^
    6d
    Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov)
    P1, N=117, Active, not recruiting, M.D. Anderson Cancer Center | Enrolling by invitation --> Active, not recruiting
    Enrollment closed
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    CA 19-9 (Cancer antigen 19-9)
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    Keytruda (pembrolizumab) • Zyclara (imiquimod) • sotigalimab (PYX-107)
    14d
    CAR-T triggers TAM reeducation and adaptive anti-tumor response via TREM2 deficiency or CD40 agonist. (PubMed, Cell Rep Med)
    Notably, the clinical agonist sotigalimab similarly enhances human CD8+ T cell migration in vitro. Our findings highlight the significance of combining GPC3-CAR-T therapy with CD40 agonist as a critical pre-requisite for eliciting reeducation of TAMs and enhancing the efficacy of CAR-T therapy in HCC.
    Journal • IO biomarker
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    CD8 (cluster of differentiation 8) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • STAT1 (Signal Transducer And Activator Of Transcription 1) • CD40 (CD40 Molecule) • TREM2 (Triggering Receptor Expressed On Myeloid Cells 2)
    |
    sotigalimab (PYX-107)
    2ms
    APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma (clinicaltrials.gov)
    P1/2, N=34, Terminated, M.D. Anderson Cancer Center | Active, not recruiting --> Terminated; <75% participant accrual
    Trial termination
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    Keytruda (pembrolizumab) • sotigalimab (PYX-107)
    3ms
    A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC) (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Yale University | Trial completion date: Feb 2026 --> Aug 2026 | Trial primary completion date: Aug 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • sotigalimab (PYX-107)
    4ms
    INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, University of Texas Southwestern Medical Center | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
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    oxaliplatin • sotigalimab (PYX-107)
    5ms
    SHR-2005, an FcγR-Dependent CD40 Agonistic Antibody with Potent Antitumor Activities and Favorable Safety Profile. (PubMed, Mol Cancer Ther)
    Notably, SHR-2005 induced significantly lower IL-6 secretion than the APX005M analogue in human peripheral blood mononuclear cells, indicating a favorable safety profile. In conclusion, the CD40 agonistic antibody SHR-2005 was highly reliant on FcγR for agonistic activation and exhibited promising potential for clinical development as monotherapy or in combination with the anti-PD-L1 antibody for the treatment of solid tumors. Based on promising efficacy and tolerance in preclinical studies, SHR-2005 is currently being evaluated in an ongoing phase I clinical trial for the intravesical treatment of high-risk non-muscle-invasive bladder cancer.
    Journal
    |
    IL6 (Interleukin 6) • CD40 (CD40 Molecule) • CD40LG (CD40 ligand)
    |
    sotigalimab (PYX-107)
    6ms
    Phase I Study of APX005M in Pediatric Central Nervous System Tumors (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Pediatric Brain Tumor Consortium | Trial completion date: Jun 2025 --> Sep 2025
    Trial completion date
    |
    TMB (Tumor Mutational Burden) • CD4 (CD4 Molecule)
    |
    sotigalimab (PYX-107)
    6ms
    Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov)
    P1, N=150, Enrolling by invitation, M.D. Anderson Cancer Center | Recruiting --> Enrolling by invitation | Trial completion date: May 2025 --> May 2027 | Trial primary completion date: May 2025 --> May 2027
    Enrollment status • Trial completion date • Trial primary completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • Zyclara (imiquimod) • sotigalimab (PYX-107)
    12ms
    Phase I Study of APX005M in Pediatric Central Nervous System Tumors (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Pediatric Brain Tumor Consortium | Trial completion date: Sep 2024 --> Jun 2025
    Trial completion date • Tumor mutational burden • IO biomarker
    |
    TMB (Tumor Mutational Burden) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD4 (CD4 Molecule)
    |
    sotigalimab (PYX-107)
    12ms
    A Phase 2 Study of Sotigalimab, a CD40 Agonist Antibody, Plus Concurrent Chemoradiation as Neoadjuvant Therapy for Esophageal and Gastroesophageal Junction Cancers. (PubMed, Cancer Res Commun)
    Sotigalimab combined with NCRT for esophageal or GEJ cancers was generally well tolerated and achieved path CR rates that compare favorably to historical data and are promising for this treatment strategy.
    P2 data • Journal
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    CD40 (CD40 Molecule)
    |
    carboplatin • paclitaxel • sotigalimab (PYX-107)
    12ms
    A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC) (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Yale University | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • sotigalimab (PYX-107)
    1year
    Design of a humanized CD40 agonist antibody with specific properties using AlphaFold2 and development of an anti-PD-L1/CD40 bispecific antibody for cancer immunotherapy. (PubMed, Transl Oncol)
    Due to the unique epitope, it demonstrates superior activation compared to APX005M (S267E)...Furthermore, in humanized transgenic mice challenged with huPD-L1-expressing tumor cells, BA4415 induced superior anti-tumor activity. This novel anti-PD-L1/CD40 bispecific antibody holds potential for strong anti-tumor therapeutic efficacy by selectively restricting CD40 stimulation in tumors.
    Journal
    |
    CD40 (CD40 Molecule)
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    PD-L1 expression
    |
    sotigalimab (PYX-107)