March 21, 2018 3:49 AM ET


Company Overview of Chronix Biomedical, Inc.

Company Overview

Chronix Biomedical, Inc., a molecular diagnostics company, develops blood tests primarily for monitoring minimal residual disease in cancer patients. It develops Second Opinion supplementary test, a biomarker diagnostic test that enables the physician to determine whether cancer actually remains in the body post chemotherapy; and technology for measuring personalized biomarkers in cancers of the colorectum, prostate, lung, ovarian, pancreas, blood, and central nervous system. The company was founded in 1997 and is based in San Jose, California. It has laboratories in Göttingen, Germany; and Brookings, South Dakota.

5941 Optical Court

Suite 203E

San Jose, CA 95138

United States

Founded in 1997





Key Executives for Chronix Biomedical, Inc.

Co-Founder, Chief Executive Officer, Chief Science Officer and Director
Age: 63
Co-Founder and Director
Age: 65
Chief Financial Officer and Senior Vice President of Finance & Administration
Age: 59
Chief Oncology Expert and Member of Medical Advisory Board
Chief Technology Officer
Compensation as of Fiscal Year 2017.

Chronix Biomedical, Inc. Key Developments

Chronix Biomedical, Inc. Reports Positive Results in Organ Transplant Rejection

Chronix Biomedical, Inc. reported the successful completion of an R&D programme to establish whether its technology can be used to detect early signs of rejection in organ transplant patients, a potential new application. The company has completed two clinical trials to validate its methodology in heart and liver transplant patients and has presented the results of these studies formally at a scientific meeting and in a peer reviewed journal. Circulating graft-derived cell-free DNA (GcfDNA) is becoming recognised as a biomarker for acute transplant rejection. Moreover, if GcfDNA could be monitored real-time, it would allow physicians to adjust immunosuppressive therapy to prevent damage to the transplanted organ. However, the current approaches to evaluate GcfDNA require massive parallel sequencing of donor and recipient's DNA, which is expensive and time consuming. The company has developed a simpler methodology using digital PCR to obtain an assessment of GcfDNA that allows faster and more frequent monitoring of transplant patients. This has now been validated in two clinical studies and the results have been presented and/or published. Earlier this month, Chronix presented the results of its clinical study in heart transplant patients at the American Association of Clinical Chemistry (AACC) annual meeting. The study evaluated GcfDNA in 219 blood samples from 84 adult cardiac transplant patients that were taken periodically over at least one year following transplantation. As expected, the ratio of GcfDNA to overall cfDNA was found to be initially high (>5%) on the first day after transplantation and to fall by more than 95% (<0.25%) over seven days where, in stable patients, it remained throughout the one-year observation period. The study's key findings were: Median GcfDNA was 2.7-fold higher in samples from the 19 patients with biopsy-proven rejection than in the samples from 23 patients who were biopsy-negative for rejection. Median GcfDNA was significantly higher in biopsy-proven acute rejection, compared clinically stable patients without suspicion of rejection (p<0.0001). Median GcfDNA was significantly elevated in samples taken as early as nine to 30 days prior to a biopsy-proven acute rejection episode (n=14; p<0.0001). The high-sensitivity cardiac troponin I assay (hsTroponin I), which is currently used for monitoring for rejection in this indication, showed only a moderate correlation with GcfDNA (r= 0.50), and was less sensitive for detection of rejection. A second study in liver transplant patients was published in PLOS Medicine earlier this year. This study evaluated GcfDNA in 107 adult liver transplant patients over a one-year period post-transplant. The study also found GcfDNA, relative to cfDNA, to be high (>50%) on the first day post-transplant and to fall by more than 80% over seven to ten days (<10%), where it remained, in stable patients, over the one year observation period. This study's key findings were: Median GcfDNA was almost ten-fold higher in the 17 patients with biopsy-proven acute rejection, than in the 88 stable patients, a statistically significant difference (p<0.001). Liver function testing had a low overall correlation with GcfDNA (r=0.28-0.62). Diagnostic sensitivity and specificity were 90.3% and 92.9% for GcfDNA. The area under the curve, a standard measurement of diagnostic performance, was higher for GcfDNA (97.1%) than for conventional liver function tests (82.6%-95.7%). The successful completion of these two studies allows Chronix to plan further work and to commercialise tests in the transplantation area, which will complement its activities in cancer diagnostics. Chronix's primary focus is the commercialisation of diagnostic tests for the real-time therapeutic monitoring of response to cancer therapy, which are based on its proprietary copy number instability (CNI) score, derived from circulating cell-free tumour DNA (cfDNA). The company is conducting a number of validation studies designed to support future regulatory submissions for therapeutic monitoring tests in several cancer types. The company believes these tests could 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 outcomes. 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 chemotherapy and immunotherapy at scientific meetings. Results from a blinded clinical validation study in eight different tumours treated with immunotherapy were recently published in Clinical Cancer Research. In addition, results from a study on CNI as a prognostic test for recurrence in head and neck cancer were presented at this year's ASCO annual meeting.

Chronix Biomedical, Inc. Reports Positive Interim Pancreatic Cancer Data

Chronix Biomedical, Inc. reported 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 chemotherapy 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. Patients were also assessed by radiologic imaging (RECIST). The interim analysis 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.

Chronix Biomedical, Inc. Announces Details from it's Study of Copy Number Instability Score Test in Head and Neck Cancer

Chronix Biomedical, Inc. announced further details from its study of its copy number instability score test in head and neck cancer. This study found: 29/42 patients with =T3 tumours and 11/12 with T4 tumours had elevated CNI scores, with significantly higher CNI scores seen for T4 tumours (p=0.04)1. Patients with tumour lymph node invasion (n=37) had significantly higher CNI scores than those with negative lymph nodes (n=17), p= 0.0004. CNI scores showed a steep decline after surgical resection and increased with disease progression. Pre-operative CNI scores was a stronger predictor of time to recurrence (p=0.00007) than lymph node status (p=0.05). High baseline CNI correlated with time to recurrence (p=0.018). Chronix is developing a number of tests for the prognosis and diagnosis of cancer and, in particular, the real-time therapeutic monitoring of response to cancer therapy, based on its proprietary CNI score. Chronix and its collaborators have shown that CNI scores 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. Such a test should allow treating physicians to identify non-responding patients quickly and switch them to alternative treatments sooner, avoiding unnecessary side-effects and potentially achieving better treatment outcomes.

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