A: By applying CSPTM technology, GeneCentric is developing universal drug response biomarkers to enable more effective and efficient drug development informed by high resolution, genomic-defined cancer subtypes. This approach is distinct from other strategies which seek to generate biomarkers by profiling responders to specific drugs. Instead, CSP-derived genomic profiles are designed to characterize tumor biology by combining gene expression data with disease-related molecular pathways and immune cell expression through advanced computational biology technologies.

A: Today, new treatment approaches such as immunotherapy and molecularly targeted therapies have begun to change the landscape for cancer treatment. This has resulted in dramatic improvements in long term survival rates compared with conventional chemotherapy, but the benefit has only been realized in a subset of patients. We believe that by targeting biological subtypes, drug developers could increase clinical development success for new therapies while expanding indications for existing drugs and achieving better patient outcomes overall.

A: CSPTM leverages enormous, publicly available gene expression datasets complemented by proprietary data and tools to develop discrete sets of key genes that define cancer subtypes. By reducing the multitude of genes associated with each cancer to discrete key gene sets, GeneCentric enables rapid development of tumor specific clinical assays. CSPTM assays are “platform agnostic”, capable of being deployed on established, commercial instruments.

GeneCentric’s ability to identify and reduce to practice a select set of genes that define cancer subtypes and predict drug response underlies the company’s core patents and proprietary position.

A: Our initial subtypes were developed in conjunction with our scientific founders, Chuck Perou and Neil Hayes, who are experts in lung and head and neck cancer. Our subsequent profilers, such as bladder cancer, were developed in response to interest from our pharmaceutical partners. We plan to announce additions to our completed profilers shortly, also added due to commercial opportunities.

A: GeneCentric’s CSPTM provide unique value at each phase of drug development. As a couple of examples, CSPTM can be investigated as a response biomarker on retrospective data sets, which can be particularly useful if there were unexpected findings in the study. As I noted before, CSPTM profilers were developed to be platform agnostic, and therefore, can be developed as companion diagnostics to be integrated into a prospective trial to support drug approval or expand market potential. Conversely, our CSPTM can be applied in the setting of prospective clinical studies, to enrich for patient responders by qualifying them not merely on the basis of a particular alteration or mutation, but rather on their particular subtype comprised of both tumor and immune biology features to better characterize the nature of an individual’s cancer as well as the likelihood of response to both the active agent being tested, as well as the comparator agent against which it is being evaluated. This approach can increase the likelihood of favorable response to the active agent as well as accelerate conduct of the study – contributing to overall program success.

A: We’re looking forward to publishing some recent results using the CSPTM technology.

A: We’ve all been excited about the recent successes that patients have been realizing with the expanded use of immunotherapy for the treatment of many different types of cancer. This has been truly transformative for patients who previously had little hope.

As we develop more treatment options for cancer patients, the fundamental tenets of precision medicine become even more critical: finding the right drug for the right patient. Therefore, the ability to define the fundamental biology of each patient’s tumor, through the development of better biomarkers (and future companion diagnostics), becomes even more critical.

In addition to thinking about the science of precision medicine, it’s interesting to look at the strategic moves that significant healthcare companies are making. For example, Roche acquiring Foundation Medicine, Flatiron Health, and Ignyta; LabCorp acquiring Covance; CVS acquiring Aetna, all signal that companies are thinking about different ways to deliver healthcare in the future.

A: Many of the fundamental issues facing precision medicine overall are also at play in the development of subtype profiler assays we are advancing with our academic and industry partners. From the technical perspective, the drive toward liquid biopsy for detection and characterization of cancers, as well as assessment of response, is an area of tremendous effort, investment and potential. Progress has not been as rapid as many hoped, and translating our assays to the setting of liquid biopsies is also one of our objectives. On the practical side, the appreciation of both the clinical and economic value of NGS and novel biomarkers is a cause being spearheaded by PMWC among others. Resetting the value proposition for biomarker development and use among payers and providers, in order to enable their more effective and efficient development would be a transformational change for both industry and diagnostic companies, with the greatest beneficiaries being patients and the clinicians who care for them.

A: I’d like to thank the PMWC for understanding the importance of bringing together such an esteemed audience and for expanding its activities into North Carolina.