[Translation] A Phase I clinical study evaluating the safety, tolerability and pharmacokinetics of SNC109 injection in subjects with recurrent glioblastoma

一项在复发胶质母细胞瘤受试者中评估SNC109注射液的安全性、耐受性和药代动力学的I期临床研究

[Translation]

A Phase I clinical study evaluating the safety, tolerability and pharmacokinetics of SNC109 injection in subjects with recurrent glioblastoma

Start Date-

Sponsor / Collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

NCT06616727 / Enrolling by invitationPhase 1

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma

A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM

Start Date26 Dec 2023

Sponsor / Collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

NCT05868083 / RecruitingPhase 1

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SNC-109 CAR-T Cell Therapy in Subjects With Recurrent Glioblastoma

This is a single arm clinical study to estimate the safety, tolerability and pharmacokinetic (PK) characteristics of Chimeric Antigen Receptor-modified T cells (CAR-T) SNC-109 in patients with recurrent glioblastoma (r-GBM) and preliminarily evaluate the effectiveness, the immunogenicity of the product, as well as their correlation between the changes of cytokines from baseline level after cellular infusion.

Start Date24 Jun 2022

Sponsor / Collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

[+1]

100 Clinical Results associated with HER2 x EGFRvIII

100 Translational Medicine associated with HER2 x EGFRvIII

0 Patents (Medical) associated with HER2 x EGFRvIII

Literatures (Medical) associated with HER2 x EGFRvIII

15 Sep 2023·Frontiers in bioscience (Landmark edition)

Present Status and Advances in Chimeric Antigen Receptor T Cell Therapy for Glioblastoma.

Review

Author: Yin, Jinlong ; Sun, Han ; Zhou, Shuchang ; Choi, Sun Il

Adoptive chimeric antigen receptor (CAR) T cells designed to recognize specific tumor antigens have shown promising results in cancer therapy. While CAR T cell therapy has demonstrated notable clinical effectiveness for hematologic disease, efforts to develop therapies for solid tumors, including glioblastoma (GBM), have been hampered by heterogeneity, an immunosuppressive tumor microenvironment, and difficulty in trafficking. Several specific tumor antigens, such as IL13Rα2, EGFRvIII, and HER2, have been attempted in clinical trials; however, limited efficacy has been observed. In this review, we discuss the current status of CAR T therapy for GBM in clinical trials and highlight the potential target antigens for CAR T cells. Additionally, we summarize the mechanisms used to enhance their efficacy and explore the challenges and future prospects of CAR T cell therapy for GBM.

01 Mar 2023·ImmunoInformatics

Modeling interaction of Glioma cells and CAR T-cells considering multiple CAR T-cells bindings

Article

Author: Rockne, Russell C ; Brown, Christine E ; Wang, Dongrui ; Cho, Heyrim ; Sahoo, Prativa ; Li, Runpeng ; Wang, Qixuan

Chimeric antigen receptor (CAR) T-cell based immunotherapy has shown its potential in treating blood cancers, and its application to solid tumors is currently being extensively investigated. For glioma brain tumors, various CAR T-cell targets include IL13Rα2, EGFRvIII, HER2, EphA2, GD2, B7-H3, and chlorotoxin. In this work, we are interested in developing a mathematical model of IL13Rα2 targeting CAR T-cells for treating glioma. We focus on extending the work of Kuznetsov et al. (1994) by considering binding of multiple CAR T-cells to a single glioma cell, and the dynamics of these multi-cellular conjugates. Our model more accurately describes experimentally observed CAR T-cell killing assay data than the models which do not consider multi-cellular conjugates. Moreover, we derive conditions in the CAR T-cell expansion rate that determines treatment success or failure. Finally, we show that our model captures distinct CAR T-cell killing dynamics from low to high antigen receptor densities in patient-derived brain tumor cells.

01 Jan 2023·Journal of Nuclear Medicine

Antigen-Dependent Inducible T-Cell Reporter System for PET Imaging of Breast Cancer and Glioblastoma

Article

Author: Alanizi, Aryn ; Liu, Raymond ; Parker, Matthew F L ; Tlsty, Thea D ; Wilson, David M ; Zhu, Iowis ; Lapi, Suzanne E ; Rodriguez, Carlos I ; Shin, Jaehoon ; Blecha, Joseph ; Roybal, Kole T ; Watchmaker, Payal B ; Okada, Hideho ; Wright, Brian ; Flavell, Robert R ; Kalita, Mausam ; Luu, Justin

For the past several decades, chimeric antigen receptor T-cell therapies have shown promise in the treatment of cancers. These treatments would greatly benefit from companion imaging biomarkers to follow the trafficking of T cells in vivo. Methods: Using synthetic biology, we engineered T cells with a chimeric receptor synthetic intramembrane proteolysis receptor (SNIPR) that induces overexpression of an exogenous reporter gene cassette on recognition of specific tumor markers. We then applied a SNIPR-based PET reporter system to 2 cancer-relevant antigens, human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor variant III (EGFRvIII), commonly expressed in breast and glial tumors, respectively. Results: Antigen-specific reporter induction of the SNIPR PET T cells was confirmed in vitro using green fluorescent protein fluorescence, luciferase luminescence, and the HSV-TK PET reporter with 9-(4-¹⁸F-fluoro-3-[hydroxymethyl]butyl)guanine ([¹⁸F]FHBG). T cells associated with their target antigens were successfully imaged using PET in dual-xenograft HER2+/HER2- and EGFRvIII+/EGFRvIII- animal models, with more than 10-fold higher [¹⁸F]FHBG signals seen in antigen-expressing tumors versus the corresponding controls. Conclusion: The main innovation found in this work was PET detection of T cells via specific antigen-induced signals, in contrast to reporter systems relying on constitutive gene expression.

News (Medical) associated with HER2 x EGFRvIII

09 Feb 2021

·www.globenewswire.com

Apollomics, Inc. and Edison Oncology Announce Licensing

- Apollomics licenses worldwide rights (ex-China, Hong Kong and Taiwan) to develop and commercialize EO1001 - - EO1001 is an irreversible, pan-erbB inhibitor of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) - FOSTER CITY, Calif. and HANGZHOU, China and MENLO PARK, Calif., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Edison Oncology Holding Corp., today announced that Apollomics has been granted worldwide rights, excluding China, Hong Kong and Taiwan, for the development and commercialization of EO1001. EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. “We are excited to add EO1001 to our clinical development portfolio as its pan-erbB inhibition and well-tolerated preclinical safety profile makes it a potential targeted therapy for the treatment of solid tumor malignancies that overexpress EGFR and/or HER2,” said, Sanjeev Redkar, PhD, Co-Founder and President of Apollomics. “In preclinical models, EO1001 is potent against mutations in both the intracellular and extracellular domain of EGFR and has demonstrated activity in tumors with the ability to penetrate the central nervous system. As we advance our clinical development pipeline, we continue to seek assets like EO1001 with clearly defined mechanisms of action and differentiating attributes that we believe can make a difference for cancer patients worldwide. Looking ahead, a Clinical Trial Notification (CTN) Application in Australia will be submitted to initiate a clinical trial in the second quarter of this year.” Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan. Edison Oncology will receive an upfront cash payment and will be eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for EO1001 in the territories. “Our extensive and successful preclinical work with EO1001 has led us to this collaboration with Apollomics who will now advance the asset into clinical trials with their experienced development team. Over 90% of solid tumors overexpress erbB pathways, and with the data we have produced to date, we are confident that EO1001 has the potential to improve treatment outcomes for patients suffering from life-threatening cancers,” concluded Jeffrey A. Bacha B. Chief Executive Officer of Edison Oncology. About EO1001 EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, and against mutations in the extracellular domain of EGFR including the EGFR-variant III (EGFRvIII) mutation that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well tolerated and demonstrated activity against treatment-resistant ErbB-driven tumors, including malignancies in the central nervous system, in vivo. About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. About Apollomics, Inc. Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company’s existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit . Edison Oncology Contacts: Company Contact:Jeffrey BachaChief Executive Officer(650) 690-1927jb@eohc.com Media and Investor Relations Contact:Amato and Partners, LLCInvestor Relations Counseladmin@amatoandpartners.com Apollomics Contacts: Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@apollomicsinc.com U.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.com

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