NIH, Big Pharma Launch Cancer Immunotherapy Drive

“Moonshot” goal: Spread success to patients in half the time

The National Institutes of Health (NIH) and 11 leading biopharmaceutical companies have launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totalling $215 million as part of the Cancer Moonshot. 

PACT will first focus on efforts to identify, develop, and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance immunotherapy treatments that harness the immune system to attack cancer. The Foundation for the National Institutes of Health (FNIH) will manage the partnership, with the FDA 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.

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 urgently needed for these therapies to benefit the maximum number of people.

“We have seen dramatic responses from immunotherapy, often eradicating cancer completely for some cancer patients,” said NIH Director Francis S. Collins, MD, PhD.  “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.”

PACT will facilitate systematic and uniform clinical testing of biomarkers to advance understanding of the mechanisms of response and resistance to cancer therapy.  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.

This approach 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 Maria C. Freire, PhD, 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, North Chicago, Illinois
  • Amgen, Thousand Oaks, California
  • Boehringer Ingelheim Pharma, Ingelheim, Germany
  • Bristol-Myers Squibb, New York
  • Celgene Corporation, Summit, New Jersey
  • Genentech, a member of the Roche Group, San Francisco
  • Gilead Sciences, Foster City, California
  • GlaxoSmithKline, Brentford, United Kingdom
  • Janssen Pharmaceutical Companies of Johnson & Johnson, New Jersey
  • Novartis Institutes for Biomedical Research, Basel, Switzerland
  • Pfizer, New York

Additional support has been provided by the Pharmaceutical Research and Manufacturers Association. The 11 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 five years, pending availability of funds.

The National Cancer Institute recently awarded cooperative agreements to support four Cancer Immune Monitoring and Analysis Centers and a Cancer Immunologic Data Commons with a total of $53.6 million in funding over five years.

Source: NIH; Thursday, October 12, 2017.