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    DRUG:

    hydroxyureamethylacylfulvene (STAR-001)

    i
    Other names: STAR-001, LP-184, irofulven-2, irofulven-second-generation
    Company:
    Lantern Pharma
    Drug class:
    Alkylating agent
    Related drugs:
    1m
    Chemotherapeutic induction of cytosolic single-stranded DNA accumulation sensitizes triple-negative breast cancer to immunotherapy. (PubMed, J Immunother Cancer)
    These findings establish cytosolic ssDNA-driven immune programs as a mechanistic link between DNA damage and antitumor immunity, providing both a predictive biomarker and a therapeutic axis for chemoimmunotherapy. Pharmacologic induction of ssDNA represents a rational strategy to enhance ICB efficacy and expand immunotherapy responsiveness in TNBC.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    hydroxyureamethylacylfulvene (STAR-001)
    3ms
    LTRN184-1AST23-1: Study of LP-184 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=64, Active, not recruiting, Lantern Pharma Inc. | Recruiting --> Active, not recruiting | N=175 --> 64 | Trial completion date: Sep 2025 --> Jul 2026 | Trial primary completion date: Feb 2025 --> Jul 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PTGR1 (Prostaglandin Reductase 1)
    |
    Opdivo (nivolumab) • Lynparza (olaparib) • Yervoy (ipilimumab) • hydroxyureamethylacylfulvene (STAR-001)
    6ms
    A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in Combination With Spironolactone in Supratentorial Glioblastoma at First Progression (clinicaltrials.gov)
    P1/2, N=68, Not yet recruiting, Lantern Pharma Inc.
    New P1/2 trial
    |
    IDH wild-type
    |
    hydroxyureamethylacylfulvene (STAR-001)
    over1year
    LTRN184-1AST23-1: Study of LP-184 in Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=175, Recruiting, Lantern Pharma Inc. | Phase classification: P1 --> P1/2 | N=30 --> 175 | Trial completion date: Jun 2025 --> Sep 2025
    Phase classification • Enrollment change • Trial completion date
    |
    hydroxyureamethylacylfulvene (STAR-001)
    over2years
    LP-184, a novel acylfulvene molecule, exhibits anti-cancer activity against diverse solid tumors with homologous recombination deficiency. (PubMed, Cancer Res Commun)
    These preclinical findings illustrate the potential of LP-184 as a pan-HRD cancer therapeutic. Taken together, our results support continued clinical evaluation of LP-184 in a large subset of HRD solid tumors.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PTGR1 (Prostaglandin Reductase 1)
    |
    HRD
    |
    hydroxyureamethylacylfulvene (STAR-001)
    over2years
    Study of LP-184 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Lantern Pharma Inc. | Phase classification: P1a --> P1
    Phase classification • Metastases
    |
    hydroxyureamethylacylfulvene (STAR-001)
    almost3years
    Study of LP-184 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1a, N=30, Recruiting, Lantern Pharma Inc. | Phase classification: P1 --> P1a
    Phase classification • Metastases
    |
    hydroxyureamethylacylfulvene (STAR-001)
    almost3years
    Conditional dependency of LP-184 on prostaglandin reductase 1 is synthetic lethal in pancreatic cancers with DNA damage repair deficiencies. (PubMed, Mol Cancer Ther)
    Our results provide valuable biomarkers for clinical testing of LP-184 in a large subset of genetically defined characterized refractory carcinomas. High PTGR1 expression and deleterious DDR mutations are present in approximately one third of PDAC making these patients ideal candidates for clinical trials of LP-184.
    Journal • BRCA Biomarker • Synthetic lethality
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATR (Ataxia telangiectasia and Rad3-related protein) • PTGR1 (Prostaglandin Reductase 1) • ERCC4 (ERCC Excision Repair 4, Endonuclease Catalytic Subunit) • ERCC3 (ERCC Excision Repair 3, TFIIH Core Complex Helicase Subunit) • RAD23B (RAD23 Homolog B)
    |
    BRCA1 mutation • PTGR1 expression
    |
    hydroxyureamethylacylfulvene (STAR-001)
    3years
    Preclinical efficacy of LP-184, a tumor site activated synthetic lethal therapeutic, in glioblastoma. (PubMed, Clin Cancer Res)
    These results establish LP-184 as a promising chemotherapeutic for GBM with enhanced efficacy in intrinsic or spironolactone-induced TC-NER deficient tumors.
    Preclinical • Journal • Synthetic lethality
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • PTGR1 (Prostaglandin Reductase 1) • ERCC3 (ERCC Excision Repair 3, TFIIH Core Complex Helicase Subunit)
    |
    MGMT expression
    |
    temozolomide • hydroxyureamethylacylfulvene (STAR-001)
    3years
    LP-184, a Tumor Site Activated Small Molecule Acylfulvene, Is Effective Preclinically in Subsets of Lung Cancer (IASLC-WCLC 2023)
    H460 KEAP1/STK11 mutant cell line derived xenograft model was used to demonstrate the anti-tumor activity of LP-184. LP-184 displayed strong nanomolar potency in 7 day ex vivo treatment in a panel of patient derived lung cancer models carrying ATM, BRCA1 or CHEK1 mutations with IC50s in the range of 30 - 200 nM, which turned out to be 12-350 times superior to that of Olaparib across the same models. LP-184 is highly effective in selected molecular subsets of lung cancer in proof-of-concept ex vivo and in vivo studies, supporting its clinical development in small cell and non-small cell lung cancers. IND-enabling repeat dose GLP toxicology studies of LP-184 show it to be well tolerated in rats and dogs. A first-in-human dose escalation Phase 1A trial with LP-184 is expected to enroll all advanced solid tumors including lung cancers.
    Preclinical • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • STK11 (Serine/threonine kinase 11) • HRD (Homologous Recombination Deficiency) • KEAP1 (Kelch Like ECH Associated Protein 1) • CHEK1 (Checkpoint kinase 1) • PTGR1 (Prostaglandin Reductase 1) • RNF168 (Ring Finger Protein 168)
    |
    HRD • STK11 mutation • KEAP1 mutation • CHEK1 mutation • KEAP1 expression • PTGR1 expression • CHEK1 expression
    |
    Lynparza (olaparib) • hydroxyureamethylacylfulvene (STAR-001)
    3years
    Study of LP-184 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=35, Recruiting, Lantern Pharma Inc.
    New P1 trial • Metastases
    |
    hydroxyureamethylacylfulvene (STAR-001)