New cell therapy! Allogeneic active degenerative degenerative cells iixadencel combined with Shonitini first-line treatment of metastatic kidney cancer has strong efficacy!

20 Aug 20, 2020 // -- Immunicum AB, a Swedish biotechnology company dedicated to the development of allogeneic, ready-to-use cell therapies, has established a unique immuno-oncology approach to improve patient survival and quality of life by launching the patient's own immune system to fight cancer.
recently, the company released the latest total lifetime (OS) data from its lead candidate therapy, the ilixadencel, in a joint targeting anti-cancer drug, Sutent, a generic name: sunitinib, Schoinidini; developed by Pfizer, for the first-line treatment of metastatic renal cell carcinoma (mRCC) Phase II MERECA clinical studies.
lixadencel is an allogeneic degenerative cell (DC) therapy that has been developed as a generic (off-the-shelf) cancer immune primer, which is injected in-tumor for the treatment of multiple solid tumors.
active ingredient in ilixadencel is degenerate cells (DCs) from healthy blood donors, which are particularly activated and produce a large number of powerful immune stimuli.
After injection through intracoursmic injection, these cells cause a local inflammatory response, recruiting and inactiveizing the patient's own DC cells and natural killer cells (NK) into the tumor environment, destroying the tumor cells and releasing a full set of tumor-specific proteins, neoantigen.
these new antigens will serve as a source of antigens, leading to tumor-specific activation of patients' cytotoxic T cells, especially cytotoxic CD8-T cells, resulting in a highly individualized, powerful anti-tumor response.
ilixadencel's preparation and function mechanism (click on the image to see the graph) MERECA is an exploratory, international, randomized, controlled, open label study that included 88 newly diagnosed, medium-risk and high-risk mRCC patients. in
study, patients were randomly grouped at a 2:1 scale, with one group receiving two in-tumor ilixadencel medications before a nephroticectomy and then schoiniinibs after a nephrotic excision, and the other receiving sciutinium treatment only after a nephrosis.
goal of the study was to assess OS and 18-month survival rates.
secondary goal is to assess safety and tolerance, tumor response, and immunoanalytology, including T-cell immersion.
the latest data as of August 2020 continue to show the separation of Kaplan-Meier's survival curve and show that the difference in the OS median favours the ilixadencel group: the median OS in the control group has reached 25.3 months, while the median OS in the control group has not yet reached because the data is premature.
43% of the surviving patients in the ilixadencel group (n=24/56), compared with 33% in the control group (n=10/30).
in this follow-up, five complete relievers (CR) in the ilixadencel group survived, while one total remissioner in the control group died during the first follow-up, as previously reported.
the study will collect and continuously update OS data every six months as planned, with the next update expected in the first quarter of 2021.
the latest results, further support the continued clinical development potential of ilixadencel as an immune trigger in renal cell carcinoma (RCC) and other solid tumor adaptations.
, the U.S. Food and Drug Administration (FDA) granted Ilixadencel Advanced Therapy for Regenerative Medicine (RMAT).
RMAT eligibility includes all benefits of Fast Track Eligibility (FTD) and Breakthrough Drug Eligibility (BTD), including the possibility of early interaction with the FDA, priority review, and accelerated approval.
the RMAT qualification, based on the MERECA results published in February.
data show that preoperative intraoperative intraoperative intraoperative intraoperative injection of ilixadencel combined with postoperative schonitinium therapy: increased survival rate (54% vs. 37%), double the total confirmed remission rate (ORR) (8) 42.4% vs. 24.0%), higher full mitigation rate (CR:6.7% vs. 0%), more durable mitigation (medium mitigation duration (DOR:7.1 months vs 2.9 months).
Immunicum will continue discussions with regulators to determine the next set of priorities and objectives for ilixadencel.
Associate Professor Alex Karlsson Parra, chief scientific officer and interim chief executive of Immunicum, said: "As our largest and longest study, the Phase II MERECA trial continues to provide insight into the potential efficacy of the ilixadencel joint standard care for patients with metastassic tumors.
therefore, we are encouraged by the data at this stage showing that only two injections of ilixadencel continue to have a positive impact on patient survival, as the group's median total lifetime is still not reached.
as the data matures, we can further analyze which patients can benefit most from iixadencel treatment and design our future research to maximize the potential for patient care.
" () Origin: Immunicum AB (publ) Announces Update on Survival Data Phase from MERECA Trial of Ilixadencel in Kidney Cancer.