Grants & Programs

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. - See more at: http://cancerresearch.org/grants-programs/clinical-accelerator/clinical-portfolio#sthash.084bQ0WY.dpuf

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. Below are clinical trials supported as of April 2016.


Direct Investment 

A first-in-human single ascending dose study of TRX518 in subjects with unresectable stage III or stage IV malignant melanoma or other solid tumor malignancies (NCT01239134)

  • Henry Koon, M.D., University Hospitals, Cleveland, OH
  • Dale Shepard, M.D., Ph.D., Cleveland Clinic, Cleveland, OH
  • Jedd D. Wolchok, M.D., Ph.D., and Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center, New York, NY

A phase I study of NY-ESO-1 vaccine in combination with ipilimumab in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated (NCT01810016)

  • Jonathan S. Cebon, Ph.D., FRACP, Austin Health/Ludwig Cancer Research, Melbourne, Australia
  • Craig E. Devoe, M.D., North Shore LIJ, North Shore University Hospital, Manhasset, NY
  • Philip Friedlander, M.D., Icahn School of Medicine at Mount Sinai, New York, NY
  • Michael A. Postow, M.D., Memorial Sloan Kettering Cancer Center, New York, NY
  • Craig L. Slingluff Jr., M.D., University of Virginia Cancer Center, Charlottesville, VA
  • Hussein Tawbi, M.D., Ph.D., University of Pittsburgh Cancer Institute, Pittsburgh, PA

A phase I study to evaluate the safety and tolerability of anti-PD-L1, MEDI4736, in combination with tremelimumab in subjects with advanced solid tumors (NCT01975831)

  • Kunle Odunsi, M.D., Ph.D., Anna-Maria Kellen Clinical Investigator, Roswell Park Cancer Institute, Buffalo, NY
  • Patrick Ott, M.D., Ph.D., Dana-Farber Cancer Institute, Boston, MA
  • Jedd D. Wolchok, M.D., Ph.D., and Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center, New York, NY

A phase II study to evaluate the clinical efficacy and safety of standards of care in combination with checkpoint blockade in patients with glioblastoma (NCT02336165)

  • David Reardon, M.D., Dana-Farber Cancer Institute, Boston, MA

Phase I/II study of chemo-immunotherapy with Toll-like receptor 8 agonist motolimod (VTX-2337) and checkpoint blockade in subjects with recurrent, platinum-resistant ovarian cancer for whom pegylated liposomal doxorubicin (PLD) is indicated (NCT02431559)

  • George Coukos, M.D., Ph.D., University Hospital of Lausanne, Lausanne, Switzerland

A phase I/II study of in situ vaccination with tremelimumab and durvalumab plus Poly-ICLC in subjects with advanced, measurable, biopsy-accessible cancers (NCT02643303)

  • Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY
  • Craig L. Slingluff Jr., M.D., University of Virginia Cancer Center, Charlottesville, VA

Phase I study to assess the safety and tolerability of tremelimumab and durvalumab, administered with high dose chemotherapy and autologous stem cell transplant in multiple myeloma (NCT02716805)

  • Alexander M. Lesokhin, M.D., Memorial Sloan Kettering Cancer Center, New York, NY
  • Hearn Jay Cho, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY


Drugs Supply and Related Investments

Production of NY-ESO-1 overlapping peptides for use in a variety of trials

  • PolyPeptide Laboratories San Diego, San Diego, CA

Poly-ICLC manufacture and stability testing

  • Oncovir, Inc., Washington, DC

A multi-peptide vaccine plus Toll-like receptor agonists in melanoma patients, with evaluation of the injection site microenvironment for resected stage IIB-IV (NCT01585350)

  • Craig L. Slingluff Jr., M.D., University of Virginia Cancer Center, Charlottesville, VA

A phase I open label, multicenter, multi-ascending dose trial evaluating the safety, tolerability, and immunogenicity of intramuscular recombinant NY-ESO-1 protein with GLA-SE adjuvant in patients with unresectable or metastatic cancer expressing NY-ESO-1 cancer (NCT02015416)

  • Immune Design, Seattle, WA

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 (NCT01003808)

  • Hiroshi Shiku, M.D., and Shinichi Kageyama, M.D., Mie University School of Medicine, Mie, Japan

A phase I study of concomitant WT1 analog peptide and NY-ESO-1

  • David O’Malley, M.D., The Ohio State University Wexner Medical Center, Columbus, OH
  • Paul Sabbatini, M.D., Memorial Sloan Kettering Cancer Center, New York, NY

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 (UMIN000007954)

  • Yuichiro Doki, Ph.D., and Hisashi Wada, M.D., Ph.D., Osaka University, Osaka, Japan

A phase IA/IB study of vaccination with NY-ESO-1 protein, Poly-ICLC, and mogamulizumab in patients with adult T cell leukemia/lymphoma expressing NY-ESO-1 antigen

  • Yuzuru Kanakura, Ph.D., and Hiroyoshi Nishikawa, M.D., Ph.D., Osaka University, Osaka, Japan

A pilot study of a novel multimodality immuno-chemotherapy platform for patients with advanced cutaneous T cell lymphoma (NCT02061449)

  • Catherine M. Diefenbach, M.D., NYU Langone Medical Center, New York, NY

A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus Poly-ICLC in stage IB-IIIA breast cancer (NCT01532960)

  • Patrick M. Dillon, M.D., University of Virginia Cancer Center, Charlottesville, VA

Evaluation of safety and immunogenicity of a multiphosphapeptide vaccine plus Poly-ICLC in participants with melanoma (NCT01846143)

  • Victor H. Engelhard, Ph.D., and Craig L. Slingluff Jr., M.D., University of Virginia Cancer Center, Charlottesville, VA

Phase I study of NY-ESO-1 protein + Poly-ICLC +/- Montanide® ISA-51 VG vaccine in patients with advanced malignant melanoma (NCT01079741)

  • Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY

Phase I/II trial of a long peptide vaccine (LPV8) + TLR agonists for resected stage IIB-IV (Mel60) (NCT02126579)

  • Craig L. Slingluff Jr., M.D., University of Virginia Cancer Center, Charlottesville, VA

Safety and immunogenicity of vaccination with XAGE1b long peptides combined with Poly-ICLC in patients with stage III/IV pulmonary adenocarcinoma

  • Christian Taube, M.D., and Maarten L. Zandvliet, Ph.D., Leiden University Medical Center, Leiden, The Netherlands


Correlative and laboratory Investments

Development of cancer immunotherapy targeting regulatory T cells

  • Hiroyoshi Nishikawa, M.D., Ph.D., Osaka University, Osaka, Japan

Early-phase NY-ESO-1 clinical trials in patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and monitoring of tumor-specific immune responses

  • Maha Ayyoub, Ph.D., Intitute Pasteur, Paris, France
  • Danila Valmori, Ph.D., Centre de Lutte Contre Le Cancer Nantes-Atlantique, Nantes, France

Immunological monitoring for the CVC trials

  • Sacha Gnjatic, Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY

NY-ESO-1 and mixed bacterial vaccine clinical trials and immune monitoring

  • Elke Jäger, M.D., Krankenhaus Nordwest, Frankfurt, Germany

Phase II study of CTLA-4 blockade and low dose cyclophosphamide in patients with advanced malignant melanoma after failure of at least one prior therapy

  • Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY
  • Anna C. Pavlick, D.O., NYU Langone Medical Center, New York, NY

Preclinical toxicity studies to enable the clinical development of the XAGE1b peptide vaccine

  • Cornelis J.M. Melief, M.D., Ph.D., Leiden University Medical Center, Leiden, The Netherlands

Vaccination of melanoma patients (stage II-IV) with ImmuFact IMP321, tumor antigenic peptides, and Montanide

  • Daniel E. Speiser, M.D., University Hospital of Lausanne, Lausanne, Switzerland


Clinical Strategy Team Grants

Team Leads: Nina Bhardwaj, M.D., Ph.D., and Sacha Gnjatic, Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY
The mutation-derived tumor landscape of advanced bladder cancer: A platform to optimize cancer immunotherapy

Team Lead: John Herr, Ph.D., University of Virginia Health System, Charlottesville, VA
Investigator(s): Robert H. Vonderheide, M.D., D.Phil., University of Pennsylvania, Philadelphia, PA; Jamal Zweit, Ph.D., Virginia Commonwealth University, Richmond, VA
Immunotherapeutic targeting cell surface neoantigen SAS1B (Ovastacin, ASTL)

Team Leads: Hideho Okada, M.D., Ph.D., and Lawrence Fong, M.D., University of California, San Francisco, San Francisco, CA
Investigator(s): Carl H. June, M.D., University of Pennsylvania, Philadelphia, PA; Pawel Kalinski, Ph.D., University of Pittsburgh, Pittsburgh, PA; Kunle Odunsi, M.D., Ph.D., Roswell Park Cancer Institute, Buffalo, NY
Enhancing T cell homing to solid cancers by stimulating proper chemokines

Team Lead: Andrew Sikora, M.D., Ph.D., Baylor College of Medicine, Houston, TX
Investigator(s): Sacha Gnjatic, Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY; Christine Chung, M.D., Johns Hopkins University, Baltimore, MD; Nham Tran, Ph.D., University of Technology, Sydney, Australia
Targeting the tumor immune microenvironment to enhance immune-stimulating effects of chemoradiotherapy

Team Lead: Mark Smyth, Ph.D., QIMR Berghofer Medical Research Institute, Herston, Australia
Investigator(s): Scott J. Antonia, M.D., Ph.D., Moffitt Cancer Center, Tampa, FL; Georgina V. Long, Ph.D., M.B.B.S., and Richard Scolyer, M.B.B.S., M.D., Melanoma Institute of Australia and University of Sydney, Australia; John Stagg, Ph.D., University of Montreal, Montreal, Canada
Targeting adenosine in the tumor microenvironment

Team Leads: Hassane Zarour, M.D., and John M. Kirkwood, M.D., University of Pittsburgh, Pittsburgh, PA
Targeting multiple inhibitory receptors in cancer patients

Team Lead: Lei Zheng, M.D., Ph.D., Johns Hopkins University, Baltimore, MD
Tipping the balance in the tumor microenvironment as a next generation platform for pancreatic cancer immunotherapy