Advanced Oncotherapy - Operational update

Advanced Oncotherapy

01/03/2022 07:00

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RNS Number : 1671D  Advanced Oncotherapy PLC  01 March 2022

PRIOR TO PUBLICATION, THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT WAS
DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION FOR THE PURPOSES OF
REGULATION 11 OF THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS 2019/310.
WITH THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INFORMATION IS NOW CONSIDERED
TO BE IN THE PUBLIC DOMAIN.

 

1 March 2022

 

ADVANCED ONCOTHERAPY PLC

 

("Advanced Oncotherapy" or the "Company")

 

 Operational update

 

Significant progress with rolling, Q-submission for US FDA 510(k) approval of
the LIGHT system at Daresbury

 

As LIGHT modules are assembled and tested in situ, the Company and its
clinical partners, in close coordination with regulatory agencies, are
continuing to perform technical verification and validation to fully map the
input and output parameters of the proton beam for required treatment
protocols

 

This necessary exercise has now resulted in the request to generate and submit
to the regulatory agencies additional specific beam measurement data to
document and confirm that performance can be maintained within the required
tolerances for particular clinical applications

 

As a result, the Company now expects to have a fully operational LIGHT system
at 230 MeV during summer 2022

 

Advanced Oncotherapy (AIM:AVO), the developer of LIGHT, the next-generation
proton therapy system for cancer treatment, today provides an operational
update on the delivery of its first operational LIGHT system capable of
accelerating protons at 230 MeV.

 

Since the last technical update published by the Company on 13 December 2021,
the Company has made significant progress including:

 

o  As outlined in previous technical updates, the Company has experienced
global supply chain delays and shortages as a result of the impact of the
COVID-19 pandemic. The Company has made good progress in overcoming and
mitigating these issues as outlined in the Company's last technical update,
and is now confident in obtaining outstanding items in a timely manner(1).

 

o  As previously communicated, the Company has agreed a Q-submission process
with the US Food and Drug Administration (FDA) for the potential 510(k)
regulatory approval for the LIGHT system. This allows the Company to submit to
the FDA bundled modules of the 510(k) submission for feedback, rather than a
single submission at the end of development. Two modules out of the four have
been submitted and agreed by the FDA (submission details on the four modules
are outlined in the notes for editors section below).

 

o  Assembly and commissioning of the LIGHT system requires a step-wise
approach to conditioning the components. To date, 17 of the 21 accelerating
modules - one proton source, one RFQ, four SCDTLs and 11 of 15 CCLs - have
been RF conditioned whilst the last four CCL modules are expected to be
conditioned by mid-April 2022. The progress on RF conditioning has removed a
major area of uncertainty and risk(2).

 

Additional data for the regulatory agencies are expected to provide further
confirmation of the differentiated and medically superior profile of the LIGHT
proton beam.

 

The LIGHT treatment plan consists of delivering a number of pulses of protons
- typically a few hundred thousand millions of protons in total - to the
tumour. The advantage of the LIGHT accelerator as a linear and pulsed machine
lies in its ability to vary the intensity and the energy of each pulse. The
amount of energy has a direct link with the depth at which radiation is
deposited within the patient's body. In contrast, operators of existing legacy
systems are not able to vary the parameters of each pulse.

 

Against this background, the Company has been working with its clinical
collaborator (the University Hospitals Birmingham NHS Foundation Trust) and
Clarivate, a global analytics company, to define the clinical protocol for
treating the first patients. These discussions have been held in close
coordination with the FDA, the UK Medicines and Healthcare products Regulatory
Agency (MHRA) and the European Notified Body, which the Company consults with
on a regular basis. As a result of these discussions, the Company has been
requested to provide new measurement data to confirm that the beam performance
is maintained within the required tolerances for the clinical use both in
terms of energy (i.e. depth in the body) and intensity (i.e. number of protons
per second). This request originates from the fact that the key LIGHT
components are now assembled in situ at Daresbury and the underlying
parameters have been optimised in recent months as the Company performs the
verification and validation activities, a key step in ensuring product
certification. This is an additional request which was not anticipated by the
Company at the time of the release of the technical update in December 2021
 and is the major contributing factor to the revised target timescale of
summer 2022 for the Company having a fully operational LIGHT system operating
at 230 MeV.

 

The Company has already completed similar measurements in the past at its
prototype LIGHT system in Geneva, with excellent results. These additional
data are expected to provide further confirmation of the differentiated and
medically superior profile of the LIGHT proton beam. The new set of
measurements will be provided for a wider range of energies - low to medium
energies - as part of the pre-defined regulatory procedure with the FDA, the
MHRA and the European Notified Body.

 

The Company aims to provide these data over the second quarter of 2022,
following which it can then proceed to finalise the integration of the
remaining high energy accelerating modules and then reach the 230 MeV
milestone by this summer.

 

Nicolas Serandour, Chief Executive Officer of Advanced Oncotherapy, said:

 

"We have made significant strides towards progressing our first-ever LIGHT
system at Daresbury over the past few months. We are pleased to have now
submitted two of the four modules required for our Q-Submission 510(k) process
with the FDA. We are confident that the additional performance data we are now
generating, that will subsequently be submitted to the regulators, will
provide further confirmation of the differentiated and medically superior
profile of the LIGHT proton beam. We look forward to working towards
commissioning the LIGHT system with the 230MeV beam required for treating
patients this summer."

 

As the Company enters the final phase of commissioning the LIGHT system at
230MeV during the summer, it will provide further updates to the market on
progress.

 

 

- ENDS -

 

 

 Advanced Oncotherapy plc                                  www.avoplc.com (http://www.avoplc.com)
 Dr. Michael Sinclair, Executive Chairman                  Tel: +44 (0) 20 3617 8728
 Nicolas Serandour, CEO

 Allenby Capital Limited (Nomad and Joint Broker)
 Nick Athanas / Liz Kirchner (Corporate Finance)           Tel: +44 (0) 20 3328 5656

 Amrit Nahal / Matt Butlin (Sales and Corporate Broking)

 SI Capital Ltd (Joint Broker)
 Nick Emerson                                              Tel: +44 (0) 1483 413 500
 Jon Levinson                                              Tel: +44 (0) 20 3871 4066

 FTI Consulting (Financial PR & IR)                        advancedoncotherapy@fticonsulting.com
                                                           (mailto:advancedoncotherapy@fticonsulting.com)
 Simon Conway / Rob Winder                                 Tel: +44 (0) 20 3727 1000

 

(1) These include dipoles and quadrupoles as well as electronic parts required
in the MAMMA (Magnetic Measurements for Medical Accelerators) and DRIPEC
(Digital Regulation Interface for Precise Electromagnet Control)

 

(2 )The radio-frequency (RF) conditioning involves gradually increasing the
input power until there is an electrical "breakdown". After each breakdown,
the accelerating modules can sustain an increase in the input power. This
process is continued and iterative until the power reached is 20% above the
nominal values. This ensures great stability when operating at nominal power.
As the Daresbury LIGHT system is expected to be the first linear proton
accelerator to be commissioned for medical use, the RF conditioning is
unprecedented, hence carrying some level of uncertainty with regards to the
time needed to complete this important task. This risk has been significantly
removed following recent progress.

 

Notes for editors

 

The following outlines some of the key technical components for the LIGHT
system (referred in today's announcement):

 

·      Radio-frequency quadrupole (RFQ) - The RFQ is a copper
accelerating structure which focuses, bunches and accelerates protons up to
5MeV. The RFQ sits between the proton source and the side-coupled drift tube
linacs.

 

·      Side-coupled drift tube linacs (SCDTLs) - The LIGHT accelerator
includes four SCDTL modules which accelerate protons from 5MeV to 37.5MeV. The
SCDTLs sit between the RFQ and the CCLs.

 

·      Coupled cavity linacs (CCLs) - The CCL structures or "higher
speed accelerators" are an essential part of the LIGHT Accelerator. They
consist of a series of "cells" which accelerate the protons from 37.5MeV to
energies that can be applied usefully to a clinical setting (70MeV to 230MeV).

 

The following section outlines the four modules required for submission by the
Company to the FDA during the agreed Q-submission process:

 

·      Module 1: Premarket submission cover sheet.

 

·      Module 2: Substantial equivalence evaluation and discussion
(e.g., table comparing applicant device to predicate device, narrative related
to the same, etc.), product release roadmap, product description, system
architecture, biocompatibility report, planned marketing brochure, design and
development process description, manufacturing process description, list of
critical contract manufacturers, third-party medical device manufacturer's
certificates, LIGHT System Risk Management Plan and the LIGHT system
preliminary Hazard Analysis, system integration and verification and
validation (V&V) plan (including usability testing), and all final risk
analysis reports.

 

·      Module 3: Unique Device Identification (UDI), labelling,
including users manuals, radiobiological tests report, and electromagnetic
compatibility (EMC) test report.

 

·      Module 4: Q-Submission paperwork, International Medical Device
Regulators Forum (IMDRF) essential principle coverage report, international
standards coverage report, risk test coverage report(s), V&V test coverage
report, clinical evaluation report, and declaration.

 

About Advanced Oncotherapy Plc

 

Advanced Oncotherapy, a UK headquartered company with offices in London,
Geneva, The Netherlands and in the USA, is a provider of particle therapy with
protons that harnesses the best in modern technology. Advanced Oncotherapy's
team "ADAM," based in Geneva, focuses on the development of a proprietary
proton accelerator called, Linac Image Guided Hadron Technology (LIGHT).
LIGHT's compact configuration delivers proton beams in a way that facilitates
greater precision and electronic control.

 

Advanced Oncotherapy will offer healthcare providers affordable systems that
will enable them to treat cancer with innovative technology as well as
expected lower treatment-related side effects.

 

Advanced Oncotherapy continually monitors the market for any emerging
improvements in delivering proton therapy and actively seeks working
relationships with providers of these innovative technologies. Through these
relationships, the Company will remain the prime provider of an innovative and
cost-effective system for particle therapy with protons.

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