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    DRUG:

    golidocitinib (DZD4205)

    i
    Other names: DZD4205, AZD-4205, AZD 4205, AZD4205
    Company:
    Dizal Pharma
    Drug class:
    JAK1 inhibitor
    Related drugs:
    4ms
    JACKPOT33: Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC) (clinicaltrials.gov)
    P2, N=69, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial • Combination therapy • Metastases
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel • golidocitinib (DZD4205)
    5ms
    Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. (PubMed, Lancet Oncol)
    In this phase 2 study, golidocitinib showed a favourable benefit-risk profile in treating relapsed or refractory peripheral T-cell lymphoma. The results of this study warrant further randomised clinical studies to confirm activity and assess efficacy in this population.
    P2 data • Journal
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    JAK1 (Janus Kinase 1)
    |
    golidocitinib (DZD4205)
    6ms
    Phase 1 Dose Escalation and Expansion Study of Golidocitinib, a Highly Selective JAK1 Inhibitor, in Relapsed or Refractory Peripheral T Cell Lymphomas. (PubMed, Ann Oncol)
    In this phase I study, golidocitinib demonstrated an acceptable safety profile and encouraging antitumor efficacy in heavily pretreated patients with r/r PTCLs. These results support the initiation of the multinational pivotal study in patients with r/r PTCLs.
    P1 data • Clinical Trial,Phase I • Journal
    |
    JAK1 (Janus Kinase 1)
    |
    golidocitinib (DZD4205)
    7ms
    Phase 2 Study of Golidocitinib, a JAK1 Selective Inhibitor, As Maintenance Therapy in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy (JACKPOT26) (ASH 2023)
    In conclusion, golodocitinib showed manageable safety profile and promising effect in maintaining and enhancing tumor response in patients with PTCL post first-line therapies. This result supports further clinical development of golidocitnib in the first-line setting. The updated data will be presented in the conference.
    Clinical • P2 data
    |
    JAK1 (Janus Kinase 1)
    |
    golidocitinib (DZD4205)
    10ms
    Rare Lymphomas: Getting "a Bit Ahead". (PubMed, Cancer Discov)
    According to data from the phase III IELSG37 trial, consolidation radiotherapy is unnecessary for patients with primary mediastinal B-cell lymphoma who respond completely to standard immunochemotherapy. Two other studies of peripheral T-cell lymphomas and adult T-cell leukemia/lymphoma, respectively, point to golidocitinib, an investigational JAK1 inhibitor, and mogamulizumab, which targets CCR4, as potential new treatment options.
    Journal
    |
    CCR4 (C-C Motif Chemokine Receptor 4)
    |
    Poteligeo (mogamulizumab-kpkc) • golidocitinib (DZD4205)
    11ms
    Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8) (clinicaltrials.gov)
    P2, N=160, Recruiting, Dizal Pharmaceuticals | Trial completion date: Jul 2023 --> Dec 2024 | Trial primary completion date: Jan 2023 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    golidocitinib (DZD4205)
    11ms
    Peripheral T-cell lymphomas. (PubMed, Hematol Oncol)
    Do we require an autologous stem cell transplantation in all patients? Is there room for improvement in the setting of relapsed and refractory disease?
    Journal
    |
    azacitidine • Adcetris (brentuximab vedotin) • Copiktra (duvelisib) • Ezharmia (valemetostat) • Itari (linperlisib) • golidocitinib (DZD4205)
    over1year
    Preliminary Biomarker Data from a Phase 1/2 Study of Golidocitinib Demonstrates Targeting JAK/STAT Pathway to Treat Peripheral T-Cell Lymphoma (ASH 2022)
    No apparent correlation between mutations in JAK/STAT pathway and clinical response was observed while baseline high pSTAT level seems to predict clinical benefit. Larger sample size is needed to confirm the findings.
    P1/2 data
    |
    ALK (Anaplastic lymphoma kinase) • JAK2 (Janus kinase 2) • JAK1 (Janus Kinase 1)
    |
    golidocitinib (DZD4205)
    2years
    A PHASE I/II STUDY OF GOLIDOCITINIB, A SELECTIVE JAK1 INHIBITOR, IN REFRACTORY OR RELAPSED PERIPHERAL T CELL LYMPHOMA (EHA 2022)
    The majority of TEAEs were reversible or clinically manageable with dose modifications. Conclusion Golidocitinib shows good safety and promising anti-tumor efficacy in r/r PTCL, indicating its potential as a therapeutic option for this unmet medical need.
    P1/2 data
    |
    JAK1 (Janus Kinase 1)
    |
    golidocitinib (DZD4205)
    over3years
    Discovery of (2R)-N-[3-[2-[(3-methoxy-1-methyl-pyrazol-4-yl)amino]pyrimidin-4-yl]-1H-indol-7-yl]-2-(4-methylpiperazin-1-yl)propenamide (AZD4205) as a potent and selective Janus Kinase 1 (JAK1) inhibitor. (PubMed, J Med Chem)
    JAK1, JAK2, JAK3, and TYK2 belong to the JAK (Janus kinase) family. Compound 21 has good preclinical pharmacokinetics. Compound 21 displayed an enhanced antitumor activity in combination with approved EGFR inhibitor, osimertinib, in a preclinical non-small cell lung cancer (NSCLC) xenograft NCI-H1975 model.
    Journal
    |
    JAK2 (Janus kinase 2) • JAK1 (Janus Kinase 1) • JAK3 (Janus Kinase 3) • TYK2 (Tyrosine Kinase 2)
    |
    EGFR H1975
    |
    Tagrisso (osimertinib) • golidocitinib (DZD4205)
    4years
    Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=10, Completed, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed | N=120 --> 10 | Trial completion date: Jul 2022 --> Jan 2020 | Trial primary completion date: Jul 2020 --> Sep 2019
    Clinical • Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • golidocitinib (DZD4205)
    over4years
    Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=120, Active, not recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • golidocitinib (DZD4205)