CodaLytic / Codagenix - LARVOL DELTA

The novel codon-modified Zika virus CDX-602 shows anti-tumor efficacy and remodels the tumor microenvironment in preclinical models (AACR 2024) - "We have previously demonstrated that CodaLytic, a codon-modified influenza virus, can kickstart the cancer immunity cycle at various steps in several mouse models with differing baseline immune contextures...Taken together, this preclinical data establishes CDX-602 as a novel virotherapeutic candidate that engages multiple mechanisms of action that contribute to anti-tumor activity. CDX-602 is the second virotherapeutic candidate derived from Codagenix's codon modification platform, further supporting the utility of this synthetic viral engineering technology for viroimmunotherapy of cancer and highlighting its potential across multiple viral species."

Preclinical • Tumor microenvironment • Breast Cancer • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • MRC1

Immunovirotherapy with the codon-modified influenza virus CodaLytic™ modulates the quality of the tumor immune infiltrate in support of anti-tumor immunity (SITC 2023) - "Conclusions CodaLytic treatment induced changes in the murine tumor immune infiltrate suggesting anti-tumor immune activity independently of the baseline immune contexture associated with the tumor model. This supports the utility of CodaLytic, a codon-modified virus being developed for breast cancer immunovirotherapy, as a valuable component of novel therapeutic regimens."

IO biomarker • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • GZMB

Codagenix Announces Presentation of Updated Preclinical CodaLytic Data at Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting (PRNewswire) - "Codagenix Inc...today announced the presentation of preclinical data for CodaLytic™, a codon-modified virus being developed for breast cancer immunovirotherapy, at the Society for the Immunotherapy of Cancer (SITC) 38th Annual Meeting being held virtually and in-person November 1-5, 2023 in San Diego, California. 'These results demonstrate that CodaLytic treatment induced tumor immune infiltration driving anti-tumor efficacy in multiple, diverse preclinical models, and underscore the potential utility of this candidate as a valuable component of novel therapeutic regimens...'"

Preclinical • Oncology

A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Codagenix, Inc | N=24 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Metastases • Oncolytic virus • Trial withdrawal • Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor

The Codon-Modified Influenza Virus CodaLytic™ Rescues ImmuFnostimulatory Activity and Anti-Tumor Efficacy in PD-1-Refractory Tumor Models (FCI 2023) - "In human tumoroid cultures, cytotoxicity was observed in 50% of specimens vs 17% with pembrolizumab and 33% with CodaLytic alone. In this system, specific cytokine secretion patterns associated with response. Together with additional data, CodaLytic emerges as a potent virotherapeutic capable of restoring immune infiltration and anti-tumor efficacy when used in combination with checkpoint inhibition in PD-1 resistant models."

Preclinical • Infectious Disease • Influenza • Oncology • Respiratory Diseases • CD8 • PD-1 • PTPRC

The codon-modified influenza virus CodaLytic™rescues immunostimulatory activity and anti-tumor efficacy in PD-1-refractory tumor models (AACR 2023) - "Primary human tumoroids were incubated with CodaLytic +/- 10 μg/ml pembrolizumab using the 3D-Explore platform by Nilogen Oncosystems. Taken together, this and additional preclinical data confirms the emergence of CodaLytic as a potent immunostimulatory agent capable of restoring immune cell infiltration and anti-tumor efficacy when used in combination with checkpoint inhibition in PD-1 resistant models. This data supports future development of CodaLytic for immuno-virotherapy of tumor types in which checkpoint therapy is less established."

Preclinical • Breast Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCL2 • CCL4 • CD8 • CXCL10 • CXCL9 • PD-1 • PTPRC

Preclinical development of CodaLytic™, a codon-modified influenza virus, as a novel virotherapeutic agent for breast cancer immunotherapy (SABCS 2022) - "Characterization of the tumor immune infiltrate after CTLA-4 combination and pharmacodynamic changes achieved after CodaLytic/checkpoint combination treatment in human breast cancer tumoroids will further support identification of correlates of efficacy with translational implications. Together with preclinical toxicology data and demonstrated clinical safety of this attenuated influenza virus after intranasal administration in healthy individuals, CodaLytic emerges as a promising novel viroimmunotherapeutic agent and is planned to enter a phase 1 clinical trial in early 2023."

IO biomarker • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • IFNG

Virotherapy with CodaLytic™, a codon-modified influenza virus, induces an anti-tumor immune microenvironment across preclinical models with different immune contextures (SITC 2022) - "Human breast cancer tumoroids maintaining the orignal patient TME were incubated ex vivo with 10 8 PFU CodaLytic, 10 μg/ml pembrolizumab or both. Conclusions CodaLytic treatment induced favorable changes in multiple murine tumor models independently of their intrinsic immune contexture and sensitized B16F10 melanomas to PD-1 blockade. Ongoing work investigates correlates of TCK in human tumoroid cultures beyond baseline immune infiltration to support future development of CodaLytic for immuno-virotherapy."

Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • IFNG • PTPRC

A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Codagenix, Inc

New P1 trial • Oncolytic virus • Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor

CodaLytic™, a novel codon-pair deoptimized influenza virus creates an immune-stimulatory tumor microenvironment leading to monotherapy efficacy in a preclinical model of breast cancer (SITC 2021) - "Additional holistic gene expression analysis is ongoing to further characterize the mechanisms of immune activation. Taken together with preclinical safety data and demonstrated clinical safety and immunogenicity of this attenuated influenza virus after intranasal administration in healthy individuals, CodaLytic is a promising immunotherapeutic to be further developed as monotherapy and in combination with immune checkpoint inhibitors or other modalities."

IO biomarker • Monotherapy • Preclinical • Tumor microenvironment • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • IFNG

Codagenix to Present Promising Preclinical Data for Oncolytic Virus Therapeutic CodaLytic at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (PRNewswire) - “Codagenix, Inc…announced they will present data indicating preclinical efficacy of CodaLytic™, its first rationally attenuated oncolytic virus immunotherapy, at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, held both virtually and in person November 10-14, 2021. ‘These data demonstrate the promise of CodaLytic as a novel oncolytic virus immunotherapy capable of hindering tumor clearance, immune stimulation, and inducing an anti-tumor immune response to protect against metastasis. The advent of this new, rapidly expanding vertical at Codagenix underscores the enormous utility and adaptability of our codon deoptimization platform’…‘We are excited to advance CodaLytic as a lead candidate that overcomes many of the latent challenges of first-generation oncolytic virus therapeutics and broaden our patient impact.’”

Preclinical • Breast Cancer • Oncology

Codagenix Appoints Johanna Kaufmann, Ph.D., Executive Vice President, Oncology to Lead Customization of Oncolytic Viruses for Solid Tumors (PRNewswire) - "Codagenix Inc...announced the appointment of innovative oncology leader Johanna Kaufmann, Ph.D., as Executive Vice President, Oncology. In her new role, Dr. Kaufmann will lead the Company's oncology franchise, overseeing the development of oncolytic virus therapies targeting breast cancer, melanoma, and prostate cancer. Codagenix expects to advance its CodaLytic^TM oncolytic virus for the treatment of triple negative breast cancer into Phase 1 testing later this year."

New P1 trial • Breast Cancer • Oncology • Triple Negative Breast Cancer