April 30, 2017 11:51 AM ET

Biotechnology

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

Phone:

408-960-2306

Fax:

408-960-2305

Key Executives for Chronix Biomedical, Inc.

Co-Founder, Chief Executive Officer, Chief Science Officer and Director
Age: 62
Co-Founder and Director
Age: 64
Chief Financial Officer and Senior Vice President of Finance & Administration
Age: 58
Chief Oncology Expert and Member of Medical Advisory Board
Chief Technology Officer
Compensation as of Fiscal Year 2016.

Chronix Biomedical, Inc. Key Developments

Chronix Biomedical, Inc. Presents Cancer Prognostic Test Results

Chronix Biomedical, Inc. announced that results of a clinical trial of its liquid biopsy test have been accepted for presentation at the American Society of Clinical Oncology Annual Meeting. The poster presentation will cover results of a study evaluating the Copy Number Instability (CNI)-score as a prognostic test in head and neck cancer. The study compares the Chronix CNI-score test's accuracy as a predictor of time to progression with the current method based on clinical parameters. Predicted time to progression is an important factor that can aid the therapeutic decision (in this condition. Chronix is developing applications for its CNI-score based tests for the prognosis and diagnosis of cancer and, in particular, the real-time therapeutic monitoring of response to cancer therapy. Chronix and its collaborators have shown that its CNI-score based tests can accurately predict whether a patient will respond to treatment after one or two cycles of therapy, potentially 6-8 weeks earlier than is possible using imaging based methods. Such a tool would allow treating physicians to identify non-responding patients quickly and switch them to alternative treatments sooner, avoiding unnecessary side-effects and costs and potentially achieving better treatment outcomes. The company has presented results at major scientific meetings from studies of its CNI-score based test in therapeutic monitoring applications in patients receiving radiotherapy, chemotherapy and immunotherapy. Results of a clinical study using Chronix's test in patients receiving immunotherapy in eleven different cancer types were recently published in the journal, Clinical Cancer Research. The paper is believed to be the first peer-reviewed publication of a therapeutic monitoring strategy with immunotherapy. Chronix intends to conduct a number of studies in individual cancers to validate CNI-score tests in specific therapeutic monitoring applications and support regulatory submissions. The first such study, in pancreatic cancer, is already underway and Chronix is finalizing the design of similar validation studies in non-small cell lung cancer, melanoma and colorectal cancer.

Chronix Biomedical, Inc. Announces Publication of Positive Results of A Study Using its Circulating Cell-Free Tumour

Chronix Biomedical, Inc. announced the publication of positive results of a study using its circulating cell-free tumour DNA-based test as a means to predict therapeutic response to immunotherapy in multiple solid tumour types. Immunotherapy has become prominent in recent years as a result of remarkable response rates seen in previously unresponsive cancers and overall survival benefits seen in patients. However, there are several issues with the approach. First, only a minority of patients usually respond or have disease control with treatment. Second, there can be serious adverse effects with immunotherapy, including an acceleration of cancer growth referred to as hyper-progression. Third, immunotherapy is in general very expensive and consequently there is a high cost to healthcare payers given that many patients do not respond. The publication describes a blinded, prospective study designed to validate an algorithm, based on changes in Chronix’s proprietary genomic copy number instability (CNI) score, for predicting response to treatment after one or two cycles of immunotherapy in a range of cancers. The study was conducted using blood samples from 56 patients with different tumour types including lung, kidney, breast, pancreatic, colorectal cancers and melanoma. All patients were undergoing treatment with immunotherapy, mostly anti-PD1 immune checkpoint inhibitors with concurrent chemotherapy2. Three important points were observed in this study: The study showed Chronix’s test provided an 83% overall prediction accuracy in predicting response and disease control/progression, with a positive predictive value for progression of 92% after one cycle of immunotherapy. After a second cycle of immunotherapy, the CNI-score yielded a 100% positive predictive value for progression. Six cases of hyper-progression were observed, five of which could be identified by CNI-score at a significantly earlier time point than by the current practice of imaging (six- nine weeks earlier). One patient with progressive disease who had been misclassified as stable on the basis of imaging assessments was able to be identified by the CNI score. The Clinical Cancer Research paper is the first peer-reviewed publication describing Chronix’s CNI-based approach with immunotherapy and may be the first for any therapeutic monitoring strategy based on a liquid biopsy with this class of drug3. The study demonstrates that Chronix Biomedical’s CNI-based therapeutic monitoring test can identify progressing and hyper-progressive patients earlier than with currently available technologies. This could allow treating physicians to switch progressing or hyper-progressive patients to alternative therapies sooner and achieve better treatment outcomes, as identifying these patients through imaging or other methods can take several months.

Chronix Biomedical, Inc. Reports the Outcome of Two Pilot Studies of its Liquid Biopsy Test

Chronix Biomedical, Inc. reported 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.

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Recent Private Companies Transactions

Type
Date
Target
Private Placement
June 4, 2016
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