Advance clinical development into the next phase, with CBP501 as the first product to reach the market
First written in FY2016. 22 of 47 entries say "Restated". Latest entry: 2026-10-23.
No other company in this theme has enough history to compare yet.
- FY2026SoftenedAnnual report
「Based on the results of the CBP501 Phase 1b clinical trial using this approach, pancreatic cancer was selected as the target indication for the CBP501 Phase 2 clinical trial. The company has now successfully completed a Phase 2 clinical trial to evaluate CBP501's efficacy, safety, and dosage and administration, and is preparing for the next clinical trial phase.」
The disclosure states that the Phase 2 trial of CBP501 has been completed and preparations for the next phase are under way, but the specific reference in the immediately preceding half-year filing to preparations for a Phase 3 trial for pancreatic cancer has been generalized to “the next clinical trial.” - FY2026-H1RestatedAnnual report
「In the United States, approval was subsequently obtained to initiate a Phase 2b clinical trial as the next-stage clinical trial. After advancing some preparations for its initiation, we are currently proceeding in parallel with regulatory applications and preparations to initiate a Phase 3 clinical trial in Europe, for which we aim to obtain approval.」
For CBP501, the company continues to prepare for the Phase 2b trial in the United States and to submit applications and make preparations for the Phase 3 trial in Europe. - FY2025-H1AdvancedAnnual report
「Subsequently, in the United States, the company obtained regulatory approval to start the Phase 2b trial as the next clinical trial phase and has undertaken some preparations for its commencement. In parallel, it is currently submitting applications to the regulatory authorities and preparing to start a Phase 3 trial in Europe aimed at obtaining approval.」
For CBP501, the company obtained approval to start a Phase 2b trial in the United States and reached the stage of submitting applications to the regulatory authorities and preparing to start a Phase 3 trial in Europe. - FY2024AdvancedAnnual report
「Based on the results of the CBP501 Phase 1b clinical trial using this approach, pancreatic cancer was selected as the target indication for the CBP501 Phase 2 clinical trial. The company has now successfully completed a Phase 2 clinical trial to evaluate CBP501's efficacy, safety, and dosage and administration, and is preparing for the next clinical trial phase.」
The company successfully completed the Phase 2 clinical trial of CBP501 for pancreatic cancer and moved to the preparation stage for the next clinical trial phase. - FY2024-Q3AdvancedAnnual report
「The clinical trial achieved its primary endpoint in the three-drug combination arm, which included CBP501. Following this achievement, the company obtained regulatory approval in the United States to start the next clinical trial, a Phase 2b trial, and has begun some preparations for its commencement. In Europe, it is currently submitting applications to the regulatory authorities and preparing to start a Phase 3 trial aimed at obtaining approval.」
Following achievement of the primary endpoint for CBP501, the company obtained approval to start a Phase 2b trial in the United States and moved forward with applications and preparations to start a Phase 3 trial in Europe. - FY2024-Q1RestatedAnnual report
「The drug candidates currently under development are at the preparation stage for the next clinical trial in pancreatic cancer for CBP501, while CBS9106 has completed its Phase 1 clinical trial and is at the planning stage for the next clinical trial.」
The company has reconfirmed that CBP501, its lead product candidate for commercialization, is at the preparation stage for the next clinical trial in pancreatic cancer. - FY2023SoftenedAnnual report
「Based on the results of the CBP501 Phase 1b clinical trial using this approach, pancreatic cancer was selected as the target indication for the CBP501 Phase 2 clinical trial. The company is currently conducting a Phase 2 clinical trial to evaluate CBP501's efficacy, safety, and dosage and administration, while preparing for the next clinical trial phase.」
Whereas the previous quarter's filing explicitly referred to achieving the primary endpoint in the Phase 2 trial and preparing for the Phase 3 trial, this filing refers only to conducting the Phase 2 trial for pancreatic cancer and preparing for the "next phase." - FY2023-Q3RestatedAnnual report
「For CBP501, the Company achieved the primary endpoint in the Phase 2 clinical trial, decided to end it early, and is preparing to initiate a Phase 3 clinical trial.」
The Company positions CBP501 as its lead product candidate for launch and has reaffirmed that it is preparing to initiate a Phase 3 clinical trial following achievement of the primary endpoint and early termination of the Phase 2 trial. - FY2023-Q2AdvancedAnnual report
「The trial achieved its primary endpoint in the three-drug combination arm including CBP501, and the Company decided to end the trial early after the first stage of its two-stage design. Preparations are currently under way to begin a Phase 3 clinical trial.」
In the CBP501 Phase 2 trial, the three-drug combination arm achieved its primary endpoint, resulting in a decision to end the trial early after the first stage. The Company advanced to the preparation stage for initiating a Phase 3 clinical trial. - FY2023-Q1AdvancedAnnual report
「Under US FDA regulation, the Company is conducting a Phase 2 clinical trial combining CBP501 with an immune checkpoint inhibitor antibody for third-line treatment of pancreatic cancer. The trial has completed subject enrollment in the first stage of a two-stage design, and dosing and observation are continuing.」
In the CBP501 Phase 2 trial, the Company completed subject enrollment in the first stage and advanced to the dosing and observation stage. - FY2022RestatedAnnual report
「CBP501 is the compound assumed to be the Company's first product for launch under its future business plan, and the success or failure of its development can be said to hold the key to realizing the Company's business plan.」
The Company positions CBP501 as its first product candidate for launch and considers its clinical development and launch to be the highest-priority issues under its business plan. - FY2022-Q3RestatedAnnual report
「The drug candidate compounds currently under development are at the early stage of the Phase 2 clinical trial for CBP501, while CBS9106 has completed its Phase 1 clinical trial.」
The Company continues its policy of developing CBP501 as its lead product candidate for launch and describes its current development stage as the early stage of a Phase 2 trial. - FY2022-Q2RestatedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and is awaiting receipt of the final report. In parallel, the Company has begun a Phase 2 clinical trial for pancreatic cancer.」
The Company has reaffirmed the development status of CBP501: the Phase 1b expansion phase is in its final stages, and a Phase 2 clinical trial for pancreatic cancer has begun. - FY2022-Q1AdvancedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and is awaiting receipt of the final report. The subsequent Phase 2 clinical trial is under way.」
The CBP501 Phase 1b expansion phase is awaiting receipt of the final report, and the Company has advanced to the stage of initiating the subsequent Phase 2 clinical trial. - FY2021AdvancedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer. The application to initiate the Phase 2 clinical trial has already been approved, and preparations are under way to begin dosing.」
The Company completed dosing in the CBP501 Phase 1b expansion phase and advanced from the final stages to the stage of preparing to begin dosing in the Phase 2 clinical trial. - FY2021-Q3RestatedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and preparations are under way for a Phase 2 clinical trial.」
The Company has reaffirmed that the CBP501 Phase 1b expansion phase is in its final stages following completion of dosing and that preparations are under way for a Phase 2 clinical trial. - FY2021-Q2AdvancedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and preparations are under way for the next clinical trial.」
The Company completed dosing in the CBP501 Phase 1b expansion phase and advanced from the final stages to the preparation stage for the next clinical trial. - FY2021-Q1AdvancedAnnual report
「The clinical trial is currently in its final stages, having completed enrollment for the expansion phase, the second part of the trial, for pancreatic and colorectal cancer.」
For the CBP501 Phase 1b expansion phase, the Company completed enrollment of subjects with pancreatic and colorectal cancer and advanced to the final stages. - FY2020RestatedAnnual report
「CBP501 is the compound assumed to be the Company's first product for launch under its future business plan, and the success or failure of its development can be said to hold the key to realizing the Company's business plan.」
The Company has reaffirmed its positioning of CBP501 as its first product candidate for launch and its importance to the business plan. - FY2020-Q3RestatedAnnual report
「The drug candidate compounds currently under development are at the Phase 1b clinical trial stage for CBP501 and the Phase 1 clinical trial stage for CBS9106.」
The Company continues the clinical development of CBP501 and CBS9106 and has reaffirmed that CBP501 is in Phase 1b and CBS9106 is in Phase 1. - FY2020-Q2RestatedAnnual report
「Following completion, under US FDA regulation, of two Phase 2 clinical trials for malignant pleural mesothelioma and non-small cell lung cancer, the Company is conducting a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody based on newly obtained findings. This Phase 1b trial is currently in its second part, the expansion phase, for pancreatic and colorectal cancer.」
The Company has reaffirmed that it is conducting the expansion phase of the Phase 1b trial of CBP501 in combination with an immune checkpoint inhibitor antibody. - FY2020-Q1RestatedAnnual report
「Following completion, under US FDA regulation, of two Phase 2 clinical trials for malignant pleural mesothelioma and non-small cell lung cancer, the Company is conducting a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody based on newly obtained findings. This is a Phase 1b trial.」
The Company has reaffirmed that it is conducting a Phase 1b trial of CBP501 in combination with an immune checkpoint inhibitor antibody following completion of the Phase 2 clinical trial. - FY2019-Q3RestatedAnnual report
「Following completion, under US FDA regulation, of two Phase 2 clinical trials for malignant pleural mesothelioma and non-small cell lung cancer, the Company is conducting a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody based on newly obtained findings. This is a Phase 1b trial. During the second-quarter accounting period, the Company completed the dose-escalation phase, the first part of the Phase 1b trial, and, after carefully reviewing the results, began the expansion phase, the second part of the trial, for pancreatic and colorectal cancer.」
The Company has reaffirmed that CBP501 is at the stage of conducting the expansion phase for pancreatic and colorectal cancer following completion of the dose-escalation phase. - FY2019-Q2AdvancedAnnual report
「During the cumulative second-quarter period, the Company completed the dose-escalation phase, the first part of the Phase 1b trial, and, after carefully reviewing the results, began the expansion phase, the second part of the trial, for pancreatic and colorectal cancer.」
For CBP501, the Company completed the dose-escalation phase of the Phase 1b trial and advanced to the stage of beginning the expansion phase for pancreatic and colorectal cancer. - FY2019-Q1RestatedAnnual report
「Following completion, under US FDA regulation, of two Phase 2 clinical trials for malignant pleural mesothelioma and non-small cell lung cancer, the Company is conducting a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody based on newly obtained findings. This is a Phase 1b trial.」
The Company has reaffirmed that it is conducting a Phase 1b trial of CBP501 in combination with an immune checkpoint inhibitor antibody based on findings following completion of the Phase 2 clinical trial. - FY2018RestatedAnnual report
「The Company expects to complete the first half of the Phase 1b trial during 2018 and, based on the results of this trial, select multiple cancer types and begin an expansion-phase trial.」
The Company has reaffirmed that the CBP501 Phase 1b trial is in progress and indicated that it expects to complete the first part of the trial and begin the expansion-phase trial during 2018. However, because the source describes these as expectations rather than achievements, this was classified as REAFFIRMED. - FY2018-Q3RestatedAnnual report
「Following completion, under US FDA regulation, of two Phase 2 clinical trials for malignant pleural mesothelioma and non-small cell lung cancer, the Company is conducting a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody based on newly obtained findings. This is a Phase 1b trial.」
The Company has reaffirmed that it is conducting a Phase 1b trial of CBP501 in combination with an immune checkpoint inhibitor antibody based on new findings following completion of the Phase 2 clinical trials. - FY2018-Q2RestatedAnnual report
「The drug candidate compounds currently under development are at the stage of conducting a Phase 1b clinical trial for CBP501 based on new findings following completion of the Phase 2 clinical trial, and at the Phase 1 clinical trial stage for CBS9106.」
The Company has reaffirmed that it is conducting a Phase 1b trial for CBP501. - FY2018-Q1AdvancedAnnual report
「The Company reviewed its previous clinical development plan, which had assumed that the next clinical trial for CBP501 would be a Phase 2b trial, and, based on newly obtained findings, initiated a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody, namely a Phase 1b trial.」
The Company states that it initiated a Phase 1b trial of CBP501 in combination with an immune checkpoint inhibitor antibody. However, enrollment of subjects had not begun by the end of the quarter. - FY2017AdvancedAnnual report
「April 2017: Obtained FDA IND approval to initiate a Phase 1b clinical trial combining CBP501, cisplatin and an immune checkpoint inhibitor antibody.」
There was concrete progress in obtaining FDA IND approval for the Phase 1b trial combining CBP501 with an immune checkpoint inhibitor antibody, the next stage for CBP501. - FY2017-Q3SoftenedAnnual report
「Under the most aggressive plan as of the beginning of the fiscal year, the Company had expected that approval to initiate the CBP501 Phase 1b trial might be obtained by the third quarter, in which case it anticipated incurring a substantial amount of clinical development costs. However, approval to initiate the trial had not been obtained by the end of the third quarter, and only the amount required for preparations was recorded as an expense.」
Preparations for initiating the Phase 1b trial are continuing, but approval to initiate the trial, which had been expected by the end of the third quarter, was not obtained. - FY2017-Q1ReframedAnnual report
「During the cumulative first-quarter period, the Company reviewed its clinical development plan, which had assumed that the next clinical trial for CBP501 would be a Phase 2b trial, and decided to prepare with the aim of newly initiating a Phase 1b trial.」
The Company revised its plan from the previously assumed Phase 2b trial to a plan aimed at initiating a Phase 1b trial. - FY2016First statedAnnual report
「CBP501 is the compound assumed to be the Company's first product for launch under its future business plan, and the success or failure of its development can be said to hold the key to realizing the Company's business plan.」
The Company positions CBP501 as its first future product for launch and considers the next clinical trial and obtaining regulatory approval to be key priorities.