CoImmune Announces Positive Results from Phase 1/2 Clinical Trial of Allogeneic CAR-CIK Cells in Pediatric and Adult Patients with Acute Lymphoblastic Leukemia
Oral presentation at 63rd ASH Annual Meeting & Exposition shows that treatment based on company’s proprietary technology platform induced sustained responses without severe toxicities
Company also announces presentation of preclinical proof-of-concept data in Acute Myeloid Leukemia
DURHAM, N.C., Dec. 15, 2021 (GLOBE NEWSWIRE) — CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, today announced that results from a Phase 1/2 clinical trial evaluating CARCIK-CD19, an investigational treatment based on the company’s chimeric antigen receptor (CAR) modified cytokine induced killer (CIK) cell platform, demonstrated sustained responses in pediatric and adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who had relapsed after allogeneic hematopoietic stem cell transplantation (HSCT). The results were presented during an oral session at the American Society of Hematology’s (ASH) 63rd Annual Meeting & Exposition held December 11-14th in Atlanta, GA.
“We demonstrated that potent anti-leukemic activity can be achieved with less toxicity using CAR T cells generated from healthy donor-derived blood cells, differentiated to CIK cells, and engineered with the non-viral Sleeping Beauty transposon,” said the study’s scientific leader Chiara Magnani, Ph.D., Tettamanti Research Center, Department of Pediatrics, University of Milano-Bicocca, Monza, Italy. “In this study, we saw robust CARCIK-CD19 cell expansion in most B-ALL patients that had relapsed after HSCT, and a sustained response was induced irrespective of the donor type and without severe toxicities.”
Of the 21 patients infused in the multi-center dose-escalation trial, CARCIK-CD19 cells were obtained by HLA-identical sibling (n=6, 29%), matched unrelated (n= 7, 33%), and haploidentical donors (n=8, 38%). Complete response was achieved by 13 out of 21 patients (61.9%, 95%CI=38-82%), including 11 out of 15 patients who were treated with the two highest doses (73.3%, 95%CI=45-92%). At a median follow-up of two years, in the highest dose treated cohort, the median overall survival (OS) was 73% at six months and 48% at one year. Event-free survival (EFS) was 33% at six months and 22% at one year. No dose limiting toxicity was observed, and secondary graft-versus-host disease (GVHD) was not induced by CARCIK-CD19.
CoImmune is also announcing the presentation of two additional posters at the ASH Annual Meeting & Exposition that featured preclinical data evaluating its CAR-CIK technology platform for the development of a potential treatment for Acute Myeloid Leukemia (AML).
- In a poster titled, “CD123 and CD33 Co-Targeting By Balanced Signaling on CAR-CIK Cells Reduces Potential Off-Target Toxicity While Preserving the Anti-Leukemic Activity of Acute Myeloid Leukemia,” researchers demonstrated proof-of-concept of a dual-targeting approach with transacting co-stimulation that displays high antitumor activity against AML while reducing potential off-target toxicity.
- In a poster titled, “Combining the Expression of CD33.CAR and CXCR4 to Increase CAR-CIK Cell Homing to Bone Marrow Niche and Leukemic Stem Cell Eradication in Acute Myeloid Leukemia,” researchers demonstrated the ability of CXCR4-modified CD33.CAR-CIK cells to infiltrate the bone marrow niche in a mouse model, which is where leukemic stem cells reside and often lead to relapse.
“We believe that CAR-CIK cell technology has the potential to enhance efficacy with greatly reduced toxicity because CIK cells possess the killing mechanisms of both T-cells and NK-cells while also resisting the induction of GVHD,” said Charles Nicolette, Ph.D., chief executive officer of CoImmune. “Combined with our proprietary non-viral Sleeping Beauty gene transfer technology that may be more efficient than recombinant viruses, we are in a position to dramatically alter the immuno-oncology landscape. We are focused on moving ahead with clinical programs in ALL and AML based on these impressive preclinical results.”
About CoImmune, Inc.
CoImmune is a privately held, clinical stage immuno-oncology company that will redefine cancer treatment using best-in-class cellular immunotherapies. Our allogeneic CAR-CIK technology platform for liquid and solid tumors is a variation on CAR-T therapy that promises enhanced efficacy with greatly reduced toxicity. Our autologous RNA-loaded dendritic cell technology for solid tumors uses amplified total tumor mRNA to program highly engineered dendritic cells to generate immune responses against neoantigens without the need to identify them. For more information visit www.coimmune.com.
Investor Contact:
Lori Harrelson
Chief Financial Officer
CoImmune, Inc.
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Berry & Company Public Relations
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