NIH/NCI 478 - Advanced Biomaterials to Improve Cancer Modeling for Research

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will NOT be accepted.

Number of anticipated awards: 2-4

Budget (total costs, per award):

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

Phase II: up to $2,250,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Synthetic, advanced biomaterials encompass a diverse range of materials, biological components, and applications that are poised to transform cancer research through precise 3D tumor models and microenvironment simulations and could lead to developments that reduce treatment side effects and improve cancer patient outcomes. These sophisticated models can accelerate drug development, by allowing researchers to predict how drugs might work in the human body more accurately. Traditional biomaterials (e.g., scaffolds and hydrogels) are generally static in morphology, and animal-derived products can induce inflammatory responses, and often degrade at unpredictable and uncontrolled rates. Traditional biomaterials sourced from tumors have inter- and intra- batch variability, quick gelation times, and requires careful handling for mechanical property modifications. Growth factor content can also stimulate confounding signaling cascades making it difficult for use in mechanistic cancer studies. Improved integration of existing biomaterials with advanced synthetic biomaterials (e.g. acrylates, collagen, hyaluronic acid, polyethylene glycol, tumor-sourced extracellular cellular matrix, alginate, chitosan, etc.) with cutting-edge sensors, AI, microfluidics, 3D/4D bioprinting, and other biomaterials may also open new avenues for research. Additionally, advances in biomaterials have the potential to address key issues like reproducibility (i.e. reduced batch-to-batch variability), bioactivity (e.g. active motifs promoting cell adhesion), mechanical properties (e.g. stiffness, strain, cross-linking, and plasticity), and biocompatibility. These tunable mechanics are possible through novel approaches that integrate photomediated, enzymatic, and polymerization-based chemistries. Successful commercialization of such biomaterials could enable broader access to advanced biomaterial-based cancer models and propel cancer biology research.

Project Goals

The short-term goal of this topic is to support the development and commercialization of versatile and accessible set of biomaterial-based tools (kits and reagents), and services for improved biomaterial-based cancer models to enable more rigorous and reproducible cancer research (basic and preclinical). The mid-term goal is providing the research community improved in vitro models to complement or replace in vivo models for regulatory use and the long-term goal to integrate biomaterials into personalized cancer models capable of improving treatment strategies for patients. Specific activities responsive to this solicitation topic should fall into one of the following three areas: 1) kits and reagents that are user-friendly (no specific skills or non- standard/expensive lab equipment required); 2) biomaterials allowing researchers (if kits and reagents) or the small business (if services) to program or tune the biomaterial for specific cancer applications: 3) biomaterials with the capacity to change or adapt in response to tumor initiation, progression, or metastasis (e.g., adaptable response to tumor, changes in stiffness, strain or crosslinking, local heat sensitive responses) to probe the mechanisms of cancer biology or for passive diagnostic readout (e.g. fluorescence, pH change, temperature fluctuations, imaging readout of polymer alignment).

Projects considered responsive to this solicitation include, but are not limited to: biomaterials that enable the culture of cancer cells that are difficult or can’t currently be cultured, or the long-term culture and manipulation of cancer tissue or organoids that are free from xenogeneic contaminants and are chemically defined, biomaterial that mimic aspects of the immune system (e.g., neutrophils, immunomodulatory molecules or tertiary lymphoid structures), or biomaterials that enable dynamic remodeling of the tumor or its microenvironment.

Activities not responsive to announcement:

Materials that are not biocompatible and/or do not modulate or mimic the environment or tissue in a cancer-relevant manner will not be considered responsive (i.e. biomaterials that don’t allow the study of cancer (tumor, microenvironment, or hostresponse, drug efficacy or toxicity); biomaterials intended solely for drug delivery or therapeutic use (e.g. microneedles, nanovesicles, etc.); biomaterials used in static phantoms intended solely for advancing imaging capabilities; technologies not directly applicable to cancer; services not applicable to cancer.

Phase I Activities and Deliverables:

Develop an advanced biomaterial prototype or suite of biomaterial-based services with a cancer biological context and/or application:

Conduct appropriate proof-of-concept studies for potential uses of the technology.
Characterize the proposed biomaterial-based technology:
- Report the biomaterials composition and preparation and its potential application(s).
- Report the biomaterials capabilities such as longevity and stability and observation time-period for investigative cancer research for each given cancer application.
- Demonstrate its versatility, i.e. how it can be programmed /fine-tuned for specific cancer applications.
- Demonstrate reproducibility.
Demonstrate its ease of use: the biomaterials must be designed for use by researchers with no specific skills and nonstandard/expensive lab equipment required.
Estimate the production costs or service pricing.
Provide the technology production workflow or services provided to support cancer biomaterial commercialization
Provide an early commercialization plan/strategy.
Report collaborations with preclinical or clinical cancer research sites and/or strategic business partners.
Present Phase I results and future development plan to NCI staff.

Phase II Activities and Deliverables:

Benchmark the technology to the current existing methods in terms of feasibility, cost, throughput, safety.
Show feasibility to scale production of the technology at a price point that is compatible with market success and widespread adoption by the basic cancer research community and/or clinical labs (as appropriate).
Establish QA/QC parameters at every step of the process to ensure reliability of results generated by your biomaterial technology with a cancer biological context.
Develop a working prototype kit/tool/device for the technology and/or establish a marketing partnership/alliance with an established strategic business partner (e.g. diagnostic company).
For biomaterial-related cancer research services deliverables should include a comprehensive market analysis, a timeline for commercialization efforts (including infrastructure, hiring, financing or strategic partnership agreements), and a detailed advertising/outreach strategy for services being offered.
Present Phase II findings to NCI program staff.

Receipt date: Friday, October 18, 2024, 5:00 p.m. ET

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

View the full PHS2025-1 Contract Solicitation.