Clinical Accelerator Mission and Model

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The Anna-Maria Kellen Clinical Accelerator, the clinical arm of Cancer Research Institute (CRI), is a unique academia-nonprofit-industry collaboration model that serves as an “incubator” to accelerate clinical trials of promising new immunotherapy combinations. The Clinical Accelerator, building on 60+ years of CRI’s dedication to funding the most innovative basic science in tumor immunology, enables experts to advance their most ambitious clinical and translational research ideas to cure cancer, and accelerates studies that one group or company could not do alone. Importantly, it assembles the world’s most outstanding and prominent tumor immunologists and clinical experts to challenge the status quo and push the boundaries of science. Funding from a group of New York-based philanthropists makes this bold ambition possible, as they have a passionate commitment to supporting the best science. The program funds $20m-$30m annually in innovative clinical trials.

Unlike most investigator-initiated studies that are typically carried out at a single center, the Clinical Accelerator partners in creative ways to fund and deliver robust multi-center studies conducted with a high level of rigor, regulatory oversight, data monitoring, and industry-level bio-banking. Moreover, unlike groups with a fixed site network, the Clinical Accelerator goes wherever the most exciting cancer immunotherapy science locates. As such, it enables new ways to collaborate among renowned clinical researchers from top academic institutes. The program also partners with innovative biopharmaceutical companies to harness and gain early access to emerging technologies and agents.

OUR MISSION: GETTING MORE EFFECTIVE IMMUNOTHERAPIES TO PATIENTS, SOONER

Although several immunotherapies have been approved, the unmet medical need for cancer patients remains high, and only a minority of patients enjoy a durable benefit from approved immunotherapies.

IMMUNOTHERAPY COMBINATION

Immunotherapy agents on their own have limitations, and it will take multi-modality approaches to cure most cancers. Effective combination therapies rely on the synergies between the stimulation of the immune system by immunotherapies and direct attacks on cancer cells by other therapies.

Kill (some) cancer cells to release unique markers; stimulate immunity against cancer cells; block the tumor's escape and help t-cells kill the cancer

HOW TO DEVELOP IMMUNOTHERAPY COMBINATIONS?

Success in cancer immunotherapy combination requires clinical research in three major areas:

  • Right combinations: Identify scientifically rational combinations that are likely to work better together than alone, by addressing multiple deficiencies in an immune response against cancer or synergizing with other established cancer treatments.
  • Personalization: Learn how to create personalized immunotherapy or combination treatment regimens based on each patient’s unique cancer and immune response.
  • Biomarkers: Discover new cancer markers that will allow early prediction about the treatments that are most likely to be safe and effective for a specific patient.

However, the potential number of questions is extensive, exemplified by 940+ clinical IO agents as combination candidates, 50+ cancer types being tested with IO agents, and 3000+ ongoing clinical trials for cancer immunotherapy that need 570,000+ patient volunteers. We can no longer build new science on old clinical infrastructure – doing one study to answer one question. As such, the clinical accelerator will conduct ‘basket’ or ‘umbrella’ platform studies – each of which will be designed to answer multiple questions, with multiple agents.  

OUR MODEL: SCIENCE-DRIVEN VENTURE PHILANTHROPY

The Anna-Maria Kellen Clinical Accelerator is designed to accelerate and de-risk clinical studies and the development of next-generation cancer immunotherapy combinations. Developed over the course of a decade by Cancer Research Institute and its nonprofit partners, the Clinical Accelerator is powered by a series of modules, each of which is designed to overcome distinct obstacles to advancement of the most effective clinical trials.

Six parts of the Clinical Accelerator Model

Nonprofit Academic Partners

Our nonprofit academic partners consist of leading cancer charities, renowned academic oncology trial organizations, and multinational cancer research foundations. Our partners work with us to source, design, fund, and manage multi-center clinical trials, and also to extend CRI’s network internationally to reach additional experts and patients.

Global Clinical Researcher Network

The Clinical Accelerator network includes approximately 80 of the world’s leading physician-scientists with expertise in tumor immunology and cancer immunotherapy clinical trials, immune monitoring, and correlative research. The researchers are organized in different expert focus groups, based on their expertise in different cancer types and research areas in immuno-oncology. 

Clinical Trials Management Team

A highly experienced team of clinical trials management professionals—from CRI and our nonprofit partners—offer a comprehensive suite of capabilities spanning regulatory sponsorship, protocol development, medical monitoring, data capturing, reporting and analysis, and more.

Immunotherapy Landscape Analysis

Our internal diligence research provides the updated, unbiased, and extensive landscape research of clinical immuno-oncology. Our internal team also works with our clinical experts on specific immunotherapy topics of interest on an ad hoc basis. Together, we identify and validate novel combination treatment strategies to feed our pipeline of future clinical trials.

Centralized Access to Therapies

Through strategic partnerships with industry and nonprofit organizations, we gain access to a portfolio of priority drugs for testing within our expert focus groups, including checkpoint inhibitors, therapeutic vaccines, innate immune stimulants, targeted therapies, and many other promising treatments and technologies with high therapeutic potential.

Venture Philanthropic Capital Fund

A philanthropic venture fund, investing at a run-rate of $20 to $30 million per year, is designed to de-risk the launch of early-stage combination clinical trials, and to enable the program’s clinical research pipeline to become self-sustaining over time through returns on investment.

Bioinformatics and Immune Monitoring

Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical trials across our global trial network sites in order to generate novel insights into biomarkers for safety and efficacy, novel treatment strategies, and personalization of treatment regimens.

HOW DOES THE MODEL WORK?

Flowchart of how Clinical Accelerator model works

  1. Crowdsource: Source ideas for promising combinations from a managed network of 60 of the world's top cancer researchers. 
  2. Access: Central coordination across companies to negotiate access to any IO agents
  3. Start: Collaborative study design supported with investment, regulatory sponsor and monitoring
  4. Understand: Coordinated translational research insights to drive biomarkers and future science
  5. Sustain: Unlock proof of concept (POC) for pivotal pharmaceutical development, which generates returns back to CRI that are reinvested in future trials

Scientific insights guide future trial selections | Financial returns fund future trials

EVERYONE BENEFITS

  Contribution Benefit
Scientists Guide the drug selection and trial designs, and run the clinical trials and correlative studies Pursue the boldest research ambitions, and provide better treatments for their patients
Companies Provide study drugs and offer access to new immunotherapy agensts Access to agents from other companies, work with world-leading experts, and receive venture philanthropic support
Donors Offer philanthropic investment to enable innovative, lifesaving clinical trials One-time donation grows and increases in impact over years
Patients Participate in clinical trials that explore novel immunotherapy combinations Gain immediate access to cutting-edge treatments that have the potential to cure devastating cancer types
Nonprofit Partners Offer co-funding, scientific expertise, expert networks, and relationships with companies Rapidly launch innovative immunotherapy clinical trials and maximize the impact of philanthropic donation

 

*Immunotherapy results may vary from patient to patient.

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