IMGS-001 / ImmunoGenesis - LARVOL DELTA

ImmunoGenesis…announced today that the company has been awarded a $10.8 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the continued clinical investigation of IMGS-001 in patients with solid tumors (Canada Newswire) - "The focus of this grant, the company's second from CPRIT, will be to support the phase 1b dose-expansion portion of the trial across multiple solid tumor cohorts. The phase 1b expansion focuses on demonstrating safety and initial clinical benefit in multiple solid tumor cohorts characterized by a high degree of immune exclusion where CD8 T cells--the immune system's soldiers--are present but locked out of the tumor."

Financing • Solid Tumor

Cytotoxic PD-L1/PD-L2 dual-specific antibodies couple tumor stroma remodeling with checkpoint blockade to drive rejection of "cold" cancers (CICON 2025) - "A Phase I trial evaluating the efficacy of the lead DIPDL antibody, IMGS-001, for the treatment of refractory solid tumors is proceeding in indications informed by single cell sequencing data showing distribution of PD-Ligand expression across component populations of the TME...These DIPDL represent a new generation of immunotherapeutic which couple superior PD-1 pathway blockade with direct depletion of both immunosuppressive and T-cell exclusionary stroma and tumor cells. Across murine models, these DIPDL deliver transformative efficacy overcoming limitations of simple PD-1 blockade and have moved to an ongoing Phase I clinical trial where early data suggests potential to extend the benefit of checkpoint blockade immunotherapy to "cold" tumor patients."

Checkpoint block • Checkpoint inhibition • IO biomarker • Stroma • Breast Cancer • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L2

A phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of IMGS-001 in patients with relapsed or refractory advanced solid tumors. (ASCO 2025) - P1 | "The study will enroll approximately 25 patients in Phase 1a and up to 250 in Phase 1b. The first two cohorts (0.3 and 1 mg/kg) have completed without any dose limiting toxicities (DLTs), and cohort 3 (3 mg/kg) is enrolling as of the submission date."

Clinical • IO biomarker • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L2

ImmunoGenesis to present IMGS-001 Phase 1a/1b Clinical Study Updates at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - "ImmunoGenesis...announced today that a Trial in Progress poster for its first-in-human, Phase 1a/1b clinical trial of IMGS-001 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being....This Phase 1a/1b first-in-human, open-label, multicenter study (NCT06014502) includes a dose escalation and an expansion portion to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care treatment. The study will enroll approximately 25 patients in Phase 1a and up to 250 in Phase 1b. The first three of five planned dose cohorts have completed without any dose limiting toxicities (DLTs), with cohort 4 (10 mg/kg) now enrolling."

Trial status • Solid Tumor

ImmunoGenesis Expands Phase 1a/b Trial of IMGS-001 for Advanced Solid Tumors to Ochsner MD Anderson Cancer Center (GlobeNewswire) - "ImmunoGenesis...announced expansion of the Phase 1a/b clinical trial of ImmunoGenesis’ lead candidate, IMGS-001, to Ochsner MD Anderson Cancer Center in southeastern Louisiana....Anticipated tumor types in the dose expansion portion of the study include ovarian, colorectal, and triple-negative breast cancer."

Trial status • Colorectal Cancer • Ovarian Cancer • Triple Negative Breast Cancer

ImmunoGenesis to Present in Innovation Track of the 2025 NeauxCancer Oncology Conference in New Orleans (PRNewswire) - "ImmunoGenesis...announces its participation in the 2025 NeauxCancer Conference organized by the Cancer Advocacy Group of Louisiana (CAGLA), being held March 27 – 29, 2025 in New Orleans...President and CEO James Barlow will discuss how ImmunoGenesis plans to transform immuno-oncology with its pipeline of products designed to overcome immune resistance. He will provide an update on the active Phase 1a/1b study of their lead compound, IMGS-001, including preliminary data on enrolled subjects....Mr. Barlow will also discuss the recently initiated phase 2 trial for the company's second clinical asset, IMGS-101 (evofosfamide), a hypoxia reversal agent being studied in combination with checkpoint inhibition."

P1 data • Trial status • Solid Tumor

Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: ImmunoGenesis | Phase classification: P1a/1b ➔ P1

Metastases • Phase classification • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Evofosfomide potentiates the efficacy of a novel anti-PD-L1/PD-L2 monoclonal antibody against immune excluded tumors (SITC 2023) - "Background Evofosfamide (Evo) is a hypoxia-activated prodrug of the cytotoxin bromo-isophosphoramide mustard...1 Moreover, in a phase 1 clinical trial, the combination of Evo with the anti-CTLA-4 Ipilimumab resulted in objective responses in patients with cold tumors...Conclusions These data indicate that Evo and IMGS-001 in combination improves upon the efficacy of either treatment alone, and those improvements are not observed for Evo in combination with anti-PD-1 treatment. This novel combination treatment will continue to be tested in preclinical models and has potential to be tested in a clinical trial."

Clinical • Melanoma • Oncology • Solid Tumor • PD-L2

ImmunoGenesis Doses First Patient in Phase 1a/1b Clinical Trial of IMGS-001 in Relapsed or Refractory Advanced Solid Tumors (PRNewswire) - "ImmunoGenesis...today announced the first patient has been dosed in the company's Phase 1a/1b clinical trial of its lead candidate, IMGS-001, at The University of Texas MD Anderson Cancer Center in Houston, Texas....The Phase 1a/1b first-in-human, open-label, multicenter study (NCT06014502) consists of a dose escalation and expansion portion to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care treatment."

Trial status • Oncology • Solid Tumor

Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=105 | Recruiting | Sponsor: ImmunoGenesis

Metastases • New P1 trial • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

ImmunoGenesis and Cancer Focus Fund Announce $4.5 Million Investment to Support First-in-Human Trial of IMGS-001 for Relapsed or Refractory Advanced Solid Tumors (PRNewswire) - "ImmunoGenesis...announced that Cancer Focus Fund plans to invest $4.5 million to support the Phase 1a/1b clinical trial of ImmunoGenesis' lead candidate, IMGS-001....The investment will support the portion of the IMGS-001 Phase 1a/1b multi-site clinical trial being conducted at MD Anderson. It coincides with ImmunoGenesis' Series A financing, which is expected to close in the third quarter."

Financing • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

Preclinical characterization of IMGS-001, a dual antagonist anti-PD-L1, anti-PD-L2 antibody with effector function, to treat patients resistant to immune checkpoint blockade (SITC 2022) - "These results, with a favorable PK, the absence of off-target activity and a clean toxicology profile, support the clinical development of IMGS-001. IMG-S001 would increase the benefit of IO therapy for patients with immune-infiltrated tumors and could mediate significant clinical responses against immune-excluded cancers."

Checkpoint inhibition • IO biomarker • Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • PD-L1

Development of IMGS-001, a novel anti-PD-L1/PD-L2 dual specific, multi-functional antibody, to treat immune excluded tumors (SITC 2022) - "It has an EC 50 of 0.3-1.1nM in a PD-1 blockade assay, the same range as pembrolizumab and avelumab. It’s mechanisms of elimination of immunosuppressive cells with PD-1 pathway blockade could benefit patients that are resistant to existing PD-(L)1 drugs by restoring immune driven anti-tumor activity. IMGS-001 is poised to enter clinical trial in immune excluded tumors by the end of 2022."

Oncology • PD-L2

ImmunoGenesis to Present Pre-Clinical Data from Lead Program at Society for Immunotherapy of Cancer Conference (PRNewswire) - "ImmunoGenesis...announced that two poster presentations on its lead development program, IMGS-001, will be presented at the Society for Immunotherapy of Cancer 37th Annual Meeting (SITC 2022), November 8-12, 2022, in Boston, MA."

Preclinical • Oncology

ImmunoGenesis CEO James Barlow to Present on Company's Immuno-Oncology Clinical Development Targeting Immune-Excluded, 'Cold' Cancers at BIO CEO & Investor Conference (PRNewswire) - "ImmunoGenesis...announced today that President and CEO James Barlow will present on the company and its multiple immune-oncology therapeutic development programs targeting immune-excluded cold cancers at the upcoming 2022 BIO CEO & Investor Conference...Evofosfamide....is on target to be in clinic in combination with immune checkpoint blockades in 2022."

Clinical • New trial • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Hematological Malignancies • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor

Data from ImmunoGenesis' Lead Programs Presented in Six Posters at Society for Immunotherapy of Cancer (SITC) Conference (PRNewswire) - "Further, preliminary data in a syngeneic murine model of EL4 showed that antibody dependent cellular cytotoxicity capable PD-L2 blocking antibodies are therapeutically superior to PD-L1 or PD-L2 blockade alone....ADCC-capable PD-Ligand bispecific antibodies suppress the growth of U2940 lymphoma in immunodeficient mice more efficiently than Rituximab, and in a syngeneic model of PD-L1/PD-L2 double positive colon carcinoma, these antibodies demonstrate superiority to PD-1 blocking antibodies to limit tumor growth and increase survival."

Preclinical • Oncology

Data from ImmunoGenesis' Lead Programs to be Presented at Society for Immunotherapy of Cancer (SITC) Conference (PRNewswire) - "ImmunoGenesis...announced the acceptance of six poster presentations on its lead development programs at the Society for Immunotherapy of Cancer 36th Annual Meeting (SITC 2021), which will be held November 10-14, 2021, in Washington, DC."

Clinical data • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer

Data from ImmunoGenesis' Lead Programs to be Presented at Society for Immunotherapy of Cancer (SITC) Conference (PRNewswire) - "ImmunoGenesis...announced the acceptance of six poster presentations on its lead development programs at the Society for Immunotherapy of Cancer 36th Annual Meeting (SITC 2021), which will be held November 10-14, 2021, in Washington, DC."

Clinical data • Preclinical • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer

ImmunoGenesis Awarded $15.5 M Grant from Cancer Prevention and Research Institute of Texas (CPRIT) (GlobeNewswire) - "Funding will support pre-clinical and clinical development through a Phase 1A/1B trial of IMGS-001, a novel Checkpoint Inhibitor Drug Candidate. IMGS-001 has been designed to overcome resistance to immunotherapies in immunologically 'cold' tumors…ImmunoGenesis, Inc. today announced that it has been awarded a $15.5 M grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance development of IMGS-001, the company’s dual specific Checkpoint Inhibitor and Tumor Microenvironment (TME) remodeling agent."

Grant • Oncology