiomics, we found that ependymal pathology correlates with periventricular gradients and involves an immune-reactive state marked by transporter and junctional protein dysregulation. We further defined the gene regulatory networks underpinning the MS ependymal state and predicted ligands known to be enriched in MS CSF that could drive the emergence of this state. One of the candidates, IFNγ, increased murine ependymal permeability in vivo, indicating that CSF ligands can modulate ependymal function and regional inflammation. These findings identify CSF-driven ependymal dysfunction as a contributor to periventricular pathology in MS.

PMID 42881221
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PubMedDiagnostics (Basel, Switzerland)2026-10-16

Rapid CSF Molecular Diagnosis of Listeria monocytogenes Meningoencephalitis in an Elderly Immunocompetent Patient: A Case Report.

Andrejkovits Ákos Vince ÁV, Ladó Róbert R, Pop Adrian Vlad AV, Coșeriu Răzvan Lucian RL et al.

Background/Objectives: Listeria monocytogenes is an uncommon but potentially life-threatening cause of central nervous system infection, predominantly affecting older adults and immunocompromised patients. Neurolisteriosis may present with nonspecific neurological manifestations, and the absence of classical meningeal signs may delay diagnosis. We report a case of L. monocytogenes meningoencephalitis in an elderly patient without known immunosuppression, with rapid cerebrospinal fluid (CSF) molecular testing facilitating early diagnosis and appropriate antimicrobial treatment. Case presentation: A 76-year-old man with significant cardiovascular comorbidities was admitted with a 3-day history of fever, headache, nausea, vomiting, fatigue, and gait instability. He was alert on admission, with only mild meningeal signs, and initial cranial computed tomography showed no acute intracranial abnormalities. CSF analysis revealed inflammatory changes. Empirical ceftriaxone therapy was supplemented with vancomycin, followed by the initiation of intravenous ampicillin and gentamicin after molecular identification of L. monocytogenes. The diagnosis was subsequently confirmed by CSF culture, while blood cultures remained negative. Clinical and laboratory parameters improved progressively, accompanied by marked improvement in CSF findings on follow-up examination. The patient was discharged in stable condition after 18 days of hospitalization. Conclusions: Neurolisteriosis should be considered in elderly patients presenting with fever and neurological symptoms, even in the absence of overt immunosuppression or prominent meningeal signs. This case highlights the diagnostic value of rapid CSF molecular testing, particularly when blood cultures are negative and the initial clinical presentation is nonspecific. Early recognition of L. monocytogenes infection and timely initiation of targeted antimicrobial therapy are essential to improving outcomes.

PMID 42882317
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PubMedCancers2026-10-16

The Landscape of Tumor Dissemination in Leptomeningeal Disease: Mapping CTC Plasticity and Regional Heterogeneity Across Blood and CSF Compartments.

Shishido Stephanie N SN, Chaudhuri Baishali B, Mushran Vidur V, Ihle Kena K et al.

Background/Objectives: Leptomeningeal disease (LMD) is among the most severe complications of metastatic breast cancer, with median survival measured in weeks. Definitive diagnosis relies on neuroimaging and cerebrospinal fluid (CSF) cytology, which carries a false-negative rate of 40-50% at a single lumbar puncture. Improved tools for detecting and characterizing tumor cells across systemic and central nervous system (CNS) compartments are urgently needed. Methods: We applied an enrichment-free, fluorescence whole-slide imaging (fWSI)-based liquid biopsy platform to ante-mortem and post-mortem peripheral blood (PB) and CSF from five patients with metastatic breast cancer and confirmed or suspected LMD, collected through the City of Hope LEGACY warm autopsy program. Circulating tumor cells (CTCs) were classified by immunophenotype (cytokeratin [CK], vimentin [VIM], CD45/CD31) and morphology. Select cells underwent single-cell copy number variation (CNV) profiling by low-pass whole-genome sequencing. Results: Across 23 samples (11 PB, 12 CSF), we identified marked compartmental heterogeneity in CTC burden, phenotype, and genomic architecture. In the one patient (Patient 1) sampled across all four ventricular-to-cisternal CSF sites, CTC frequency declined from proximal to distal compartments (11.4% in the right lateral ventricle to 0.6% at the foramen magnum), a single-patient observation consistent with a proximal-to-distal gradient. Patients with active, untreated LMD showed high CSF CTC incidence with both epithelial and mesenchymal phenotypes, whereas the two patients receiving intrathecal therapy each showed low or absent CSF CTCs; given the small numbers involved and a plausible technical confound in a third patient, we interpret this association cautiously. Single-cell CNV profiling of CSF-derived CTCs across patients with active LMD revealed highly concordant chromosomal aberration profiles, 100% of CK+ CSF CTCs analyzed carried chromosomal aberrations, consistent with, though not formally establishing, expansion of a genomically evolved subclone within the leptomeningeal compartment; PB-derived cells showed substantially greater heterogeneity. In the two patients with paired post-mortem arterial and venous PB, arterial blood showed higher total rare cell counts in both, and higher CK-positive CTC incidence in one (1425.73 vs. undetectable epi.CTC/mL); the other showed the reverse for this specific metric. Conclusions: Enrichment-free, multi-compartment liquid biopsy reveals a regionally heterogeneous and biologically structured landscape in breast cancer LMD not resolvable by conventional cytology or single-site venous sampling. These findings are consistent with a hypothesis-generating model in which the leptomeningeal space acts as a selective niche for clonally convergent tumor expansion. They also point to the potential of regionally resolved CTC profiling for monitoring LMD treatment response in future, larger cohorts.

PMID 42882819
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PubMedClinical and translational science2026-10-16

A Systematic Intracranial Exposure-Response Evaluation of Brain-Penetrant Inhibitors: Informing Dose Selection for Brain Metastases.

Zhao Yuqian Y, Huang Weize W

Brain metastases (BMs) represent a major clinical challenge due to their high incidence in cancers such as non-small cell lung cancer (NSCLC) and breast cancer, and the limited efficacy of systemic therapies resulting from inadequate drug penetration across the blood-brain barrier. Although several brain-penetrant tyrosine kinase inhibitors (TKIs) have been developed, the quantitative relationship between intracranial drug exposure and intracranial clinical response has not been well established, leaving an important gap in dose selection strategies. In this study, we systematically evaluated the intracranial exposure-response relationship across brain-penetrant small-molecule TKIs. Fourteen TKIs were identified based on guideline-recommended therapies for BMs. For each drug, plasma and cerebrospinal fluid (CSF) pharmacokinetic profiles were simulated using published population pharmacokinetic models, with CSF exposures extrapolated using known unbound plasma fractions and CSF-to-plasma unbound concentration ratios (Kp,uu,CSF) in humans. Key intracranial exposure metrics, including the CSF steady-state trough and average concentrations relative to IC50 (Cmin,ss/IC50 and Cave,ss/IC50) and the percentage of the steady-state dosing interval during which CSF concentrations remained above IC50 (T% > IC50), were derived and correlated with intracranial outcomes from published clinical studies. Overall, significant positive correlations were observed between intracranial exposure metrics and both intracranial objective response rate (ORR) and complete response rate (CR). Greater exposure coverage above IC50 was associated with improved intracranial efficacy. This work demonstrates a positive intracranial exposure-response relationship across brain-penetrant TKIs and provides a quantitative benchmark to inform dose selection beyond traditional plasma exposure metrics. These findings highlight the importance of achieving sufficient CNS drug concentrations to optimize the therapeutic effect in patients with BMs.

PMID 42886004
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PubMedJournal of clinical medicine2026-10-16

Lower-Limb Muscle Architecture and Strength in Men with Radiographic Axial Spondyloarthritis: A Cross-Sectional Ultrasound Study.

Kılıçoğlu Mehmet Serkan MS, Kara Mert M, Kültür Çamlı Esra E, Lutfi Delal D et al.

Background/Objectives: To compare lower-limb muscle architecture and strength between men with radiographic axial spondyloarthritis (r-axSpA) and controls. Methods: In this controlled cross-sectional study, 30 men with r-axSpA and 30 age-matched healthy men underwent bilateral ultrasound assessment of the vastus lateralis (VL), gastrocnemius medialis (GM), gastrocnemius lateralis (GL), and tibialis anterior (TA). Fascicle length was derived trigonometrically. Strength was assessed using hand-held dynamometry. Results: Differences represent r-axSpA minus controls, with 95% confidence intervals. VL, GM, and GL thickness differences were -0.32 (-0.50 to -0.13), -0.18 (-0.34 to -0.02), and -0.21 (-0.36 to -0.05) cm, respectively. Pennation-angle differences were -2.38 (-3.48 to -1.28), -1.99 (-3.35 to -0.63), -2.46 (-3.69 to -1.23), and 0.26 (-0.68 to 1.22) degrees for VL, GM, GL, and the TA superficial region, respectively. TA superficial-region thickness and derived fascicle length were greater: +0.53 (0.29 to 0.78) and +2.40 (1.36 to 3.45) cm, respectively. Knee extensor, ankle dorsiflexor, and ankle plantar flexor strength differences were -86.3 (-123.6 to -48.8), -52.0 (-78.2 to -26.6), and -57.9 (-92.3 to -24.1) N, respectively. Conclusions: Men with r-axSpA showed greater TA superficial-region thickness and derived fascicle length alongside lower dorsiflexion strength. These preliminary findings require confirmation in independent studies using validated measurement methods.

PMID 42881978
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