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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012

The Chemical Biology Consortium - A New NCI Initiative

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Submit a NExT Application

The NCI Chemical Biology Consortium (CBC)-currently under development-will facilitate the discovery and development of new agents to treat cancer. This effort will be managed by the NCI's Experimental Therapeutics Program (NExT) through SAIC-Frederick. It is envisioned that initiation of this consortium will provide cutting-edge chemical tools for probing complex signaling pathways and will serve as the starting point for the elaboration of first-in-class targeted therapies. The mission of the CBC is to increase the flow of early stage drug candidates into NCI's drug development pipeline. The CBC will be an integrated research consortium at the interface of chemical biology and molecular oncology that will, working with various programs within the NCI's Division of Cancer Treatment and Diagnosis (DCTD) and the Center for Cancer Research (CCR), establish an iterative cancer drug discovery group on the scale of a small biotechnology concern.

CBC Participants

By establishing a network of chemical biologists and molecular oncologists from government, industry and academia, these CBC associate organizations and the NCI (collectively "Participants") can further address the unmet needs in therapeutic oncology focusing on areas such as "undruggable" targets and under-represented malignancies e.g. pediatric tumors and natural products. Through the CBC and the interactions among the various Participants, the NCI's drug discovery and development pipeline can be enabled from target identification through proof-of-concept (POC) clinical trials. It is expected and understood that NCI will have the option to clinically develop successful compounds (NMEs) created by the CBC. The long-term vision of the CBC is to bridge the gap between basic scientific investigation and clinical research supported by the NCI. This integrated process will allow NCI to maximize the return on its investment in molecular oncology over the past decade by making the following world-class resources available to CBC Participants:

  • Molecular and small animal imaging
  • Animal modeling of targeted therapies, including pre-clinical, pharmacokinetics and pharmacodynamics
  • Development and validation of pharmacodynamic assays to confirm drug effect on molecular target in preclinical studies and clinical trials conducted under an exploratory investigational new drug (IND) or in a traditional Phase I/II setting
  • High throughput screening of compound libraries, including natural products
  • A network of medicinal chemists and chemistry intellectual thought leaders
  • A fully functional and experienced drug development program

Current Status of Therapeutics Discovery at NCI

The primary strength of the NCI's drug discovery and development program has been focused upon the transition from early development to first-in-human studies. NCI's current system is highly-efficient at taking late-stage preclinical drug candidates through the final steps of development that lead to a successful IND filing with the Food and Drug Administration (FDA). The core elements for this stage of development are toxicology and production of clinical-grade material. These functions are the most expensive and least available in the academic sector. Furthermore, the NCI's efforts to move agents from late preclinical studies to first-in-human clinical trials have been significantly enhanced over the past three years. The DCTD and the CCR have moved to significantly improve the flow of molecules from intramural and extramural academic investigators into the clinic, as recently exemplified by the ABT-888 Phase 0 trial 1,2. The critical feature of this effort has been the linkage of the molecular pharmacology and early clinical testing resources of the CCR with the extramural resources of DCTD in the areas of screening, imaging, pre-clinical pharmacology and toxicology, and formulation to produce an NCI-led oncologic therapeutics development effort capable of substantively facilitating the clinical testing of novel anticancer molecules.

The NCI has also assembled, and supports, a large set of highly-talented clinical investigators who can launch the initial human evaluation of a new agent with efficiency and skill at the conclusion of preclinical development. For novel molecular entities that have no prior experience in humans, this is an invaluable resource.

Through the establishment of the CBC and the recruitment of the Participants, the NCI experimental therapeutics effort will prioritize its resources to meet the following objectives:

  • Focusing on the identification of novel targets, the creation of new molecules that interrogate those targets, and the screening and the identification of new molecules that serve as lead structures around which potential drugs can be designed and tested by a restructured NCI therapeutics pipeline. This will be accomplished in part by funding contracts that will provide support for the development of a Consortium of Chemists, Chemical Biologists, and Molecular Oncologists, formed in recognition of the increasing need for a highly interdisciplinary and creative research effort to propel the NCI into the era of personalized therapeutic cancer medicine.
  • Establishing an iterative drug discovery effort that will coalesce all segments of the current NCI therapeutics research activity, so that the development of promising chemical leads into bone fide clinical candidates can be accelerated.
  • Building an enhanced and robust drug pipeline with the goal of producing new clinical agents for first-in-human clinical testing in an aggressive and achievable timeframe.

More Information about the CBC

Although the CBC is still in the development process, several public documents are available to provide interested participants with background information about the consortium.

  • A Request for Information, which closed in May 2008, and a Request for Proposals from SAIC-F, which closed in November 2008, were the first public notices of this program. As progress is made in the initiation of the consortium, new information will be posted on this Web page.
  • A pamphlet called Chemical Biology Consortium: Accelerating the discovery and development of new anticancer agents outlines the process of selecting small molecules as potential candidates for preclinical development within the CBC and describes how the program will be governed.
  • All consortium members will be required to sign a good-faith Intellectual Property Agreement. This agreement details the management structure of the CBC and provides a mechanism for cooperation among the participants for pursuing collaborative projects. The agreement outlines confidentiality requirements, resource and data sharing, and describes expectations for how intellectual property will be protected and managed under the existing statutory (Bayh-Dole) framework.
  • For more information about CBC programmatic goals and procedures, contact:

1 1Kummar S, Kinders R, Gutierrez ME, Rubinstein L, Parchment RE, Phillips LR, Ji J, Monks A, Low JA, Chen A, Murgo AJ, Collins J, Steinberg SM, Eliopoulos H, Giranda VL, Gordon G, Helman L, Wiltrout R, Tomaszewski JE, Doroshow JH. Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies. J Clin Oncol. Published online April 13, 2009. 10.1200/JCO.2008.19.7681.

2 Donawho CK, Luo Y, Luo Y, et al. ABT-888, an orally active poly (ADP-ribose) polymerase inhibitor that potentiates DNA-damaging agents in preclinical tumor models. Clin Cancer Res 2007:13;2728-2737.