NCI Experimental Therapeutics (NExT) Program Pipeline
The NExT Program supports oncology projects for novel therapeutic agents from target validation through Phase II clinical trials. The most common supported agent types are small molecules and biologics. However, NExT does support a number of imaging, radiotherapeutic, and nanotechnology therapeutic-based projects.
NExT Discovery and Development Stages
Small Molecule Discovery
At this time, there are no projects in the Target Validation or Lead Development stages.
The current NExT Discovery portfolio spans three stage gates, from early stage with Exploratory Screening projects, three mid-stage Screening/Hit-to-Lead projects, and one project at the Candidate Selection stage.
**The portfolio is routinely updated as more projects are accepted/resource-allocated or closed within the program.**
Exploratory Screen Development
| Applicant | Institute | Proposal Title |
|---|---|---|
| Pattenden, Samantha | University of North Carolina | Development of a High Throughput Assay Based on Chromatin Accessibility |
| Campbell, Judith | California Institute of Technology | Screening for inhibitors of DNA2 protein, a novel cancer treatment target. |
Screening/Hit-to-Lead
| Applicant | Institute | Proposal Title |
|---|---|---|
| Fesik, Stephen | Vanderbilt University | Discovery of Small Molecule, Direct inhibitors of Oncogenic Wnt Signaling |
| Fesik, Stephen | Vanderbilt University | Direct Inhibitors of MYC and its Binding Partners |
| Stauffer, Shaun | Cleveland Clinic Foundation | Discovery of Small Molecule Inhibitors of Oncogenic Hippo Signaling Pathway |
Candidate Selection
| Applicant | Institute | Proposal Title |
|---|---|---|
| Fesik, Stephen | Vanderbilt University | Discovery of small molecule inhibitors of WDR5 |
Small Molecule Pre-Clinical Development
| Applicant | Institute | Title | Sector |
|---|---|---|---|
| Patrick Grohar | Children's Hospital of Philadelphia | Development of AIT-102 (EC-8042) as a Targeted therapy for Ewing Sarcoma and Rhabdoid Tumor | Academic |
| Ernesto Guccione | Mt. Sinai | IND-enabling studies for WNTinib, a novel selective therapeutic for CTNNB1 mutant hepatocellular carcinoma | Academic |
| Linda Vahdat | Dartmouth University | Phase 2 randomized, placebo-controlled study of ammonium tetrathiomolybdate in TNBC | Academic |
| Tin Tin Su | SuviCa | Developing a small molecule inhibitor of eEF2 | Biotech |
| Judith Leopold | Mekanistic Therapeutics | MTX-531, a first-in-class dual inhibitor of PI3K and EGFR for targeting solid tumors | Biotech |
| Brian Leigh | Tracon Pharmaceuticals | Development of TRC102 as a Novel Inhibitor of Base Excision Repair | Biotech |
| Jing Wu | NCI Center for Cancer Research | [1-13C]-a-ketoglutarate as an Imaging Probe in IDH-mutant Gliomas | Government |
| Mark Suto | Southern Research Institute | DNA Methyltransferase Inhibitors Td-Cyd and Aza-TdC | Non-Profit |
| Alan D'Andrea | Dana Farber Cancer Institute | Polymerase Theta Inhibitor Overcomes PARP Inhibitor Resistance | Non-Profit |
| Douglas Faller | Takeda Pharmaceuticals | TAK-243, a small molecule UAE inhibitor | Pharma |
Biologics Pre-Clinical Development
| Applicant | Institute | Title | Sector |
|---|---|---|---|
| Yuesheng Zhang | Virginia Commonwealth University/Roswell Park | PEPDG278D for Treatment of HER2-positive Breast Cancer | Academic |
| Crystal Mackall | Stanford University | CAR T Cells targeting Glypican-2 (GPC2) for children and young adults with recurrent and refractory neuroblastoma and medulloblastoma | Academic |
| Sidi Chen | Yale University | Translating a metabolic enhancer for CAR-T towards IND-enabling stage | Academic |
| Tony Giordano | Abcon Therapeutics, Inc. | ATX101 for Treating T-cell Lymphoma | Biotech |
| Kazusa Ishii | NCI Center for Cancer Research | Clinical-Grade Vector Manufacturing for CD22 TCR-T Cell Therapy | Government |
| Donald Kufe | Dana Farber Cancer Institute | Targeting MUC1-C with an ADC for Treatment of Aggressive Recalcitrant Cancers | Non-Profit |
| Jan Schnitzer | Proteogenomics Research Institute for Systems Medicine | Developing hAnnA1-based immunoconjugates for cancer detection and treatment | Non-Profit |
| Kate Rittenhouse | For-Robin | hJAA-F11, a Humanized Anti-Thomsen Friedenreich Antibody for Cancer Therapy | Non-Profit |
| John Lee | Fred Hutchinson Cancer Research Center | STEAP1 chimeric antigen receptor T cell therapy for prostate cancer | Non-Profit |
Phase I/II Clinical Trials
All NExT Clinical stage projects that enter the program are operated and managed through NCI's Cancer Therapy Evaluation Program (CTEP) Investigational Drug Branch (IDB) through a few different mechanisms. Negotiation of a Collaborative Research and Development Agreement (CRADA) is the first step in the onboarding of any NExT Clinical stage project. CTEP maintains a list of agents for use in combination and other studies that can be utilized. Please click each link for a list of active CTEP CRADAs and Agents.