University of Virginia

Contact Info:

Archana Thakur

1340 Jefferson Park Avenue

Charlottesville, VA 22908

https://med.virginia.edu/center-for-human-therapeutics-cgmp-facility/

Grants and Identifiers:

RRID: RRID:SCR_025475

Instrumentation:

Services Provided:

Relevant Publications:

1.) Ninmer EK, Petroni GR, Gaughan E, Poklepovic AS, Kaur V, Haden K, Chianese-Bullock KA, Smith KT, Wright P, Bryant JL, Brighton D, Engel JA, Bullock TNJ, Slingluff CL Jr (2026 Apr 1). Randomized Phase I/II Clinical Trial of a Melanoma Helper Peptide Vaccine with or without Systemic Agonistic Anti-CD27 Antibody (Varlilumab). Cancer research communications, 6(4), 994-1005. . PMCID: 13130881.

2.) Ninmer EK, Petroni GR, Gastman BR, Gaughan EM, Isaacs JM, Haden K, Kaur V, Wages NA, Chianese-Bullock KA, Smith KT, Wright P, Bryant J, Dunlap-Brown M, Engel JA, Bekiranov S, Mauldin IS, Truong TG, Bullock TNJ, Slingluff CL Jr (2026 Mar 3). Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). Journal for immunotherapy of cancer, 14(3), . . PMCID: 12959172.

Description:

Offers manufacturing of cellular and biologics for safety and initial efficacy testing in first–in– human, pilot, and Phase I clinical trials. Facilitates bench–to–bed translation into novel cellular therapies. Provides focused scientific, technical, and regulatory support for investigator-initiated investigational new drug applications (INDs) in cell and gene therapy. Current and completed trials include hematologic malignancies multiple myeloma, breast cancer, prostate cancer, glioblastoma, neuroblastoma, and pancreatic cancer. The potential applications of cellular therapy and biologics are not limited to cancer, a large number of disease indications such as cardiovascular, autoimmune diseases, diabetes, neurological diseases, etc.