The Pierian Spring Blog
In late February, the American Society of Clinical Oncology (ASCO) partnered with the Society for Immunotherapy of Cancer (SITC) to host the first ASCO-SITC Clinical Immuno-Oncology Symposium, held in Orlando. We learned, along with 1000 other attendees, about the leading clinical research regarding immunotherapy (IO) treatment and the exciting, yet, gradual move from IO research to actual patient application.
The concept of immunotherapy, using the body’s immune system to help fight cancer, is making tremendous strides in today’s cancer research. In just the last five years, research has proven that manipulation of the immune system can control, or in some cases, completely eradicate tumors. As chemotherapy, targeted therapy, radiation therapy, and surgery are used to aggressively destroy cancer cells, with IO, researchers are working to develop strategies to harness the body’s own immune system to combat cancer. When the immune system is strengthened, risk on the patient’s long-term health is reduced in comparison to more aggressive cancer treatment approaches.
What happens when IO therapy is combined with traditional treatment approaches? The potential for positive outcomes in the oncology field grows even more substantially. Researchers have been testing immunotherapy as one component in combination cancer treatment, and the idea is gaining traction. At ASCO’s symposium, many presenters mentioned the theory of the “abscopal effect” (ab meaning “away from,” and scopus meaning “target”), a term coined in the 1950s to describe the phenomenon when treating metastatic cancer with radiation. The abscopal effect occurs when the localized treatment of a tumor causes not only a shrinking of the treated tumor, but also a shrinking of other tumors outside the scope of irradiated area. In 2015, EB Golden and colleagues ran a clinical trial which demonstrated that abscopal responses were consistently detected in patients treated with the combination of radiation therapy and immunotherapy. In practice, a breast cancer patient receiving IO combined with radiation has been shown to demonstrate a positive response on a spinal lesion or other location in addition to the irradiated tumor. The thinking is that radiation primes the immune system to recognize tumor-specific targets as those cells die, which is then translated into a systemic effect.
Research combining chemotherapy and immunotherapy was also presented and discussed. To change the tumor’s microenvironment, researchers are using doses of chemo to destroy cells that are blocking the immune system from functioning, instead of using the dosage required to kill cancer cells. This process converts the “unresponsive” cancers to responsive, allowing immunotherapy to work effectively.
But what dose and schedule of chemotherapy is enough to kill the cells blocking the immune system, yet not so strong that it wipes out the body’s defense mechanism? Which cytotoxic is best, what is the best dose and schedule, is this approach beneficial for all tumor types and all patients? Which patients would respond better to a combination of immunotherapy plus chemotherapy as opposed to those who would fare better with one treatment or the other? There are clearly more questions than answers at this time.
At the symposium, a recognized leader in the field, Lisa Butterfield, led a session on “Immune Biomarkers in the Blood” featuring research findings on immune biomarkers and their ability to offer insight into the interactions between the immune system and cancer. These interactions can help to define which immunotherapy should be selected to best defend the body using its immune system.The current research focus is on finding markers that suggest a patient will respond to any immunotherapy (IO), rather than using the biomarker to determine which IO would work best for their specific tumor and cancer.
The more we know, the better the outcome. At Pierian Biosciences, we’ve invested years of research in developing a series of functional assays including our latest platform, ImmunoINTEL. The ImmunoINTEL platform is being developed as a functional I-O platform incorporating information from intra-tumoral as well as peripheral immune mediators that will predict which immunotherapeutic will be of greatest benefit for each individual patient. Our goal is for the information provided by the assay to deliver the intelligence needed to determine which treatment or combinations of treatment will be most effective based on a patient’s actual tumor response in the lab, before introducing the treatment to the patient. A functional assay should more precisely predict a cancer treatment outcome and thereby increase efficacy cut costs by eliminating ineffective treatments, avoid the toxicity associated with ineffective therapies and improves the patients overall quality of life, resulting in a more effective and successful treatment experience from day one. We call that a win/win.
Immunotherapy is making great strides in the treatment of cancer, evidenced by the fact that the ASCO-SITC Immuno-Oncology Symposium drew 1,000 of us who came to listen. At Pierian, we too, are embracing immunotherapy by providing the tools that oncologists need to develop customized treatments that result in significantly improved treatment outcomes.:
 Winslow, R. Cancer’s Super-Survivors/How the Promise of Immunotherapy Is Transforming Oncology. Wall Street Journal. Dec 4 2016.
 Disis, M.L. & Kaufman, H.L. Cancer Immunotherapy: The End of the Beginning or the Beginning of the End. Ummunsym.org Daily News, published February 17, 2017.
 Mole, R.H. Whole body irradiation; radiobiology or medicine? Br J Radiol 1953; 26:234-41. 10.1259/0007-1285-26-305-234
 Golden EB, Chhabra A, Chachoua A, et al. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol 2015;16:795-803. 10.1016/S1470-2045(15)00054-6
 Thaker, P. H. (2017, February). Phase I study of the safety and activity of formulated IL-12 plasmid administered intraperitoneally in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer. Poster session presented at the ASCO-SITC Clinical Immuno-Oncology Symposium, Orlando, FL. Retrieved from: http://meetinglibrary.asco.org/content/178595-194
 Nyberg, K. (2017, February 24). Leveraging Immune Biomarkers in the Blood to Guide Immunotherapy—Current Application and Future Prospects [Daily News]. Retrieved from http://immunosym.org/daily-news/leveraging-immune-biomarkers-blood-guide-immunotherapy-current-application-and-future
CLIENT: Pierian Biosciences
DATE: February 17, 2017
PROJECT: PR – Blog post – Response to FiercePharma article
Author: Robert Henry
A recent FiercePharma article on the top 15 cancer drugs for 2022 predicts they will total nearly $90 billion in sales. That’s a big jump, considering global spending on all cancer drugs was $107 billion last year. Immunotherapy-based drugs, largely described as checkpoint inhibitors, are a big driver in these price increases. According to FiercePharma, “This brand-new category of cancer drugs works by activating the immune system, enabling it to recognize cancer cells and destroy them. The class of drugs has achieved unprecedented efficacy in a broad range of cancers and provides a much-needed new treatment approach alongside chemotherapy and targeted cancer drugs, which tend to lose efficacy over time.”
The emerging field of immuno-oncology shows great promise, despite the high price of immunotherapy drugs. That’s not the case for some chemotherapy agents. According to a study in JAMA Internal Medicine, several chemotherapy drugs did not to offer the long-term survival rates to justify their high price.
For cancer warriors – clinicians, patients and researchers – it’s time to deploy new weapons in the fight against cancer. We’re entering this fight with technology platforms based on the MiCK and CEER assays, now renamed ChemoINTEL and PathwayINTEL respectively, to help clinicians identify the most effective targeted therapy for cancer patients. They provide patient-centric, personalized intelligence on the effectiveness of chemotherapy and targeted therapy treatments, to help support clinical decision-making and drug development. Our strategy is to conduct clinical studies to support regulatory approval of these platforms by the Food and Drug Administration.
Cancer isn’t going away. Chemotherapy drug prices aren’t going down. Providers and researchers need more tools in their toolkit. At Pierian, we’re working hard to bring our treatment directing diagnostics to transform the cancer treatment experience for cancer patients across the globe.
Client: DiaTech Holdings/Pierian Biosciences, Inc.
Date: September 21, 2016
Project: PR – Op-Ed: Response to New Clinical Trials Requirements from HHS
Cancer deaths have declined substantially in the past decade. According to the National Cancer Institute, from 2003 to 2012, cancer deaths rates decreased by 1.8 percent per year among men, 1.4 percent per year among women, and 2.0 percent per year among children. While these are certainly promising developments, cancer isn’t going away any time soon.
For many cancer patients, hope for a cure lies in the results of clinical trials, which might point to newer, more effective treatments. The 2016 announcement from the Department of Health and Human Services, which calls for making information about clinical trials more widely available, offers these patients a ray of hope. It improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies.
As a member of the biotech community, I’m delighted about the new requirements. No matter what the results might be, the more clinical trial information is shared, the faster we develop transformational diagnostic tools and therapies.
These requirements coincide with our own clinical trials journey. Our technology platforms based on the MiCK and CEER assays and now renamed ChemoINTEL and PathwayINTEL respectively, help clinicians identify the most effective targeted therapy for cancer patients. They provide patient-centric, personalized intelligence on the effectiveness of chemotherapy and targeted therapy treatments, to help support clinical decision-making and drug development. Our strategy is to conduct clinical studies to support regulatory approval of these platforms by the Food and Drug Administration.
Prior to the new rules going into effect, the sharing of summary results for clinical trials was inconsistent. Effective January 18, 2017, summary results must be posted within a year of a trial’s completion, even if the product being tested is not yet FDA-approved.
This is a step forward for patients and their families looking for promising new treatments. According to FDA Commissioner Robert M. Califf, M.D., “When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers.”
Some in the biotech community may be wary that all this transparency might interfere with their proprietary solutions. But clinical trials are everyone’s risk, responsibility and ultimately, reward.
The more information we share, whether positive or negative, the more we can drive down the cancer death rate even further. That’s good news for everyone.
.Robert Henry is the president and chief executive officer of Pierian Biosciences
Cancer. The numbers tell the story. 1.6 + million people diagnosed this year. National expenditures for cancer care totaling nearly $125 billion. Significant advances in the last thirty years of creating standards of care for many diseases. Effectively treating cancer goes beyond a standard approach. Welcome to the era of personalized medicine; treating patients as individuals, a therapeutic, biomarker-based approach emphasizing the use of personal genetics. Now imagine taking this method one step further. Curating actionable information related to the targeted treatment, delivered directly to physicians.
A powerful combination of data, bioscience, art and intelligence.
We are Pierian Biosciences. Our mission is profoundly changing the cancer treatment experience for patients and providers.
Our name, a Greek mythology reference to a metaphorical knowledge source of art and science. Our company is Inspired by Dr. Paul Kalanithi’s indelible book “When Breath Becomes Air”, detailing his relationship with medicine, through the moment of diagnosis and then treatment. The precision used as he writes about the first time he looked at his scans and the terrible time when his oncologist is away, treating him as a problem, not a patient. Denied the medicine he needs by a resident who provided the “standard of care.”
Pierian Biosciences model and innovative approach are rooted in individuality. Integrating an individual’s response and the variability in their individual instance of cancer to determine the right course of treatment. Taking the data one step further, Pierian gathers information throughout the entire treatment process, from diagnosis to recurrence. Providers now have a wealth of information, beyond the average and genetic profile.
Harvesting that information and measuring cancer cells in real-time is what matters. Breakthrough medicine. The right information, served at the right time, leading to predictive and personalized cancer treatments.
Customizing cures based on the person, not the disease. Measuring molecular changes in cell structures over a 48-hour period, providing physicians and clinicians feedback as to what chemotherapies may predict positive outcomes. Real-time, actionable information.
We are Pierian Biosciences. Personalized Cancer Intelligence.