• Interim data from an ongoing validation study in pancreatic cancer suggest CNI score is a better predictor of response to chemotherapy than CA19-9
  • Data supports choice of pancreatic cancer as lead indication for Chronix regulatory strategy

San Jose, CA, USA and Göttingen, Germany (14 June 2017) – Chronix Biomedical, Inc., a developer of novel blood-based cancer molecular diagnostics, reports a positive interim analysis of its ongoing validation study of its Copy Number Instability (CNI)-based therapeutic monitoring test in pancreatic cancer. The study compares the accuracy of Chronix’s CNI-based test at predicting a clinical response, as early as after the first cycle of chemotherapy1 compared to CA19-9, a commonly used biomarker. CA-19-9 is often used as an aid in prediction of response in pancreatic cancer, but suffers drawbacks, of which one is that it is only present in a proportion of patients.2 Patients were also assessed by radiologic imaging (RECIST). The interim analysis3 was performed on samples from the first 37 patients enrolled in the study and found:

  • CA19-9 levels could only be measured in 29 of 37 (78%) evaluable patients.
  • Directional changes in CA19-9 and CNI scores from baseline to cycle two agreed in only 18 of the 29 patients with CA19-9 results.
  • Nine of the 11 cases in which CA19-9 and CNI dynamics were discordant had response evaluations (RECIST) and CNI predicted outcome in 7 cases (78% concordance).
  • In contrast CA19-9 was increasing and incorrectly predicting progression when the response was stable disease or better and therefore only showed a 22% concordance.
  • In the 27/29 patients with available imaging, CNI provided a better prediction of response (n=18) than CA19-9 (n=10), a statistically significant difference (p=0.03).

The study continues to accrue patients and Chronix hopes to present updated results from a subsequent interim analysis at a major scientific meeting later this year or in early 2018. Chronix is developing CNI-based tests for diagnosis of cancer and, in particular, the real-time therapeutic monitoring of response to cancer therapy. The company is conducting validation studies designed to support future regulatory submissions in several individual cancers, the most advanced of which is pancreatic cancer. This study will continue to enroll patients and evaluate CNI scores prior to the start of treatment and after the first, second and fourth cycles of chemotherapy. Final results are expected early next year.

Pancreatic cancer has one of the worst prognosis as well as the most limited treatment options of all of the common solid tumour types. However, the recent introduction of a new second line therapy choice makes it a viable target for Chronix’s therapeutic monitoring approach. The company believes its CNI-based test could be used to identify non-responding patients quickly and allow treating physicians to switch them to other anti-tumour therapies sooner, avoiding unnecessary side-effects and potentially achieving better treatment outcome.

Chronix Biomedical’s CMO, Dr Ekkehard Schütz, commented:

The interim data suggest the validation study will show CNI to be superior to the currently used biomarker, which is itself severely limited by the fact it is only present in a proportion of all pancreatic cancer patients. We believe that the early prediction of response possible with CNI will help physicians improve treatment of this condition, even with the current limited choice of approved therapies.

Chronix and its collaborators have shown that CNI can accurately determine, whether a patient is responding to treatment after just one or two cycles of therapy, potentially 6-8 weeks earlier than is possible using imaging-based methods. The company has presented data from studies of CNI tests in patients who have received radiotherapy, chemotherapy4 and immunotherapy.Results from a clinical study in eight different tumours where patients received immunotherapy were recently published in the journal, Clinical Cancer Research.The company has also just presented a poster showing the potential of CNI as a prognostic test for recurrence in head and neck cancer at the ASCO annual meeting.7

About Chronix Biomedical

Chronix Biomedical, Inc. is a US-based molecular diagnostics company developing blood tests for the screening and monitoring of cancer. 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. Chronix already offers supplemental screening evaluation tests based on copy number instability for diagnosis of breast and prostate cancer. For more information visit www.chronixbiomedical.com.


1 FOLFIRINOX (folinic acid, fluorouracil, irinotecan and oxaliplatin); CAPIRI (capcitabine and irinotecan); or gemcitabine +/- nab-paclitaxel.

2 CA19-9 is present in 70-90% of PDAC patients, depending on race.

3 The interim analysis was performed based on a data cut from January 2017.

4 Changes in tumor cell-free DNA copy number instability (CNI) predict therapeutic response in metastatic cancers, Weiss et al, American Association for Cancer Research 2016 Annual Meeting (see link).

5 Tumor cell-free DNA copy number instability (CNI) predicts therapeutic response to immunotherapy prior to cycle 2” Weiss et al (see link)

6 Tumor Cell-Free DNA Copy Number Instability Predicts Therapeutic Response to Immunotherapy, Weiss at al (see link).

7 Cell-free DNA for treatment monitoring and outcome predictor in head and neck cancer, Beck et al (see link)   



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