- |||||||||| 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
- |||||||||| Enweida (envafolimab) / 3DMed, Tracon Pharma, Ascletis, suvemcitug (APX003) / Mabwell (Shanghai) Biosci, Pyxis Oncology
Enrollment open, Combination therapy, Metastases: A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Apr 5, 2022 P2, N=110, Recruiting, Optimization of the dosing frequency and sequence of this combination is warranted. Not yet recruiting --> Recruiting
- |||||||||| 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
- |||||||||| Enweida (envafolimab) / 3DMed, Tracon Pharma, Ascletis, suvemcitug (APX003) / Mabwell (Shanghai) Biosci, Pyxis Oncology
New P2 trial, Combination therapy, Metastases: A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Dec 7, 2021 P2, N=110, Not yet recruiting,
- |||||||||| 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
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 (APX005M) / Apexigen, Yale University, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, P1 data, Clinical Trial,Phase I, Journal: CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open-label, multicentre, phase 1b study. (Pubmed Central) - Jan 27, 2021 P1b/2 APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population.
- |||||||||| 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
- |||||||||| 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
- |||||||||| 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).
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