Investigator Sponsored Clinical Studies (ISS) and Researcher Sponsored Pre-Clinical Studies (RSS)

In addition to our own ongoing and planned research programmes, Immodulon is committed to delivering innovative cancer treatments to patients worldwide and believes in the need to support independent ethical research both in clinical and pre-clinical settings. Such ISS and RSS research would typically emanate from, and be conducted by, qualified third-party expert Investigators/Researchers.

 

For Immodulon, these external scientific studies provide further data and help to ensure we better understand the benefit/risk profile of our treatments as well as explore new opportunities to address unmet medical needs.

 

The clinical research must set out to address meaningful scientific and/or clinical objectives supported by valid study designs in which the privacy rights, safety and welfare of patients are of paramount importance. The Investigator is responsible for conducting the clinical study in compliance with established ICH-GCP requirements and will take on the legal and regulatory responsibilities of ‘Trial Sponsor’ for the conduct and management of the ISS as defined by all applicable national and international laws and regulations as appropriate.

 

The pre-clinical research must focus on meaningful scientific objectives supported by valid study designs and in full coherence with the local laws and research regulations.

 

Documentary evidence will be requested to demonstrate the appropriate training, accreditation and qualifications of the Investigator/Researcher.

Areas of Research Interest

Non-Clinical

  • Analysis of IMM-101- components (cell wall proteins, lipids, carbohydrates etc.) responsible for the observed immunological effects
  • Effects of IMM-101 on the innate and adaptive immune system
  • Cancer models research (efficacy and mechanisms of action)
  • Effects of different routes of administration of IMM-101 on the immune response
  • Potential beneficial non-immunological effects of IMM-101 

Clinical

  • Cancers for which improved treatments are a high medical need (e.g., Pancreatic cancer, Glioblastoma, Sarcoma, etc.)
  • Cancers with low responsive rates to immune checkpoint inhibitors (CPIs)
  • Different treatment combinations with IMM-101 + CPIs as the basis
  • New routes of IMM-101 administration (e.g. intra-tumoral administration or inhalation)
How to submit a proposal

The request for support for such a study will come directly from the independent Investigator/Researcher and should be directed to Immodulon’s dedicated email: ISS@immodulon.com.

The review process

Requests to Immodulon for proposed research projects should be accompanied by a proposal and brief synopsis in the first instance. Receipt of this concept proposal/synopsis and request for support will be acknowledged by Immodulon within seven days. The submitted documentation will be reviewed by Immodulon’s internal ISS review committee and a decision to proceed or not to the next step will be given within two months. It is important that the Researcher/Investigator is aware that a decision will be based on scientific merit and alignment with the company’s R&D focus and other internal company decision criteria. Assuming a positive outcome, the Investigator/Researcher will be approached to request full details of the proposal and a full protocol in order to progress to full approval. Before the support can be initiated a contractual agreement, (safety) data exchange agreement, and regulatory bodies (ECs/IRBs, FDA, MHRA, MOHs etc.) approvals or formal approvals for animal experiments must be in place.

The required written contractual agreement between Immodulon and the – relevant employer of the – Investigator/Researcher will state that the Investigator/Researcher complies with applicable local laws, rules, guidelines and regulations. This agreement will importantly also include a detailed summary of the procedures for safety data reporting, data capture and data protection and other information flow (non-exhaustive list). Immodulon may consider financial support for ISS and RSS research when merited, which will be documented in a separate agreement.

Immodulon will only undertake ISS with third-party Investigators who are able to demonstrate clear evidence of high ethical and scientific standards as it relates to clinical research in human subjects and as stipulated by the International Conference of Harmonization (ICH) Efficacy Guidelines E6 – GCP. In addition, Researchers undertaking RSS using animal subjects will be required to provide equivalent evidence of ethical standards and/or Good Laboratory Practice.