- |||||||||| 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, Also, they identify DEX as a lead to develop new modulators of K conductances. 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, Not yet recruiting --> Recruiting Trial primary completion date: Sep 2021 --> Mar 2022
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Enrollment closed: Psilocybin for the Treatment of Cluster Headache (clinicaltrials.gov) - Sep 13, 2021 P1, N=24, Active, not recruiting, Trial primary completion date: Sep 2021 --> Mar 2022 Recruiting --> Active, not recruiting
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial completion date, Trial primary completion date: Psilocybin for the Treatment of Cluster Headache (clinicaltrials.gov) - Aug 18, 2021 P1, N=24, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Nov 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 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 completion date: Nov 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 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.
- |||||||||| dexpramipexole (KNS-760704) / Knopp Biosciences, Biogen, Yale University
Enrollment change: Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Jul 8, 2021 P2, N=194, Completed, 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. N=102 --> 194
- |||||||||| 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, We suggest that, besides interventions that reduce ionic disturbance caused by mutant Nav1.7 channels, an alternative therapeutic strategy might target the bioenergetic burden and mitochondrial damage that occur in SFN associated with Nav1.7 gain-of-function mutations. 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, Patients with prior AD treatment are more likely to have an AD with significant gene-drug interaction potential as their next-intended treatment and therefore may benefit most from PGx testing. 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.
- |||||||||| 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.
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial primary completion date: Psilocybin for the Treatment of Cluster Headache (clinicaltrials.gov) - Jan 8, 2021 P1, N=24, Recruiting, No abstract available Trial primary completion date: Dec 2020 --> Jun 2021
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial completion date: Psilocybin for the Treatment of Migraine Headache (clinicaltrials.gov) - Jan 7, 2021 P1, N=24, Active, not recruiting, Trial primary completion date: Dec 2020 --> Jun 2021 Trial completion date: Oct 2020 --> Oct 2021
- |||||||||| 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 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
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