Periodic Reporting for period 1 - ImmunoGrow (Making life-saving cancer therapies more widely available by simplifying production processes, reducing costs and enhancing patient safety through its patent-protected biomimicking mesh material.)
Periodo di rendicontazione: 2019-08-01 al 2019-10-31
By engaging with over 35 stakeholders and potential industry partners, GMT identified a critical step in its mesh’s manufacture that is critical for applications in cell therapy. This involved the use of a chemical treatment to activate the surface of our mesh-based technology so that the covalent attachment of the ‘active’ monoclonal antibody was strong and durable. As a result, focus shifted towards a redesigned technical validation step that involved testing the viability of methods of surface activation. This work, conducted with the Royal College of Surgeons Ireland (RCSI), found that the available methods yielded little improvement as a result of the polymer composition of the underlying mesh technology.
While the work described above was ongoing, other aspects of the agreed work packages were developed including the regulatory, IP and Go-to-Market strategies. Using free assistance provided as part of a start-up support program, a regulatory strategy was developed. By conducting the work in-house, the team is better positioned to respond to likely changes in this rapidly evolving space. A Go-to-Market strategy was developed including an assessment of the key product attributes and likely customer buying behaviour. Rather then undertaking a full Freedom to Operate analysis while uncertainty remained around the underlying IP portfolio, a comprehensive due diligence process was undertaken to assess the portfolio’s robustness and to familiarise our partners with its contents.
While the work described above was ongoing, other aspects of the agreed work packages were developed including the regulatory, IP and Go-to-Market strategies. Using free assistance provided as part of a start-up support program, a regulatory strategy was developed. By conducting the work in-house, the team is better positioned to respond to likely changes in this rapidly evolving space. A Go-to-Market strategy was developed including an assessment of the key product attributes and likely customer buying behaviour. Rather then undertaking a full Freedom to Operate analysis while uncertainty remained around the underlying IP portfolio, a comprehensive due diligence process was undertaken to assess the portfolio’s robustness and to familiarise our partners with its contents.
Task 1.1 Market Potential - Using the comparable pricing gold standard competitors, this market is estimated to be worth €81m by 2023 and €114m by 2030. While not a significant market opportunity in itself, it is important to, in some way, quantify demand from the early-stage, preclinical market. As tools and processes used at these earliest stages are ‘locked in’ to IND applications, it is vital that researchers be given access to the ImmunoGrow technology. GE estimates that there are 375 active T-Cell therapy programs with the figure rising every year. Providing for the fact that the consumable provided to this segment is on a much smaller scale, this market is estimated to be worth €34m by 2023 and €48m by 2030.
Task 1.2 Regulatory Strategy - ImmunoGrow will be designed in compliance with ISO 13485 standards and manufactured under GMP conditions using GMP-compliant materials. However, as ImmunoGrow is not strictly considered a medical device, it will be certified to ISO 9001 standards.
Task 1.3 Intellectual Property (IP) Management - As it was possible that IP could be generated as part of the technical work undertaken during the project, it was decided that a full Freedom to Operate analysis would be conducted at the end of the project. Should the work be successful and contain protectable IP, it could be incorporated into this work. However, it also avoided unnecessary expenditure in the event of an unsuccessful outcome.
Task 1.4 Go-to-Market Strategy - An extensive review of the stakeholders involved in the CAR-T area was conducted and GMT developed a Go-To-Market strategy that promoted its use in academic centres with the aim of incorporating the devices use at the pre-IND stage.
Task 1.5 Validation of Product Performance - See below in next section.
Task 1.6 Business Plan - Incorporating aspects of manufacturing, operations and staffing and product development, in addition to the information gained during the work above, GMT developed a business plan prior to the outcome of the technical work in anticipation of a successful outcome.
Task 1.2 Regulatory Strategy - ImmunoGrow will be designed in compliance with ISO 13485 standards and manufactured under GMP conditions using GMP-compliant materials. However, as ImmunoGrow is not strictly considered a medical device, it will be certified to ISO 9001 standards.
Task 1.3 Intellectual Property (IP) Management - As it was possible that IP could be generated as part of the technical work undertaken during the project, it was decided that a full Freedom to Operate analysis would be conducted at the end of the project. Should the work be successful and contain protectable IP, it could be incorporated into this work. However, it also avoided unnecessary expenditure in the event of an unsuccessful outcome.
Task 1.4 Go-to-Market Strategy - An extensive review of the stakeholders involved in the CAR-T area was conducted and GMT developed a Go-To-Market strategy that promoted its use in academic centres with the aim of incorporating the devices use at the pre-IND stage.
Task 1.5 Validation of Product Performance - See below in next section.
Task 1.6 Business Plan - Incorporating aspects of manufacturing, operations and staffing and product development, in addition to the information gained during the work above, GMT developed a business plan prior to the outcome of the technical work in anticipation of a successful outcome.
Following on from feedback in 1.1 above, it was decided that work would be undertaken to address the issue of surface activation conjunction with the Royal College of Surgeons Ireland (RCSI). Specifically, potential customers had requested that a plan for the covalent attachment of monoclonal antibodies to the mesh’s surface be developed as this existed as a key regulatory requirements of theirs. The work with RCSI was designed to assess the feasibility of applying commonly available means of surface activation and to act as the precursor to further work in the future on finalising this key treatment step. As it was expected that this work would be carried out following a seed round, further investment of time towards the resolution of this issues was required.
During the work, it was discovered that the treatment methods for surface activation were ineffective as a result of the inert nature of the polymers used to create these fibrous constructs. Also, as a result of their thin nature, the application of more concentrated forms of these treatments resulted in the fibre’s complete degradation. As our customers had identified that as a pre-requisite for their consideration of any future product, further work on the material was unwarranted.
During the work, it was discovered that the treatment methods for surface activation were ineffective as a result of the inert nature of the polymers used to create these fibrous constructs. Also, as a result of their thin nature, the application of more concentrated forms of these treatments resulted in the fibre’s complete degradation. As our customers had identified that as a pre-requisite for their consideration of any future product, further work on the material was unwarranted.