LOS ANGELES, October 4, 2022 /PRNewswire/ — ImaginAb Inc., a global biotechnology company developing next-generation 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agents and therapeutic radiopharmaceuticals (RPT), is pleased to announce the following business updates.
Summary:
ImaginAb has made significant progress in its clinical development plans this year as it aims to achieve regulatory approval of the CD8 ImmunoPET imaging agent in multiple regions and to increase the number of partnerships utilizing this technology.
in the January 2022ImaginAb announced a significant expansion of its pipeline four active programs focuses on the development of Radiopharmaceutical therapies (RPT).
CD8 ImmunoPET progress:
ImaginAb is continuing clinical development of CD8 ImmunoPET with the goal of filing a Biologics License Application (BLA) within the next two years. The clinical development program consists of company and investigator funded studies.
Phase I IBM study:
in the Aug 2021ImaginAb completed its Phase I IBM study demonstrating the utility of CD8 ImmunoPET in detecting disease pathology in patients with inclusion body myositis (IBM).
Phase IIa ‘BOT’ study:
in the December 2021ImaginAb completed enrollment in its Phase IIa Baseline-on Treatment (BOT) study and in July 2022 it has completed the 12-month follow-up process of the subjects and has now entered the data analysis phase. Preliminary analyzes are encouraging and initial results will be presented at the Society of Immunotherapy of Cancer (SITC) conference to be held in Bostonin November 2022.
Phase IIb ‘iPREDICT’ study:
ImaginAb officially launched its Phase IIb ‘iPREDICT’ study to measure the predictive power and prognosis of CD8 ImmunoPET imaging, building on the data from its promising Phase IIa ‘BOT’ study. The study aims to enroll 80 patients over 22 sites in the USA, Australiaand Europe, which focuses on many types of cancer, including melanoma, Merkel cells, kidney cells, non-small cell lung cancer and select solid tumors. Data is…
