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    DRUG:

    cinrebafusp alfa (PRS-343)

    i
    Other names: PRS-343, PRS 343, HER2/41BB bispecific antibody
    Company:
    Pieris Pharmaceuticals, Servier
    Drug class:
    HER2 inhibitor, CD137 agonist
    Related drugs:
    11d
    PRS-343-PCS_04_16: PRS-343 in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=85, Completed, Pieris Pharmaceuticals, Inc. | Trial completion date: Oct 2021 --> Dec 2023 | Trial primary completion date: Oct 2021 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    cinrebafusp alfa (PRS-343)
    11d
    PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=41, Completed, Pieris Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Phase classification: P1b --> P1
    Trial completion • Phase classification • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tecentriq (atezolizumab) • cinrebafusp alfa (PRS-343)
    1year
    Combination of cinrebafusp alfa with ramucirumab and paclitaxel is well tolerated and elicits encouraging clinical activity in patients with HER2-positive gastric/gastroesophageal junction (GEJ) adenocarcinoma (AACR 2023)
    The combination of cinrebafusp alfa with ramucirumab and paclitaxel was safe and tolerated in the 5 patients treated. Preliminary activity of cinrebafusp alfa in combination with ramucirumab and paclitaxel demonstrated a high response rate indicating that the combination can elicit clinical responses in patients who have progressed on trastuzumab deruxtecan or checkpoint inhibitor regimens.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Cyramza (ramucirumab) • cinrebafusp alfa (PRS-343)
    almost2years
    A phase 2, multi-center, open-label study of cinrebafusp alfa (PRS-343) in patients with HER2-high and HER2-low gastric or gastroesophageal junction (GEJ) adenocarcinoma (ESMO-GI 2022)
    No abstract available
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2-H
    |
    cinrebafusp alfa (PRS-343)
    2years
    A phase 2, multi-center, open-label study of cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma and in combination with tucatinib in patients with HER2 low gastric or gastroesophageal junction (GEJ) adenocarcinoma (AACR 2022)
    Background: For patients (pts) with HER2-overexpressing metastatic gastric cancer, trastuzumab + chemotherapy +/- pembrolizumab is a standard first-line option but only provides an incremental overall survival (OS) benefit vs chemotherapy. Recruitment is ongoing. Approximately 10 sites in 3 countries in US, Asia and Europe are expected to participate.
    Clinical • P2 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2-H
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • paclitaxel • Cyramza (ramucirumab) • Tukysa (tucatinib) • cinrebafusp alfa (PRS-343)
    over2years
    PRS-343-PCS_04_16: PRS-343 in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=85, Completed, Pieris Pharmaceuticals, Inc. | Recruiting --> Completed | Trial primary completion date: May 2021 --> Oct 2021
    Clinical • Trial completion • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    cinrebafusp alfa (PRS-343)
    3years
    [VIRTUAL] Clinical and biomarker activity of PRS-343, a bispecific fusion protein targeting 4-1BB and HER2, from a phase 1 study in patients with advanced solid tumors (Study PRS-343-PCS_04_16) (AACR 2021)
    The authors did not submit an updated abstract. The original abstract should be considered final.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    cinrebafusp alfa (PRS-343)
    3years
    PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1b, N=45, Active, not recruiting, Pieris Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tecentriq (atezolizumab) • cinrebafusp alfa (PRS-343)
    3years
    PRS-343-PCS_04_16: PRS-343 in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=110, Recruiting, Pieris Pharmaceuticals, Inc. | Suspended --> Recruiting | Trial completion date: May 2021 --> Sep 2021 | Trial primary completion date: Jan 2021 --> May 2021
    Clinical • Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    cinrebafusp alfa (PRS-343)
    3years
    PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1b, N=45, Recruiting, Pieris Pharmaceuticals, Inc. | Suspended --> Recruiting | Trial completion date: Feb 2021 --> Jul 2021 | Trial primary completion date: Dec 2020 --> May 2021
    Clinical • Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tecentriq (atezolizumab) • cinrebafusp alfa (PRS-343)
    over3years
    PRS-343-PCS_04_16: PRS-343 in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=110, Suspended, Pieris Pharmaceuticals, Inc. | N=78 --> 110 | Trial completion date: Sep 2020 --> May 2021 | Recruiting --> Suspended | Trial primary completion date: Apr 2020 --> Jan 2021
    Clinical • Enrollment change • Trial completion date • Trial suspension • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    cinrebafusp alfa (PRS-343)
    over3years
    PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1b, N=45, Suspended, Pieris Pharmaceuticals, Inc. | N=70 --> 45 | Trial completion date: Aug 2020 --> Feb 2021 | Recruiting --> Suspended | Trial primary completion date: Apr 2020 --> Dec 2020
    Clinical • Enrollment change • Trial completion date • Trial suspension • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tecentriq (atezolizumab) • cinrebafusp alfa (PRS-343)
    almost4years
    [VIRTUAL] A phase I dose escalation study of PRS-343, a HER2/4-1BB bispecific molecule, in patients with HER2-positive malignancies (ESMO 2020)
    We will also present results of a PRS-343/atezolizumab combination trial in HER2+ solid tumors...Based on these data, a phase II trial in gastric/GEJ cancer has been planned in combination with ramucirumab and paclitaxel...Funding: Pieris Pharmaceuticals. Clinical trial identification: NCT03330561.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8)
    |
    HER-2 positive
    |
    Tecentriq (atezolizumab) • paclitaxel • cinrebafusp alfa (PRS-343)