Drugs / APR-246
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold myelodysplastic syndrome 1 milestone | |||||
| Clinical hold | US (FDA) | — | myelodysplastic syndrome | 2021-08-04 | “In August 2021, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine” aprea.com ↗ “FDA) has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine.” aprea.com ↗ |
| Clinical hold non-Hodgkin lymphoma 1 milestone | |||||
| Clinical hold | US (FDA) | — | non-Hodgkin lymphoma | 2021-08-11 | “clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL). In August 2021, FDA placed a clinical hold on this trial.” aprea.com ↗ “FDA) has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab” aprea.com ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT04214860 | Dec 2019 → Jan 2022 | myeloid neoplasm | Aprea Therapeutics | Completed | Met primary |
| Phase 1 | NCT00900614 | May 2009 → Oct 2010 | hematopoietic and lymphoid cell neoplasm, prostate neoplasm | Aprea Therapeutics | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT04419389 | Mar → Aug 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma | Aprea Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04383938 | Jun 2020 → Apr 2022 | gastric cancer, non-small cell lung carcinoma, urinary bladder cancer, urothelial carcinoma | Aprea Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT03588078 | Sep 2018 → May 2020 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Groupe Francophone des Myelodysplasies | Completed | No outcome recorded |
| Phase 1/2 | NCT03391050 | Jan → Aug 2018 | melanoma | Aprea Therapeutics | Terminated | No outcome recorded |
| Phase 1/2 | NCT03072043 | May 2017 → Nov 2019 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02999893 | Apr 2017 → Oct 2020 | carcinoma of esophagus | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02098343 | Mar 2014 → Apr 2019 | — | Aprea Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03931291 | Sep 2019 → Aug 2021 | acute myeloid leukemia | Aprea Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03268382 | Jul 2017 → Jul 2019 | ovarian serous adenocarcinoma | Aprea Therapeutics | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03745716 | Jan 2019 → Nov 2020 | myelodysplastic syndrome | Aprea Therapeutics | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2021-12-14 | Aprea Therapeutics | Results Recap and Update of Positive Data from Three Presentations in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Presented at the 2021 American Society of Hematology (ASH) Annual Meeting aprea.com ↗
Lead investigators from clinical trials evaluating eprenetapopt in patients with TP53 mutant MDS or AML presented positive, updated data at the 2021 ASH Annual Meeting. |
| 2021-12-13 | Aprea Therapeutics | Results Aprea Therapeutics Presents Primary Analysis from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML at the 2021 American Society of Hematology (ASH) Annual Meeting aprea.com ↗
In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 60% and the median RFS was 12.5 months. |
| 2021-12-09 | Aprea Therapeutics | Regulatory Aprea Therapeutics Announces Removal of FDA Clinical Hold on Eprenetapopt in Lymphoid Malignancies aprea.com ↗ |
| 2021-09-20 | Aprea Therapeutics | Results Aprea Therapeutics Presents Data From Phase 1/2 Trial of Eprenetapopt (APR-246) in Advanced Solid Tumors at ESMO Congress 2021 aprea.com ↗
In the bladder/urothelial cohort, 1 patient with locally advanced TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission (CR) by RECIST criteria at the first response assessment at 9 weeks. |
| 2021-08-12 | Aprea Therapeutics | Regulatory Aprea Therapeutics Announces Clinical Hold on Lymphoid Malignancy Program aprea.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. |
| 2021-08-05 | Aprea Therapeutics | Regulatory Aprea Therapeutics Announces a Partial Clinical Hold on Myeloid Malignancy Programs aprea.com ↗
As part of the clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved. |
| 2021-07-21 | Aprea Therapeutics | Results Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML aprea.com ↗
In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 58% and the median RFS was 12.1 months. |
| 2021-06-16 | Aprea Therapeutics | Results Aprea Therapeutics Announces Phase 1/2 Trial of Eprenetapopt + Venetoclax + Azacitidine in TP53 Mutant AML Meets Complete Remission Primary Efficacy Endpoint aprea.com ↗
Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the Phase 1/2 trial evaluating the frontline treatment of eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant AML has met the pre-specified primary efficacy endpoint of complete remission (CR) rate. |
| 2021-04-08 | Aprea Therapeutics | Regulatory Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of Acute Myeloid Leukemia (AML) aprea.com ↗
“We are pleased to have been granted Orphan Drug designation by FDA for eprenetapopt in AML, building on the Fast Track designation in AML that was granted in November 2020,” said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. |
| 2020-12-28 | Aprea Therapeutics | Results Aprea Therapeutics Announces Results of Primary Endpoint from Phase 3 Trial of Eprenetapopt in TP53 Mutant Myelodysplastic Syndromes (MDS) aprea.com ↗
The trial did not meet the predefined primary endpoint of complete remission (CR) rate. |
| 2020-11-30 | Aprea Therapeutics | Regulatory Aprea Therapeutics Receives FDA Fast Track Designation for Eprenetapopt in the Treatment of TP53 Mutant Acute Myeloid Leukemia (AML) aprea.com ↗
BOSTON, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eprenetapopt in the treatment of patients with TP53 mutant acute myeloid leukemia (AML). |
| 2020-06-12 | Aprea Therapeutics | Results Aprea Therapeutics Presents Results From French Phase Ib/II Clinical Trial of APR-246 (Eprenetapopt) and Azacitidine in Patients with TP53 Mutant Myelodysplastic Syndromes and Acute Myeloid Leukemia at the 25th European Hematology Association Annual Meeti aprea.com ↗
As of the April 1, 2020 data cutoff, the overall response rate (ORR) in 28 evaluable MDS patients was 75%, with a 57% complete remission (CR) rate, by International Working Group (IWG) criteria. |
| 2020-01-30 | Aprea Therapeutics | Regulatory Aprea Therapeutics Receives FDA Breakthrough Therapy Designation for APR-246 in Combination with Azacitidine for the Treatment of Myelodysplastic Syndromes (MDS) with a TP53 Mutation aprea.com ↗
Aprea Therapeutics, Inc. (NASDAQ: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes (MDS) with a susceptible TP53 mutation. |
| 2019-12-12 | Aprea Therapeutics | Results Recap and Update of Positive Data from Phase Ib/II Clinical Trials of APR-246 and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Presented at the 2019 American Society of Hematology (ASH) An aprea.com ↗
Median overall survival (OS) for all enrolled patients (n=55) was 10.8 months. |
| 2019-12-09 | Aprea Therapeutics | Results Aprea Therapeutics Presents Results From U.S. Phase Ib/II Clinical Trial of APR-246 and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) at the 2019 American Society of Hematology (ASH) Annual aprea.com ↗
As of the data cutoff, the overall response rate (ORR) in 33 evaluable MDS patients was 88%, with a 61% complete remission (CR) rate, by International Working Group (IWG) criteria. |
| 2019-04-16 | Aprea Therapeutics | Regulatory Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS) aprea.com ↗
In addition, FDA has also granted Orphan Drug Designation to APR-246 for treatment of MDS. |
| 2019-04-03 | Aprea Therapeutics | Results Results From Combination of APR-246 with Immuno-Oncology Agents Presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta aprea.com ↗
Anti-tumor activity was observed with APR-246 monotherapy; the combination treatment with APR-246 and anti-PD-1 enhanced the effects of PD-1 blockade in a T cell-dependent manner, as assessed by reduced tumor growth and improved survival. |
| 2018-12-02 | Aprea Therapeutics | Results Aprea Therapeutics Presents Results From Phase Ib/II Clinical Study of APR-246 and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego aprea.com ↗
The overall response rate in 20 evaluable patients was 95%, with 14 (70%) patients achieving a complete remission (CR) at data cutoff. |
| 2018-06-17 | Aprea Therapeutics | Results Aprea Therapeutics Presents Results From Phase Ib/II Clinical Study of APR-246 and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) at the 2018 European Hematology Association (EHA) Annual Meeting in Stockholm aprea.com ↗
The overall response rate in 9 evaluable patients was 100%, with 8 patients achieving a complete response (CR) and 1 patient achieving a marrow CR (mCR). |
| 2018-04-16 | Aprea Therapeutics | Results Aprea Therapeutics Presents Results From Phase Ib/II Clinical Study of APR-246 and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) at the 2018 American Association of Cancer Research (AACR) Annual Meeting in Chicago aprea.com ↗
The overall response rate in 8 evaluable patients was 100%, with 6 patients achieving a complete response (CR) and 2 patients achieving a marrow CR (mCR). |
| 2016-10-10 | Aprea Therapeutics | Results Aprea Therapeutics Announces Efficacy and Safety Data in High-Grade Serous Ovarian Cancer Patients Treated with APR-246 in Presentation at 2016 European Society for Medical Oncology (ESMO) Annual Meeting aprea.com ↗
Of 22 patients with radiologically measurable lesions, 3 had confirmed complete response, 10 had confirmed partial response, 8 had stable disease and 1 was not evaluable. |
| 2016-06-06 | Aprea Therapeutics | Results Aprea AB announces efficacy and safety data in high-grade serous ovarian cancer patients treated with investigational APR-246 presented at 2016 ASCO Annual Meeting aprea.com ↗
All 21 patients treated in the study that are evaluable according to RECIST criteria have stable disease or better. |
All press releases naming this drug 29 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APR-246 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02999893 ↗ |
| Known as | eprenetapopt | “BACKGROUND: We conducted a phase I, multicenter, open-label, dose-finding, and expansion study to determine the safety and preliminary efficacy of eprenetapopt (APR-246)...” PMID 36084396 ↗ Sep 20225“Eprenetapopt (APR-246), a novel first-in-class drug, leads to p53 protein reconformation and reactivates its proapoptotic and cell-cycle arrest functions.” PMID 33600210 ↗ Feb 2021 “Eprenetapopt (APR-246) is a novel, first-in-class, small molecule that restores wild-type p53 functions in TP53-mutant cells.” PMID 33449813 ↗ Jan 2021 “Eprenetapopt (APR-246) is a first-in-class, small-molecule p53 reactivator.” PMID 36990622 ↗ Apr 2023 “APR-246 (eprenetapopt) + Acalabrutinib in CLL” NCT04419389 ↗ “Eprenetapopt (APR-246) is a first-in-class,” PMID 35816664 ↗ Jul 2022 |
| Known as | PRIMA-1MET | “APR-246 (also known as PRIMA-1MET), a first-in-class agent targeting mutant p53 resulting in re-expression of wild-type p53 activity.” NCT02999893 ↗ |
| Action | Restore | “APR-246 (also known as PRIMA-1MET), a first-in-class agent targeting mutant p53 resulting in re-expression of wild-type p53 activity.” NCT02999893 ↗ |
| Modality | Small molecule | “Eprenetapopt (APR-246) is a novel, first-in-class, small molecule” PMID 33449813 ↗ Jan 2021 |
| Route | Intravenous | “Intravenous infusion” NCT00900614 ↗ |
| Target | TP53 | “TP53, a key tumour suppressor gene, is mutated in 70-80% of OC (both adenocarcinoma and squamous cell carcinoma) providing an attractive potential target for an OC...” NCT02999893 ↗ |