CIK-CAR CD19 immunotherapy (CoImmune)

- Technology will be coupled with modified Cytokine Induced Killer (CIK) cells in development program focused on solid tumors with initial trials in small cell lung cancer - DURHAM, N.C., June 27, 2023 /PRNewswire/ -- CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, today announced it has exercised its option to obtain an exclusive license in the Delta-like Ligand 3 (DLL3)-targeted, allogeneic Chimeric Antigen Receptor-Cytokine Induced Killer (CAR-CIK) cell therapy field to interleukin-18 (IL-18) Armored CAR technology under a prior agreement with Memorial Sloan Kettering Cancer Center (MSK). The company is coupling the technology with allogeneic CIK cells and launched a development program focused on solid tumors with initial trials planned in small cell lung cancer (SCLC). "Traditional CAR T cells have proven to be poorly effective against solid tumors due, in part, to the immunosuppressive tumor microenvironment, but we have demonstrated the potential for CAR-CIK cells to be effective in combination with additional technologies that may be able to improve proliferation, persistence and reverse immunosuppression," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "IL-18 expression has the potential to greatly enhance the potency of DLL3-targeted therapy and we look forward to advancing our development of CMN-009, an IL-18 armored anti-DLL3 CAR-CIK therapeutic for SCLC." CoImmune has the option to select up to three targets for IL-18 CAR products in the allogeneic cell therapy field under the agreement with MSK. In March 2023, the company announced it had selected CD19 as the first target to support the clinical development of CMN-008 (Armored CAR-CIK cells) in B-cell malignancies. CoImmune plans to file an Investigational New Drug (IND) application for CMN-008 to treat acute lymphoblastic leukemia (ALL) this year. The DLL3 target has been identified as a tumor-specific cell surface marker on neuroendocrine cancers including SCLC. A paper recently published in Journal of Clinical Investigation, titled, "IL-18-secreting CAR T cells targeting DLL3 are highly effective in small cell lung cancer models," describes an effort by researchers including Renier J. Brentjens, M.D., Ph.D., Deputy Director and Chair of Medicine, Roswell Park Comprehensive Cancer Center, to develop a CAR against DLL3 that displays antitumor efficacy in xenograft and murine SCLC models. The data reported show IL-18 armored CAR-DLL3 T cells could eradicate disease at very low doses, especially when combined with a PD-1 checkpoint inhibitor. "Our preclinical studies with a model of metastatic SCLC demonstrated that IL-18 production increased the activation of both CAR T cells and endogenous tumor-infiltrating lymphocytes," said Dr. Brentjens, who previously developed the IL-18 Armored CAR technology at MSK. "We also observed increased infiltration, repolarization and activation of antigen-presenting cells. Human IL-18-secreting anti-DLL3 CAR T cells were able to eradicate disease at dose levels where standard anti-DLL3 CAR-T cells were ineffective. We saw strong synergy with PD1 checkpoint inhibition, suggesting a potential for curative responses at lower, subtherapeutic administrations of IL-18 armored anti-DLL3 CAR T cells. These results define DLL3-targeting CAR T cells that produce IL-18 as a promising novel strategy against DLL3-expressing solid-tumor cancers." CoImmune's IL-18 armored CARCIK-DLL3 product prototype, CMN-009, will be studied in animal models throughout the remainder of 2023. Additional technologies licensed from MSK (e.g., SEAKER, SHIELD) will be tested in combination with CMN-009 to further enhance functionality. The Company expects to initiate IND-enabling studies in the first half of 2024. 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 . Investor Contact: Lori Harrelson Chief Financial Officer CoImmune, Inc. [email protected] Media Contact: Adam Daley Berry & Company Public Relations [email protected] 212-253-8881 SOURCE CoImmune, Inc.

- Allogeneic CARCIK-CD19 therapy after hematopoietic stem cell transplantation relapse induced complete responses in 76.2 percent of 21 patients in the two highest dose groups - - 81.3 percent of complete responders in highest dose groups were minimal residual disease negative - - Additional presentations evaluate CAR-CIK strategy in acute myeloid leukemia - DURHAM, N.C., Dec. 13, 2022 /PRNewswire/ -- CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, today announced the presentation of results from a Phase I/II clinical trial evaluating CARCIK-CD19, an investigational treatment based on the company's chimeric antigen receptor (CAR) modified cytokine induced killer (CIK) cell platform, in pediatric and adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who had relapsed following hematopoietic stem cell transplantation (HSCT). The results are being presented at the American Society of Hematology's (ASH) 64th Annual Meeting and Exposition held December 10-13 in New Orleans. "For more than 15 years, we have been working to advance innovative pre-clinical and clinical research in the field of cellular and gene therapy for childhood and adult acute lymphoblastic leukemia, and these data presented at the ASH annual meeting represent a promising breakthrough," said Andrea Biondi, M.D., Professor of Pediatrics at the University of Milano-Bicocca and Scientific Director of the M. Tettamanti Research Center. "In the Phase I/II dose-finding study, CARCIK-CD19 cells demonstrated an excellent safety profile with anti-leukemia activity in heavily pretreated patients with B-ALL relapsed after HSCT. Importantly, the persistence of these cells was associated with a longer duration of response and reduced risk of leukemia relapse." The Phase I/II dose escalation clinical trial included 27 patients (4 children and 23 adults) with B-ALL relapsed post-HSCT, six of whom participated under a compassionate use protocol and received the highest dose level. The study was conducted as a collaboration between the Pediatric and Haematology Departments of Monza and Bergamo (Italy), respectively. Results show that 18 out of 27 patients (66.7%, 95%CI=46.0-83.5%) achieved complete response (CR), with 14 (77.8%) of the overall responders negative for minimal residual disease (MRD). In the two highest dose groups, 16 out of 21 patients (76.2%, 95%CI=52.8-91.8%) achieved CR, with 13 of the responders at the highest dose (81.3%) MRD-negative. The median follow-up was 2.8 years (range, 0.05-4.4 years, last update as of July 2022). Event-free survival (EFS) was significantly longer in the two highest dose groups (p=0.0265) and was associated with the percentage of bone marrow blasts after lymphodepletion (≥ 5% vs <5%) (p=0.0245). Graft versus host disease never occurred after treatment with CARCIK-CD19, and no dose limiting toxicity was observed. In a prospective study also presented at the ASH Annual Meeting, Giuseppe Gaipa, Ph.D., and Benedetta Rambaldi, M.D., Ph.D., evaluated the impact on clinical outcome of proliferation, differentiation, and expansion of CARCIK-CD19 cells in 20 of the patients treated in Phase I/II clinical trial. The cells were detectable up to 12 months in vivo, a majority of which presented with CD8+ memory phenotype. Their persistence after day 90 was correlated with duration of response (p=0.0045), and MRD-negativity was associated with longer survival (p=0.004). CoImmune is also announcing the presentation two additional preclinical studies at the ASH Annual Meeting that evaluated the CAR-CIK strategy in acute myeloid leukemia (AML). Both were performed at the M. Tettamanti Research Center, Monza, Italy. In a poster titled, "Tuned IL3-Zetakine Coupled to a CD33 Costimulatory Receptor As a Dual CAR for Safer and Selective Targeting of Acute Myeloid Leukemia," Sarah Tettamanti, Ph.D., and colleagues describe a bispecific CAR-CIK strategy for AML that demonstrated the potential for improved efficacy and high specificity for CD123 and CD33 on leukemic cells while reducing the risk of life-threatening toxicities. In a poster titled, "Overexpression of CXCR4 Enhances the Efficacy of CAR-T Therapy for Acute Myeloid Leukemia," Marta Serafini, Ph.D., and colleagues found that combining the expression of CD33-CAR and CXCR4 improves in vivo CAR-CIK cell migration and retention within the bone marrow and subsequent AML eradication. In an AML mouse model, median survival improved with CXCR4 overexpression (p<0.0001). "Immunotherapies have the potential to allow the body to attack cancer cells with higher efficacy and improved safety when compared to traditional approaches to cancer treatment, but researchers have yet to advance the development of CAR-T cells to reach this full potential," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "We are focused on advancing the science of immunotherapy with fundamentally new approaches as the only company developing gene-modified CAR-CIK cells. These new data demonstrate the potential for CAR-CIK cells to improve outcomes for B-ALL patients, while also opening the door to promising strategies that may increase the therapeutic potential in AML and solid tumor indications." 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 . Investor Contact: Lori Harrelson Chief Financial Officer CoImmune, Inc. [email protected] Media Contact: Adam Daley Berry & Company Public Relations [email protected] 212-253-8881 SOURCE CoImmune, Inc.