Progress of Clinical Programs
The iQ Group Global Ltd (NSX:IQG) is also pleased to announce that OncoTEX Inc, a US oncology therapeutic company, in which iQX Ltd (NSX:IQX) holds 19% equity position, has signed a manufacturing agreement with Sterling Pharma Solutions. The partnership will facilitate preclinical production of OncoTEX Inc's novel platinum-resistant drug candidate, OxaliTEX, and is in final partnership discussions with a world-class clinical research organization for preclinical and regulatory activities.
Life Science Biosensor Diagnostics Pty Ltd (LSBD)
GBS Inc. (NASDAQ:GBS), a subsidiary of LSBD, is a biotechnology diagnostic company that owns the licence to commercialise a pipeline of non-invasive, real-time point of care tests developed from the Biosensor Platform, starting with two tests urgently needed to address diabetes and the COVID-19 pandemic.
The patent-protected Saliva Glucose Biosensor is the first real-time, non-invasive saliva-based glucose test for diabetes management intended to replace painful finger-prick blood testing. GBS Inc. intends to commercialise and launch the Saliva Glucose Biosensor following the regulatory approval process in the Asia Pacific region, where approximately 170 million people live with diabetes.
The Saliva Glucose biosensor development is currently at the commercial design and transfer to manufacture phase and this process has been outsourced to Cambridge Consultants in the United Kingdom. The Saliva Glucose Biosensor has been indicated by the FDA to follow the De Novo regulatory pathway as it is innovative and without precedent. The company is currently formulating its regulatory strategy and is working with Precision Medicine Architects in finalising its clinical strategy and clinical study protocols for pre-submission to the FDA.
GBS Inc. also plans to commercialise and launch a SARS-CoV-2 Antibody Biosensor, a rapid point-of-care diagnostic test to monitor exposure and immunity levels in real-time in the fight against COVID-19. The SARS-CoV-2 Biosensor is being developed in collaboration with the Wyss Institute for Biologically Inspired Engineering at Harvard University. Through this latest study, GBS and the Wyss Institute intend to validate the performance and the feasibility of a collaboratively developed electrochemical assay built on the GBS biosensor strip and the Wyss Institute's eRapid electro-chemical sensing platform for the detection of IgG antibodies.
The research team at Harvard University's Wyss Institute will receive anonymized, de-identified, infected, and uninfected human serum and saliva samples of COVID-19 patients, with at least 35 post-pandemic positive samples and 35 negative samples which may include pre-pandemic negative samples from healthy donors. The repository's samples will be sourced from clinical collaborators such as Brigham and Women's Hospital, Massachusetts General Hospital, and Beth Israel Deaconess Hospital.
When the SARS-CoV-2 test development is complete, the company intends to file for-Emergency Use Authorization with the FDA.
"Our partnership with the Wyss Institute will allow us to continue our mission to create the medicines of tomorrow. The approval by Harvard Longwood campus Institutional Review Board (IRB) to use clinical COVID-19 samples is a significant step forward in the validation of our Biosensor technology during a time when global rapid point-of-care diagnostics is paramount," Dr. George Syrmalis, Chief Executive Officer and Chairman of The iQ Group Global, said.
Further to this, the company is collaborating with Johns Hopkins University, Bloomberg School of Public Health, through a sponsored research agreement that will inform GBS Inc.'s commercialization strategy for two non-invasive, rapid Point of Care (POC) diagnostic tests already in development: the SARS-CoV-2 Antibody Biosensor and the Saliva Glucose Biosensor.
The SARS-CoV-2 test, the saliva glucose test and the entire Biosensor diagnostic test portfolio, upon regulatory approval, will be sold and distributed Globally by the following licensee subsidiaries: GBS Inc (NASDAQ:GBS), BioSensX (North America) Inc, BioSensX (Europe) Inc, and Glucose Biosensor Systems (MENA) Holdings Inc *.
OncoTEX is developing its world-first oncology drug platform, TEX Core platform, which is capable of generating innovative small molecule therapies capable of overcoming multiple limitations seen within current cancer therapeutics and are highly targeted to tumour cells by conjugating texaphyrin with FDA approved anti-cancer therapeutics.
OxaliTEX is the first clinical candidate developed from the TEX Core platform, designed to target platinum-resistant ovarian cancer tumour cells by overcoming issues associated with the current platinum-based standard of care (SOC) and is being developed for platinum-resistant ovarian cancer. Unlike current platinum-based SOC oncology therapeutics, OxaliTEX is tumour localising, well-tolerated, overcomes platinum-resistance, and is MRI-detectable, allowing clinicians and patients to easily monitor tumour regression during treatment.
The partnership with Sterling Pharma Solutions will facilitate the production of OxaliTEX that meets the FDA regulatory requirements necessary for clinical use. Manufacturing is the first development step in the multistep process that will culminate with an Investigative New Drug (INDA) application that will be submitted to the FDA.
In 2020, OncoTEX initiated the screening of OxaliTEX in patient-derived xenografts of colorectal cancer in partnership with Champions Oncology. Other discovery partners include Charles River Labs which will partner with OncoTEX to evaluate optimal OxaliTEX regimens. The development and discovery of OxaliTEX has been published in high profile peer-reviewed publications such as Proceedings of the National Academy of Sciences of the United States of America (2020) and Chem (2020). Most recently, OncoTEX presented preclinical work at the 2021 National Conference of the American Association of Cancer Research (AACR).
OncoTEX has further enriched its pipeline with three additional drug candidates.
- GemTEX (exploring the use of DNA replication inhibitors)
- ParpTEX (exploring the use of PARP inhibitors) are part of our Chemotherapy program and
- MangaTEX is part of our Photothermal program.
The early discovery and proof of concept efforts are ongoing through a Sponsored Research Agreement with the Jonathan Sessler lab at the University of Texas at Austin.
OncoTEX continues to grow its already strong IP portfolio. Since 2019, the composition of OxaliTEX has been granted patent protection in the USA (2019), Mexico (2020), Australia (2021), Singapore (2021) and has a notice of allowance in Israel. The prosecution of the OxaliTEX patent continues in multiple other jurisdictions. In addition, OncoTEX will continue to file IP on all other discoveries out of the TEX Core platform such as MangaTEX which was filed in 2020.
OncoTEX continues to work with the co-inventors of TEX Core and the OncoTEX Scientific Advisory Board consists of experts from MD Anderson Cancer Center, University of Texas at Austin, and UT Dell Medical School.
"Ovarian cancer is considered an orphan disease meaning few patients are afflicted with it globally, however, the prognosis of those diagnosed is poor and OncoTEX is committed to changing this. Our partnership with Sterling Pharma Solutions is a significant milestone in our preclinical development of OxaliTEX, and will set the foundations to support our future pipeline of drug candidates from the Tex Core platform," Dr. Syrmalis said.
About The iQ Group Global
The iQ Group Global is a group of companies that find, fund and develop bioscience discoveries to create life-changing medical innovations. Recognised by The Australian Financial Review for the second consecutive year as one of the country's Most Innovative Companies in 2020, The iQ Group Global's flagship innovations include the Biosensor Platform and TEX Core, a first-in-class oncology drug platform with the ability to develop a pipeline of novel oncology compounds. Visit our website: theiqgroupglobal.com
About GBS Inc. (NASDAQ:GBS)
GBS Inc. is a biosensor diagnostic technology company focused on commercialising the Saliva Glucose Biosensor in the Asia Pacific Region, and launching a non-invasive SARS-CoV-2 Antibody Biosensor to monitor exposure and immunity levels in the fight against COVID-19 at point of care. GBS Inc. was incorporated in 2016, as a Delaware corporation with headquarters in New York City, United States.
About OncoTEX Inc.
OncoTEX Inc is an oncology company and member of the iQ Group Global. OncoTEX Inc owns TEX Core, a novel oncology drug platform that enables the development of well-tolerated, MRI-detectable cancer therapeutics that target drug-sensitive and drug-resistant solid tumours.
About IQX Limited