REG - IQ-AI Limited - Clinical Trial Updates

IQ-AIAnnouncement

14/06/2024 08:45

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RNS Number : 4807S  IQ-AI Limited  14 June 2024

June 14, 2024

IQ-AI Ltd

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

 

IQ-AI Reports Phase 1 Update and Shares Plans for Phase 2 Clinical Trial

As the end of the Phase 1 clinical trial draws closer, IQ-AI Ltd (LSE: IQAI)
shares the latest Phase 1 updates and outlines plans for continued development
of the oncology-focused drug, oral gallium maltolate ("GaM").

Brief Background & Progress to Date

In April 2021, after reviewing the pre-clinical research completed by Dr.
Christopher Chitambar, MD, Emeritus Professor of Medicine and Biophysics,
Division of Hematology and Oncology and Dr. Kathleen Schmainda, PhD, Professor
of Biophysics, both at the Medical College of Wisconsin ("MCW"), the directors
of IQAI made the decision to finance a Phase 1 clinical trial at the MCW
Cancer Center ("MCWCC"). This commitment enabled the trial to commence after
obtaining authorization to proceed from the FDA and, in March 2022, the trial
was officially opened for enrollment of adult patients with relapsed or
refractory glioblastoma.

The successful execution of the trial is primarily due to the efforts of the
clinical team, led by Dr. Jennifer Connelly, MD (Neuro-Oncology), and Dr.
Christopher Chitambar, MD (Hematology and Medical Oncology). Interest in the
trial has grown considerably in the past two years, as evidenced by the
growing number of presentations and lectures requested globally from Dr.
Connelly.

The clinical Phase 1 study is designed to treat groups of patients with
relapsed glioblastoma brain tumors with different doses of oral GaM for a
minimum of 2 months to evaluate drug toxicity and patient's tolerance to
treatment and to establish a recommended dose for a Phase 2 clinical trial.
Patients are allowed to continue treatment for longer than 2 months if
treatment is tolerated without limiting side-effects and there is no
progression of disease. In a cancer where, historically, patients experience
progression of disease within 1 - 6 months following relapse, the
Investigators found that some patients remained on treatment without disease
progression for greater than 6 months; one patient experienced no progression
of disease for longer than one year. All patients treated with GaM have
tolerated the drug well and have not experienced dose-limiting adverse
side-effects. Based on the current rate of patient enrollment to the study,
the trial is expected to conclude this fall. The results of this Phase 1 study
are in the process of being compiled and are expected to be reported in a
publication by spring 2025.

While the results of the present study are encouraging, the directors of IQAI
are acutely aware that the efficacy of GaM in glioblastoma can only be
established in a well-designed Phase 2 clinical trial with an appropriate
number of patients.

IQAI has exclusive rights to the results and data of the phase 1 trial for
worldwide commercialization. This incorporates regulatory milestones from the
FDA including FDA Fast Track designation, two orphan drug designations
("ODD"), and two rare pediatric disease ("RPD") designations.

Phase 2 Trial

The clinical team has already begun defining the phase 2 protocol. It will be
a multi-center trial, estimated to span approximately three years, with a
target enrolment of 50-60 patients. Overall survival ("OS") will be the
endpoint. Our ongoing access to the FDA under Fast Track designation will help
identify intermediate endpoints which may compress the timeline and expedite
the approval process. End-of-phase 1 / 2 meetings with the FDA are critical in
the development process, and we anticipate scheduling our end-of-phase 1
meeting when the phase 1 data analysis nears completion.

Firm costs are currently being determined but are projected between $2 - $2.5
million over the duration of the trial which is expected to commence in 2025.
IQAI anticipates making a significant contribution to the costs of the Phase 2
trial, in combination with possible grants and further support from charitable
foundations if necessary. We had previously expected to seek a partner for
this stage of development but now believe that it would better commercially to
continue in a proprietorial role during phase 2.

Intellectual Property

Intellectual Property ("IP") encompasses a diverse array of forms, such as
data, dosing schema, biomarkers or diagnostic parameters, various methods of
delivery, etc. We are acutely aware of the value IP has and are exploring
potential mechanisms to strengthen our position. In our possession today are
exclusive rights to phase 1 trial data and imminently the EAP data. Post
approval, we will take full advantage of the seven years' market exclusivity
offered by Orphan Drug Designation, which allows sponsors to sell the drug
without competition. We intend to invest to strengthen IP during the
seven-year market exclusive period including formulation improvements,
delivery alternatives, and combination treatments.

Real World Data ("RWD") obtained in our Expanded Access Program ("EAP") can
significantly enhance the generalizability of studies by providing insights
into how diverse patient groups may respond to treatments in real-world
settings. If RWD suggests certain groups will respond more effectively to
treatment, a potential biomarker could be identified in those groups which
would be a further form of IP. The RWD could be leveraged to guide future
study designs, support regulatory submissions, reduce post-market surveillance
studies, and more.

Partnership Potential

Significant progress has already been made using our own financial resources
since first committing to sponsor this trial three years ago. Following the
anticipated successful conclusion of the Phase 1 trial we intend to continue
with direct financial involvement in the Phase 2 trial. Assuming a successful
Phase 2 trial, the prospects, and opportunities for partnership with a larger
partner will be significantly enhanced but there is also a possibility that
negotiations could commence during the trial.

Research and Development

The iron-mimetic characteristics of GaM, which enable the anti-tumor activity,
apply to all solid tumors. Other research projects are being planned that
expand beyond adult brain tumors. As these efforts ramp up, new investment
opportunities will arise. While we intend to focus on the current development
path of GaM, we are keeping informed of those early pre-clinical projects and
potential new clinical trials. Pediatric cancers for which we have Rare
Pediatric Disease ("RPD") designations are of particular interest.

"The preliminary data from the clinical study is highly encouraging and has
motivated us to continue the development in subsequent studies," said Trevor
Brown, CEO of IQ-AI.

--ENDS-

 

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

 

For further information, please contact:

 

 IQ-AI Ltd

 Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda

 Tel: 020 7469 0930
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Lucy Williams/Heena Karani

 Tel: 020 7220 9797

 

About Imaging Biometrics® LLC:  IB is a wholly owned subsidiary of IQ-AI
Limited, (LON: IQAI), and focuses on delivering quantitative imaging platforms
and therapeutics that transform how clinicians diagnose and treat patients
more efficiently and effectively. For more information about Imaging
Biometrics, visit the company's website at www.imagingbiometrics.com
(http://www.imagingbiometrics.com/) . Follow IB on Twitter, @IQAI_IB.

 

 

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