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- || OPN-2853 / Opna Bio
P1/2 data, P2a data, Clinical Trial,Phase II, Journal: Phase IIa Study of PLX2853 in Gynecologic Cancers With Known ARID1A Mutation and Phase Ib/IIa Study of PLX2853/Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer. (Pubmed Central) - Nov 3, 2023
This study confirmed the safety profile of PLX2853 and demonstrated the feasibility of combination with carboplatin. Although these results did not meet the prespecified response criteria, evidence of clinical activity highlights the rationale for further exploration of BET inhibitors in patients with ARID1A-mutated gynecologic malignancies, possibly in combination with agents targeting potential feedback mechanisms such as the PI3K pathway.
- OPN-2853 / Opna Bio
Phase 1b/2a clinical trial of the oral BET inhibitor PLX2853 as monotherapy for ARID1A mutated gynecologic cancers and in combination with carboplatin for platinum resistant ovarian cance (Section 47; Poster Board #22) - Mar 14, 2023 - Abstract #AACR2023AACR_4802;
P2a
This study in a larger cohort of gynecologic cancer patients confirmed the safety profile of the agent and demonstrated the feasibility of combination with carboplatin. While these results did not meet the pre-specified response criteria, evidence of clinical activity nevertheless highlights the rationale for further exploration of BRD4 inhibitors in patients with ARID1A-mutated gynecologic malignancies, possibly in combination with agents targeting potential feedback mechanisms such as the PI3K pathway, frequently activated in these cancers.
- | Mekinist (trametinib) / Novartis, OPN-2853 / Opna Bio
New P1/2 trial, Metastases: Testing the Safety and Effectiveness of Combining Two Drugs, PLX2853 and Trametinib in the Treatment of Advanced Uveal Melanoma (clinicaltrials.gov) - Jan 10, 2023
P1/2, N=54, Not yet recruiting, Sponsor: Alliance for Clinical Trials in Oncology
- OPN-2853 / Opna Bio
Phase classification, Metastases: A Study of PLX2853 in Advanced Malignancies. (clinicaltrials.gov) - Jul 25, 2022
P1b, N=49, Completed, Sponsor: Opna-IO LLC
While these results did not meet the pre-specified response criteria, evidence of clinical activity nevertheless highlights the rationale for further exploration of BRD4 inhibitors in patients with ARID1A-mutated gynecologic malignancies, possibly in combination with agents targeting potential feedback mechanisms such as the PI3K pathway, frequently activated in these cancers. Phase classification: P1b/2a --> P1b
- | OPN-2853 / Opna Bio
Enrollment change, Trial termination, Combination therapy, Monotherapy, Metastases: PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - Jul 23, 2022
P2a, N=37, Terminated, Sponsor: Opna-IO LLC
Phase classification: P1b/2a --> P1b N=67 --> 37 | Active, not recruiting --> Terminated; study terminated due to business realignment
- | OPN-2853 / Opna Bio, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment change, Trial termination, Combination therapy, Metastases: PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Jul 23, 2022
P1b/2a, N=19, Terminated, Sponsor: Opna-IO LLC
N=67 --> 37 | Active, not recruiting --> Terminated; study terminated due to business realignment N=110 --> 19 | Active, not recruiting --> Terminated; study terminated due to business realignment
- | OPN-2853 / Opna Bio
Enrollment closed, Combination therapy, Monotherapy, Metastases: PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - Apr 12, 2022
P2a, N=67, Active, not recruiting, Sponsor: Opna-IO LLC
N=110 --> 19 | Active, not recruiting --> Terminated; study terminated due to business realignment Recruiting --> Active, not recruiting
- | OPN-2853 / Opna Bio, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Apr 12, 2022
P1b/2a, N=110, Active, not recruiting, Sponsor: Opna-IO LLC
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Jul 2022 | Trial primary completion date: Feb 2023 --> Jul 2022
- ||| OPN-2853 / Opna Bio
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Study of PLX2853 in Advanced Malignancies. (clinicaltrials.gov) - Feb 8, 2022
P1b/2a, N=49, Completed, Sponsor: Plexxikon
Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Jul 2022 | Trial primary completion date: Feb 2023 --> Jul 2022 Recruiting --> Completed | N=166 --> 49 | Trial completion date: Jun 2022 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2021
- PLX2853 / Daiichi Sankyo
Final Results of a Phase 1b Study of BET Inhibitor PLX2853 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5102;
P1b, P1b/2
The RP2D is 80 mg QD continuous dosing. This clinical trial is registered at clinicaltrials.gov: NCT03787498.
- | PLX2853 / Daiichi Sankyo, PLX51107 / Daiichi Sankyo
Journal: Inhibition of Bromodomain and Extra Terminal (BET) Domain Activity Modulates the IL-23R/IL-17 Axis and Suppresses Acute Graft-Versus-Host Disease. (Pubmed Central) - Nov 1, 2021
Our findings identify a role for BET proteins in regulating the IL-23R/STAT3/IL-17 pathway. Based on our preclinical data presented here, PLX51107 will enter clinical trial for refractory acute GVHD in a Phase 1 safety, biological efficacy trial.
- || OPN-2853 / Opna Bio
Trial completion, Enrollment change, Trial completion date: A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Aug 12, 2021
P1b, N=22, Completed, Sponsor: Plexxikon
Based on our preclinical data presented here, PLX51107 will enter clinical trial for refractory acute GVHD in a Phase 1 safety, biological efficacy trial. Active, not recruiting --> Completed | N=36 --> 22 | Trial completion date: Nov 2021 --> Jun 2021
- || OPN-2853 / Opna Bio
Enrollment closed: A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Jun 25, 2021
P1b, N=36, Active, not recruiting, Sponsor: Plexxikon
Active, not recruiting --> Completed | N=36 --> 22 | Trial completion date: Nov 2021 --> Jun 2021 Recruiting --> Active, not recruiting
- | Venclexta (venetoclax) / Roche, AbbVie
Journal, IO biomarker: BET inhibitors synergize with venetoclax to induce apoptosis in MYC-driven lymphomas with high BCL-2 expression. (Pubmed Central) - May 15, 2021
Consequently, coadministration of BETi and ABT199/venetoclax restored cell death and in vivo therapy. Collectively, these data identify BIM-dependent apoptosis as a critical mechanism of action for this class of BETi that, via coadministration of BH3 mimetics, can deliver effective tumor control in DLBCL.
- PLX2853 / Daiichi Sankyo
[VIRTUAL] Phase 1b/2a study of PLX2853, a small molecule BET inhibitor, in subjects with advanced solid tumors and lymphoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_827;
P1b/2a
PLX2853 shows encouraging signs of clinical activity and is well tolerated at the anticipated RP2D of 80 mg/day . PLX2853 is being evaluated as monotherapy and in combination.
- || OPN-2853 / Opna Bio
Trial completion date, Trial primary completion date, Metastases: A Study of PLX2853 in Advanced Malignancies. (clinicaltrials.gov) - Mar 25, 2021
P1b/2a, N=166, Recruiting, Sponsor: Plexxikon
PLX2853 is being evaluated as monotherapy and in combination. Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Feb 2021 --> Dec 2021
- | OPN-2853 / Opna Bio
Trial completion date, Trial primary completion date: A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 24, 2021
P1b, N=36, Recruiting, Sponsor: Plexxikon
Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Feb 2021 --> Dec 2021 Trial completion date: Jul 2021 --> Nov 2021 | Trial primary completion date: Feb 2021 --> Jun 2021
- Mekinist (trametinib) / Novartis, PLX2853 / Daiichi Sankyo, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
[VIRTUAL] BET bromodomain inhibition synergizes with MEK inhibitors in uveal melanoma () - Mar 11, 2021 - Abstract #AACR2021AACR_3718;
In conclusion, our studies suggest that co-targeting of MEK and BET proteins may be required to maximize the responses of UM cells to BET inhibitors. Clinical trials with the combination of BET and MEK inhibitors are warranted.
- | OPN-2853 / Opna Bio
Trial completion date, Metastases: A Study of PLX2853 in Advanced Malignancies. (clinicaltrials.gov) - Nov 25, 2020
P1b/2a, N=166, Recruiting, Sponsor: Plexxikon
Clinical trials with the combination of BET and MEK inhibitors are warranted. Trial completion date: May 2021 --> Oct 2021
- PLX2853 / Daiichi Sankyo
[VIRTUAL] Phase 1b Study of BET Inhibitor PLX2853 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3659;
P1b
As dose escalation continues, PK, PD, preliminary safety, and efficacy data will be reviewed further to determine the clinical significance of this BET inhibitor and identify the RP2D. This clinical trial is registered at clinicaltrials.gov: NCT03787498.
- ||| OPN-2853 / Opna Bio
Enrollment open, Combination therapy, Monotherapy, Metastases: PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - Oct 13, 2020
P2a, N=67, Recruiting, Sponsor: Plexxikon
This clinical trial is registered at clinicaltrials.gov: NCT03787498. Not yet recruiting --> Recruiting
- ||| OPN-2853 / Opna Bio, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment open, Combination therapy, PARP Biomarker, Metastases: PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Oct 7, 2020
P1b/2a, N=110, Recruiting, Sponsor: Plexxikon
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| OPN-2853 / Opna Bio
New P2a trial, Combination therapy, Monotherapy, Metastases: PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - Aug 7, 2020
P2a, N=67, Not yet recruiting, Sponsor: Plexxikon
- JQ-1 / Roche, PLX2853 / Daiichi Sankyo, PLX51107 / Daiichi Sankyo
Brd4 inhibition enhances checkpoint therapy by inducing MDSC apoptosis (Virtual Meeting II: All Session Times Are U.S. EDT) - May 16, 2020 - Abstract #AACRII2020AACR-II_4875;
Finally, depletion of MDSCs in vivo with PLX51107 significantly enhanced the efficacy of anti-PDL1 therapy as compared to either agent alone (p< 0.05 in EMT6, 4T1, and LLC tumor models). These results identify Brd4 and the TXNIP/ASK1 apoptosis pathway as novel regulators of MDSC survival, and provide evidence to further investigate Brd4 inhibitors in combination with immune based therapies for solid tumors.
- | OPN-2853 / Opna Bio
Trial completion date, Trial primary completion date: A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 25, 2020
P1b, N=36, Recruiting, Sponsor: Plexxikon
These results identify Brd4 and the TXNIP/ASK1 apoptosis pathway as novel regulators of MDSC survival, and provide evidence to further investigate Brd4 inhibitors in combination with immune based therapies for solid tumors. Trial completion date: Jun 2020 --> Jul 2021 | Trial primary completion date: Jan 2020 --> Feb 2021
- ||||| PLX2853 / Daiichi Sankyo
Clinical: #ASH19 | #ClinicalTrialsInProgress |Dose Escalation Study of BET Inhibitor #PLX2853 in Patients w/Relapsed/Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome | #BETi #Bromodomain #leusm @doctorpemm et al @LeukemiaMDA https://t.co/MtH9292ec5 (Twitter) - Nov 24, 2019
- PLX2853 / Daiichi Sankyo, PLX51107 / Daiichi Sankyo
Bromodomain and Extraterminal (BET) Domain Inhibition with PLX51107 and PLX2853 Improves Survival and Decreases Acute GVHD Severity in Murine Models (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_6177;
PLX2853 given at lower doses demonstrated similar improvements in survival and GVHD scoring, consistent with increased potency . Preliminary in vivo and in vitro studies of PLX2853 on GVT and on CD8+ CTLs show that PLX2853 retains GVT effects .
- PLX2853 / Daiichi Sankyo
Dose Escalation Study of BET Inhibitor PLX2853 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2216;
P1b
As dose escalation continues, PK, PD, preliminary safety and efficacy data will be assessed further to determine the clinical significance of target engagement . This clinical trial is registered at clinicaltrials.gov: NCT03787498.
- || OPN-2853 / Opna Bio
Enrollment open: A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 5, 2019
P1b, N=36, Recruiting, Sponsor: Plexxikon
This clinical trial is registered at clinicaltrials.gov: NCT03787498. Not yet recruiting --> Recruiting
- || OPN-2853 / Opna Bio
New P1 trial: A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Dec 25, 2018
P1b, N=36, Not yet recruiting, Sponsor: Plexxikon