FAQ

This is a list of our most frequently asked questions.  

What is an investigator sponsored trial?

An investigator sponsored trial is a research effort where a sponsor or investigator is seeking support from Agenus to conduct a clinical investigation.

A sponsor takes responsibility for and initiates a clinical investigation. A sponsor can be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

An investigator is the individual who conducts the investigation (i.e., under whose immediate direction the investigational drug is administered or dispensed to a subject). An investigator of an IST assumes the responsibilities of, and must comply with, FDA regulations applicable to both a sponsor and an investigator. These responsibilities include the submission and maintenance of an IND.

  

What types of support can be provided by Agenus?

Agenus may support an IST with funding and/or drug supply or materials (including Agenus information, placebo, or other medicinal products necessary for the research). 

  

What are Agenus' current areas of interest?

Agenus will consider IST’s utilizing botensilimab +/- balstilimab or other agents.

  • Other agents in our pipeline are not currently open to IST proposals except on a case-by-case basis.
  • Improving on standard of care in early lines of therapy, i.e. neoadjuvant, adjuvant, or 1L therapy
  • Strategies to overcome primary and secondary resistance to immunotherapy including liver and/or brain metastases
  • Improving management of immune related adverse events, including prophylaxis strategies for immune mediated diarrhea/colitis
  • Additional consideration will be given to studies that have:
    • A strong translational component that may help elucidate mechanism of action and contribute to predictive models/signatures
    • Adaptive or innovative trial designs that more efficiently evaluate biomarker selected populations with varied mechanisms of resistance
    • A strong rationale for exploring monotherapy and/or combination(s) in a population considered unlikely to respond to immunotherapy.


What are the requirements/role of the sponsor/Investigator who initiates the trial?

  • Possess the scientific, technical and operational capabilities to conduct the trial, including adequately trained staff and statistical support

  • Submit a well-designed protocol and budget

  • Develop and maintain the case report forms

  • Initiate and monitor the trial

  • Comply with any and all pertinent laws, regulations, and guidelines (e.g. IND)

  • Comply with any and all requirements of institution(s) with which they are associated or in which research will occur (e.g. IRB)

  • Report safety data to regulatory authorities (FDA), the IRB and Agenus

  • Provide periodic ongoing trial updates to Agenus

  • Submit a written report of the final trial results to Agenus

  • Publish the results in a scientific journal and provide a copy of the manuscript to Agenus

  

What is the role of Agenus?

  • Provide approved support as outlined in the legal agreement in a timely manner

  • Provide any scientific/medical feedback to the Investigator-initiator at any point in time regarding the proposal, the protocol, or any aspect of study conduct where Agenus has a concern about the scientific integrity of the study or patient well-being

  

What documents are required before an IST can be reviewed/activated?

  • An IST concept proposal/protocol

  • A fully executed IST agreement between the sponsor/investigator and Agenus

  • A fully executed safety data exchange agreement between the sponsor/investigator and Agenus

  • An IRB or health authority approval

Note: Please refer to the IST Handbook under the ‘Resources’ tab for the complete list of required documents.

  

How does the overall process work?

  • Everything begins with you registering in the Agenus IST portal

  • Once you have registered, you will then be able to submit research proposals to Agenus

  • Once you have submitted a concept proposal, it will be reviewed by the Agenus IST Review Committee; if there are any questions, you will receive notification from Agenus for clarification or additional information

  • When required follow up is received, the Agenus IST Review Committee will make an initial decision; this decision could be approval, decline or deferred

  • If the proposal is approved, the process then moves into protocol development and review; once you have completed a draft protocol, Agenus medical personnel will review the protocol in a similar fashion as the initial concept proposal review with a primary focus on the scientific integrity of the study design and overall patient well-being; the end result will be a similar set of decision outcomes as the initial proposal

  • If you submit a full draft protocol with the initial proposal (not required), then both the proposal and protocol review would occur in one review step versus two

  • Once the protocol is approved, we will then finalize contractual terms of the Agenus support being provided and expectations for you as the study sponsor

  • After the contract is finalized and all supporting documentation has been obtained, you will then be ready to start the conduct of the study

  • Once study conduct is complete, we will then move into closing out the study and enter the publications phase of the study (final deliverables from the study as defined in the contract)

  • Per the contractual terms, Agenus will request review of any defined deliverables from the study (abstracts, publications, etc.)

  • At any point, you will be able to go into your account in the system and see the status of your proposal(s) and/or study(s)

  

What do I need to do to submit a proposal after I have registered at this site?

  • The first step is to click on the Submit a New IST button

  • This will take you to the first of two parts to the proposal submission process

  • Part one is the online form that basically captures categorical information about your concept proposal; this information is collected directly in the system to enable the proper internal routing and classification of the proposal

  • After you have submitted your concept proposal, you will receive an automatic notification from the system via e-mail confirming success of your submission

  • Part two of the process is submission of the draft protocol which captures the detail of the actual study you are proposing, including aspects of the overall study design, target population, statistical analysis plan, etc.

  • After attaching the protocol, you can also submit any other needed attachments at this point or later in the process such as the itemized budget for funding support requested

  • After you have submitted your protocol, you will receive an automatic notification from the system via e-mail confirming success of your submission

  • At any time, you can then login and check the status of the proposal, add additional attachments to the system

  

What does Agenus expect of the investigator-initiator?

  • Conduct a high-quality ethical study

  • Complete required documentation in a timely manner.  Please refer to the IST Handbook under the ‘Resources’ tab for information.

  • Meet applicable deadlines as defined in the legal agreement

  • Ensure patient safety

  • Report any safety issues and adverse events in a timely fashion as defined in the legal agreement

  • Disclose any affiliation or financial conflicts of interest

  • Ensure financial transparency

  • Publish study results

  • Ask questions whenever needed

  

What should the sponsor of the study expect from Agenus?

  • Professional interactions with Agenus employees who ensure patient safety is of paramount importance

  • Timely responses to any inquiries or requests coming from the sponsor, including decisions on completed proposals

  • An easy to use IST portal

  • No involvement of Agenus sales or marketing employees in any aspect of an IST

  • Compliance with data protection laws with respect to the personally identifiable information of the sponsors/investigators

  

How are support decisions made within Agenus?

  • Once reviewed for completeness, all proposals go through a review process that is made up of key medical personnel for the given product/therapy area

  • Decisions are made based primarily on the overall scientific rationale of the proposal; additional considerations include alignment with Agenus’ areas of scientific interest, qualifications of the proposal sponsor, availability of internal funding resources, a fair market value assessment of any funding requested, and evaluation if similar research is already being conducted or has been conducted.

  

How do I contact Agenus if I have questions about this system or the overall process?