On April 21, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported that its bladder cancer abstract has been selected for presentation in a poster session, including a live panel discussion on the results, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in Chicago, Illinois June 3rd through the 7th (Press release, BioTime, APR 21, 2016, View Source;p=RssLanding&cat=news&id=2159019 [SID:1234511206]).

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The Company has been developing a urine-based diagnostic that could be more effectively used for screening for bladder cancer in patients presenting with hematuria, confirming indeterminate cytology findings, and diagnosing recurrence of bladder cancer in patients in remission. OncoCyte presented interim clinical study data for the non-invasive detection of bladder cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April of 2015 demonstrating a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer. At AACR (Free AACR Whitepaper) OncoCyte reported a ROC AUC of .91, sensitivity of 90% and specificity of 83%. The study to be presented at ASCO (Free ASCO Whitepaper) continued the development of the diagnostic first reported in the 2015 study.

"ASCO is one of the largest medical meetings of the year and OncoCyte is excited to be presenting clinical data for our diagnostics for the second year in a row," commented William Annett, Chief Executive Officer. "Our bladder test has the potential to screen approximately four million patients along the cancer spectrum annually and reflects our robust clinical pipeline of diagnostics assays. We are looking forward to sharing our results with the medical community as well as our shareholders."

The data will be presented by Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research.

Presentation Title: "Derivation of gene expression classifiers for the non-invasive detection of bladder cancer in the hematuria and recurrence surveillance populations."
Session Title: Tumor Biology
Poster Session: 1 PM – 4:30 PM June 6, 2016
Poster Discussion Session: 4:45 PM – 6 PM, June 6, 2016

About Bladder Cancer

Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. Bladder cancer in the U.S. was estimated to cost $125B in 2010, growing to $155B in 2014. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease.

On April 21, 2016 Transgene (Paris:TNG), a company focused on discovering and developing targeted immunotherapies for the treatment of cancer and infectious diseases, reported a business update for the quarter ending March 31, 2016 (Press release, Transgene, APR 21, 2016, View Source [SID:1234511236]).

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Operating revenue:

The following table summarizes the first quarter operating revenue1 for 2016 compared to the same period in 2015:

Q1
In millions of euros 2016 2015

Revenue from collaborative and licensing agreements 0.4 0.5
Government financing for research expenditures 1.6 2.3

Operating revenue 2.0 2.8
During the first quarter of 2016, revenue from collaborative and licensing agreements was mainly composed of research services and royalties.

As of March 31, 2016, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2016 (€1.6 million in the first quarter of 2016 versus €2.0 million over the same period in 2015). This decrease was due to lower eligible research and development expenses, explained by the restructuring of the Company.

Cash, cash equivalents, available-for-sale financial assets and other financial assets:

Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €23.5 million as of March 31, 2016, compared to €31.7 million as of December 31, 2015. Cash burn was €8.2 million in the first quarter of 2016, versus €8.9 million for the same quarter last year. Net cash outflows linked to the restructuring plan amounted to €2.0 million over the period. Excluding the above disbursements, cash burn stood at €6.2 million in the first quarter of 2016, reflecting the first positive effects of the reorganization plan.

As a reminder, Transgene secured up to €30 million of new funding in January 2016, to be drawn within the fiscal year. This consisted of a loan facility of €20 million from the EIB (European Investment Bank), and the commitment by its major shareholder, Institut Mérieux, to provide additional funding of approximately €10 million.

Key achievements of the first quarter of 2016:

Pexa-Vec: first patient with advanced hepatocellular carcinoma treated in the Phase 3 trial conducted by Transgene’s partner, SillaJen, Inc.
Loan agreement of €20 million from the European Investment Bank (EIB), under the IDFF (Infectious Diseases Finance Facility) program
Finalization of the restructuring plan and sale of the production asset to ABL Europe for an amount of €3.5 million
Management team strengthened: Maud Brandely, MD, PhD appointed Chief Medical Officer, and John Felitti, JD, LLM appointed as General Counsel & Corporate Secretary
Outlook:

Transgene confirms that it expects 2016 cash burn to be around €35 million, which includes the development plan as currently programmed, as well as extraordinary items such as restructuring expenditures (€6 million) and a milestone payment to SillaJen, Inc. Projected cash burn excludes the impact of the possible Conditional Marketing Approval submission in Europe for TG4010 and the associated Phase 3 trial initiation, which is currently being evaluated.

On April 21, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that data from three immuno-oncology studies will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place June 3 to June 7, 2016 in Chicago (Press release, Immune Design, APR 21, 2016, View Source [SID:1234511207]).

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The ASCO (Free ASCO Whitepaper) presentation details are as follows:

Pilot trial of intratumoral (IT) G100, a toll-like receptor-4 (TLR4) agonist, in patients with Merkel cell carcinoma (MCC): Final clinical results and immunologic effects on the tumor microenvironment (TME).

Abstract # 3021

Session Type: Poster Discussion Session
Session Title: Developmental Therapeutics—Immunotherapy

Date: Sunday, June 05
Time: 8 a.m. — 11:30 a.m. (poster session) / 4:45 p.m. — 6 p.m. (poster discussion)
Location: Hall A (poster session) / Hall B1 (poster discussion)
Poster Board: #343

Presenter: Shailender Bhatia, M.D., University of Washington, Fred Hutchinson Cancer Research Center

Using G100 (glucopyranosyl lipid A) to transform the sarcoma tumor immune microenvironment

Abstract #: 11017

Session Type: Poster Discussion Session
Session Title: Sarcoma

Date: Monday, June 6, 2016
Time: 8 a.m. — 11:30 a.m. (poster session) / 3 p.m. — 4:15 p.m. (poster discussion)
Location: Hall A (poster session) / S406 (poster discussion)
Poster Board: 143

Presenter: Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center

Single-agent LV305 induces anti-tumor immune and clinical responses in patients with advanced or metastatic sarcoma and other cancers expressing NY-ESO-1

Abstract # 3093

Session Type: Poster
Session Title: Developmental Therapeutics—Immunotherapy

Date: Sunday, June 5
Time: 8 a.m. — 11:30 a.m.
Location: Hall A
Poster Board: 415

Presenter: Neeta Somaiah, M.D. Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center

Additional data than those included in the abstracts may be included in the presentations.

On April 21, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA) a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that clinical data for its lead drug candidate CB-839, the Company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 3 to June 7, 2016 in Chicago, Illinois (Press release, Calithera Biosciences, APR 21, 2016, View Source;p=RssLanding&cat=news&id=2159182 [SID:1234511237]). Clinical results to be presented include data from Calithera’s Phase I combination trial in solid tumors. Calithera will hold an investor and analyst briefing Monday, June 6, 2016, in Chicago, Illinois at 6:30 p.m. CT. The meeting will be webcast live and available for replay for 30 days at www.calithera.com under the Investors section.

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Phase 1 study of CB-839, a small molecule inhibitor of glutaminase in combination with paclitaxel in patients with triple negative breast cancer.
Abstract #1011
Presenter: Angela DeMichele, MD, MSCE, University of Pennsylvania
Date: June 5, 2016
Poster Display: 8:00 a.m. – 11:30 a.m. CT, Hall A, Board #116, Breast Cancer—Triple-Negative/ Cytotoxics/ Local Therapy
Poster Discussion: 4:45 p.m. – 6:00 p.m. CT, Hall D2

Phase 1 study of CB-839, a small molecule inhibitor of glutaminase, alone and in combination with everolimus in patients with renal cell cancer.
Abstract #4568
Presenter: Funda Meric-Benstam, MD, University of Texas MD Anderson Cancer Center
Date: June 6, 2016
Poster Display: 1:00 p.m. – 4:30 p.m. CT, Hall A, Board #190, Genitourinary (Nonprostate)

The aim of this study was to compare the performance of 2- (2D) and 3-dimensional (3D) quantitative computed tomography (CT) methods for classifying lung nodules as lung cancer, metastases, or benign.
Using semiautomated software and computerized analysis, we analyzed more than 50 quantitative CT features of 96 solid nodules in 94 patients, in 2D from a single slice and in 3D from the entire nodule volume. Multivariable logistic regression was used to classify nodule types. Model performance was assessed by the area under the receiver operating characteristic curve (AUC) using leave-one-out cross-validation.
The AUC for distinguishing 53 primary lung cancers from 18 benign nodules and 25 metastases ranged from 0.79 to 0.83 and was not significantly different for 2D and 3D analyses (P = 0.29-0.78). Models distinguishing metastases from benign nodules were statistically significant only by 3D analysis (AUC = 0.84).
Three-dimensional CT methods did not improve discrimination of lung cancer, but may help distinguish benign nodules from metastases.

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