^
    7d
    INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov)
    P2, N=58, Completed, University of Texas Southwestern Medical Center | Active, not recruiting --> Completed
    Trial completion
    |
    oxaliplatin • sotigalimab (PYX-107)
    21d
    Intratumoral sotigalimab with pembrolizumab induces rapid activation of antigen presenting cells and drives anti-tumor responses in non-injected tumors in metastatic melanoma: A phase I/II study. (PubMed, Cancer Discov)
    TCR sequencing showed increased T-cell clonality with expanded new clones shared across tumors. Clinical responses correlated with these immunologic changes, but not with baseline features associated with response to anti-PD1 monotherapy.
    P1/2 data • Journal
    |
    LAMP3 (Lysosomal Associated Membrane Protein 3) • ITGAX (Integrin Subunit Alpha X)
    |
    Keytruda (pembrolizumab) • sotigalimab (PYX-107)
    22d
    Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov)
    P1, N=300, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting | N=117 --> 300
    Enrollment open • Enrollment change
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • Zyclara (imiquimod) • sotigalimab (PYX-107)
    3ms
    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: Nov 2025 --> Jun 2026
    Trial completion date
    |
    TMB (Tumor Mutational Burden) • CD4 (CD4 Molecule)
    |
    sotigalimab (PYX-107)
    3ms
    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
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • Zyclara (imiquimod) • sotigalimab (PYX-107)
    4ms
    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
    |
    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)
    6ms
    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
    |
    Keytruda (pembrolizumab) • sotigalimab (PYX-107)
    6ms
    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)
    7ms
    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
    |
    oxaliplatin • sotigalimab (PYX-107)
    9ms
    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)
    9ms
    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)
    9ms
    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)