PPMX-T001 Monotherapy Development Fails to Meet Primary Endpoint, Creating Uncertainty over Continued Development
First written in FY2021. 3 of 6 entries say "Restated". Latest entry: FY2023.
The whole theme swung hardest in 2022: 19 of 40 companies on the "Worse" side.
29 other companies' latest entry also says "Restated".
- FY2023RestatedAnnual report
「PPMX-T001 is not expected to affect the Company's future revenue and is not included in the Company's plans.」
Reconfirms that PPMX-T001 is not expected to affect Company revenue after the agreement expires. - FY2022SoftenedAnnual report
「Because the patents covered by the agreement with Chugai Pharmaceutical Co., Ltd. will expire on 21 June 2022, the agreement with the company is also scheduled to expire on the same date. PPMX-T001 is not expected to affect the Company's future revenue and is not included in the Company's plans.」
It was explicitly stated that the agreement with Chugai Pharmaceutical is scheduled to expire and that PPMX-T001 is not expected to affect future Company revenue or plans. - FY2022-Q3RestatedAnnual report
「For GC33, efficacy in patients was confirmed in a Phase I monotherapy trial, but the primary endpoint was not met in the Phase II trial, which is not currently being conducted. Meanwhile, the results of a Phase I trial combining GC33 with the immunotherapy drug atezolizumab, in which efficacy was confirmed in patients, have been presented at a scientific conference. ERY974 (anti-GPC3/anti-CD3) is a bispecific antibody capable of binding simultaneously to two targets. Its Phase I trials in the US and Europe ended in August 2019, and a domestic Phase I trial is currently under way. In addition, Phase I clinical trials of ERY974 in combination with atezolizumab and the angiogenesis inhibitor bevacizumab have been initiated in Japan and Taiwan.」
Reconfirms that the Phase II trial of GC33 monotherapy has not been conducted since the primary endpoint was not met, while clinical trials related to the combination therapy and ERY974 are under way. - FY2022-Q2RestatedAnnual report
「For GC33, efficacy in patients was confirmed in a Phase I monotherapy trial, but the primary endpoint was not met in the Phase II trial, which is not currently being conducted. Meanwhile, the results of a Phase I trial combining GC33 with the immunotherapy drug atezolizumab, in which efficacy was confirmed in patients, have been presented at a scientific conference.」
Reiterates that the Phase II trial of GC33 monotherapy has not been conducted since the primary endpoint was not met, while efficacy was confirmed with the combination therapy. - FY2022-Q1AdvancedAnnual report
「In addition, Phase I clinical trials of ERY974 in combination with atezolizumab and the angiogenesis inhibitor bevacizumab have been initiated in Japan and Taiwan.」
Discloses that Phase I clinical trials of ERY974 in combination with atezolizumab and bevacizumab have been initiated in Japan and Taiwan in connection with PPMX-T001. - FY2021First statedAnnual report
「In monotherapy development, the primary endpoint was not met in the Phase II trial, and no subsequent research and development plans have been disclosed. Meanwhile, the results of a Phase I trial in combination with atezolizumab, in which efficacy was confirmed in patients, have been presented at a scientific conference.」
Explains that the primary endpoint was not met in the Phase II monotherapy trial, while development of the combination therapy and ERY974 is continuing.