Hello, my name is Gurabaksh Kor. I'm an assistant professor of internal medicine at Mount Sinai Hospital in New York, and I am presenting the updated results of IMAGINE-1, the pivotal phase two clinical trial evaluating anitocaptogenin-autolucel, anitocell in relapsed refractory multiple myeloma. For those who don't know, anitocell is a CAR T construct that targets BCMA using a CD3 zeta signaling domain and a 4,1-BB costumelature domain. However, it is unique because the antigen binding domain is a novel synthetic protein called the D domain. The D domain is a triple alpha helical structure that is known for stability and simplicity and has now been repurposed as antigen binders for therapeutic considerations. Because the size of the D domain is very small and it has simple architecture with minimal There is actually high CAR T transduction efficiency along with high CAR T expression. As a result, you have more CAR positive cells. The size of the D domain also allows for anitocell to have a fast off-rate, meaning that it is able to detach itself from the BCMA target. We feel that the size and the fast off-rate of D domain is likely contributing to the optimal cell tumor killing without prolonged inflammation leading to toxicities. In this phase two clinical trial, patients in the relapse refractory setting were enrolled who had at least three or more prior lines of therapy, were exposed to a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 antibody. The primary endpoint was an overall response rate per the 2016 IMWG criteria. 129 patients were enrolled and ultimately 117 patients were dosed with anitocell. In terms of demographics, the median age was 68 years of age with 50% of the patients were being 65 years and older and 9% being older than 75 years of age. 76% of the patient population was white, 15% was African American or black, and 9% were Asian or others. 39% had high-risk prognostic features such as bone marrow plasma cell percentage more than 60%, high-risk cytogenetics or extramedullary disease. 100% were refractory to their last line of therapy with 86% being triple class refractory and 40% being pentarefractory. In terms of efficacy, at a median 12.6 month follow-up and a 4.6 month follow-up of all The overall response rate was 97%, with a CRRB better rate of 68% and a VGPR or a very good partial response of 85% or better. The responses have deepened over time. The CRR rate has improved from 62% as presented at ASH 2024, now 68% at EHA that we're presenting. Of the patients where MRD data was evaluable, which was 75 patients, 70 achieved an MRD negative result at 10 to the minus 5, with the median time to response as well as MRD negativity of being one month. The estimated 6 month PFS is 92%, with an estimated 6 month OS being 97%. The 7% estimated 12 month PFS was 79% and the 12 month estimated OS is 95%. In terms of safety, 85% of the patients experienced grade 1 or no CRS, with 15% of the patients experiencing no CRS at all. The median onset of CRS was 4 days, with the median duration being 2 days. In terms of ICANs, 92% of the patients experienced no ICANs, with only 8% of the patients experiencing ICANs of any grade. There were no grade 4 or 5 ICANs that were reported. In addition, no delayed or non-ICAN neurotoxicities were observed, including no incidence of Parkinsonism, no cranial nerve palsies and no Guillain-Barre syndrome at a median follow-up of 12.6 months. Similarly, no delayed or non-ICAN neurotoxicities have been observed in the phase 1 study. In conclusion, Anitocell utilizes a novel CAR-T construct targeting BCMA. It has really good efficacy with overall response rates of 97%, CR rates of 68% and actually very good travelable safety profile with no high-grade neurotoxicities that were observed and no delayed Parkinsonism, no cranial nerve palsies or no Guillain-Barre that were observed in the phase 1 as well as the phase 2 portion of the study.
HealthTree • July 3, 2025