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Partnership aims to accelerate development of new immunotherapy strategies

Monday, October 23, 2017

The Partnership for Accelerating Cancer Therapies (PACT) has launched thanks to a partnership between the NIH and 11 biopharmaceutical companies. The goal of the new partnership is to accelerate the development of new cancer immunotherapy strategies for more patients in half the time. The initiative specifically aims to explore the question: Why doesn’t immunotherapy work for all cancers, in all patients, and what can be done about it?

PACT partners include AbbVie, North Chicago, Illinois; Amgen, Thousand Oaks, California; Boehringer Ingelheim Pharma, Ingelheim, Germany; Bristol-Myers Squibb, New York; Celgene, 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; and Pfizer, New York.

Additional support has been provided by the Pharmaceutical Research and Manufacturers Association (PhRMA). 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 the five years of the partnership, pending availability of funds.

This collaboration is the result of an idea that developed approximately two years ago when the NIH began to investigate ways to work with the private sector in cancer research in an effort to develop new treatments that would affect the most people. PACT is a five-year public-private research initiative totaling $215 million as part of the Cancer Moonshot, an initiative started in 2016. Since its inception, Cancer Moonshot has resulted in a large number of new initiatives aimed at accelerating cancer research, making more therapies available to more patients, preventing new cancers and even detecting the disease at an early stage.

PACT will initially focus its efforts on identifying, developing and validating robust biomarkers in an effort to advance new immunotherapy treatments that employ the immune system to attack cancer. New immunotherapies have resulted in impressive responses in certain cases of cancer. They have been the focus of intense investment by biopharmaceutical companies in an effort to provide new options specifically for patients who do not respond to other therapies.

“Amgen has seen first-hand the impact immunotherapies can have on the lives of cancer patients, yet we know far too little about why certain patients respond to these therapies and why others do not,” said David Reese, M.D., senior vice president of Translational Sciences at Amgen.

The PACT collaboration brings together leading researchers from the National Cancer Institute (NCI) and the pharmaceutical industry to overcome central obstacles to optimizing the power of immune-oncology therapies.

“By harmonizing the way we use biomarker tools, we believe we can reduce data heterogeneity and accelerate development of immunotherapies,” said Axel Hoos, M.D., Ph.D., co-chair of PACT and senior vice president of Oncology R&D at GlaxoSmithKline.

The research conducted under the partnership will 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 specific approach will allow for consistent generation of data, uniform and harmonized asssays to support data reproducibility, comparability of data across trials and discovery and validation of new biomarkers for immunotherapy and related combinations. Part of this process will include tracking combination immunotherapies and then recording which are likely to be most effective. There are ongoing discussions to determine which biomarkers to study first.

“A systemic approach like PACT will help us to achieve success faster,” said Francis S. Collins, M.D., Ph.D., NIH director.

Immunotherapy is one of the most promising fronts on the war against cancer, and PACT represents a unified focus on the part of a number of organizations to advance efforts in the field.

“While much progress has been made in cancer research, there are currently unmet needs that exist in oncology,” said Tom Hudson, M.D., vice president of Oncology Discovery and Early Development at AbbVie.

One of the most challenging and often problematic inefficiencies in research is redundancy in data collection relating to cancer drug trials. In fact, the Biden Cancer Initiative, building on the work set forth by Cancer Moonshot, was started, at least in part, to “reduce disparities in cancer outcomes through better organization of resources and systems.”

Delivering these results might be a challenge, but the goal is not viewed as impossible. An additional goal of the PACT partnership is to facilitate information sharing by all stakeholders to better coordinate clinical efforts, align investigative approaches, reduce duplication and enable more high-quality trails to be conducted.

“Often, clinical trials are closely tied to one project or organization. In contrast, this collaboration allows us to share information freely among all partners, combining and building on the knowledge we each gain to accelerate the pace and efficiency of new discoveries,” said Nicholas Dracopoli, Ph.D., vice president of Oncology Diagnostics at Janssen Pharmaceuticals.
Partners are in agreement that PACT has the potential to impact immunotherapy studies in a positive, exciting manner.

“This partnership, and the data partners have committed to making publicly accessible to the broader community, will facilitate our continued progress in helping to find the cancer treatments that benefit the most people,” said Douglas R. Lowy, M.D., acting director of the NCI.

“We are at the beginning of a new era of personalized cancer treatments. PACT’s planned research has the potential to advance understanding of the field,” said Kacy Hutchison, vice president of North America Government Affairs for Gilead Sciences.

 

This article was reprinted from Volume 21, Issue 42, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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