Grants & Programs

Clinical Portfolio

Through our partnership with Ludwig Cancer Research, together we have established a unique and mutually beneficial approach to partnering with biotech and pharmaceutical companies that has allowed us to gain access to several of the most highly sought-after immunotherapeutic agents for inclusion in next-generation CVC clinical studies.


Current Menu of Agents Available to CVC Members

Vaccine Targets

NY-ESO-1 Protein & Overlapping Long Peptides: highly immunogenic cancer antigen for use as a vaccine target, produced in multiple forms, with GMP (clinic-grade) supply developed with funding from CRI's venture fund.

Immune Modulators

Anti-CTLA-4 (Tremelimumab): Tremelimumab is a fully human monoclonal antibody owned by MedImmune. The antibody binds to the protein CTLA-4, expressed on the surface of activated T lymphocytes. Anti-CTLA-4 antibodies comprise a new generation of immunotherapies for the potential treatment of cancer. Tremelimumab is currently in phase 2 clinical development for solid tumors.

Anti-GITR (TRX518): This antibody from GITR, Inc., targeting the glucocorticoid-induced tumor necrosis factor receptor, is the first of its class to enter human clinical trials thanks to funding from CRI. Activated GITR plays a role in directing the antitumor immune response via activating tumor-antigen-specific T effector cells, as well as abrogating the suppression induced by inappropriately activated T regulatory cells. TRX518 is designed to have activating and sustaining effects on T cells for enhancing the immune system's responses against cancer cells, including responses that may occur with TRX518 alone, as well as complementary responses in combination with other cancer therapies including vaccines. 

Anti-OX40: Anti-OX40, from MedImmune, is a monoclonal antibody agonist of the OX40 receptor which is a member of the tumor necrosis factor (TNF) receptor superfamily expressed on the surface of activated T-cells. The immune stimulating properties of OX40 agonists could provide an immunologic stimulus to overcome some of the immunosuppressive properties of cancer, and thus offers potential as a new class of agents for the treatment of cancer.

Anti-PD-L1 (Anti-B7-H1, MEDI4736): B7 homolog 1 (B7-H1), from MedImmune, is part of a complex system of receptors and ligands that are involved in controlling T-cell activation. Preclinical research suggests that tumors expressing B7-H1 evade detection and elimination of a tumor by the immune system. Preclinical studies of MEDI4736, a human monoclonal antibody directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells.

Adjuvants

Poly-ICLC (Hiltonol): immunomodulatory viral mimic, from Oncovir, capable of enhancing the anti-cancer immune attack. CRI through its venture fund financed production of a batch for inclusion in a wide variety of future CVC immunotherapy studies. To-date, CRI and Ludwig have made this drug available for 10 CVC studies spanning many different types of cancer.



Clinical Investments

Reagents Manufactured

Poly-ICLC

NY-ESO-1

Current Trials Funded

A phase 1 study to evaluate the safety and tolerability of anti-PD-L1, MEDI4736, in combination with tremelimumab in subjects with advanced solid tumors (NCT01975831)
Trial locations: Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Roswell Park Cancer Center, Buffalo, New York, USA; Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Principal Investigator: Jedd D. Wolchok, M.D., Ph.D.
Participating Investigators: Kunle Odunsi, M.D., Ph.D., Stephen Hodi, M.D.

Multi-center phase I study of NY-ESO-1 vaccine in combination with ipilimumab (anti-CTLA4) in patients with unresectable or metastatic melanoma (NCT01810016)
Trial locations: Memorial Sloan-Kettering Cancer Center, New York, New York, USA; University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA; University of Virginia Cancer Center, Charlottesville, Virginia, USA; NYU Langone Medical Center, New York, New York, USA
Principal Investigator: Jedd D. Wolchok, M.D., Ph.D.
Participating Investigators: Anna Pavlick, D.O., Yvonne Saenger, M.D., Craig L. Slingluff Jr., M.D., Hassane M. Zarour, M.D.

A first-in-human single ascending dose study of TRX518 in subjects with unresectable stage III or stage IV malignant melanoma (NCT01239134)
Trial location: Memorial Sloan-Kettering Cancer Center, New York, New York, USA
Principal Investigator: Jedd D. Wolchok, M.D., Ph.D.

Drug Supply Provided

Phase I study of immunization with NY-ESO-1f peptide combined with ATP0001 and Montanide ISA-51 as adjuvant in patients with NY-ESO-1 or LAGE-1 expressing cancers
Agent Provided: NY-ESO-1f (p91-110)
Trial Location: Krankenhaus Nordwest, Frankfurt, Germany
Principal Investigators: Elke Jäger, M.D.

Immunotherapy of stage II-IV melanoma patients by vaccination with tumor antigens, adjuvanted with Montanide, CpG oligonucleotides +/- the kationic peptide LL37
Agent Provided: NY-ESO-1 long peptides (p79-108)
Trial Locations: Ludwig Institute for Cancer Research, Lausanne, Switzerland; The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Principal Investigators: Daniel Speiser, M.D., Patrick Hwu, M.D.

NY-ESO-1 long peptides + Montanide vaccine combination with rapamycin in treatment of liposarcoma
Agent Provided: NY-ESO-1 long peptides (p79-108)
Trial Location: Ohio State University, Columbus, Ohio, USA
Principal Investigator: Hans Iwenofu, M.D.

Evaluation of safety and immunogenicity of a multi-phosphapeptide vaccine plus Poly-ICLC in participants with melanoma
Agent Provided: Poly-ICLC
Trial Location: University of Viginia, Chalottesville, Virginia, USA
Principal Investigator: Craig L. Slingluff Jr., M.D.

A multipeptide vaccine plus Toll-like receptor agonists in melanoma patients, with evaluation of the injection site microenvironment for resected Stage IIB-IV
Agent Provided: Poly-ICLC
Trial Location: University of Viginia, Chalottesville, Virginia, USA
Principal Investigator: Craig L. Slingluff Jr., M.D.

A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus Poly-ICLC in stage 1B-IIA breast cancer
Agent Provided: Poly-ICLC
Trial Location: University of Viginia, Chalottesville, Virginia, USA
Principal Investigator: Craig L. Slingluff Jr., M.D.

Safety and immunogenicity of vaccination with XAGE1B long peptides combined with Poly-ICLC in patients with stage III/IV pulmonary adenocarcinoma
Agent Provided: Poly-ICLC
Trial Location: Leiden University Medical Center, Leiden, The Netherlands
Principal Investigator: Cornelis Melief, M.D., Ph.D.

A phase II open label randomized study of Poly-ICLC-matured dendritic cells as an adjuvant for NY-ESO-1 peptide vaccination compared to Montanide ISA-51 in patients with melanoma
Agents Provided: NY-ESO-1 long peptides (p79-108), Poly-ICLC
Trial Location: NYU Langone Medical Center, New York, New York, USA
Principal Investigator: Nina Bhardwaj, M.D., Ph.D.

A phase I study of cancer vaccine CHP-NY-ESO-1 in combination with Poly-ICLC in patients with esophageal cancer or malignant melanoma expressing NY-ESO-1
Agents Provided: Poly-ICLC, CHP-NY-ESO-1
Trial Location: Mie University Hospital, Mie, Japan
Principal Investigators: Hiroshi Shiku, M.D., Alexander Knuth, M.D.

A phase I study of vaccination with NY-ESO-1 protein mixed with Poly-ICLC, OK-432 (Picibanil), and ISA-51 (Montanide) in patients with advanced cancers expressing NY-ESO-1 antigen
Agents Provided: NY-ESO-1 protein, Poly-ICLC
Trial Location: Osaka University Hospital, Osaka, Japan
Principal Investigators: Yuichiro Doki, Hisashi Wada

Phase I/II trial of a long peptide vaccine (LPV8) + TLR agonists for resected stage IIB/IV
Agents Provided: NY-ESO-1 long peptides (p79-108), Poly-ICLC
Trial Location: University of Virginia, Charlottesville, Virginia, USA
Principal Investigators(s): Craig L. Slingluff Jr., M.D.

Phase I/IIa study of vaccination of melanoma patients (stages II-IV) with ImmuFact IMP321 tumor antigenic peptides and Montanide
Agents Provided: Mage-A3.As KVAELVHFL, Melan-AGIGILTV, Melan-A ELAGIGILTV, NA-17 VLPDVFIRC, NY-ESO-1b SLLMWITOC
Trial Location: Hospital Center of Vaudois University, University of Lausanne, Lausanne, Switzerland
Principal Investigator: Olivier Michielin, M.D., Ph.D.

Phase I study of of NY-ESO-1 protein + Poly-ICLC +/- Montanide ISA-51 VG vaccine in patients with advanced malignant melanoma
Agent Provided: NY-ESO-1 protein
Trial Location: NYU Langone Medical Center, New York, New York, USA
Principal Investigator: Nina Bhardwaj, M.D., Ph.D.

Phase I study of NY-ESO-1f-derived peptide (p91-110) combined with Montanide ISA-51 and Poly-ICLC in patients with advanced cancers expressing NY-ESO-1
Agents Provided: NY-ESO-1f (p91-110), Poly-ICLC
Trial Location: Krankenhaus Nordwest, Frankfurt, Germany
Principal Investigator: Elke Jäger, M.D.

Phase I vaccine study of NY-ESO-1f with Montanide ISA-51 and OK-432 (Picibanil) in patients with advanced cancer
Agent Provided: NY-ESO-1f (p91-110)
Trial Location(s): Okayama University Hospital; Osaka University Hospital; Tokyo University Hospital, Japan
Principal Investigator: Eiichi Nakayama, M.D.

Immunization of patients with tumors expressing NY-ESO-1 antigen with a complex of NY-ESO-1 protein, cytosine-phosphorothioate-guanine (CpG), and liposome
Agent Provided: NY-ESO-1 protein
Trial Location: Hokkaido University Hospital; Nagoya University Hospital, Japan
Principal Investigator: Shin-Ichiro Nishimura