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Investigator
Initiated
Trials

Welcome To The Istari Investigator Initiated Study (IIS) Program:

As part of our commitment to delivering innovative therapies to patients and advancing the scientific understanding of immuno-oncology, Istari believes in supporting ethical, independent, unsolicited research conducted by qualified third-party investigators.

The value of the scientific research produced by these investigators is key to complementing Istari-sponsored research by helping to ensure we better understand the benefit/risk profile of our therapies, as well as enabling us to explore new opportunities addressing unmet medical needs.

Do you have an idea for an Investigator Initiated Study (IIS)?

We welcome unsolicited proposals from qualified sponsors with promising ideas in our areas of strategic interest (see ‘General Areas of Strategic Interest’ below). Well-written, scientifically sound studies that enhance the understanding of our investigational products, improve patient care, and spark new ideas for disease-related research will be considered. Our medical science personnel are available to guide you through the process, from concept pre-approval to submitting the final budget and protocol.

If you have questions or would like to discuss your concept, please reach out to Medical Affairs or your known Istari clinical or scientific representative.

Investigator initiated studies (IIS) are studies initiated, developed, designed and managed by a qualified sponsor who assumes sole responsibility for conduct and management of the study (including regulatory obligations, etc.). Istari will consider working with a broad range of sponsors including, but not limited to, the following:

  • Academic medical centers
  • Individual investigators / Researchers
  • Collaborative study groups
  • Networks and cooperative groups
  • Healthcare providers and institutions
  • Government research institutions

Support for an approved IIS may come in various forms including supplying drug products, funding, materials and/or information as allowed under local laws and regulations.

  • Projects proposing provision of external support will also be considered (e.g., grant or institutional funding, materials, use of core services, support provided by other collaborators/organizations).

The following are not considered investigator-initiated studies:

  • Access to investigational medicines through compassionate use or expanded access. Details on these programs can be found here.

All investigator-proposed research must offer meaningful scientific and/or clinical objectives supported by clear and valid study designs in which the privacy rights, safety and welfare of participants is of paramount importance, as applicable.

Requirements of a Sponsor/Investigator for Istari to consider supporting an IIS proposal include but are not limited to the following:

  • Is qualified in terms of background, education, and experience to conduct and complete the proposed research
  • Is not debarred, disqualified, restricted or excluded from engaging in activities relating to development or approval of drugs by any regulatory authority
  • If research involves treatment of patients, their relevant license is current
  • Assumes all responsibilities and obligations to comply with all relevant laws and regulatory requirements (e.g., Good Clinical Practice and safety reporting regulations)
  • They or their appointed representative holds the IND or equivalent clinical trial authorization (as applicable)
  • Agrees to the terms and conditions outlined when submitting the proposal and the final research agreement, which includes but is not limited to the following:
    • Provides safety reports to Istari in accordance with the research agreement
    • Provides study status updates in accordance with the research agreement
    • Submits the final study report and manuscript, as applicable, and in accordance with the research agreement

Istari’s general areas of strategic interest include but are not limited to IIS in the following areas:

  • Clinical investigations of efficacy and safety in solid tumors, alone or in combination with immune checkpoint inhibitors or other therapies/procedures, with Istari assets still in development (e.g., Phase I to III clinical studies).
    • Priority consideration will be given to those with direct intratumoral administration in cutaneous, subcutaneous, or nodal lesions or those that are amenable to injection (e.g., via ultrasound guidance), including those amenable to convection enhanced delivery into brain lesions
    • This could include window of opportunity studies and studies in the neoadjuvant or adjuvant treatment settings
      • Note: Clinical applications involving administration into the viscera/deep tissue may require additional consideration
    • Translational research studies including, but not limited to the following:
      • Immune cell activation in the tumor microenvironment (injected and noninjected lesions) and periphery
      • Tumor, immune cell or humoral markers associated with immune activation and/or anti-tumor response
      • Investigations providing additional mechanistic insight with PVSRIPO alone or in combination with other therapies in solid cancers
    • Nonclinical or Animal Investigations:
      • Note: Appropriate institutional and other relevant clearance per current guidance (e.g., CDC, WHO GAPIII) is required to allow use of PVSRIPO (i.e., a live poliovirus vaccine-based recombinant virus) in the nonclinical research setting.
      • If cleared, proof-of-concept studies for future clinical applications or those proposing investigations that may yield critical mechanistic or other insight may be considered

There are three main steps in our IIS approval process and our medical science personnel are available to guide you.

  1. Discuss Concept with Medical Affairs team
    Email: medicalaffairs@istarioncology.com and request a consult or discuss with your existing clinical or scientific affairs contact. Your representative will discuss your concept with the core IIS review team and provide you with feedback. If there is interest, a concept form (click here for example) and instructions on how to submit your initial concept proposal in the IIS portal will be provided.
  2. Submit Your Preliminary Concept
    Submit the details of your proposed concept in the IIS portal for consideration by the study review team.
  3. Submit final proposal
    If your proposed concept is approved, you will be provided with the application and link to submit the full proposal with additional details, including final protocol and other pertinent information as applicable (e.g., informed consent) and an itemized budget via the IIS portal.

Proposals will be reviewed and approved based on scientific merit and alignment with Istari’s areas of strategic interest. We evaluate all funding requests against local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.

Accepted projects will then move through the following stages:

  1. Start-up
  2. Conduct
  3. Close-Out

Please direct any questions to Medical Affairs via Email: medicalaffairs@istarioncology.com or your known Istari clinical or scientific representative.

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