DK210 (EGFR) / Deka BioSci - LARVOL DELTA

Phase 1 study of DK210 (EGFR), a tumor-targeted IL2 x IL10 dual immunocytokine, in advanced cancer patients: Dose escalation, immune activation, and safety results. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05704985 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P1 data • Oncology • EGFR • IL10 • IL2

DEKA-1: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: DEKA Biosciences | Trial completion date: Feb 2025 ➔ Oct 2025 | Trial primary completion date: Sep 2024 ➔ Mar 2025

Biomarker • IO biomarker • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Genetic Disorders • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatology • Kidney Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Triple Negative Breast Cancer • EGFR • IL10 • IL2

Immune biomarkers from phase 1 first-in-human trial treating advanced cancer patients with DK210(EGFR) compared to ex vivo DiakineTM response assay (SITC 2024) - P1 | "Ethics Approval The study was approved by University of Oklahoma/Castle IRB (approval number DEKA-1 (RM1017); City of Hope/WCG (approval number 20233898); NEXT Oncology/Salus IRB (approval number NXVIR22.60); UT Southwestern (approval number STU-2023-0521); Mary Crowley Cancer Research (approval number 23-08); Feinstein Institute for Medical Research (approval number 23-0724); MD Anderson Cancer Center (approval number 2023-0167). All participants gave informed consent before taking part in the study."

IO biomarker • Metastases • P1 data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • EGFR • GZMB • HAVCR2 • IFNG • IL10 • IL1B • IL6 • LAG3 • PD-1 • TIGIT

Balanced Diakine™ targeted cytokines localize within the immunological synapse and augment immune response in combination with T cell engagers (SITC 2024) - "Conclusions DK210 (CD19) either alone or in combination with TCE uncouples anti-tumor activity from CRS-related cytokines; enhances the cytolytic function of CD8+ T cells; and augments both the duration and avidity of effector-to-target cell interactions. These results provide mechanistic rationale for the Diakine™ platform constructs to be combined with TCEs to potentially improve therapeutic index."

Combination therapy • Oncology • CD8 • EGFR • GZMB • IFNG • IL10 • IL1B • IL2 • IL6 • TNFA

DK210 (EGFR) Induces Immune Response Without Increased CRS or Regulatory T Cells in Solid Tumors (OncLive) - P1 | N=60 | NCT05704985 | Sponsor: DEKA Biosciences | "Evidence of wild-type IL-2 signaling was reported at all DK210 (EGFR) dose levels and minimal therapeutic exposure was achieved at dose levels ranging from 4 mg to 8 mg 3 times per week. With a target of area under the curve (AUC) 150 ng/mL per hour, the 2-mg dose cohort achieved an AUC exposure of approximately 145 ng/mL per hour with confirmed 6-month stable disease (SD). Evaluation of on-treatment patient plasma showed a 20-fold increase in INF- in cohorts 1, 2, and 3; however, this increase plateaued at the 8-mg dose. Although DK210 (EGFR) was found to induce CD3-positive T-cell and NK cell expansion, it did not increase Tregs among patients with SD."

Biomarker • P1 data • Colorectal Cancer • Head and Neck Cancer • Kidney Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer • Skin Cancer

Safety and activity of Diakine DK2 10 (EGFR), a next generation tumor-targeted IL2 x IL10 dual immunocytokine, in patients with advanced cancer: Initial results of the phase 1 first-in-human trial. (ASCO 2024) - P1 | "DK2 10 (EGFR) was well tolerated and associated with therapeutically relevant on-target biomarker signals consisting of effector T cell expansion and elevated IFNɣ. These data suggest the EGFR targeted balanced combination of IL-2 with IL-10 improves safety and increases potency of anti-tumor function by dissociating CRS from T cell activation. Further exploration of DK2 10 (EGFR) in RCC and NSCLC as monotherapy and in combination is planned."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Eosinophilia • Epstein-Barr Virus Infections • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • EGFR • IL10 • IL18 • IL2 • IL2RA • IL5 • LAG3 • PD-L1 • TIGIT

Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: DEKA Biosciences

Biomarker • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatology • Kidney Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Triple Negative Breast Cancer • EGFR • IL10 • IL2

DEKA-1 a dose-finding Phase 1 trial: observing safety and biomarkers using DK210 (EGFR) for inoperable locally advanced and/or metastatic EGFR+ tumors failing systemic therapy (SITC 2023) - P1 | "Preliminary human data shows an encouraging safety and efficiency profile. The dose-escalation study is expected to be completed by the end of this year (NCT05704985)."

Biomarker • Clinical • Metastases • P1 data • Gastrointestinal Cancer • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor • EGFR • IL10

DEKA-1 a dose-finding phase I trial: Observing safety and biomarkers using DK210 (EGFR) for inoperable locally advanced and/or metastatic EGFR+ tumors with progressive disease failing systemic therapy (ESMO 2023) - P1 | "Key eligibility criteria include: 1) confirmed progressive disease on at least one line of systemic treatment, 2) EGFR overexpression or amplification documented in histology reports, 3) at least a 4 week or 5 half-lives window since last treatment, and 4) excluding subjects with long QT syndrome, multiple myeloma, multiple sclerosis, myasthenia gravis or uncontrolled infectious, psychiatric, neurologic, or cancer disease. Plasma and tissue samples will be investigated for pharmacodynamic and predictive biomarkers and genetic signatures associated with IFN-gamma secretion, aiming to select subjects for treatment in phase 2."

Biomarker • Clinical • IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Melanoma • Multiple Myeloma • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • IFNG • IL10

Deka Biosciences Closes USD $20 Million Series B2 Financing Led by MPM BioImpact (PRNewswire) - "...Deka Biosciences..today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm. The proceeds of the financing will support the advancement of Deka's pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK210 (EGFR).... The previous financings have enabled Deka to advance a pipeline of multiple DiakinesTM, conduct critical IND enabling experiments, manufacture drug substance/drug product with Cytovance Biologics, start the first Phase I clinical trial, as well as to expand into a new facility."

Financing • Oncology

Unexpected Antibody-Like Stability and Characteristics of the Targeted Dual Cytokine Fusion Therapeutic, DK210(EGFR) (PEGS 2023) - No abstract available

EGFR

Deka Biosciences Announces First-in-Human Dose in Phase 1 Clinical Trial of DK210 (EGFR) (PRNewswire) - "Deka Biosciences...announced today that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR)."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Skin Cancer • Solid Tumor

Phase 1 Trial of DK210 Begins Dosing Patients With EGFR+ Solid Tumors (Targeted Oncology) - P1 | N=NA | NCT05704985 | Sponsor: DEKA Biosciences | "'The Diakine™ platform combines the potent anti-cancer function of interleukin-2 [IL-2] with the inflammation-controlling function of interleukin-10 and targets these cytokines to the tumor,' Alexander Spira...'The main goals of the trial are to establish the effective dose, tolerability, and efficacy across EGFR-expressing tumor types,' added Spira."

Media quote • P1 data

Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: DEKA Biosciences | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • IO biomarker • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatology • Immune Modulation • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • EGFR • IL10 • IL1B • IL6 • TNFA

Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: DEKA Biosciences

Biomarker • IO biomarker • Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatology • Immune Modulation • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • EGFR • IL10 • IL1B • IL6 • TNFA

"#DekaBiosciences Receives #FDA Clearance of #DK210 (#EGFR) Investigational #NewDrugApplication https://t.co/eAt9LFN1db" (@1stOncology)

FDA event • NDA • EGFR

Deka Biosciences Receives FDA Clearance of DK210 (EGFR) Investigational New Drug Application (PRNewswire) - "Deka Biosciences...announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for DK210 (EGFR) and concluded that Deka may proceed with a Phase 1 clinical trial in the United States. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, and biomarkers for response of DK210 (EGFR) in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors (EGFR) (NCT05704985)."

IND • New P1 trial • Oncology • Solid Tumor • EGFR

Deka Biosciences, Inc Announces Submission of Investigational New Drug (IND) Application for Lead Oncology Asset, DK210 (EGFR) (PRNewswire) - "Deka Biosciences, Inc....announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on December 23, 2022. The IND application supports Deka's DK210 (EGFR), a promising new cancer treatment that combines normal interleukin-2 with a high affinity interleukin-10, that is designed to accumulate in tumors by binding to the epidermal growth factor receptor (EGFR)....'We are thrilled to advance DK210 (EGFR) to the clinical phase and anticipate beginning our Phase 1 trial as soon as possible after the FDA's acceptance of our IND'....The IND filing comes nearly 18 months after the discovery of DK210 (EGFR), and the company is projecting to dose its first patient in early 2023."

IND • New trial • Oncology