sotigalimab (PYX-107) / Pyxis Oncology 
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 0 Diseases   8 Trials   8 Trials   215 News 


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  • ||||||||||  sotigalimab (APX005M) / Apexigen
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  APX005M and Doxorubicin in Advanced Sarcoma (clinicaltrials.gov) -  Nov 19, 2021   
    P2,  N=32, Recruiting, 
    These limitations stand to evolve alongside EHR technologies. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment change, Combination therapy, Metastases:  CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab (clinicaltrials.gov) -  Nov 15, 2021   
    P1/2,  N=143, Completed, 
    Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2021 --> Dec 2022 N=400 --> 143
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial primary completion date:  Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) -  Sep 26, 2021   
    P1,  N=45, Recruiting, 
    Trial Registration NCT03214250 Trial primary completion date: Sep 2021 --> Mar 2022
  • ||||||||||  Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
    Trial completion date, Trial primary completion date, Metastases:  Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov) -  Aug 18, 2021   
    P1,  N=60, Recruiting, 
    Trial primary completion date: Sep 2021 --> Mar 2022 Trial completion date: May 2021 --> May 2022 | Trial primary completion date: May 2021 --> May 2022
  • ||||||||||  Review, Journal:  Current status of intralesional agents in treatment of malignant melanoma. (Pubmed Central) -  Jul 20, 2021   
    This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology, Opdivo (nivolumab) / BMS
    Trial primary completion date, Metastases:  PRINCE: Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) -  Jun 24, 2021   
    P1b/2,  N=129, Active, not recruiting, 
    Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents. Trial primary completion date: Jul 2022 --> Mar 2021
  • ||||||||||  sotigalimab (APX005M) / Apexigen, Yale University
    Journal:  APX005M, a CD40 agonist antibody with unique epitope specificity and Fc receptor binding profile for optimal therapeutic application. (Pubmed Central) -  Jun 22, 2021   
    We developed a novel antibody, APX005M, which binds with high affinity to the CD40 ligand-binding site on CD40 and is optimized for selective interaction with Fcγ receptors to enhance agonistic potency while limiting less desirable Fc-effector functions like antibody-dependent cellular cytotoxicity of CD40-expressing immune cells. APX005M is a highly potent inducer of innate and adaptive immune effector responses and represents a promising CD40 agonist antibody for induction of an effective anti-tumor immune response with a favorable safety profile.
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial completion, Combination therapy, Metastases:  CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab (clinicaltrials.gov) -  May 4, 2021   
    P1/2,  N=400, Completed, 
    APX005M is a highly potent inducer of innate and adaptive immune effector responses and represents a promising CD40 agonist antibody for induction of an effective anti-tumor immune response with a favorable safety profile. Terminated --> Completed
  • ||||||||||  sotigalimab (APX005M) / Apexigen
    Trial primary completion date, Combination therapy, Metastases:  APX005M and Doxorubicin in Advanced Sarcoma (clinicaltrials.gov) -  Apr 22, 2021   
    P2,  N=27, Recruiting, 
    Safety was manageable; consistent with ph1b . Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  Review, Journal, IO biomarker:  Agonistic CD40 Antibodies in Cancer Treatment. (Pubmed Central) -  Apr 7, 2021   
    In this article, we focus on CD40 expression and immunity in cancer, agonistic human CD40 antibodies, and their pre-clinical and clinical development. With the broad pro-inflammatory effects of CD40 and its ligand on dendritic cells and macrophages, and downstream B and T cell activation, agonists of this pathway may enhance the anti-tumor activity of other systemic therapies.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma (clinicaltrials.gov) -  Dec 7, 2020   
    P1/2,  N=41, Recruiting, 
    Recruiting --> Terminated Trial completion date: Jun 2020 --> Dec 2022 | Trial primary completion date: Jun 2020 --> Dec 2021
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment open, Combination therapy, Metastases:  A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Na (clinicaltrials.gov) -  Oct 19, 2020   
    P1,  N=36, Recruiting, 
    Trial completion date: Jun 2020 --> Dec 2022 | Trial primary completion date: Jun 2020 --> Dec 2021 Not yet recruiting --> Recruiting
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases:  CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab (clinicaltrials.gov) -  Oct 1, 2020   
    P1/2,  N=400, Recruiting, 
    Not yet recruiting --> Recruiting N=174 --> 400 | Trial completion date: Dec 2021 --> Dec 2020 | Trial primary completion date: Aug 2021 --> Nov 2020
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial primary completion date:  Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) -  Sep 19, 2020   
    P1,  N=45, Recruiting, 
    N=174 --> 400 | Trial completion date: Dec 2021 --> Dec 2020 | Trial primary completion date: Aug 2021 --> Nov 2020 Trial primary completion date: Sep 2020 --> Sep 2021
  • ||||||||||  Neo Vax (NEO-PV-01) / BioNTech
    Enrollment change, Trial termination, Trial primary completion date, Metastases:  A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma (clinicaltrials.gov) -  Sep 3, 2020   
    P1b,  N=22, Terminated, 
    Trial primary completion date: Sep 2020 --> Sep 2021 N=40 --> 22 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2020 --> May 2020; Closed due to historically slow enrollment compounded by the COVID-19 pandemic.
  • ||||||||||  Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment open, PD(L)-1 Biomarker, Metastases:  Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov) -  Aug 31, 2020   
    P1,  N=60, Recruiting, 
    N=40 --> 22 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2020 --> May 2020; Closed due to historically slow enrollment compounded by the COVID-19 pandemic. Active, not recruiting --> Recruiting
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment open, Trial completion date, Trial primary completion date:  INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov) -  Apr 27, 2020   
    P2,  N=58, Recruiting, 
    Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Jul 2021 Not yet recruiting --> Recruiting | Trial completion date: Nov 2020 --> Nov 2022 | Trial primary completion date: Nov 2020 --> Nov 2022
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab (clinicaltrials.gov) -  Apr 1, 2020   
    P1/2,  N=174, Recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Nov 2020 --> Nov 2022 | Trial primary completion date: Nov 2020 --> Nov 2022 Trial completion date: Aug 2020 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Aug 2021
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial initiation date:  INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov) -  Feb 28, 2020   
    P2,  N=58, Not yet recruiting, 
    Trial completion date: Aug 2020 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Aug 2021 Initiation date: Jan 2020 --> Apr 2020
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment open:  Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) -  Feb 21, 2020   
    P1,  N=45, Recruiting, 
    Initiation date: Jan 2020 --> Apr 2020 Active, not recruiting --> Recruiting
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment closed:  Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) -  Nov 19, 2019   
    P1,  N=45, Active, not recruiting, 
    N=16 --> 26 | Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jul 2019 --> Jul 2020 Recruiting --> Active, not recruiting
  • ||||||||||  sotigalimab (APX005M) / Pyxis Oncology
    Trial completion:  Study of the CD40 Agonistic Monoclonal Antibody APX005M (clinicaltrials.gov) -  Jul 25, 2019   
    P1,  N=43, Completed, 
    Updated biomarker and clinical response data will be presented. Active, not recruiting --> Completed
  • ||||||||||  CP-870893 / Pfizer, selicrelumab (RG7876) / Roche, APX005M / Apexigen, Yale University
    Biomarker, Review, Journal, IO Biomarker:  New emerging targets in cancer immunotherapy: the role of Cluster of Differentiation 40 (CD40/TNFR5). (Pubmed Central) -  Jul 6, 2019   
    Ongoing studies investigate CD40 activation in combination with chemotherapy, radiation, targeted therapies and immunomodulatory agents. Further studies are awaited to specifically identify patients with the greatest clinical benefit based on predictive biomarkers.