Drugs / talabostat
talabostat
also known as
PT-100 · Talabostat mesylate · BXCL701 · Talabostat mesilate · Val-Boro-Pro · Valinyl-l-boroproline
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04123574 | Oct 2019 → Dec 2021 | malignant pancreatic neoplasm | BioXcel Therapeutics Inc | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00303940 | Dec 2005 → Feb 2010 | central nervous system neoplasm, childhood germ cell tumor, childhood malignant neoplasm, kidney cancer +4 | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04171219 | Mar 2020 → Mar 2025 | cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00489710 | Dec 2006 → May 2007 | kidney cancer | University of Nebraska | Withdrawn | No outcome recorded |
| Phase 2 | NCT00083239 | — | melanoma, skin cancer | Point Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00086203 | ? → Sep 2007 | B-cell chronic lymphocytic leukemia | Point Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00083252 | — | melanoma, skin cancer | Point Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00080080 | — | lung cancer | Point Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00116389 | — | metastatic neoplasm, pancreatic adenocarcinoma | Point Therapeutics | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00290017 | Feb 2006 → ? | non-small cell lung carcinoma | Point Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT00243204 | Jan 2006 → ? | non-small cell lung carcinoma | Point Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2024-02-12 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC) bioxceltherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) |
| 2023-11-08 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) of Adenocarcinoma Phenotype bioxceltherapeutics.com ↗
As of a September 6, 2023 data cutoff, evaluable patients with adenocarcinoma (n=29) showed a median OS of 15.5 months (95% CI 9.6–NR), and a 12-month survival rate of 59%. |
| 2023-10-10 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Small Cell Neuroendocrine Prostate Cancer bioxceltherapeutics.com ↗ |
| 2023-02-13 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Announces Positive Full Data from Phase 2 Trial of BXCL701 in Rare, Aggressive Form of Prostate Cancer; to be Presented at 2023 ASCO Genitourinary Cancers Symposium bioxceltherapeutics.com ↗
BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrated composite response rate of 25% in patients with metastatic SCNC-variant castration-resistant prostate cancer |
| 2023-01-11 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Announces Promising Top-Line Results from Phase 2 Trial of BXCL701 in Aggressive Form of Rare Prostate Cancer bioxceltherapeutics.com ↗ |
| 2022-02-14 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Presents Positive Data from Phase 2 Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2022 ASCO Genitourinary Cancers Symposium bioxceltherapeutics.com ↗ |
| 2021-10-18 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Announces Expansion of Phase 2 Trial of BXCL701 in De Novo and Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer bioxceltherapeutics.com ↗
The Company’s decision to advance BXCL701 into the second stage of the Phase 2a efficacy portion of the study follows the achievement of the protocol-specified efficacy threshold for cohort expansion, meaning observation of three composite responses. |
| 2021-09-15 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Presents Results from Ongoing Phase 2 Trial of BXCL701 in Combination with KEYTRUDA® in Aggressive Forms of Prostate Cancer at ESMO bioxceltherapeutics.com ↗
today announced data from its ongoing Phase 1b/2 trial of BXCL701, the Company's investigational, oral innate immunity activator, in metastatic castration-resistant prostate carcinoma (mCRPC) in a poster presentation at the 2021 European Society for Medical Oncology (ESMO) Congress. |
| 2020-11-09 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics to Present BXCL701 Clinical Data at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting bioxceltherapeutics.com ↗
With three Partial Responses over the course of the two programs, and a manageable side effect profile, we continue to be encouraged by BXCL701’s potential for treating several difficult-to-treat cancers. |
| 2019-09-04 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Receives FDA Orphan Drug Designation for BXCL701 for the Treatment of Acute Myeloid Leukemia (AML) bioxceltherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) for BXCL701, an investigational orally-available systemic innate immunity activator with dual mechanisms of action, for the treatment of Acute Myeloid Leukemia (“AML”). |
| 2019-06-03 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Announces FDA Clearance of IND Application for Triple Combination in Pancreatic Cancer and CTA Acceptance for Double Combination in Aggressive Form of Prostate Cancer (tNEPC) for Lead Immuno-Oncology Program, BXCL701 bioxceltherapeutics.com ↗
FDA clearance of IND for BXCL701 triple combination therapy with Nektar’s bempegaldesleukin and BAVENCIO ® ( avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer |
| 2019-04-01 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Showcases Data on BXCL701 in Combination with OX40 Agonist in Late-breaking Poster Presentation at AACR Annual Meeting bioxceltherapeutics.com ↗
today presented promising preclinical data demonstrating potential for combining the Company’s BXCL701, an oral immunomodulator, and an OX40 agonist antibody as a possible combination therapy for certain solid tumors at the American Association for Cancer Research (AACR) Annual Meeting. |
| 2019-03-25 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Files Clinical Trial Application for the Development of BXCL701 and Pembrolizumab in Neuroendocrine Prostate Cancer (tNEPC) bioxceltherapeutics.com ↗ |
| 2018-11-09 | Nektar Therapeutics | Results Nektar Therapeutics Presents New Clinical and Preclinical Data for its Immuno-Oncology Pipeline at the 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting nektar.com ↗
In a triple combination with NKTR-214 and an anti-PD-1 antibody, BXCL701 generated complete and durable responses in models with high densities of tumor associated. |
| 2018-11-05 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Announces FDA Acceptance of IND for Lead Immuno-oncology Candidate, BXCL701, in Treatment Emergent Neuroendocrine Prostate Cancer bioxceltherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”), has accepted its Investigational New Drug (“IND”) application for its lead immuno-oncology candidate, BXCL701. |
| 2018-10-08 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Announces Submission of IND for Lead Immuno-oncology Candidate, BXCL701, in Treatment Emergent Neuroendocrine Prostate Cancer bioxceltherapeutics.com ↗
today announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (“FDA”) to evaluate its lead immuno-oncology candidate, BXCL701 |
| 2018-07-24 | BioXcel Therapeutics Inc | Results DPP8/9 Inhibition - The Primary Mechanism of BioXcel Therapeutics’ Lead Immuno-Oncology Asset, BXCL701, Highlighted in Peer-Reviewed Journal bioxceltherapeutics.com ↗
This publication highlights one component of BXCL701’s dual mechanism of action, providing valuable insights on the effects of DPP8/9 inhibition. |
| 2018-06-04 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics and Nektar Therapeutics Present Preclinical Pancreatic Cancer Data for BXCL701, NKTR-214 and Anti-PD1 Combination Therapy at ASCO 2018 Annual Meeting bioxceltherapeutics.com ↗
Results from the preclinical study demonstrate that BXCL701, a dipeptidyl peptidase (DPP) and fibroblast activation protein (FAP) inhibitor, in combination with NKTR-214, a CD122-biased agonist, and an anti-PD-1 antibody represents a new treatment approach against pancreatic cancer. |
| 2018-05-17 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Announces Data Presentation at ASCO 2018 Annual Meeting bioxceltherapeutics.com ↗
This triple combination therapy also has the potential to address resistance to therapy by promoting and facilitating immune infiltration, thus providing a rationale for further clinical investigation as a potential therapeutic candidate in pancreatic cancer. |
| 2017-10-05 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics to Present Data on [BXCL701] at the 24th Annual Prostate Cancer Foundation Scientific Retreat bioxceltherapeutics.com ↗
The findings from multiple studies demonstrate that [BXCL701], a dipeptidyl peptidases (DPP) inhibitor, can synergistically inhibit tumor growth in combination with immune checkpoint inhibitors by increasing cytokine levels and immune-cell modulation in relevant cancer models. |
| 2017-04-03 | BioXcel Therapeutics Inc | Results BioXcel Presents Promising Data Demonstrating BXCL701 / Anti-PD1 Combination Increases Anti-Tumor Cytokines and Tumor Growth Inhibition at 2017 AACR Annual Meeting bioxceltherapeutics.com ↗
These findings show that BXCL701 in combination with an anti-PD1 agent, may demonstrate clinical benefit in patients that do not respond to ICI therapy. |
All press releases naming this drug 30 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | talabostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00083252 ↗ |
| Known as | BXCL701 | “talabostat (BXCL701)” NCT04171219 ↗ |
| Known as | PT-100 | “A Phase I Trial and Pharmacokinetic Study of Talabostat (PT-100, Val-Boro-Pro) in Combination With Temozolomide or Carboplatin in Pediatric Patients With Relapsed or Refractory...” NCT00303940 ↗4“Talabostat mesylate (PT-100) tablets” NCT00086203 ↗ “talabostat (PT-100) tablets” NCT00083239 ↗ “talabostat (PT-100) tablets” NCT00083252 ↗ “talabostat (PT-100) tablets” NCT00080080 ↗ |
| Known as | Talabostat mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL67279 ↗ |
| Known as | Talabostat mesylate | “Talabostat mesylate (PT-100) tablets” NCT00086203 ↗ |
| Known as | Val-Boro-Pro | “A Phase I Trial and Pharmacokinetic Study of Talabostat (PT-100, Val-Boro-Pro) in Combination With Temozolomide or Carboplatin in Pediatric Patients With Relapsed or Refractory...” NCT00303940 ↗ |
| Known as | Valinyl-l-boroproline | ChEMBL registry synonym — accepted as the source's own label CHEMBL67279 ↗ |
| Action | Inhibit | “talabostat, a dipeptidyl peptidase (DPP) inhibitor” PMID 20460632 ↗ May 2010 |
| Modality | Small molecule | “a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPPs)” NCT04123574 ↗ |
| Route | Oral | “Patients also receive oral talabostat on days 7-20” NCT00303940 ↗ |