Research on expanding PPMX-T003 indications to hematologic and solid cancers
First written in FY2021. 12 of 24 entries say "Advanced", first in FY2022. Latest entry: 2026-08-21.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「As of the date of submission of this document, a clinical trial structure had been established with the participation of 10 leading hospitals nationwide. Against the target enrollment of 7 cases set at the start of the trial, 2 cases were enrolled in 2023, 1 in 2024 and 2 in 2025, bringing the current total to 5 cases. Because recruitment is taking time due to the ultra-rare nature of the target disease, the trial period has been extended twice and now runs through the end of March 2027.」
For the investigator-initiated Phase I/II trial targeting ANKL, the number of sites reached 10 nationwide and enrolled cases increased from 4 to 5. However, owing to enrollment delays caused by the ultra-rare nature of the disease, the trial period has been extended twice and now runs through the end of March 2027. - FY2026-H1SoftenedAnnual report
「The trial was originally scheduled for completion during the current fiscal year, but because the number of enrolled cases stood at only 4 as of the end of September 2025, a 1-year extension of the trial period is planned based on the judgment of the coordinating investigator. In addition, the number of clinical trial sites is scheduled to be increased from 9 to 10 to promote future subject enrollment.」
The investigator-initiated Phase I/II trial targeting ANKL had enrolled only 4 cases as of the end of September 2025, resulting in a plan to extend the expected completion date by 1 year. The number of sites is also scheduled to be increased from 9 to 10 to promote enrollment. - FY2025AdvancedAnnual report
「The investigator-initiated Phase I/II trial launched under this program was originally scheduled for completion during the current fiscal year. However, because subject enrollment did not progress as planned due to the ultra-rare nature of the disease, the trial period was extended by 1 year based on the judgment of the coordinating investigator. The trial was selected again for the AMED program in February 2025. To accelerate future subject enrollment, the number of clinical trial sites had been increased from 7 to 9 as of the date of submission of this report.」
The investigator-initiated Phase I/II trial targeting ANKL was extended by 1 year because of delayed enrollment. The project was selected again for AMED funding in February 2025, and the number of clinical trial sites was increased from 7 to 9 to accelerate enrollment. - FY2025-H1RestatedAnnual report
「In addition, the company is conducting collaborative drug-discovery research with Nagoya University and others to clarify the mechanism of action of PPMX-T003 as a treatment for hematologic cancers, including acute myeloid leukemia and malignant lymphoma, as well as solid cancers.」
Collaborative research with universities and others is continuing, with a view to expanding PPMX-T003 to hematologic and solid cancers. - FY2024-Q3RestatedAnnual report
「The company has also identified the potential for this antibody to become an effective treatment for aggressive NK-cell leukemia (ANKL), an ultra-rare disease. In the investigator-initiated Phase I/II trial being conducted following selection for the Japan Agency for Medical Research and Development (AMED) program for pre-designation practical support for rare disease drugs under its drug-discovery support initiative, 2 patients received dosing in September 2023. With Hiroshima University Hospital as the lead site, 7 clinical trial sites have been established nationwide, creating a structure under which subjects can participate in the trial and receive the investigational drug immediately when identified. Measures are also being taken to promote subject enrollment by calling for cooperation not only from hematologists but also from general internal medicine and gastroenterology physicians nationwide.」
For the ANKL trial, the company reconfirmed dosing for 2 patients in September 2023 and the structure of 7 sites nationwide, and is calling on general internal medicine and gastroenterology physicians to cooperate in promoting subject enrollment. No new dosing results were reported, so this was treated in substance as a continuation and reconfirmation. - FY2024-Q2AdvancedAnnual report
「In September of this year, the first patient received dosing, followed by the second patient. With Hiroshima University Hospital as the lead site, 7 clinical trial sites have been established nationwide, and a structure is in place to administer the investigational drug immediately when subjects are identified.」
In the investigator-initiated Phase I/II trial targeting ANKL, dosing began for the first patient in September 2023, followed by the second patient. A dosing structure has also been established across 7 sites nationwide. - FY2024-Q1RestatedAnnual report
「Following selection in March 2022 for the Japan Agency for Medical Research and Development (AMED) program for pre-designation practical support for rare disease drugs under its drug-discovery support initiative, submission of the clinical trial notification for the investigator-initiated Phase I/II trial was completed as scheduled in March 2023, and the Pharmaceuticals and Medical Devices Agency (PMDA) inspection was also completed. With Hiroshima University Hospital as the lead site, 7 clinical trial sites have been established nationwide, creating a structure that allows the investigational drug to be administered immediately when subjects are identified.」
For the investigator-initiated Phase I/II trial targeting ANKL, the company has reconfirmed that preparations have been completed following submission of the clinical trial notification and completion of the PMDA inspection. - FY2023AdvancedAnnual report
「As scheduled, submission of the clinical trial notification for the investigator-initiated Phase I/II trial was completed in March 2023, and the Pharmaceuticals and Medical Devices Agency (PMDA) inspection was also completed. Following subject enrollment, dosing is scheduled to begin.」
For the investigator-initiated Phase I/II trial targeting ANKL, submission of the clinical trial notification and completion of the PMDA inspection have been achieved, bringing the trial close to the stage of beginning dosing after subject enrollment. - FY2023-Q3RestatedAnnual report
「The company is also conducting collaborative research with Tokai University to develop a treatment for aggressive NK-cell leukemia (ANKL), an ultra-rare disease. In March 2022, the project was selected for the Japan Agency for Medical Research and Development (AMED) program for pre-designation practical support for rare disease drugs under its drug-discovery support initiative. The company is currently coordinating with universities, medical institutions and others toward submission of the clinical trial notification for an investigator-initiated clinical trial. In addition, the company is conducting collaborative drug-discovery research on clinical efficacy with Nagoya University and Gunma University to clarify the mechanism of action of PPMX-T003 as a treatment for hematologic cancers, including acute myeloid leukemia and malignant lymphoma, as well as solid cancers.」
Collaborative research with Tokai University targeting ANKL, coordination toward an investigator-initiated clinical trial following selection for the AMED program, and collaborative research with Nagoya University and Gunma University targeting hematologic and solid cancers are continuing. - FY2023-Q2RestatedAnnual report
「The company is also conducting collaborative research with Tokai University to develop a treatment for aggressive NK-cell leukemia (ANKL), an ultra-rare disease. In March 2022, the project was selected for the Japan Agency for Medical Research and Development (AMED) program for pre-designation practical support for rare disease drugs under its drug-discovery support initiative. The company is currently coordinating with Tokai University, medical institutions and others toward submission of the clinical trial notification for an investigator-initiated clinical trial.」
For ANKL development, collaborative research with Tokai University and coordination toward submission of the clinical trial notification for an investigator-initiated clinical trial following selection for the AMED program are continuing. - FY2023-Q1AdvancedAnnual report
「In March 2022, the project was selected for the Japan Agency for Medical Research and Development (AMED) program for pre-designation practical support for rare disease drugs under its drug-discovery support initiative. The company is currently coordinating with Tokai University, medical institutions and others toward submission of the clinical trial notification for an investigator-initiated clinical trial.」
Following selection for the AMED program for ANKL development, the company has moved to the coordination stage with universities and medical institutions toward submitting the clinical trial notification for an investigator-initiated clinical trial. - FY2022AdvancedAnnual report
「In addition, collaborative research with Tokai University identified the potential to use this antibody's ability to inhibit iron uptake as a treatment for aggressive NK-cell leukemia (ANKL), an ultra-rare disease. As a result, in March 2022, the project was selected for the Japan Agency for Medical Research and Development (AMED) program for pre-designation practical support for rare disease drugs under its drug-discovery support initiative.」
In addition to research into expanding PPMX-T003 to hematologic and solid cancers, research targeting ANKL was selected for an AMED program, and development advanced toward an investigator-initiated clinical trial and commercialization. - FY2022-Q3RestatedAnnual report
「In addition, the company is conducting collaborative drug-discovery research on clinical efficacy with Nagoya University, Fujita Health University and Gunma University to clarify the mechanism of action of PPMX-T003 as a treatment for hematologic cancers, including acute myeloid leukemia and malignant lymphoma, as well as solid cancers.」
Collaborative research with 3 universities is continuing, with a view to expanding PPMX-T003 to hematologic and solid cancers. - FY2022-Q2RestatedAnnual report
「In addition, the company is conducting collaborative drug-discovery research on clinical efficacy with Nagoya University, Fujita Health University and Gunma University to clarify the mechanism of action of PPMX-T003 as a treatment for hematologic cancers, including acute myeloid leukemia and malignant lymphoma, as well as solid cancers.」
Collaborative research with 3 universities is continuing, with a view to expanding PPMX-T003 to hematologic and solid cancers. - FY2022-Q1RestatedAnnual report
「In addition, the company is conducting collaborative drug-discovery research on clinical efficacy with Nagoya University, Fujita Health University and Gunma University to clarify the mechanism of action of PPMX-T003 as a treatment for hematologic cancers, including acute myeloid leukemia and malignant lymphoma, as well as solid cancers.」
Collaborative research with Nagoya University, Fujita Health University and Gunma University is continuing, with a view to expanding PPMX-T003 to hematologic and solid cancers. - FY2021First statedAnnual report
「Separately from polycythemia vera, the company is conducting collaborative drug-discovery research on clinical efficacy with Nagoya University, Fujita Health University, Gunma University and others to clarify the mechanism of action of PPMX-T003 as a treatment for hematologic cancers, including acute myeloid leukemia and malignant lymphoma, as well as solid cancers.」
Through collaborative research with multiple universities, the company is studying the mechanism of action and clinical efficacy of PPMX-T003 with a view to expanding its indications.