The CRI Anna-Maria Kellen Clinical Accelerator

The CRI Anna-Maria Kellen Clinical Accelerator is a unique nonprofit-academia-industry collaboration model that serves as an “incubator” for multi-center clinical trials testing promising new cancer immunotherapy combinations. As part of the CRI Trials umbrella of clinical programs, the Clinical Accelerator powers integrative, science-driven, collaborative clinical research platforms designed to facilitate and de-risk cancer immunotherapy drug development by leveraging the global CRI Network of immuno-oncology experts and CRI’s philanthropic venture fund.

Clinical Accelerator Components

The CRI Anna-Maria Kellen Clinical Accelerator is a venture philanthropy-backed strategy that supports multi-centered clinical trials testing novel immunotherapy combinations in hard-to-treat cancers, such as those of the pancreas, prostate, and ovary.

CRI plays a central role, not only in funding these studies but in convening its network of world experts to propose and vet trial concepts that are scientifically sound and mechanistically based; in assuring that the proposed trials are non-redundant and would not be carried out without CRI support; and in securing the relevant agents from biotech and pharmaceutical companies to be used in combination to provide industry quality data that accelerates the adoption of the studied combination into commercial development. 

Additionally, emphasis is placed on supporting the in-depth, multi-omic correlative assessment of the precious patient blood and tissue samples secured during the trial so that we learn from every patient to accelerate progress toward effective new immunotherapy combinations.

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CRI Venture Philanthropy Fund

Philanthropic dollars fuel the CRI Venture Fund, which deploys capital to accelerate the creation and execution of innovative immunotherapy clinical trials that aim to improve clinical outcomes for cancer patients.

The CRI Venture Fund realizes returns on its invested capital based on the clinical and regulatory development of the therapeutics it financially supports. Milestone payments (returns) are based on predetermined clinical and regulatory triggers. Earned milestone payments are then available to support future clinical studies through the CRI Venture Fund.

Global Clinical Research Network

The CRI Clinical Accelerator research network includes more than 90 of the world’s leading physician-scientists who have expertise in diverse clinical practices, cancer immunotherapy clinical trials, and immune monitoring. CRI’s leadership position in advancing cancer immunology research for more than 65 years has yielded deep relationships with a global network of scientists, clinicians, and research institutions. Based on their areas of expertise, our researchers are organized into different focus groups, called drug selection committees. These committees propose science-based, biologically driven immunotherapy combinations to be studied in our clinical trials. These proposals are prioritized by the Clinical Accelerator leadership team, financed by our Venture Philanthropy Fund, and made possible through our robust relationships with academia and industry.

Immuno-Oncology Landscape Analyses

The CRI Immuno-Oncology Landscape analyses present unbiased, scientifically curated, and routinely updated overviews of new investigational I-O agents and cancer immunotherapy clinical trials. These analyses allow the Clinical Accelerator to identify opportunities where the testing of novel immunotherapy combinations can generate the most impact. Thus, CRI is better able to support our global research network in creating rational, non-duplicative clinical trials. The results of our analyses are made available to the public on our website in addition to publication in peer-reviewed scientific journals.

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Centralized Access to Therapies

The CRI Clinical Accelerator team actively monitors the rapidly evolving cancer immunotherapy landscape and works directly with industry and nonprofit organizations to source innovative agents for evaluation in our clinical trials. These strategic partnerships have enabled access to more than 40 different clinical-stage agents to date. Our drug selection committees propose how combinations of these agents should be studied in the clinic by members of our global research network. Such combinations include checkpoint inhibitors, therapeutic vaccines, immunomodulators, oncolytic viruses, and many other promising treatments and technologies with high therapeutic potential.

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Clinical Accelerator Leadership

The Clinical and Scientific Advisory Committee guides the clinical vision, strategy, and studies of the Clinical Accelerator. The management team is composed of highly experienced professionals with relevant experience in immunology, business development, regulatory sponsorship, clinical trial management, and data analysis and reporting. This team works closely with members of the scientific leadership in developing, implementing, and executing CRI-sponsored clinical trials.

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Partnerships

The CRI Clinical Accelerator leverages relationships with nonprofits and companies to fund and deliver multi-center studies that could not be accomplished alone. Through these global partnerships, we advance ambitious clinical and translational research aimed at expanding the benefits of immunotherapy to more patients and, ultimately, curing cancer. Our partners provide key support to the program by contributing strategic direction and managing the logistical operations of our trials. They also provide critical funding and/or access to emerging technologies and therapeutic agents. The CRI Clinical Accelerator is proud to be supported by these outstanding organizations and welcomes new partnerships to de-risk novel combination strategies in immuno-oncology.

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CRI Investments

In 2021, CRI decided to pursue early-stage equity investments in private companies that have direct affiliations with CRI and whose mission aligns with that of CRI. Annually, CRI surveys the CRI Network of scientists regarding near-term, early-stage investment opportunities. Criteria for investment includes companies started by CRI scientists or where they hold senior positions.

CRI conducts business, financial, legal, and scientific due diligence on identified opportunities. A key element of the scientific due diligence is leveraging CRI’s Network to assist in evaluating the quality and validity of the technology.

CRI Investment Portfolio

CompanyCRI ConnectionFocusStage
Surge TherapeuticsMichael Goldberg, PhD – FounderIntraoperative immunotherapySeriesA
Cartography BiosciencesAnsuman Satpathy, MD, PhD – FounderImmunotherapy target discoverySeries A
Cellinfinity BioSidi Chen, PhD – FounderCell therapy platformSeed
Undisclosed Company FounderImmunometabolismSeed

Clinical Accelerator Trials

The CRI Anna-Maria Kellen Clinical Accelerator aims to reduce inefficiencies and duplicative efforts by building multi-site, multi-company platform trials with deep translational and correlative science to advance immunotherapy. Below are clinical trials supported by the Clinical Accelerator as of November 2022.

Clinical Trials – Active

Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC) (NCT04918186)

  • Helen MacKay, MD, Sunnybrook Health Sciences Centre, Canada
  • Kunle Odunsi, MD, PhD, University of Chicago
  • Anna Tinker, MD, BCCA, Vancouver Cancer Centre, Canada
  • Dmitriy Zamarin, MD, PhD, Memorial Sloan Kettering Cancer Center

Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (REVOLUTION) (NCT04787991)

  • Robert Vonderheide, MD, DPhil, University of Pennsylvania
  • George Fisher, MD, PhD, Stanford Medicine
  • Andrew Ko, MD, University of California, San Francisco
  • Mark O’Hara, MD, University of Pennsylvania
  • Eileen O’Reilly, MD, Memorial Sloan Kettering Cancer Center
  • Osama Rama, MD, Dana Farber Cancer Institute
  • Zev Wainberg, MD, University of California, Los Angeles
  • Robert Wolff, MD, The University of Texas MD Anderson Cancer Center

Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with NSCLC (NCT04093167)

  • Adrian Sacher, MD, Princess Margaret Cancer Centre
  • Andrea Fung, MD, PhD, Kingston Health Sciences Centre
  • Cheryl Ho, MD, Vancouver Cancer Centre (Study chair)
  • Garth Nicholas, MD, The Ottawa Hospital Research Institute
  • Peter Ellis, MD, Juravinski Cancer Centre at Hamilton Health Sciences
  • Valsamo (Elsa) Anagnostou, MD, Johns Hopkins University (Study chair)

Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (PORTER) (NCT03835533)

  • Charles Drake MD, PhD, Columbia University
  • Julie Graff, MD, Oregon Health & Science University
  • Karen Autio, MD, Memorial Sloan Kettering Cancer Center
  • Kristopher Weintzel, MD, Angeles Clinic
  • Larry Fong, MD, University of California, San Francisco
  • Matt Galsky, MD, Mount Sinai
  • Sumit Subhudhi, MD, PhD, MD Anderson Cancer Center (Study chair)

Treatment with Nivolumab and Ipilimumab or Nivolumab Alone According to the Percentage of Tumoral CD8 Cells in Advanced Metastatic Cancer (NCT03651271)

  • Alexandra Drakaki, MD, PhD, University of California, Los Angeles
  • Apostolia Tsimberidou, MD, PhD, MD Anderson Cancer Center
  • Danny Khalil, MD, PhD, Memorial Sloan Kettering Cancer Center
  • David Oh, MD, PhD, University of California, San Francisco
  • Padmanee Sharma, MD, PhD, MD Anderson Cancer Center (Study chair)
  • Saad Khan, MD, Stanford University
  • Stephen Hodi, MD, Dana Farber Cancer Institute

Clinical Trials – Completed

Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects with NSCLC (NCT03164772)

  • Hirva Mamdani, MD, Karmanos Cancer Institute
  • Jhanelle Gray, MD, Moffitt Cancer Center (Study chair)
  • Jiaxin Niu, MD, Banner MD Anderson
  • Jonathan Thompson, MD, Medical College of Wisconsin
  • Joshua Sabari, MD, NYU Langone

Safety and Efficacy of APX005M with Gemcitabine and Nab-Paclitaxel with or without Nivolumab in Patients with Previously Untreated Metastatic Pancreatic Adenocarcinoma (NCT03214250)

  • Andrew Ko, MD, University of California, San Francisco
  • Eileen O’Reilly, MD, Memorial Sloan Kettering Cancer Center
  • George Ficher, MD, Stanford University
  • Mark O’Hara, MD, University of Pennsylvania
  • Osama Rahma, MD, Dana-Farber Cancer Institute
  • Robert Vonderheide, MD, DPhil, University of Pennsylvania (Study chair)
  • Robert Wolff, MD, MD Anderson Cancer Center
  • Zev Wainberg, MD, University of California, Los Angeles

Results

Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer (NCT02431559)

  • Blanca Navarro, MD, University Hospital of Lausanne, Lausanne, Switzerland
  • Bradley Monk, MD, Arizona Oncology
  • David O’Malley, MD, Ohio State University
  • George Coukos, MD, PhD, University Hospital of Lausanne, Lausanne, Switzerland (Study chair)
  • Paul DiSilvestro, MD, Woman and Infants Hospital
  • Roisin O’Cearbhail, MD, Memorial Sloan Kettering Cancer Center

Results

Phase 2 Study of Durvalumab (MEDI4736) in Patients with Glioblastoma (NCT02336165)

  • David Reardon, MD, Dana-Farber Cancer Institute (Study chair)
  • Gavin Dunn, MD, PhD, Washington University, St Louis
  • Hui Gan, MD, Austin Hospital, Australia
  • Jennifer Clarke, MD, MPH, University of California, San Francisco
  • Jorg Dietrich, MD, Mass General Hospital
  • Michael Lim, MD, Johns Hopkins
  • Thomas Kaley, MD, Memorial Sloan Kettering Cancer Center
  • Tim Cloughesy, MD, University of California, Los Angeles

Results

A Phase 1 Study to Evaluate MEDI4736 in Combination with Tremelimumab (NCT01975831)

  • Antoni Ribas, MD, PhD, University of California, Los Angeles   
  • Jedd Wolchok, MD, PhD, Memorial Sloan Kettering Cancer Center (Study chair)
  • Kunle Odunsi, MD, UChicago Medicine Comprehensive Cancer Center
  • Margaret Callahan, MD, PhD, Memorial Sloan Kettering Cancer Center (Study chair)
  • Mario Sznol, MD, Yale University
  • Patrick Dillon MD, University Virginia Health
  • Patrick Ott, MD, Dana-Farber Cancer Institute
  • Reva Schneider, MD, Mary Crowley Cancer Center

Results

Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors (TRX518-001) (NCT01239134)

  • Henry Koon, MD, University Hospitals
  • Dale Shepard, MD, PhD, Cleveland Clinic
  • Jedd D. Wolchok, MD, PhD, and Margaret Callahan, MD, PhD, Memorial Sloan Kettering Cancer Center

Results

Studies Supported by Reagents

Studies Supported with Reagents

A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients (MEL58) (NCT01585350)

  • Craig L. Slingluff Jr., MD, University of Virginia Health System

A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer (NCT02015416)

  • Immune Design, Seattle, WA

Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers (NCT00291473)

  • Hiroshi Shiku, MD, and Shinichi Kageyama, MD, Mie University School of Medicine, Mie, Japan

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

  • David O’Malley, MD, The Ohio State University Wexner Medical Center
  • Paul Sabbatini, MD, Memorial Sloan Kettering Cancer Center

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

  • Yuichiro Doki, PhD, and Hisashi Wada, MD, PhD, Osaka University, 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

  • Yuzuru Kanakura, PhD, and Hiroyoshi Nishikawa, MD, PhD, Osaka University, Japan

A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence (NCT02334735)

  • Nina Bhardwaj, MD, PhD, Icahn School of Medicine at Mount Sinai

Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41) (NCT01532960)

  • Catherine M. Diefenbach, MD, NYU Langone Medical Center

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

  • Patrick M. Dillon, MD, University of Virginia Health System

A preclinical mouse vaccination experiment to compare the effectiveness of Poly-ICLC to that of the more common QS-21

  • Samuel Danishefsky, PhD, Memorial Sloan Kettering Cancer Center

Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma (Mel63; CHAMP) (NCT02425306)

  • Craig L. Slingluff Jr., MD, University of Virginia Health System

Results

Evaluation of a Multi-phosphopeptide Vaccine Plus PolyICLC in Participants With High Risk and Advanced Malignancies (Mel59) (NCT01846143)

  • Victor H. Engelhard, PhD, and Craig L. Slingluff Jr., MD, University of Virginia Health System

Safety Study of Adjuvant Vaccine to Treat Melanoma Patients (NCT01079741)

  • Nina Bhardwaj, MD, PhD, Icahn School of Medicine at Mount Sinai

Phase I/II trial of a long peptide vaccine (LPV8) + Toll-like receptor agonists for resected stage IIB-IV

  • Craig L. Slingluff Jr., MD, University of Virginia Health System

Role of Toll-like receptor 3 in macrophage-mediated programmed cell removal of tumor cells

  • Irving Weissman, MD, Stanford University School of Medicine

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

  • Christian Taube, MD, and Maarten L. Zandvliet, PhD, Leiden University Medical Center, The Netherlands

A Phase 1/2 Study of In Situ Vaccination with Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers (NCT02643303)

  • Craig Slingluff Jr., MD, University of Virginia Health (Study chair)
  • Danae Hamouda, MD, Toledo University
  • Elizabeth Gaughan, MD, University of Virginia Health
  • Igor Puzanov, MD, Roswell Park Cancer Institute
  • Keisuke Shirai MD, Dartmouth University
  • Megan Kruse, MD, Cleveland Clinic       
  • Michael Lowe, MD, Emory University
  • Nina Bhardwaj, MD, PhD, Mount Sinai (Study chair)

Results

Clinical Accelerator Press

The CRI Anna-Maria Kellen Clinical Accelerator team and affiliated scientists publish our new developments and contributions in the field of immunotherapy in prestigious journals, blog posts, and press releases.

Press Releases

Publications

Media Mentions

Blog Articles

121 Million Invested

19 Trials Supported

1050+ Patients Treated

65+ Articles Published

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