Dana-Farber’s Year of Milestones – 2017

As 2017 comes to a close, Laurie H. Glimcher, MD, has completed her first full year as President and CEO of the Dana-Farber Cancer Institute. Under Gilmcher’s leadership, Dana-Farber has achieved many milestones in cancer science and medicine. Dana-Farber is one of the world leaders in leveraging the human immune system to fight cancer, and in 2017 its team of researchers demonstrated the effectiveness of the first-ever personalized cancer vaccine in a clinical trial for melanoma.

Each patient a part of its melanoma study achieved complete remission from advanced phases of the disease, either from the vaccine they developed or in combination with another immunotherapy. These findings marked a transformation for cancer research. Dana-Farber remains as determined as ever to keep expanding the benefits of such discoveries to more patients.

Dana-Farber has been pivotal to drug development. Of the 75 cancer drugs approved by the FDA since 2011, Dana-Farber has been deeply involved in nearly half—including the recent landmark approval of CAR T-cell therapy, a new immunotherapy, for adults with non-Hodgkin lymphoma.

Dana-Farber currently has 900 clinical trials of various innovative therapies underway. Only select trials are supported by federal funding, the rest are available to patients because of the support Dana-Farber receives from its partners. Dana-Farber is considered a prestigious cancer center because it not only offers a commitment to research but also to patient care. Its success and commitment to its patients was recognized by Becker’s Hospital Review when they named Dana-Farber one of the 100 Great Hospitals in America for 2017.

NIH partners with 11 leading biopharmaceutical companies to accelerate the development of new cancer immunotherapy strategies for more patients

In late 2017, The National Institutes of Health and 11 leading biopharmaceutical companies started the Partnership for Accelerating Cancer Therapies (PACT). PACT is a five-year, $215 million, public-private research collaboration that is part of the Cancer Moonshot. PACT’s initial efforts will be focused on identifying, developing and validating robust biomarkers with the goal of advancing new immunotherapy treatments that harness the immune system to attack cancer. The PACT partnership will be managed by the Foundation for the National Institutes of Health (FNIH) and the Food and Drug Administration serving in an advisory role.

Eric Hargan, Acting Health and Human Services Secretary stated, “This new public-private partnership is a significant step forward in the battle against cancer and a real boost to the potential of immunotherapy. We are excited for this partnership, which will strengthen efforts already underway across HHS.”

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

This partnership will help to increase the overall understanding of response mechanisms and resistance to cancer therapy by facilitating systematic and uniform clinical testing of biomarkers. PACT’s research will define a set of standardized biomarkers to be tested across a variety of studies allowing them to be integrated into immune and other related oncology biomarkers into clinical trials.

In addition, PACT will facilitate information sharing amongst stakeholders to better coordinate clinical efforts, align investigative approaches, reduce duplication and enable more high-quality trials to be conducted. The constant gene uniform and harmonized assays will be facilitated in support of data reproducibility, comparability of data across trials, and discovery and validation of new biomarkers for immunotherapy and related combinations.

FNIH President and Executive Director Maria C. Freire, Ph.D. stated, “A scientific and organizational challenge this complex cannot be addressed effectively by any one organization acting alone. Instead, it requires the energies and resources of public and private partners working in close collaboration.”

Dr. Harvey Berger Discusses Ponatinib

Ariad Pharma CEO on Latest Leukemia Data from CNBC.

Dr. Harvey Berger discusses ponatinib, an oral drug developed by ARIAD to treat chronic myeloid leukemia(CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Ponatinib was designed to treat the resistant and tolerant forms of CML helping patients who have a mutation resistant to other cancer therapies.

ARIAD collaborators presented compelling clinical data about ponatinib at the American Society of Clinical Oncologists Meeting. Dr. Berger stated that “Well over one half of the patients who have failed every other CML drug, and had a very difficult time with their disease, now have a new treatment that will make a big difference in their lives.”

ARIAD collaborators presented compelling data about ponatinib and Dr. Harvey Berger has made numerous statements about this data at several points throughout the past few years. For instance, Dr. Berger stated, “Well over one half of the patients who have failed every other CML drug, and had a very difficult time with their disease, now have a new treatment that will make a big difference in their lives.”

Ponatinib was approved by the FDA on December 14, 2012, for patients with resistant or intolerant CML and Ph+ ALL. The approval was under the FDA Accelerated Approval program which required ARIAD to carry out additional studies. The FDA then granted full approval in 2016 that included a label update to Ponatinib.


Medinol Announces First Commercial Implantations of EluNIR™ Ridaforolimus-Eluting Coronary Stent System

Medinol announced that it obtained CE-mark for EluNIR™, its novel Drug Eluting Stent. This stent features a unique design to optimize clinical outcomes. The EluNIR will feature a low metal footprint and a proprietary elastomeric coating. EluNIR has demonstrated impressive outcomes in two randomized pivotal studies.

Medinol’s Chief Scientific Officer, Dr. Yoram Richter, stated “EluNIR is the culmination of over 20 years of Medinol research, development and science dedicated to improving clinical outcomes with coronary stent systems. Given the excellent results we have observed in our clinical studies for EluNIR, and the renewed focus on metallic drug eluting stents, we are excited to bring EluNIR to the European interventional cardiology community as physicians continue to drive towards optimizing results for their patients.”

Dr. Alaide Chieffo noted, “Our first cases were very successful and the EluNIR stent system with its metallic spring tip demonstrated high deliverability. The first case involved LAD disease distal to a very tortuous LIMA. The second case involved a severely calcified and diseased LAD that could not be crossed with another new generation DES despite lesion preparation with Rotablator, and was successfully treated with EluNIR. In a third case, the lesion was in a proximal RCA with unfavorable take-off and insufficient guiding-catheter support, and was also treated nicely with EluNIR. I have confidence in the longer term outcome as we continue to follow the patient’s’ progress.”

EluNIR will be available to select centers in Europe and other locations by late 2017. In 2018, a full range of sizes will be available. The EluNIR Stent System is an investigational device, not available for sale in the United States and Japan.