- |||||||||| 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,
Active, not recruiting --> Recruiting
- |||||||||| fosmanogepix (APX001) / Amplyx Pharma, APX001 / 3SBio, Apexigen
Preclinical, Journal: Synthesis of analogs of the Gwt1 inhibitor manogepix (APX001A) and in vitro evaluation against Cryptococcus spp. (Pubmed Central) - Aug 12, 2020
Several compounds demonstrated significantly (8- to 32-fold) improved antifungal activity against both Cryptococcus neoformans and C. gattii as compared to manogepix. Further in vitro characterization identified three analogs with a similar preliminary safety and in vitro profile to manogepix and superior activity against Cryptococcus spp.
- |||||||||| fluconazole / Generic mfg.
Preclinical, Journal: In Vitro Activity of APX001A (Manogepix) and Comparator Agents against 1,706 Fungal Isolates Collected During an International Surveillance Program (2017). (Pubmed Central) - Jun 10, 2020
isolates; corresponding anidulafungin, micafungin, and fluconazole MIC values were 16- to 64-fold higher...Aspergillus isolates (>98%) exhibited a wild-type phenotype for the mold-active triazoles (itraconazole, posaconazole, and voriconazole)...The extended spectrum of APX001A was also notable for its potency against many less common, yet antifungal-resistant strains. Further studies are in progress to evaluate the clinical utility of the methyl phosphate prodrug, APX001, in difficult-to-treat resistant fungal infections.
- |||||||||| sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date, Combination therapy: APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers (clinicaltrials.gov) - Apr 28, 2020
P2, N=26, Recruiting,
Further studies are in progress to evaluate the clinical utility of the methyl phosphate prodrug, APX001, in difficult-to-treat resistant fungal infections. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Jul 2021
- |||||||||| 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,
The present studies demonstrated in vitro and in vivo APX001A/APX001 potency against A. fumigatus These results have potential relevance for clinical dose selection and evaluation of susceptibility breakpoints. Active, not recruiting --> Recruiting
- |||||||||| fosmanogepix (APX001) / Amplyx Pharma, APX001 / 3SBio, Apexigen
Preclinical, Journal: APX001 is Effective in the Treatment of Murine Invasive Pulmonary Aspergillosis. (Pubmed Central) - Jan 29, 2020
The observed survival and tissue clearance were comparable to a clinically relevant posaconazole dose. These results warrant the continued development of APX001 as a broad spectrum, first in class treatment for invasive fungal infections.
- |||||||||| fluconazole / Generic mfg., fosmanogepix (APX001) / Amplyx Pharma, APX001 / 3SBio, Apexigen
Journal: APX001 and Other Gwt1 inhibitor Prodrugs are Effective in Experimental Coccidioides immitis Pneumonia. (Pubmed Central) - Jan 29, 2020
In a survival experiment, both APX001 and APX2097-treated mice survived significantly longer than control and fluconazole treated mice. APX001 and other members of this new class of antifungal agents may offer great promise as effective therapies for coccidioidomycosis.
- |||||||||| 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
- |||||||||| fluconazole / Generic Mfg., fosmanogepix (APX001) / Amplyx Pharmaceuticals, APX001 / 3SBio, Apexigen
Preclinical, Journal: In vitro and in vivo Evaluation of APX001A/APX001 and other Gwt1 inhibitors against Cryptococcus. (Pubmed Central) - Oct 18, 2019
In a CM model, APX001 and fluconazole each, alone, reduced log colony forming units (CFU)/g brain (0.78 and 1.04, respectively), whereas the combination resulted in a reduction of 3.52 log CFU/g brain.Efficacy as measured by a reduction in brain and lung fungal burden was also observed for another Gwt1 inhibitor prodrug, APX2096, where dose dependent reductions in fungal burden ranged between 5.91 and 1.79 log CFU/g lung and between 7.00 and 0.92 log CFU/g brain, representing near or complete sterilization of lung and brain tissue at the higher doses. These data support further clinical evaluation of this new class of antifungal agents for CM.
- |||||||||| fluconazole / Generic Mfg.
Preclinical, Journal: APX001A in vitro activity against contemporary blood isolates and C. auris determined by the EUCAST reference method. (Pubmed Central) - Oct 2, 2019
APX001A is the active moiety of the first-in-class drug candidate APX001...EUCAST E.Def 7.3.1 susceptibility testing included APX001A, amphotericin B, anidulafungin, micafungin, fluconazole, and voriconazole...A correlation was observed between APX001A and fluconazole MICs across all species except C. guilliermondii and C. auris, and when comparing high and low fluconazole MIC isolates of C. albicans, C. dubliniensis, C. glabrata, C. tropicalis and C. aurisAPX001A showed promising in vitro activity against most Candida and other yeast species including C. auris when compared to five comparators. WT-ULs were suggested for the common species and a new and un-explained correlation to fluconazole susceptibility was observed.
- |||||||||| sotigalimab (APX005M) / Pyxis Oncology
Trial completion: Study of the CD40 Agonistic Monoclonal Antibody APX005M (clinicaltrials.gov) - Jul 25, 2019
P1, N=43, Completed,
WT-ULs were suggested for the common species and a new and un-explained correlation to fluconazole susceptibility was observed. 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.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Enrollment change, PD(L)-1 Biomarker, Metastases: Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov) - May 17, 2019
P1, N=60, Active, not recruiting,
Recruiting --> Active, not recruiting N=29 --> 60
- |||||||||| Clinical, Journal: Drugs in Clinical Development for Fungal Infections. (Pubmed Central) - Apr 5, 2019
We also discuss two glucan synthesis inhibitors: CD101, an echinocandin with an increased half-life, and SCY-078 with oral bioavailability and increased activity against echinocandin-resistant isolates...Two novel classes of antifungal drugs are also described: glycosylphosphatidylinositol inhibitors, and the leading drug APX001, which disrupt the integrity of the fungal wall; and the orotomides, inhibitors of pyrimidine synthesis with the leading drug F901318. Finally, a chitin synthesis inhibitor and progress on human monoclonal antifungal antibodies are discussed.
- |||||||||| sotigalimab (APX005M) / Apexigen
Enrollment open, Combination therapy, Metastases: APX005M and Doxorubicin in Advanced Sarcoma (clinicaltrials.gov) - Apr 5, 2019
P2, N=27, Recruiting,
Finally, a chitin synthesis inhibitor and progress on human monoclonal antifungal antibodies are discussed. Not yet recruiting --> Recruiting
- |||||||||| fosmanogepix (APX001) / Amplyx Pharma, APX001 / 3SBio, Apexigen
APX001 protects immunosuppressed mice from scedosporiosis (Arena 2) - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_4064;
APX001 protected immunosuppressed mice from scedosporiosis due to S. apiospermum. Continued investigation of APX001 as a novel antifungal agent against scedosporiosis is warranted.
- |||||||||| 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) - Mar 22, 2019
P1/2, N=174, Recruiting,
Continued investigation of APX001 as a novel antifungal agent against scedosporiosis is warranted. N=100 --> 174 | Trial completion date: Dec 2019 --> Aug 2020 | Trial primary completion date: May 2019 --> Dec 2019
- |||||||||| sotigalimab (PYX-107) / Pyxis Oncology
Trial primary completion date: Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) - Mar 20, 2019
P1, N=45, Recruiting,
N=100 --> 174 | Trial completion date: Dec 2019 --> Aug 2020 | Trial primary completion date: May 2019 --> Dec 2019 Trial primary completion date: Sep 2019 --> Sep 2020
- |||||||||| sotigalimab (APX005M) / Apexigen
Trial initiation date, Combination therapy, Metastases: APX005M and Doxorubicin in Advanced Sarcoma (clinicaltrials.gov) - Mar 4, 2019
P2, N=27, Not yet recruiting,
Trial primary completion date: Sep 2019 --> Sep 2020 Initiation date: Dec 2018 --> Apr 2019
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed, Enrollment change, Trial completion date, PD(L)-1 Biomarker, Metastases: Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov) - Dec 26, 2018
P1, N=29, Active, not recruiting,
Initiation date: Dec 2018 --> Apr 2019 Recruiting --> Active, not recruiting | N=60 --> 29 | Trial completion date: May 2022 --> May 2021
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