IP-001 / Immunophotonics - LARVOL DELTA

SAKK 66/17: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Swiss Cancer Institute | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BRAF

Immunophotonics Completes Treatment of Last Patient in INJECTABL-1 Phase 1b/2a Clinical Trial of IP-001 for Advanced Solid Tumors (PRNewswire) - "Immunophotonics...has announced the completion of treatment of the last patient in its INJECTABL-1 multicenter Phase 1b/2a clinical trial of IP-001 for advanced solid tumors. The 41-patient trial, which focused on three distinct cancer types - colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma- was conducted in France, Germany, Switzerland, the UK, and the US."

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Soft Tissue Sarcoma

Phase II study of carboplatin + weekly paclitaxel for advanced lung squamous cell carcinoma with idiopathic interstitial pneumonia (Hanshin Cancer Group IP001). (PubMed, Med Oncol) - "CBDCA + weekly PAC had an acceptable acute exacerbation rate with a reasonable response rate, suggesting that it is a promising therapy for advanced squamous cell lung cancer with IIP. The risk factors of acute exacerbation remain to be investigated."

Journal • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma

SAKK 66/17: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BRAF

Enhancing the Immunotherapeutic Effect by IP-001 and Irreversible Electroporation in Mouse Oligometastatic Models of Pancreatic Adenocarcinoma. (PubMed, Ann Surg Oncol) - "The study provided compelling evidence for the efficacy of IRE&IP-001 therapy in suppressing pancreatic tumors, including off-target oligometastatic lesions. The observed off-target effect underscores the importance of systemic immune activation in achieving effective tumor control."

Journal • Preclinical • Hepatology • Immune Modulation • Immunology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD8

N-Dihydrogalactochitosan Drives Conventional and Alternative Activations of STING to Synergize Type I IFN and IL-1β Productions for Antitumor Immunity. (PubMed, Adv Funct Mater) - "Our findings demonstrate that GC acts as a multimodal immune stimulant via STING to generate a broad type I IFN response. This uniquely broad response holds therapeutic promise in generating enhanced antitumor and antiviral immunities."

Journal • Oncology • IL1B • STING

INJECTABL-1: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS (clinicaltrials.gov) - P1/2 | N=42 | Active, not recruiting | Sponsor: Immunophotonics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Thermal ablation enhances immunotherapeutic effect of IP-001 on orthotopic liver cancer in a rat model. (PubMed, Int J Hyperthermia) - "Combination of MWA and IP001 enhances tumor suppression in an orthotopic HCC rat model. The tumor suppression is associated to the enhanced immune responses in terms of recruiting the important cell subpopulations such as CD8 + T-cells and NK cells into tumor microenvironment and abolishing immune suppressor such as Treg cells."

Journal • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • CD8

INJECTABL-II: Dose Finding, Efficacy and Immunological Response of IP-001 Following RFA, MWA or IRE for CRLM (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: M.R. Meijerink

New P1/2 trial • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

INJECTABL-1: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Immunophotonics, Inc. | Trial completion date: May 2024 ➔ May 2025 | Trial primary completion date: May 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

INJECTABL-II: dose finding, efficacy and immunological response of a novel immuno-adjuvant (IP-001) following radiofrequency ablation, microwave ablation or irreversible electroporation for colorectal liver metastases (CIRSE 2024) - No abstract available

Clinical • Oncology

Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: Robert C. Martin | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: Robert C. Martin

New P2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

INJECTABL-II: Dose finding, efficacy and immunological response of a novel immuno-adjuvant (IP-001) following radiofrequency ablation (RFA), microwave ablation (MWA) or irreversible electroporation (IRE) for colorectal liver metastases (CRLM) (ECIO 2024) - "Phase 2 part 2: disease control rate at 16 weeks.Impact on IR: Immunotherapy is hardly effective in patients with CRLM, predominantly because of the non-immunogenic nature of MSS CRC and the immunosuppressive tumor micro-environment of CRLM. However, ablative therapy combined with IP-001, could have synergistic effects and induce a systemic immune response (abscopal effect), leading to durable disease control."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Immunology • Oncology • Solid Tumor

INJECTABL-1: Assessing if intratumoral injection of IP-001 post-ablation stimulates a systemic (ECIO 2024) - No abstract available

Oncology

COMBINATION OF IRREVERSIBLE ELECTROPORATION AND IP-001 ENHANCES IMMUNOTHERAPEUTIC EFFECT IN OLIGOMETASTATIC MODELS OF PANCREATIC ADENOCARCINOMA. (DDW 2024) - No abstract available

Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

INJECTABL-1: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Immunophotonics, Inc. | Phase classification: P1b/2a ➔ P1/2

Phase classification • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Immunophotonics Announces 1st Patient Dosed in the United States under its Investigational New Drug (IND) Application (EIN News) - "Immunophotonics, Inc...along with Dr. Robert CG Martin II, M.D, PhD, PACS, who serves as the Principal Investigator and National Coordinating Investigator at the University of Louisville, announced that the first patient has been dosed with IP-001 in the United States under Immunophotonics' Investigational New Drug (IND) application with the FDA. The patient is enrolled in the company's multi-national clinical trial, IP-IIO-622 / INJECTABL-1, at the University of Louisville in Kentucky....Immunophotonics is currently enrolling patients for treatment of colorectal cancer, non-small cell lung cancer and soft tissue sarcoma. The U.S. trial sites will play a key role in this multi-national trial and will join other sites in France, Germany, Switzerland, and the United Kingdom that are already enrolling patients."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Immunophotonics Announces 1st Patient Dosed in Multinational Clinical trial in France (EIN News) - "Immunophotonics, Inc...has announced the recruitment and the dosing of its first patient in France at Hôpital Foch in Suresnes. Immunophotonics is currently screening patients at additional study sites in France for treatment of colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma at Institut Bergonie – Bordeaux, Pitie – Salpetriere (AP-HP Sorbonne Université), and Gustave Roussy in Paris."

Trial status • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Immunophotonics Receives Green Light from FDA to Open Investigational New Drug (IND) Study for IP-001 in the U.S. (EIN News) - "Immunophotonics, Inc...has announced the U.S. Food and Drug Administration (FDA) completed its safety review of the company’s Investigational New Drug (IND) application and concluded that Immunophotonics may proceed with the clinical investigation of intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors at sites within the U.S. The U.S. study is part of an international, multi-center Phase 1b/2a Trial of IP-001 in colorectal cancer, non-small cell lung cancer, and soft-tissue sarcoma patients."

IND • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

SAKK 66/17: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=39 | Recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Jun 2023 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BRAF

Thermal ablation followed by intratumoral injection of a novel immune stimulant IP-001 in patients with advanced solid tumors: Phase IB part of study SAKK 66/17 (ESMO-IO 2022) - P1/2 | "All pts were metastatic and had received multiple prior lines of chemo- and / or immunotherapies including nivolumab (n=2), olaratumab (n=1) and lenvatinib (n=2). Conclusions TA followed by IP-001 at a dose of 4 mL is well tolerated in pts with advanced solid tumors who have failed standard treatment. The combined use of thermal tumor ablation and IP-001® at a dose of 4 ml can safely be administered in patients with advanced solid malignancies with the potential to stimulate an abscopal effect via immune stimulation."

Clinical • P1 data • Endocrine Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • STING

Immunophotonics Announces 1st Patient Dosed in IP-IIO-622 Phase 1b/2a Clinical Trial in Advanced Solid Tumor Indications (EIN News) - “Immunophotonics, Inc…has announced the initiation of recruitment and the dosing of its first patient in a clinical trial assessing safety and efficacy of its lead asset in multiple solid tumor indications. This multinational clinical trial, denominated alternatively as IP-IIO-622 or INJECTABL-1, is sponsored by Immunophotonics and will be enrolling patients for treatment of colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma. The trial has been approved in Switzerland, the United Kingdom, and France, where leading physicians in both medical oncology and interventional oncology are serving as principal investigators....The principal objective of this study is to evaluate the immunologically mediated anticancer effects of IP-001 following the use of radiofrequency ablation (RFA) in patients with advanced solid tumors.”

Trial status • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Thermal Ablation Enhances Immunotherapeutic Effect of IP-001 on Orthotopic Liver Cancer in a Rat Model (SSO 2022) - "Introduction: : Immunosuppression within the tumor microenvironment of hepatocellular carcinoma (HCC) has made immune checkpoints attractive targets for therapy, however they have failed to improve overall survival (OS) as first-line monotherapy compared to sorafenib. A combination of IP-001 and MWA in an HCC Murine model led to significant increase in macrophages (CD11b + cells) dendritic cells (CD11b + CD 103 + cells), NK cells (CD 161 + cells), significant upregulation of interferon gamma, and improvement in T helper cells. Learning Objectives: Understand the combination effects of thermal ablation and N-dihydrogalactochitosan injection Understand the immunomodulatory effects of MWA alone and in combination with N-dihydrogalactochitosan injection Understand the HCC animal effects and immune profile that can be seen after ablation"

Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immune Modulation • Inflammation • Liver Cancer • Oncology • Solid Tumor • CD8 • IFNG • ITGAE • ITGAM • KLRB1

Immunophotonics Announces Issuance of U.S. Patent Covering Lead Drug Candidate (GlobeNewswire) - "Immunophotonics, Inc...has announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 11111316. The patent covers the composition of matter of Immunophotonics’ lead drug candidate, IP-001, a proprietary synthetic biopolymer anticipated to have applications in the treatment of cancer and infectious diseases...The U.S. patent contains 19 claims encompassing the platform potential of IP-001 and structurally similar carbohydrate polymers and will provide Immunophotonics with patent protection in the U.S. until at least 2033..."

Patent • Oncology • Solid Tumor