Iq-ai Ltd Regulatory News (IQAI)

IQ-AI Ltd("IQ-AI" or the "Company")

IQAI commits to Phase1 study for drug candidate in the treatment of Glioblastoma (GBM), a grade IV brain tumour

IQAI ("the Company"), subject to relevant approvals, has agreed to finance a Phase 1 clinical trial planned to commence in the Summer to evaluate the safety and efficacy of Gallium Maltolate (GaM) in the treatment of Glioblastoma Multiforme (the "Clinical Trial"). In consideration for financing the Clinical Trial, if successful, the Company intends to apply for orphan drug status under the US FDA Orphan Drug Designation Program. This program grants IP protection to therapy to treat a rare disease or condition and, if granted, provides market exclusivity to IQ-AI for seven years post approval. Other territories, such as Europe and Japan, provide 10- and 8-years exclusivity, respectively.

Recent pre-clinical animal studies have shown that GaM can significantly reduce the size of tumours within 10 days of treatment [1], consequently the Company believes that it is now appropriate to commence human trials as soon as possible. To this end, an Investigational New Drug (IND) application has been submitted to the US FDA pending approval of a Phase I trial scheduled to begin this summer. The trial is being conducted at the Medical College of Wisconsin (MCW) Cancer Center and is designed primarily to determine the optimal dose that can be administered safely to patients. During the two-year study, investigators will closely monitor the efficacy of GaM in GBM patients. While efficacy is not the primary aim of a Phase I trial, the investigators will monitor the size of the tumour using magnetic resonance imaging (IB Neuro™, has special application for GBM diagnosis and follow up) throughout the course of the trial. Given the aggressive growth of GBM, it is possible that the investigators could obtain an early indication of the efficacy of the treatment during the trial.

GBM is the most common and aggressive primary brain cancer and has limited treatment options and a dismal prognosis. Current treatment involves maximal surgical resection followed by radiation therapy and chemotherapy (bevacizumab and temozolomide). Sadly, the median survival of patients is only around 14 months.

Dr. Christopher Chitambar, MD, Emeritus Professor of Medicine and Biophysics, Division of Hematology and Oncology at MCW is the Chair and Co-principal investigator of the study and, along with Co-principal investigator Dr. Jennifer Connelly, MD, Associate Professor of Neurology at MCW, will be enrolling patients in the study. Both are long-standing collaborators with Kathleen Schmainda, PhD, a co-founder of IB and a recognised leader in brain tumour imaging. Together they have researched and developed the use of GaM in preclinical GBM trials. Since the advanced brain tumour imaging offered by IQAI is needed to monitor treatment efficacy for this trial, the investigators approached the Company as a natural partner to provide resources and expertise for this Phase 1 clinical trial.

Trevor Brown, CEO of IQAI, said, "Current treatment protocols for GBM have done little to reduce mortality. The pre-clinical trial produced promising results, but we cannot know whether these results are replicable in humans until clinical trials are completed"

GaM is a compound unique in the way it shares certain chemical properties with iron. Iron is required in far greater amounts by cancer cells than by normal cells. Preclinical research conducted by Prof. Chitambar's group has shown that gallium can kill cancer cells by "hijacking" iron metabolism. Essentially, the cancer cells are tricked into consuming gallium instead of iron, starving the tumour and retarding cancer growth. GaM is different from existing chemotherapy drugs where many are not able to penetrate the brain and reach tumour cells. GaM can penetrate the brain using a mechanism which normally functions for the entry of iron. GaM offers the promise of real treatment advance and improved mortality rates.

There are approximately 41,000 people being treated for GBM in the US and Europe [2]. GBM has an incidence of two to three per 100,000 adults per year, and accounts for 52 percent of all primary brain tumours. Overall, it accounts for about 17% of all tumours of the brain (primary and metastatic). These tumours tend to occur in adults between the ages of 45 and 70.

"The discovery that GaM has anticancer activity against glioblastoma in an animal brain tumour model is extremely exciting; it opens the door for developing it as a drug for treatment of glioblastoma in patients", said Dr. Chitambar. "The anticancer mechanism of GaM applies to other solid tumours as well", Dr. Chitambar added.

The Directors of the Company accept responsibility for the contents of this announcement.

1. Molecular Cancer Therapeutics 17:1240, 2018

2. Glioblastoma Multiforme Market, 2024 | GBM Industry Research Report (hexaresearch.com)

For further information, please contact:

IQ-AI LimitedTrevor Brown/Vinod Kaushal/Qu Li Tel: 020 7469 0930

Peterhouse Capital Limited (Financial Adviser and Broker)

Lucy Williams/Heena Karani Tel: 020 7220 9797

-ENDS-

ABOUT Imaging Biometrics, LLC

Imaging Biometrics®, a subsidiary of IQ-AI Limited (LON:IQAI), develops and provides visualisation and analytical solutions that enable clinicians to better diagnose and treat disease with greater confidence. Through close collaboration with top researchers and clinicians, sophisticated advancements are translated into platform- independent and automated software plug-ins which can extend the base functionality of workstations, imaging systems, PACS, or medical viewers. By design, IB's advanced visualisation software seamlessly integrates into routine workflows. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com.