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NIH/NCI 452 – Translation of Novel Cancer-Specific Imaging Agents and Techniques to Mediate Successful Image-Guided Cancer Interventions

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will be accepted.

Number of anticipated awards: 3-5

Budget (total costs, per award):

Phase I: up to $400,000 for up to 12 months

Phase II: up to $2,000,000 for up to 2 years

Proposals that exceed the budget or project duration listed above may not be funded.

 

Summary

The purpose of this technology-agnostic contract solicitation is to bring highly sensitive cancer-specific imaging agents and technologies capable of imaging very small volume (1 mm3) tumors in humans to clinical utility. Current imaging technologies/techniques are in use for non-invasive cancer detection, but clinical methods are limited to detecting masses several millimeters to centimeters in size. To image small primary or metastatic tumor sites composed of 1 – 10 million cells, imaging sensitivity must be improved. This can be achieved without significant hardware advances by improving the contrast between diseased and healthy tissue captured in the image. Thus, there is a clinical need for techniques that improve image contrast between tumors and surrounding normal tissue. There are several methods that rely on the use of specialized agents that are activated when coupled to a tumor target. Such activatable agents dramatically increase the contrast between small tumor cell masses and surrounding tissue. Efforts to develop activated imaging agents and techniques have been ongoing for over a decade, and successful demonstration in cancer-bearing animals has been achieved. These developmental successes now need to be translated for clinical use.

This SBIR solicitation thus supports translation of novel activatable agents and/or techniques for sensitive cancer detection in human subjects. Clinical translation and validation should be the primary goals of the proposed research. The bulk of the proposed research must focus on translating improvements in imaging sensitivity to a clinical environment with the goal of demonstrating that tumor cell aggregates on the order of 1 mm 3 in volume can be detected in cancer patients. Research toward development and establishing biological safety of the agent or technique in preparation for clinical validation will be accepted under this solicitation in Phase I. Thus, this solicitation supports translation of developing technologies for small tumor detection in human subjects. It is not intended to support continued major development and testing of techniques or novel agents. Any technique or strategy which dramatically enhances contrast between very small cancer and normal tissue is acceptable for consideration, which can include software techniques that have already been validated in cancer-bearing animal models prior to submission of the application.

 

Project Goals

Projects in response to this solicitation will bring a new enabling imaging technique capable of sensitive tumor detection to clinical utility. Identify the targeted cancer patient population and explicitly define how the identified cancer patient population would benefit clinically from the proposed imaging probe or technique. The goal is to build upon existing development successes with activatable diagnostic probes to translate these methods into clinical utility and to demonstrate that exceedingly small tumor cell clusters (1mm3 in volume) can be detected in human subjects by imaging methods. Studies will focus on first in human protocols which demonstrate small tumor volume imaging feasibility. Confirmation of detected tumor size sensitivity should be made through biopsy or other methods.

Support under this contract solicitation will be focused on translation of novel cancer-specific imaging agents and techniques which mediate successful image-guided cancer interventions (e.g., surgical, pharmacological, immunotherapeutic, etc.) with teams that have previously demonstrated success in developing activated agents/or techniques that target a specific cancer problem in an animal model. Demonstration of success for these activated imaging probes and/or techniques must include: (i) Tumor-specific binding, (ii) Low binding to surrounding normal tissue, (iii) High output efficiency in the “on” state, (iv) very low output in the “off” unbound state, (v) studied Pharmacokinetics/Pharmacodynamics (PK/PD) in an animal model, (vi) Low toxicity.

In addition to demonstrating development success, investigator teams must demonstrate collaboration across the “bench-tobedside” gap by including clinical specialists and imaging scientists on the team from the start of the proposed work. Clinical translation and validation must be the primary goals of the proposed research. The bulk of the research must focus on determining the improvements to imaging sensitivity in a clinical environment. Probe refinements and determination of its biological safety will be accepted in Phase I in preparation for clinical validation in Phase II.

 

Phase I Activities and Deliverables:

  • Identify the targeted cancer patient population and explicitly define how the identified cancer patient population would benefit clinically from the proposed imaging probe or technique.
  • Develop and/or refine a GMP grade selected probe to yield maximal biological safety and validate very small volume tumor detection of primary and metastatic cancers in selected animal models, with keen interest in eliminating potential false positives and false negatives.
  • Acquire institutional IRB approval to perform selected optimized molecular probe dose-escalation safety studies on small number (5 – 10) of healthy human subjects.
  • Convene the project team with expertise in imaging science, cancer surgery, and pathology.
  • Submit and acquire single IRB approval for recruitment of patients undergoing cancer surgery with the selected molecular probe labeling for the selected cancer to validate the molecular probe’s capabilities to identify additional cancers that were not detected by normal white light or palpation.
  • Develop plans for a pre-regulatory submission dialogue with the FDA, to be completed before submission of an SBIR Phase II proposal, so that FDA requirements can be included in the SBIR Phase II research plan.

 

Phase II Activities and Deliverables:

  • Begin clinical validation studies through an approved single IRB at multi-sites requiring a minimum of 15 cancer patients per site with a minimum of 3 multi-centers.
  • File regulatory submission with FDA by the end of year-02, following either the 510k or PMA path (as required by FDA for the specific product use and claims sought by the contractor).
  • Secure at least one letter of commercial interest from potential customers at the end of year-01.
  • Secure two letters of commercial commitment to buy the product from customers at the end of year-02.
  • Present phase II findings and demonstrate the system via a webinar at a time convenient to the offeror and NCI program staff.

 

Receipt date: November 4, 2022, 5:00 p.m. Eastern Daylight Time

Apply for this topic on the Contract Proposal Submission (eCPS) website.

For full PHS2023-1 Contract Solicitation, click here

 

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