For the week of May 22 to May 26, 2017

Monday Tuesday Wednesday Thursday Friday

Monday's Business Reports


These business pages will run from Monday thru Friday. Different reports each day starting Monday and adding webpages throughout the week. Our Business Reports will feature local California companies.

 

OncoCyte Presents Positive Lung Cancer Blood Test Data at American Thoracic Society

ALAMEDA, CA...May 22, 2017 - OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood-based liquid biopsy tests for the early detection of cancer, today reported positive new results in its development of a highly-accurate blood-based lung cancer diagnostic. Data from a multi-site study further validate the test's commercial potential and support OncoCyte's plans to commercialize its first product, a confirmatory test for lung cancer, later this year. If successful, OncoCyte's test could eventually replace a high percentage of invasive, risky, and expensive lung biopsies with simple blood tests, improving outcomes for patients while also capturing significant cost savings for the U.S. healthcare system. The results were reported today in a poster presentation by Dr. Anil Vachani, at the American Thoracic Society 2017 International Conference in Washington, D.C.

Dr. Vachani, Associate Professor of Medicine at the Hospital of the University of Pennsylvania, reported that in a study of 299 samples collected prospectively from 29 U.S. sites, the optimized final predictive algorithm demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92.

Results from this study of the optimized final predictive algorithm confirmed the data from a previous 610-sample study that was reported in October 2016 by the Wistar Institute (OncoCyte's research partner) at the American College of Chest Physicians CHEST 2016 Annual Meeting. The development of the lung cancer diagnostic test is a result of nearly ten years of research and the analysis of thousands of samples by Wistar, followed by improvement from OncoCyte's current study.

Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. The AUC of a test is a measure of overall global accuracy that combines sensitivity and specificity, with 1.0 being perfect accuracy and 0.50 being a random result. The reported score of 0.92 means that 92% of samples were correctly identified.

OncoCyte believes the results reported today significantly exceed levels necessary for a commercially successful test.

"The robust lung cancer diagnostic test study data suggest that OncoCyte's potential lung cancer confirmatory diagnostic could result in a major reduction in the number of risky and costly lung biopsies performed annually in the U.S.," said Dr. Vachani. "I believe this test could represent a fundamental advancement in the more accurate diagnosis of suspicious lung nodules by allowing physicians to determine those who need biopsies as opposed to those who need follow-up imaging."  

William Annett, President and Chief Executive Officer, commented, "Based on the predictive level of our new algorithm, we believe we are well positioned to be the first company to provide a novel, highly accurate test to a patient market that could reach $4 billion annually, depending on market penetration and reimbursable pricing. We believe we will have the first-mover advantage that could be sustained for at least several years."

The Company's health economics research indicates that its lung cancer diagnostic test could mitigate the need for hundreds of thousands of unnecessary lung biopsies. Because lung biopsies have significant safety risks, these unnecessary lung biopsies could result in thousands of consequent hospitalizations and deaths annually.  Reducing the number of these biopsies therefore would also reduce their cost burden to private health insurers and Medicare by billions of dollars. OncoCyte's surveys of physicians and payors have consistently indicated a strong desire for a test that could reduce the number of lung biopsies, and the expectation is that such a test would be adopted quickly by both prescribers and payors.  Based on published sources, Lung RADS guidelines and NLST (National Lung Screening Trial) data, the Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from its test.

Development and Commercialization Path

For the study presented at the ATS conference, OncoCyte and its investigative partners first created an algorithm that roughly matched the Wistar study results using all 200 biomarkers included in the Wistar algorithm, and OncoCyte then optimized the algorithm's performance by using only those biomarkers with the highest predictive ability. In addition, the Company's new algorithm also factors in size of the lung nodule.

OncoCyte has now locked the algorithm of its test and is preparing to commercialize it. During the next few months, the Company plans to complete analytical validation studies and anticipates CLIA certification of its testing laboratory in mid-2017. Upon CLIA certification, OncoCyte will conduct a small CLIA lab validation study to demonstrate that the full assay system utilized in the CLIA lab provides the same results on clinical samples as those obtained in its R&D lab.

Upon CLIA certification, OncoCyte will carry out a final clinical validation study using the locked algorithm and finalized operational procedures on a new set of blinded prospectively collected samples in order to confirm that the sensitivity and specificity of the test remains within commercial parameters in the CLIA operational setting. This final study is not required before commercialization. However, the Company believes that the results of this study should enhance the probability of rapid adoption as the new standard of care for confirming diagnoses of lung cancer. Assuming successful completion of these steps, OncoCyte anticipates launching the test in the second half of 2017. Subsequent to the launch, OncoCyte plans a continued program of clinical utility and health economics studies to support adoption of the test by the medical community, and reimbursement from third party payers such as Medicare and health insurers. OncoCyte also plans to conduct additional biomarker research and clinical studies to develop improved versions of its test that could have even higher accuracy or extend the intended use to additional patient profiles.

About the Lung Cancer Diagnostic Test Study and Poster Presentation

OncoCyte's lung cancer diagnostic study utilized Wistar's biomarker panel, which has been exclusively licensed to OncoCyte. The study developed and tested OncoCyte's proprietary algorithm using approximately 300 samples collected from patients at 29 community-based, academic, and government sites across the United States. OncoCyte developed its algorithm by combining data from the top mRNA biomarkers with clinical data such as nodule size.

The samples were collected from patients with nodules ranging in size from five to 30 millimeters, the size range presenting the greatest diagnostic challenge to clinicians. For patients with these size nodules, physicians must weigh the risk of cancer against the risks posed by costly and potentially dangerous invasive biopsies to confirm whether the nodules are malignant or benign.

The original abstract was submitted in December 2016 for presentation at the American Thoracic Society 2017 International Conference, and was based on the analysis of 106 samples completed at that time.  Subsequent to the submission of that abstract, which was published in the ATS conference guide, the analysis was completed on the full set of 299 samples and the results of that analysis were presented in the final poster, which is attached to this release.

Conference Call

OncoCyte will host a conference call today at 4:30 p.m. EDT / 1:30 p.m. PDT to discuss the study results.

The dial-in number in the U.S./Canada is 888-359-3610, for international participants the number is +1 719-457-2648. For all callers, refer to Conference ID 7395442. To access the live webcast, go to the investor relations section on the Company's website, http://investors.oncocyte.com/events-and-presentations.

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial +1 719-457-0820. Use the Conference ID 7395442. Additionally, the archived webcast will be available at http://investors.oncocyte.com/events-and-presentations.


 

 

Teneobio and Poseida Announce License Agreement for the Use of UniDab™ in CAR T-Cell Therapy

MENLO PARK, CA...May 22, 2017 - Teneobio, Inc. and Poseida Therapeutics, Inc. today announced that they have entered a commercial license agreement for the use of Teneobio's UniDabs™, single-domain, human heavy chain only antibodies in Chimeric Antigen Receptor (CAR) T-cell therapy. Under the terms of the agreement Poseida has commercial rights to UniDabs™ against a cancer specific antigen for its proprietary CAR T-cell therapy programs. Teneobio will receive an upfront payment, potential clinical milestones and royalties on commercial sales world-wide. Financial terms were not disclosed.

According to Wim van Schooten, CSO of Teneobio, "This agreement further validates the utility of UniDabs™ in CAR T-cell therapy. In the last year, we have made excellent progress in identifying and advancing UniAbs™, best-in-class human heavy chain only antibodies from our proprietary UniRat® transgenic platform, for bi- and multi-specific antibody therapeutics with great manufacturability. Ultimately, the greater specificity of bi- and multivalent CARs will enable the pursuit of solid tumor CAR T-cell therapy."

Eric Ostertag, CEO of Poseida added "We are looking forward to working with Teneobio's UniDab™ technology, which shares many of the advantages with and will complement the Centyrin™ technology that we previously licensed from Janssen. When combined with our industry-leading piggyBac™ Gene Delivery System and NextGEN™ CRISPR technology, UniDabs™ may become a key component of our wholly-owned allogeneic CAR-T program, which has shown exceptional results in preclinical studies.

About Teneobio, Inc.

Teneobio, Inc. is a biotechnology company developing a new class of biologics, Human Heavy Chain Antibodies (UniAbs™), for the treatments of cancer, autoimmunity, and infectious diseases. Teneobio's discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat® and OmniFlic®), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. TeneoSeek rapidly identifies large numbers of unique binding molecules specific for therapeutic targets of interest. Versatile antibody variable domains (UniDabs™) derived from UniAbs™ can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. Teneobio's "plug-and-play" T-cell engaging platform includes a diverse set of anti-CD3 antibodies for therapeutics with optimal efficacy and reduced toxicity.

For more information, contact Omid Vafa at ovafa@teneobio.com or visit www.teneobio.com

About Poseida Therapeutics, Inc.

Poseida Therapeutics is translating best-in-class gene editing technologies into lifesaving treatments. The company is developing CAR T-cell immunotherapies for multiple myeloma and other cancer types, as well as gene therapies for orphan diseases. Poseida has assembled a suite of industry-leading gene editing technologies, including the piggyBac™ DNA Modification System, XTN™ TALEN and NextGEN™ CRISPR site-specific nucleases, and Footprint-Free™ Gene Editing.

For more information, visit www.poseida.com.

 

 

Depomed Announces Corporate Governance Updates

NEWARK, CA...May 22, 2017 - Depomed, Inc. (Nasdaq:DEPO) today announced that following a comprehensive review of the Company's corporate governance practices, the Board of Directors has taken a number of actions designed to ensure that the Company's policies are further aligned with shareholder interests and corporate governance best practices.  In addition, the Board of Directors set August 15, 2017 as the date for the Company's 2017 Annual Meeting of Shareholders.

"Our Board is committed to being responsive to our shareholders and aligning Depomed's corporate governance policies with best practices," said Jim Fogarty, Chairman of the Board of Directors of Depomed.

The actions taken by the Board of Directors, include, but are not limited to the following:

In addition to updating the Company's corporate governance policies and practices, the Board of Directors adopted a revised peer group for compensation benchmarking which reflects the Company's size and profile.  This new peer group will assist the Board of Directors in aligning the Company's compensation practices with shareholder interests.

Shareholders are encouraged to read and review the definitive proxy statement relating to the 2017 Annual Meeting of Shareholders the Company will (i) file with the SEC (and which will be available on SEC's website at www.sec.gov) and (ii) mail to shareholders entitled to vote at the meeting.

About Depomed
Depomed is a leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California.

 

 

CombiMatrix to Present at Upcoming Investor Conferences

IRVINE, CA...May 22, 2017 - CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, announces that management will present at two upcoming investor conferences:

About CombiMatrix Corporation

CombiMatrix Corporation provides sophisticated molecular diagnostic solutions and comprehensive clinical support to foster the highest quality in patient care. CombiMatrix specializes in pre-implantation genetic diagnostics and screening, prenatal diagnosis, miscarriage analysis and pediatric developmental disorders, offering DNA-based testing for the detection of genetic abnormalities beyond what can be identified through traditional methodologies. Our testing focuses on advanced technologies, including single nucleotide polymorphism chromosomal microarray analysis, next generation sequencing, fluorescent in situ hybridization and high resolution karyotyping. Additional information about CombiMatrix is available at www.combimatrix.com or by calling (800) 710-0624.