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    DRUG:

    onvapegleukin alfa (TransCon IL-2 β/γ)

    i
    Other names: TransCon IL-2 β/γ, TransCon Interleukin 2 beta/gamma, TransCon IL-2 b/g
    Associations

    News

    Trials
    Company:
    Ascendis
    Drug class:
    CD122 agonist, IL-2R agonist, IL-2Rγ agonist
    Related drugs:
    Associations

    News

    Trials
    1m
    IL Believe: A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov)
    P1/2, N=473, Recruiting, Ascendis Pharma Oncology Division A/S | Trial completion date: Aug 2027 --> Aug 2029 | Trial primary completion date: May 2026 --> Aug 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
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    IL2 (Interleukin 2)
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    Keytruda (pembrolizumab) • Kadcyla (ado-trastuzumab emtansine) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    11ms
    IL Believe: A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov)
    P1/2, N=393, Recruiting, Ascendis Pharma Oncology Division A/S | Trial completion date: May 2025 --> Aug 2027 | Trial primary completion date: Jan 2025 --> May 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
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    IL2 (Interleukin 2)
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    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    over1year
    Phase I/II dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab: Determination of recommended phase II dose (RP2D) for monotherapy (ESMO 2023)
    The RP2D for monotherapy was determined at 120 mcg/kg IV every 3 weeks while dose escalation continues for combination therapy. PK data indicated a half-life of at least 35 hours and PD data confirm durable activation and expansion of cytotoxic immune cells from TransCon IL-2 β/γ.
    P1/2 data • P2 data • Combination therapy
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    MSI (Microsatellite instability) • IL2 (Interleukin 2)
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    MSI-H/dMMR
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    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ)
    over2years
    IL believe: A phase 1/2, open-label, dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab or standard-of-care chemotherapy in patients with locally advanced or metastatic solid tumors. (ASCO 2022)
    Recombinant human interleukin-2 (IL-2, aldesleukin) can induce a response rate of ̃15% in metastatic renal cell carcinoma and metastatic melanoma, yet toxicities (vascular leak syndrome, cytokine storm) have limited its use...Parts 1 and 2 Dose Escalation (Phase 1) use a standard 3+3 design with increasing doses of intravenous (IV) TransCon IL-2 b/g alone (Part 1) or with 200 mg IV pembrolizumab in solid tumors where pembrolizumab monotherapy may have clinical activity (Part 2)...Other key objectives include the evaluation of pharmacokinetics, pharmacodynamic biomarkers, and antitumor activity according to RECIST 1.1. Recruitment started in January 2022 and is ongoing (NCT05081609).
    Clinical • P1/2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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    PD-1 (Programmed cell death 1) • IL2 (Interleukin 2)
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    PD-1 expression
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    Keytruda (pembrolizumab) • Proleukin (aldesleukin) • onvapegleukin alfa (TransCon IL-2 β/γ)
    almost3years
    IL Believe: A Study of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=86, Recruiting, Ascendis Pharma Oncology Division A/S | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
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    IL2 (Interleukin 2)
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    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ)
    3years
    IL Believe: A Study of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=86, Not yet recruiting, Ascendis Pharma A/S
    Clinical • New P1/2 trial • Combination therapy
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    IL2 (Interleukin 2)
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    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ)