^
    9ms
    KEYNOTE-C86: A Study of SEA-CD40 Given With Other Drugs in Cancers (clinicaltrials.gov)
    P2, N=77, Completed, Seagen Inc. | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Nov 2024
    Trial completion • Trial completion date • Pan tumor
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • cifurtilimab (SEA-CD40)
    over1year
    Reversible Chemical Modification of Antibody Effector Function Mitigates Unwanted Systemic Immune Activation. (PubMed, Bioconjug Chem)
    The technology was applied to an effector function enhanced agonist CD40 antibody, SEA-CD40, and experiments demonstrate significant reductions in Fc-induced immune activation in vitro and in mice and nonhuman primates despite showing retained efficacy and improved pharmacokinetics compared to the parent antibody. We foresee that this simple, modular system can be rapidly applied to antibodies that suffer from systemic immune activation due to peripheral FcγR binding immediately upon infusion.
    Journal • IO biomarker
    |
    CD40 (CD40 Molecule)
    |
    cifurtilimab (SEA-CD40)
    almost2years
    KEYNOTE-C86: A Study of SEA-CD40 Given With Other Drugs in Cancers (clinicaltrials.gov)
    P2, N=77, Active, not recruiting, Seagen Inc. | Trial primary completion date: Oct 2024 --> Jan 2024
    Trial primary completion date • Combination therapy • Pan tumor • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • cifurtilimab (SEA-CD40)
    almost2years
    Harnessing the potential of CD40 agonism in cancer therapy. (PubMed, Cytokine Growth Factor Rev)
    In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.
    Review • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CD40 (CD40 Molecule) • CD40LG (CD40 ligand)
    |
    2141-V11 • CDX-1140 • cifurtilimab (SEA-CD40) • dalnicastobart (LVGN7409) • mitazalimab (ADC-1013) • selicrelumab (RG7876) • sotigalimab (PYX-107)
    over2years
    Phase 1 dose-escalation study of SEA-CD40: a non-fucosylated CD40 agonist, in advanced solid tumors and lymphomas. (PubMed, J Immunother Cancer)
    SEA-CD40 was tolerable as monotherapy and induced potent dose dependent immune cell activation and trafficking consistent with immune activation. Evidence of monotherapy antitumor activity was observed in patients with solid tumors and lymphoma. Further evaluation of SEA-CD40 is warranted, potentially as a component of a combination regimen.
    P1 data • Journal • IO biomarker • Metastases
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CD40 (CD40 Molecule)
    |
    cifurtilimab (SEA-CD40)
    over2years
    SGNS40-001: Safety Study of SEA-CD40 in Cancer Patients (clinicaltrials.gov)
    P1, N=159, Terminated, Seagen Inc. | Trial completion date: Oct 2024 --> Apr 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Mar 2023; Study closed due to portfolio prioritization
    Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • gemcitabine • albumin-bound paclitaxel • cifurtilimab (SEA-CD40)
    over2years
    KEYNOTE-C86: A Study of SEA-CD40 Given With Other Drugs in Cancers (clinicaltrials.gov)
    P2, N=77, Active, not recruiting, Seagen Inc. | Recruiting --> Active, not recruiting | N=200 --> 77
    Enrollment closed • Enrollment change • Combination therapy • Pan tumor • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • cifurtilimab (SEA-CD40)
    almost3years
    SGNS40-001: Safety Study of SEA-CD40 in Cancer Patients (clinicaltrials.gov)
    P1, N=159, Active, not recruiting, Seagen Inc. | Trial primary completion date: Dec 2022 --> Jan 2024
    Trial primary completion date • Metastases
    |
    CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • gemcitabine • albumin-bound paclitaxel • cifurtilimab (SEA-CD40)
    almost3years
    Updated results of a phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC; SGNS40-001). (ASCO-GI 2023)
    The combination of SEA-CD40 + GnP + pembro has an acceptable safety profile and shows evidence of antitumor activity in pts with PDAC. This regimen may warrant further evaluation. Clinical trial information: NCT02376699.
    Clinical • P1 data • Metastases
    |
    CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • gemcitabine • albumin-bound paclitaxel • cifurtilimab (SEA-CD40) • dacetuzumab (SGN-40)
    3years
    Phase 2 study of SEA-CD40 combination therapies in advanced malignancies (SGNS40-002, trial in progress) (SITC 2022)
    Five indication-specific cohorts will explore 2 different regimens: cohorts 1–3 will receive SEA-CD40 with pembrolizumab while cohorts 4 and 5 will receive SEA-CD40, pembrolizumab, carboplatin, and pemetrexed. All patients will provide written informed consent. Consent All patients will provide written informed consent.
    P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • cifurtilimab (SEA-CD40) • dacetuzumab (SGN-40)
    over3years
    Safety Study of SEA-CD40 in Cancer Patients (clinicaltrials.gov)
    P1, N=159, Active, not recruiting, Seagen Inc. | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Jun 2022 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • gemcitabine • albumin-bound paclitaxel • cifurtilimab (SEA-CD40)
    almost4years
    Safety Study of SEA-CD40 in Cancer Patients (clinicaltrials.gov)
    P1, N=159, Active, not recruiting, Seagen Inc. | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2022 --> Jun 2022
    Trial completion date • Trial primary completion date
    |
    CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • gemcitabine • albumin-bound paclitaxel • cifurtilimab (SEA-CD40)