IL-3

- 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.

WARMINSTER, Penn.--( BUSINESS WIRE )--Shenandoah Biotechnology Inc., a FUJIFILM Irvine Scientific company and leading manufacturer of recombinant proteins, today announced it has expanded its CTGrade portfolio of cytokines and growth factors for cell and gene therapies manufactured following cGMP guidelines. The expanded range, which is now available directly through FUJIFILM Irvine Scientific, includes CTGrade cytokines IL-2, IL-3, IL-6, IL-7, IL-10, IL-15, IL-21, and FLT-3 ligand, with additional proteins in development that optimize cell proliferation and function for new cell and gene therapies applications. Cytokines and growth factors are signaling molecules that regulate cell growth, differentiation, and motility, as well as immune and inflammatory responses, and are therefore used for the expansion, differentiation, and maintenance of cells in most cell therapies. As manufacturers move towards clinical trials, using raw materials manufactured following cGMP guidelines is optimal to minimize variability and ensure predictable workflow performance. Designed to support basic, translational, and clinical research, as well as commercial applications, the CTGrade products are produced from E. coli and are manufactured in a facility that does not use or process beta-lactam containing materials. No animal- or human-derived materials were used during manufacturing or as ingredients. These products are manufactured, tested, and released in an ISO 9001:2015 certified facility following cGMP practices. USP chapter <1043> for ancillary materials has been considered in the manufacture of these products. The Shenandoah products are developed harnessing FUJIFILM Irvine Scientific’s extensive regulatory expertise and quality control to ensure lot-to-lot consistency, reproducibility in downstream cell culture processes, and the smooth transition of biological therapies from preclinical to clinical phases. Erik Vaessen, chief business officer, FUJIFILM Irvine Scientific, said: “ The predictability and performance of CTGrade recombinant proteins help cell and gene therapy developers accelerate delivery of life-changing therapies to market. The biological activity of these high-performing proteins adheres to WHO International standards, where applicable, providing consistent, lot-to-lot biological activity and performance, and ultimately successful progression to the clinic. ” He added: “ The availability of this expanded range directly through FUJIFILM Irvine Scientific provides our customers worldwide with a single point of access for cGMP cell culture solutions, following our acquisition of Shenandoah Biotechnology in March this year. ” All products are available from Shenandoah Biotechnology and FUJIFILM Irvine Scientific in multiple package sizes of 50 µg, 100 µg, and 1 mg, as well as with custom sizing and packaging. To view the entire range of Shenandoah Biotechnology recombinant proteins that support early research to further manufacturing visit http://www.shenandoah-bt.com .