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    DRUG CLASS:

    MUC16 inhibitor

    Related drugs:
    1m
    A Phase Ib Study of Indirect Immunization with Oregovomab and Toll-like-Receptor-3 Stimulation with Hiltonol® in Patients with Recurrent Platinum-Resistant Ovarian Cancer. (PubMed, Curr Oncol)
    The safety and compatibility of combining oregovomab with Hiltonol® have been demonstrated in this study. The potential to enhance activity of chemotherapy using oregovomab indirect immunization and Hiltonol® stimulation is proposed.
    P1 data • Journal • Platinum resistant
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    MUC16 (Mucin 16, Cell Surface Associated) • TLR3 (Toll Like Receptor 3)
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    Hiltonol (poly-ICLC) • OvaRex (oregovomab)
    3ms
    A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=300, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial
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    ubamatamab (REGN4018) • Kevzara (sarilumab)
    4ms
    Mucin 16-Directed Therapy in Pediatric Sarcomas: Case Evidence of Ubamatamab Efficacy in Epithelioid Sarcoma and Its Implications for Other Sarcoma Subtypes. (PubMed, JCO Precis Oncol)
    MUC16 is frequently detected in ES and MRTs. Ubamatamab is an encouraging anti-MUC16 therapy, demonstrating clinical efficacy. Ongoing trials (ClinicalTrials.gov identifier: NCT06444880) are evaluating ubamatamab in other rare MUC16-positive tumors.
    Retrospective data • Journal
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    MUC16 (Mucin 16, Cell Surface Associated)
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    ubamatamab (REGN4018)
    4ms
    R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov)
    P1/2, N=890, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jun 2026 --> Jan 2027 | Trial primary completion date: Jun 2026 --> Feb 2026
    Trial completion date • Trial primary completion date
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    Libtayo (cemiplimab-rwlc) • Actemra IV (tocilizumab) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    5ms
    QPT-ORE-006: Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, CanariaBio Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Jan 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    carboplatin • paclitaxel • OvaRex (oregovomab)
    5ms
    QPT-ORE-004: A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. (clinicaltrials.gov)
    P2, N=10, Active, not recruiting, CanariaBio Inc. | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Platinum sensitive
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    MUC16 (Mucin 16, Cell Surface Associated)
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    Zejula (niraparib) • OvaRex (oregovomab)
    5ms
    FLORA-4: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (clinicaltrials.gov)
    P3, N=615, Active, not recruiting, CanariaBio Inc. | Trial completion date: Aug 2027 --> Aug 2028 | Trial primary completion date: Sep 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
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    carboplatin • paclitaxel • OvaRex (oregovomab)
    6ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Platinum resistant
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    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    7ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Not yet recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2028 --> Dec 2028 | Trial primary completion date: Apr 2028 --> Dec 2028
    Trial completion date • Trial primary completion date • Platinum resistant
    |
    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    11ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial
    |
    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    12ms
    Translational findings support regimen selection for first-in-human study of ubamatamab (MUC16 × CD3 bispecific antibody) in patients with recurrent ovarian cancer. (PubMed, Clin Transl Sci)
    Integrating preclinical and clinical data determined a target trough concentration range of 5-30 mg/L, which supports evaluation of ubamatamab 250 mg with or without cemiplimab and 800 mg monotherapy once every 3 weeks in expansion cohorts. Preclinical data (cytokine release, tumor regression, monkey PK) had translational value in supporting regimen selection in dose escalation and subsequently in dose expansion after integration with patient data from dose escalation.
    P1 data • Journal
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    MUC16 (Mucin 16, Cell Surface Associated)
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    MUC16 expression
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    Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018)
    1year
    Pretargeted alpha therapy in MUC16-positive high-grade serous ovarian cancer. (PubMed, Nucl Med Biol)
    We confirmed that pretargeting with AR9.6-TCO and [225Ac]Ac-mcp-PEG8-Tz has durable antitumor effects in high MUC16-expressing tumors. These findings demonstrate great potential for using pretargeting in combination with TAT for the treatment of ovarian cancer.
    Journal
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    MUC16 (Mucin 16, Cell Surface Associated)
    |
    MUC16 expression