Making a PACT with NIH
BETHESDA, Md.—In October, the National Institutes of Health (NIH) and 11 leading biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers to advance new immunotherapy treatments against cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the U.S. Food and Drug Administration serving in an advisory role.
“This new public-private partnership is a significant step forward in the battle against cancer and a real boost to the potential of immunotherapy,” said Acting Health and Human Services Secretary Eric Hargan. “We are excited for this partnership, which will strengthen efforts already underway across HHS.”
New immunotherapies have resulted in dramatic responses in certain cancer cases. They have also been the focus of intense investment by biopharmaceutical companies seeking to provide new options for patients who do not respond to other cancer therapies, but they don’t work for all patients. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and predict their response to treatment, are needed for these therapies to provide benefit to the maximum number of people.
“We have seen dramatic responses from immunotherapy, often eradicating cancer completely for some cancer patients,” said NIH Director Dr. Francis S. Collins. “We need to bring that kind of success and hope for more people and more types of cancers, and we need to do it quickly. A systematic approach like PACT will help us to achieve success faster.”
According to an NIH spokesperson, “PACT originated out of discussions around the Cancer Moonshot in 2015 to 2016, and was first presented in the White House Cancer Moonshot Summit held with leaders from the cancer community on June 29, 2016. Following this meeting, NIH, with the help of FNIH, invited major biopharmaceutical companies to participate in a partnership design effort to identify the key questions to be addressed and outline potential solutions. Fourteen companies joined the design effort. FNIH conducted a design effort with these companies for six months beginning in August 2016, and solicited funding for the resulting design from all major pharmaceutical companies. The majority of the companies involved in the design elected to provide funding for PACT, as did several companies who had not participated in the design.”
PACT will facilitate systematic and uniform clinical testing of biomarkers to advance the understanding of the mechanisms of response and resistance to cancer therapy. The research conducted under the partnership will also integrate immune and other related oncology biomarkers into clinical trials by defining a set of standardized biomarkers to be tested across a variety of studies, an approach that will allow for: consistent generation of data; uniform and harmonized assays to support data reproducibility; comparability of data across trials; and discovery and validation of new biomarkers for immunotherapy and related combinations. PACT will also facilitate information sharing by all stakeholders to better coordinate clinical efforts, align investigative approaches, reduce duplication and enable more high-quality trials to be conducted.
“A scientific and organizational challenge this complex cannot be addressed effectively by any one organization acting alone,” said Dr. Maria C. Freire, president and executive director of the FNIH. “Instead, it requires the energies and resources of public and private partners working in close collaboration.”
PACT partners include AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corp., Genentech (a member of the Roche Group), Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research and Pfizer Inc. Additional support has been provided by the Pharmaceutical Research and Manufacturers Association (PhRMA). The 11 corporate partner organizations will contribute up to $1 million per year for five years through the FNIH for a total private sector contribution of $55 million. NIH will contribute $160 million over the five years of the partnership, pending availability of funds.
NIH’s National Cancer Institute (NCI) recently awarded cooperative agreements to support four Cancer Immune Monitoring and Analysis Centers (CIMACs) and a Cancer Immunologic Data Commons (CIDC) with a total of $53.6 million in funding over five years. The four CIMACs and one CIDC will form a network of laboratory centers that will support both adult and pediatric immunotherapy trials. Researchers at the CIMACs will perform deep tumor and immune profiling. The resulting data will be collected in the CIDC database for exploration of biomarkers of immune response. This network will also provide a foundation for the core laboratory, assay development and database functions required by PACT.
“The funding for PACT will establish a network of core laboratories to develop and validate biomarkers and related assays using a set of standards developed in conjunction with NCI, the companies and FDA. The markers and assays will be incorporated into clinical trials sponsored by NCI, industry or patient non-profit organizations, and the resulting data stored in a database that is made available to the entire oncology research community,” says an NIH spokesperson. “PACT will create a comprehensive database that integrates biomarker and clinical data that will be made available to all researchers. The CIMAC-CIDC Network will provide a foundation for the core laboratory and database functions required by PACT.”
The NCI cooperative agreements have been awarded to Dana-Farber Cancer Institute (CIMAC and CIDC), Stanford Cancer Institute (CIMAC), Precision Immunology Institute and the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai (CIMAC) and University of Texas MD Anderson Cancer Center (CIMAC).
A repository for biomarker data
DDNews also spoke about PACT with Dr. Sacha Gnjatic, associate director of the Human Immune Monitoring Core and associate professor of immunology and hematology and oncology at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.
“The NCI is funding an entity named Cancer Immunologic Data Commons that will serve to compile all the results generated from CIMACs (the four chosen centers for immune monitoring and analysis, which will generate all the data),” Gnjatic says. “This should help not only create a data repository for biomarker discovery that could be mined for secondary analysis and correlations between diverse datasets, but also advance public knowledge about immune profiles in certain classes of disease in response to various immuno-oncology drugs.”
Mount Sinai was chosen as a comprehensive center to perform immune monitoring and analysis of clinical trials testing cancer drugs that modulate the immune system. Part of its work with PACT will be to ensure that methodological approaches are reliably and reproducibly performed, so that the information can be quickly translated into useful tests to increase the chances of response to treatment.
“These efforts cast a wide net to measure not only the effect of immunomodulating drugs on tissues, cells, bacteria, proteins and genes, but also to help understand underlying immune competence before patients even start treatment that could explain their clinical outcomes,” says Gnjatic. “As a collaborative effort with three other centers funded through a U24 collaborative grant from the NCI, we expect to find new biomarkers that could rapidly lead to new or better immunotherapies. We are thrilled to be a recipient of this grant, particularly because it recognizes that the key to developing better cancer immunotherapies is to understand how the immune system changes and interacts with tumors throughout treatment.”