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  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial completion date, Trial primary completion date:  INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov) -  Apr 22, 2022   
    P2,  N=58, Recruiting, 
    Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023
  • ||||||||||  sotigalimab (APX005M) / Apexigen
    Trial initiation date:  APX005M in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov) -  Apr 20, 2022   
    P2,  N=90, Not yet recruiting, 
    Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023 Initiation date: Feb 2022 --> Sep 2022
  • ||||||||||  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) -  Mar 2, 2022   
    P1/2,  N=41, Recruiting, 
    Collectively, this combination therapy is well tolerated and has a notable clinical response rate, accompanied by broad innate and adaptive immune activation at both local and distant lesions. Trial completion date: Dec 2022 --> Apr 2024 | Trial primary completion date: Dec 2021 --> Apr 2024
  • ||||||||||  Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
    Enrollment change, Metastases:  Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov) -  Feb 8, 2022   
    P1,  N=150, Recruiting, 
    These data provide a solid rationale for combining antiangiogenic agents with immunotherapy for cancer treatment and support further clinical development of BD0801 in combination with ICIs. N=60 --> 150
  • ||||||||||  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, 
    Not yet recruiting --> Recruiting 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) / Ono Pharma, 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.
  • ||||||||||  Avastin (bevacizumab) / Roche
    [VIRTUAL] Combination of an anti-angiogenic antibody with PD1/PDL1 blockade agents produces synergistic anti-tumor efficacy in preclinical models () -  Mar 13, 2021 - Abstract #AACR2021AACR_4762;    
    In this study, we have revealed that BD0801 presents more potent activity than Bevacizumab in blockade of VEGF/VEGFR2 binding (IC50=275 ng/ml for BD0801; IC50=1451 ng/ml for Bevacizumab) and VEGFR2 activation in HUVEC assays...Our data demonstrated that the MOA of the anti-tumor synergy may involve enhanced T-cell mediated immunity, including increased tumor infiltration of CD8+ and CD4+ T cells and reduced double positive CD8+PD-1+ T cells, as well as improved vasculature normalization. Taken together, these data provide a foundation for combining BD0801 with immunotherapy for cancer treatment and support further clinical development plans for BD0801 toward this direction.
  • ||||||||||  APX701 / Apexigen, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Herceptin (trastuzumab) / Roche
    [VIRTUAL] Targeting SIRPα with APX701, a Novel Myeloid Checkpoint Inhibitor () -  Mar 11, 2021 - Abstract #AACR2021AACR_3347;    
    Together, these data demonstrate the unique binding profile of APX701 and its ability to potently reactivate myeloid cell-mediated anti-tumor immunity. Our data support the development of APX701, a promising myeloid checkpoint inhibitor, for the treatment of cancer.
  • ||||||||||  sotigalimab (PYX-107) / Pyxis Oncology
    Trial termination, Combination therapy, Metastases:  CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab (clinicaltrials.gov) -  Dec 9, 2020   
    P1/2,  N=400, Terminated, 
    Our data support the continued development of fosmanogepix as a first in class treatment for infections caused by these rare molds. Recruiting --> Terminated
  • ||||||||||  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
  • ||||||||||  APX601 / Apexigen
    [VIRTUAL] APX601, a Novel TNFR2 Antagonist Antibody for Cancer Immunotherapy () -  Oct 14, 2020 - Abstract #SITC2020SITC_1716;    
    Our data support the further development of APX601, a promising immunotherapeutic antibody with multiple potential mechanisms of action, for the treatment of a variety of solid tumors. Ethics Approval Healthy human blood samples were obtained from Stanford Blood Center (Palo Alto, CA) from consenting donors under an approved protocol.
  • ||||||||||  APX601 / Apexigen
    [VIRTUAL] APX601, a Novel TNFR2 Antagonist Antibody for Cancer Immunotherapy () -  Oct 14, 2020 - Abstract #SITC2020SITC_981;    
    Our data support the further development of APX601, a promising immunotherapeutic antibody with multiple potential mechanisms of action, for the treatment of a variety of solid tumors. Ethics Approval Healthy human blood samples were obtained from Stanford Blood Center (Palo Alto, CA) from consenting donors under an approved protocol.
  • ||||||||||  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, 
    Ethics Approval Healthy human blood samples were obtained from Stanford Blood Center (Palo Alto, CA) from consenting donors under an approved protocol. 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.
  • ||||||||||  fosmanogepix (APX001) / Amplyx Pharma, APX001 / 3SBio, Apexigen
    Biomarker, Clinical, Journal:  Galactomannan is a Biomarker of Fosmanogepix (APX001) Efficacy in Treating Experimental Invasive Pulmonary Aspergillosis. (Pubmed Central) -  Sep 1, 2020   
    In a murine invasive pulmonary aspergillosis model, fosmanogepix or posaconazole treatment resulted in a ∼6-7 log reduction in conidial equivalents (CE)/g lung tissue after 96 h versus placebo. Changes in GM levels in BAL and serum mirrored reductions in lung CE with significant decreases seen after 96 h or 72 h for fosmanogepix or posaconazole, respectively (P <0.02).