A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of IP-001 as Adjuvant Therapy in Participants With Hepatocellular Carcinoma After Complete Radiological Response After Surgical Resection and Local Ablation or Local Ablation Alone

The purpose of this study is to evaluate the safety and efficacy of a single injection of IP-001 as adjuvant therapy after local ablation or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).

开始日期2024-07-24

申办/合作机构

University of Louisville

NCT06630624

/ Recruiting临床1/2期IIT

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.

The primary objectives of this phase I/II, prospective clinical trial, are to assess the optimal dose, efficacy, safety and immunological effect of ablation and intra-tumoral injection of a novel immuno-adjuvant (IP-001) for colorectal liver metastases (CRLM). The study consists of three parts, devided into two phases.
Phase 1 is a dose-escalation study according to a classic '3+3' design, to identify the dose level at which IP-001 exhibits an acceptable level of toxicity following microwave ablation (MWA) of CRLM in refractory metastatic colorectal cancer (CRC) patients.
Phase 2, part 1 and part 2 are performed simultaneously. In phase 2 part 1, a single arm study assesses the efficacy of IP-001 following MWA for CRLM for curative intent. In phase 2 part 2, a randomized, 3-armed study assesses the efficacy and immunomodulation of IP-001 following three ablative modalities: arm A (radiofrequency ablation (RFA)), arm B (MWA) and arm C (irreversible electroporation (IRE)) for CRLM in refractory metastatic CRC patients.

开始日期2024-07-10

申办/合作机构

Stichting Onderzoek Cancer Center Amsterdam

[+2]

EUCTR2022-000176-19-FR

/ Not yet recruiting临床1/2期

Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter Phase 1b/2a trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients

开始日期2023-01-10

申办/合作机构

Immunophotonics, Inc.

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2025-04-01·Annals of Surgical Oncology

Enhancing the Immunotherapeutic Effect by IP-001 and Irreversible Electroporation in Mouse Oligometastatic Models of Pancreatic Adenocarcinoma

Article

作者: Li, Yan ; Gao, Yonglin ; Lam, Samuel S K ; Anderson, David W ; Shore, Emily ; Martin, Robert C ; Hode, Tomas

BACKGROUNDThis study aimed to evaluate the immunotherapeutic effect of irreversible electroporation (IRE) and IP-001 in pancreatic adenocarcinoma with metastasis.METHODSOrthotopic models of pancreatic adenocarcinoma with hepatic oligometastasis were established by implantation of tumor tissues (derived from Pan02 or KPC cells) size 2 mm³ into the pancreas and left liver lobe in C57BL/6J mice. One week after implantation, the tumor-burden mice were subjected to saline control, IRE, IP-001, and IRE+IP-001. For IRE therapy (1000 V, 0.1 ms, 10 pulses administered 10 times), the pancreas tumor was treated, whereas the oligometastasis was untreated as the IRE off-target tumor. Intratumoral administration of IP-001(0.4 ml/kg) was performed.RESULTSIn the KPC oligometastatic model, IRE+IP-001 therapy significantly suppressed the growth of oligometastatic tumor. Flow cytometry showed significantly increased tumor-infiltrating lymphocytes (TILs) (e.g., CD8⁺ cytotoxic T lymphocytes) and significantly increased monocytes/macrophages in the oligometastatic tumor tissues from IRE+IP-001 treatment compared with the sham control. Significantly decreased Treg cells and tumor-associated macrophages (TAMs) also were found in the oligometastatic tumor tissues from IRE+IP-001 treatment compared with the sham control. In the Pan02 oligometastatic model, both IRE+IP-001 therapy and IRE+anti-PD-L1 immunotherapy significantly suppressed the growth of oligometastatic tumor, which was associated with the increased CD8⁺ cytotoxic T lymphocytes. However, increased monocytes/macrophages were found in the mice that had IRE+IP-001 therapy, but not in the mice that had IRE+anti-PD-L1 immunotherapy.CONCLUSIONThe 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.

2024-12-31·International Journal of Hyperthermia

Thermal ablation enhances immunotherapeutic effect of IP-001 on orthotopic liver cancer in a rat model

Article

作者: Wong, Chun Fung ; Li, Yan ; Lam, Samuel S.K. ; Hode, Tomas ; Martin, Robert C.G. ; Anderson, David

BACKGROUNDThermal ablation is reported to increase immunogenicity in tumor cells via expressing tumor antigens. IP-001, a synthesized molecule, is created by attaching galactose molecules to the free amino groups of partially deacetylated glucosamine polymers. As a member of a new class of polycationic immunoadjuvants that activate multiple immune response pathways, IP-001 can both sequester ablation-released tumor antigens in situ and independently recruit and stimulate antigen presenting cells (APCs) to induce a potent tumor-specific Th1 type T cell response.METHODSAn orthotopic HCC rat model is established by implantation of 5 × 10⁶ N1-S1 cells into the left lobe of liver. When tumor size reached 1.0-1.5 cm³, the animals were divided randomly into 4 groups, (1) MWA+IP-001; (2) MWA+saline; (3) sham MWA+IP-001 and (4) sham MWA+saline (n = 5 each group).RESULTSIP001 + MWA treatment significantly suppressed tumor growth in comparison to the other 3 groups. Significantly increased infiltration of inflammatory/immune cells were found in the tumor adjacent tissues of MWA+IP-001 mice, compared to the other 3 groups. Flow cytometry results indicated that there were significant increases of cytotoxic T cells, macrophages, dendritic cells and NK cell in the combination of MWA and IP001 treated mice, compared to other 3 groups (p < 0.01). Significantly decreased number of Treg cells were found in all the treatment arms compared to untreated control (p < 0.01).CONCLUSIONCombination 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.

2023-10-01·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Study on the therapeutic effect of glucocorticoids on acute kidney injury in rats exposed to diquat.

Article

作者: Shi, Longke ; Jian, Xiangdong ; Li, Qilu ; Cui, Siqi ; Wang, Chen ; Zhang, Xiangxing ; Sun, Cece ; Kan, Baotian

AIMSTo preliminarily explore, whether glucocorticoids have a therapeutic effect on diquat-induced acute kidney injury in rats.METHOD150 Wistar rats were randomly divided into six groups: exposure model group (DQ group), dexamethasone control group (GC group), blank control group (Ctrl group), dexamethasone 2.1 mg/kg dose group (DQ+L-GC group), dexamethasone 4.2 mg/kg dose group (DQ+M-GC group), and dexamethasone 8.4 mg/kg dose group (DQ+H-GC group), with 25 rats in each group. Each group was further divided into five subgroups, 24 h, 3 d, 7 d, 14 d, and 21 d after exposure, according to the feeding time and the course of treatment, with five animals in each subgroup. The rats in DQ, DQ+L-GC, DQ+M-GC, and DQ+H-GC groups were administered 115.5 mg/kg diquat by gavage, respectively. Moreover, 30 min after gavage, rats in DQ+L-GC group, DQ+M-GC group, DQ+H-GC group and GC group were intragastric administered dexamethasone 2.1 mg/kg, 4.2 mg/kg, 8.4 mg/kg and 8.4 mg/kg, respectively. After 7 days, the intraperitoneal injection of dexamethasone was changed to 6.3 mg/kg prednisone by intragastric administration. Subsequently, 7 days later, it was changed to 3.15 mg/kg prednisone by intragastric administration until the end of the experiment on 21 days. After the start of the experiment, changes in the conditions of the rats in each group were observed at a fixed time every day, changes in the body weight of the rats were monitored at the same time, and the death of the rats was recorded at 24 h, 3 d, 7 d, 14 d, and 21 d after exposure. The rats were sacrificed by an intraperitoneal injection of 100 mg/kg sodium pentobarbital overdose. Blood was collected by puncture of the inferior vena cava, used to determine Cr and BUN. The upper segment of the left kidney was collected for histopathological examination. Elisa was used to detect neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) in the lower segment of left kidney. TLR4, Myd88, and NF-κB were detected in the right kidney.RESULTS(1) After exposure, most rats in DQ group, DQ+L-GC group, DQ+M-GC group and DQ+H-GC group showed shortness of breath, oliguria, diarrhea, yellow hair and other symptoms. No symptoms and related signs were observed in Ctrl group and GC group. (2) The weight of rats in the Ctrl group and the GC group increased slowly during the test. the body weight of the rats in the DQ, DQ+L-GC, DQ+M-GC, and DQ+H-GC groups continued to decrease after self-infection. Body weight dropped to the lowest point at approximately 7 d, and gradually increased from 7 d to 21 d. (3) A small amount of capillary congestion in the medulla was observed after 7 days in the GC group. The DQ group showed tubular atrophy, edema of the epithelial cells, and over time, the tubules were seen dilated and became irregular in shape; large amount of capillary congestion was also observed in the renal cortex and medulla. The renal injury in the DQ+L-GC group was less than that in the DQ group. DQ+H-GC group had no obvious injury before 7 d, but more renal tubules were seen in the DQ+H-GC group from 7 d to 14 d. (4) Compared with the DQ group, there was no difference before 14 d, and at 14 d-21 d, DQ+L-GC group, DQ+M-GC group, DQ+H-GC group all had different degrees of decline. NGAL content: Compared with the DQ group, the content of NGAL and KIM-1 in kidney tissue of the DQ+L-GC, DQ+M-GC, and DQ+H-GC groups decreased compared with the DQ group at each time node. (5) Compared with the Ctrl group, the expression of TNF-α, TLR4, MyD88, NF-κB in the DQ, DQ+L-GC, DQ+M-GC, and DQ+H-GC groups at each time node increased in the renal tissue. The content of TNF-α, TLR4, MyD88, NF-κB in kidney tissue of the DQ+L-GC, DQ+M-GC, and DQ+H-GC groups at each time node was lower than that in the DQ group.CONCLUSION(1) Diquat can cause kidney damage in rats, mainly manifested as renal tubular atrophy, epithelial cell edema, capillary congestion and dilation, and the renal function damage indicators have been improved to varying degrees. (2) Glucocorticoids have therapeutic effects on acute kidney injury in rats exposed to diquat. During the treatment, the efficacy of glucocorticoids did not increase with increasing doses after reaching a dose of 4.2 mg/kg. (3) TLR4 receptor-mediated TLR4/Myd88/NF-κB signaling pathway is involved in the inflammatory response of acute kidney injury in diquat poisoning rats. Glucocorticoids can inhibit the inflammatory response, thereby affecting the expression of TLR4/Myd88/NF-κB signaling pathway-related proteins.

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2024-10-28

·GlobeNewswire-Health Care

Immunophotonics to Present at the 2024 ThinkEquity Conference

ST. LOUIS, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Immunophotonics, Inc. a clinical-stage biotech company focused on the discovery and development of novel immune-activating drugs, today announced that it will be participating in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. The ThinkEquity Conference gathers institutional investors, corporate clients, and other industry professionals to highlight groundbreaking innovations and financial strategies. Lu Alleruzzo, CEO will be presenting at South Salon II at 12:00 pm ET on October 30th. Immunophotonics will also be holding one-on-one investor meetings throughout the day. Interested investors can register to attend and schedule on-on-one meetings here. About ThinkEquityThinkEquity is a boutique investment bank founded by professionals who have collaborated for over a decade, collectively financing over $50 billion in public and private capital raises, restructurings, and mergers and acquisitions. Past ThinkEquity conferences have featured over 70 company presentations, 700+ attendees, and 500+ one-on-one meetings, providing a valuable platform for companies and investors to connect. To register to attend The ThinkEquity Conference, please follow this link. About ImmunophotonicsImmunophotonics, Inc. is a privately owned clinical-stage biotech company pioneering the field of Interventional Immuno-Oncology™. IP-001, which is the first asset from the company’s intellectual property platform and is currently administered in multiple clinical trials, has the potential to overcome the local defenses of the tumor microenvironment to enable a tumor-specific anticancer immune response in solid tumor indications. By combining routine interventions that use energy to destroy tumors, such as ablation or radiation, with intratumoral injection of its proprietary immunoadjuvant, IP-001, Immunophotonics aims to trigger a systemically active cancer immunotherapy, also known as an abscopal effect. The company’s world headquarters is in St. Louis, Missouri, USA, and its European headquarters is in Bern, Switzerland. Public RelationsIR@immunophotonics.com

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2021-09-14

·GlobeNewswire

Immunophotonics Announces Issuance of U.S. Patent Covering Lead Drug Candidate

ST. LOUIS and BERN, Switzerland, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Immunophotonics, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary immune-activating carbohydrate polymers for the treatment of metastatic cancers, 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, subject to potential regulatory extension if IP-001 is approved for clinical use by the U.S. Food and Drug Administration. With this issuance, the U.S. has joined over 40 countries in granting Immunophotonics patent protection to the composition of matter underlying IP-001. Tomas Hode, Chief Innovation Officer at Immunophotonics, stated his excitement about the issuance, remarking, “We are thrilled to expand our patent coverage into the United States alongside other key markets where our composition-of-matter claims have been allowed. This patent not only covers our lead drug candidate, IP-001, but will also serve as the core of a biotechnology platform with the potential for myriad applications for activating the immune system against cancer and other diseases. With this issuance, Immunophotonics has completed a crucial step in its development of a robust patent portfolio in the field of oncology and beyond.” Immunophotonics was represented by Foley Hoag LLP of New York in its prosecution of this patent. “We were pleased with the final claims granted in Patent No. 11111316, which protect a family of molecules with a range of pharmacologically relevant structural features. This patent is an ideal foundation for a wide-ranging pharmaceutical platform,” observed Lucas Watkins, Ph.D., Deputy Chair of the Patent Prosecution Practice at Foley Hoag. About Immunophotonics, Inc. Immunophotonics is a privately owned clinical-stage biotech company that is pioneering the burgeoning field of Interventional Immuno-OncologyTM through the development of novel treatments for solid tumor cancers. IP-001, the first asset from the company’s intellectual property platform, has the potential to transform a routine tumor ablation into a systemically active cancer immunotherapy. Immunophotonics is also exploring the use of its technology platform to help prevent and combat contractions of infectious diseases. Immunophotonics is based in St. Louis, Missouri, with subsidiaries in Bern, Switzerland, and Tianjin, China. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements. Such statements — including statements regarding clinical trials, regulatory applications and related timelines, and timing for bringing any product candidate to market — involve inherent risks and uncertainties, and numerous factors could cause actual results to differ materially from those made or implied herein. All information provided in this press release is as of the date of this press release, and Immunophotonics, Inc. undertakes no duty to update such information, except as required under applicable law.

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适应症	最高研发状态	国家/地区	公司	日期
结肠癌	临床2期	德国	Immunophotonics, Inc.	2022-11-29
结肠癌	临床2期	瑞士	Immunophotonics, Inc.	2022-11-29
结肠癌	临床2期	英国	Immunophotonics, Inc.	2022-11-29
结肠癌	临床2期	美国	Immunophotonics, Inc.	2022-11-29
结肠癌	临床2期	法国	Immunophotonics, Inc.	2022-11-29
非小细胞肺癌	临床2期	瑞士	Immunophotonics, Inc.	2022-11-29
晚期恶性实体瘤	临床2期	瑞士	Immunophotonics, Inc.	2020-10-12
复发性黑色素瘤	临床2期	瑞士	Immunophotonics, Inc.	2020-10-12
软组织肉瘤	临床2期	瑞士	Immunophotonics, Inc.	2020-10-12
肝细胞癌	临床2期	荷兰	Immunophotonics, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO2023	N/A	肺腺癌一线 EGFR mutation	-	GC@NP	廠簾壓壓鬱鏇衊膚遞鹽(願鬱壓廠鹹製廠餘範夢) = 鹹築夢遞糧鬱糧願構窪襯蓋鹹鹽壓壓蓋齋觸夢 (鹹襯製蓋夢廠衊壓選蓋 ) 更多	-	2023-10-22
				Free gefitinib	廠簾壓壓鬱鏇衊膚遞鹽(願鬱壓廠鹹製廠餘範夢) = 窪顧網範膚願網積襯餘襯蓋鹹鹽壓壓蓋齋觸夢 (鹹襯製蓋夢廠衊壓選蓋 ) 更多
NCT03993678 (SAKK 66/17, ESMO_IO2022) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	4	IP-001	(積鏇積襯網蓋遞網壓艱) = none 鬱艱顧膚窪遞醖廠網夢 (築製簾鑰鏇餘鬱網選積 ) 更多	积极	2022-12-08
EULAR2017	临床4期	类风湿关节炎维持	-	ADA + MTX + high dose GC	鹽繭簾廠願齋簾糧網遞(鏇選範蓋膚觸範憲蓋構) = 餘願鏇遞繭範淵蓋鑰遞顧醖範衊鏇艱糧膚顧鹽 (窪餘願觸簾糧觸醖鑰選 ) 更多	-	2017-06-14
				ADA + MTX + placebo	鹽繭簾廠願齋簾糧網遞(鏇選範蓋膚觸範憲蓋構) = 選糧願鹹選築簾艱鹹繭顧醖範衊鏇艱糧膚顧鹽 (窪餘願觸簾糧觸醖鑰選 ) 更多
SQUIRE Study (WCLC2015)	N/A	-	-	GC+N arm continuation therapy patients	(範廠餘選廠膚鬱構遞蓋) = 繭醖鬱積鏇齋憲鹹膚膚壓夢壓鬱簾鹹鹽夢網糧 (糧夢築築鑰鏇蓋積構襯 ) 更多	-	2015-09-09
				GC arm non-progressor patients	(範廠餘選廠膚鬱構遞蓋) = 顧簾構積鬱繭築鹹夢鹽壓夢壓鬱簾鹹鹽夢網糧 (糧夢築築鑰鏇蓋積構襯 ) 更多