Data from pilot studies using Chronix’s CNI test submitted for presentation at a
high profile scientific meeting and for publication in a prominent peer-reviewed journal

San Jose, CA, USA and Göttingen, Germany (27 February 2016) – Chronix Biomedical, Inc., a developer of blood-based molecular diagnostics, is pleased to report the successful outcome of two pilot studies of its liquid biopsy test for assessing the response to treatment in different solid tumour types. Chronix’s tests use proprietary algorithms to derive a copy number instability (CNI) score from sequencing of circulating cell-free tumour DNA (cfDNA), which can be used in the prognosis, diagnosis and monitoring of therapeutic response to cancer.

The pilot studies were conducted in pancreatic cancer and in head and neck cancer. In the former, the CNI score was found to perform better in predicting response to treatment than the commonly used biomarker CA19-9, while in the latter, baseline CNI score was found to be a better predictor of time to recurrence than the currently used method based on invasion of the lymph nodes. Data from both studies have been submitted for presentation at a high profile scientific conference this year and will be reported in line with the conference organisation’s disclosure policies.

In addition, Chronix reports that a separate study of the CNI test in assessing response to treatment in a number of solid tumours has been submitted to a prominent peer-reviewed journal. Further details on this study will be disclosed on its publication, which is expected in the next few weeks.

Chronix believes its CNI technology may be particularly suited to a therapeutic monitoring strategy in oncology, which could have great utility if it permits physicians to identify non-responding patients rapidly and switch them to alternative treatment options. The company’s pilot studies suggest CNI is able to provide an indication of therapeutic response earlier than is possible with imaging, and/or with greater accuracy than with biomarkers. Changes in the CNI score have also been found to be robust with all three of commonly used treatment modalities: chemotherapy, radiotherapy or immunotherapy.

Chronix is well underway with the first of several planned validation studies, which will evaluate CNI in monitoring response to first-line gemcitabine or Folfirinox chemotherapy in metastatic pancreatic cancer. This study will enroll 150 patients and evaluate CNI scores prior to treatment and after the first, second and fourth cycles of chemotherapy and compare the performance with CA19-9. In this specific indication, a therapeutic monitoring test could be particularly useful, given the toxicity associated with chemotherapy as well as the recent introduction of a new second-line therapy choice.

Chronix expects to initiate new therapeutic monitoring validation studies in non-small cell lung cancer, melanoma and colorectal cancer this year.

Chronix is also making excellent progress with recruitment into its large 1,500 patient validation study of CNI for a diagnostic application for prostate cancer1. This study is collecting blood samples from men who have been referred for a prostate biopsy following an abnormal PSA test or after a digital rectal examination.

The study will compare diagnosis based on CNI with the tissue biopsy-derived Gleason score and show whether CNI can discriminate cancer from two other prostate conditions: benign prostatic hyperplasia (BPH), a common and treatable non-cancerous enlargement of the prostate gland, and prostatic intraepithelial neoplasia (PIN), a pre-cancerous condition usually managed by active surveillance. Results should become available in early 2018.

A previous retrospective study over 200 patients published in the peer-reviewed journal Clinical Chemistry2, showed that CNI could discriminate between prostate cancer and non-cancer controls with a diagnostic accuracy of 83%. The CNI score could also distinguish between BPH and prostatitis from prostate cancer with a diagnostic accuracy of 90%.

Based on these data, Chronix has begun to offer a CNI-based risk assessment tool for prostate cancer called the Second Opinion™ Prostate Cancer Evaluation Test3. This is used as a supplementary evaluation to assist clinicians in their decision-making process on whether to refer for tissue biopsy, a patient with an elevated PSA or a suspicious MRI or digital rectal examination. Chronix believes the use of Second Opinion™ could reduce the high rate of false positives associated with routine PSA testing that lead to many patients undergoing unnecessary and invasive prostate biopsies.

Chronix Biomedical’s CEO, Dr Howard B. Urnovitz, commented:
“We are pleased to update shareholders about our recent successful trials and our planned presentations and scientific publications this year. The data, when published, will add to the growing body of evidence supporting our copy number index score as a means to provide valuable insights to physicians for the diagnosis and treatment of cancer.”

References

1. https://clinicaltrials.gov/ct2/show/NCT02771769
2. Clin Chem. 2015 Jan;61(1):239-48. doi: 10.1373/clinchem.2014.226571. Epub 2014 Oct 2
3. The Second Opinion™ Prostate Cancer Evaluation Test is a laboratory development test and currently offered in the UK, Germany and Poland through Chronix’s certified laboratories in Germany.

Contacts

Chronix Biomedical, Inc
Dr Howard Urnovitz, CEO
+1 (408) 960-2307
hbu@chronixbiomedical.de

Shard Capital Partners LLP
(Corporate Adviser and Broker)
Dr Wang Chong
+44 20 7186 9948
wang.chong@shardcapital.com