Transgene Reports First Quarter 2016 Business Update

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.

Immune Design Announces Presentations at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

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.

Calithera Biosciences Announces Clinical Data Presentations at ASCO 2016

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)

Quantitative Computed Tomography Classification of Lung Nodules: Initial Comparison of 2- and 3-Dimensional Analysis.

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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OncoMed Announces Clinical Data to be Presented at the 2016 ASCO Annual Meeting

On April 21, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported it will present data from several clinical programs at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting being held June 3-7, 2016 in Chicago, IL (Press release, OncoMed, APR 21, 2016, View Source [SID:1234511238]).

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Presentations include the first clinical data of OncoMed’s Wnt pathway inhibitors (vantictumab and ipafricept) in combination therapy. The Phase 1b vantictumab (anti-Fzd7, OMP-18R5) clinical trial is in combination with paclitaxel in breast cancer and the Phase 1b ipafricept (FZD8-Fc, OMP-54F28) clinical trial is in combination therapy with carboplatin and paclitaxel in ovarian cancer.

In addition, updated survival data from OncoMed’s Phase 1b clinical trials of demcizumab (OMP-21M18, anti-DLL4) in non-small cell lung cancer (NSCLC) and of tarextumab (anti-Notch2/3, OMP-59R5) in small cell lung cancer will be presented.

A complete list of OncoMed’s accepted abstracts is provided below.

Poster Discussions

Saturday, June 4, 3:00pm – 4:15pm CT at E354b

1. Abstract #9023: A Phase 1b Study of the Anti-Cancer Stem Cell Agent Demcizumab (DEM), Pemetrexed (PEM) & Carboplatin (CARBO) in Patients (pts) with 1st Line Non-Squamous NSCLC

Presenter: Mark James McKeage, MBChB, MMedSc, PhD, FRACP, Auckland City Hospital and University of Auckland
Session: Lung Cancer – Non-Small Cell Metastatic
Poster Display: Hall A; Poster Board#346; 8:00 am – 11:30am CT

Sunday, June 5, 11:30am – 12:45pm CT at Arie Crown Theater

2. Abstract #2515: Phase 1b of WNT inhibitor Ipafricept (IPA, decoy receptor for WNT ligands) with Carboplatin (C) and Paclitaxel (P) in Recurrent Platinum-Sensitive Ovarian Cancer (OC)

Presenter: Roisin E. O’Cearbhaill, M.D., Memorial Sloan Kettering Cancer Center
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster Display: Hall A; Poster Board #215; 8:00am – 11:30am CT

3. Abstract #2516: Phase 1b Study of WNT Inhibitor Vantictumab (VAN, human monoclonal antibody) with Paclitaxel (P) in Patients (pts) with 1st- to 3rd-Line Metastatic HER2-Negative Breast Cancer (BC)

Presenter: Monica Mita, MD, Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster Display: Hall A; Poster Board #216; 8:00am – 11:30am CT

Poster

Saturday, June 4, 8:00am — 11:00am CT

Abstract #8564: Updated results of Phase 1b study of tarextumab (TRXT, anti-Notch2/3) in combination with etoposide and platinum (EP) in patients (pts) with untreated extensive-stage small-cell lung cancer (ED-SCLC)
Lead author: Anne Chiang, M.D., Ph.D., of the Yale School of Medicine
Session: Lung Cancer — Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Location: Hall A; Poster Board#192