Operational update

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 manner¹.

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 risk².

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
Dr. Michael Sinclair, Executive Chairman	Tel: [phone]
Nicolas Serandour, CEO
Allenby Capital Limited (Nomad and Joint Broker)
Nick Athanas / Liz Kirchner (Corporate Finance) Amrit Nahal / Matt Butlin (Sales and Corporate Broking)	Tel: [phone]
SI Capital Ltd (Joint Broker)
Nick Emerson	Tel: [phone]
Jon Levinson	Tel: [phone]
FTI Consulting (Financial PR & IR)	[e-mail]
Simon Conway / Rob Winder	Tel: [phone]

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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