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

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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)

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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 Camurus (NASDAQ STO: CAMX) reported that they have granted R-PHARM US (Princeton, NJ) the exclusive license and distribution rights for episil oral liquid in the US (Press release, Camurus, APR 21, 2016, View Source [SID:1234511235]).

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episil oral liquid, is a unique and effective treatment for the pain of oral mucositis, a treatment-limiting side effect of cancer therapies, as well as other oral lesions. Financial terms under this agreement are not disclosed.

About oral mucositis
Oral mucositis (OM) is a common side effect of cancer therapies (chemo- and radiotherapy) and is characterized by painful inflammation and ulceration of the oral mucosa. OM affects nearly all head and neck cancer patients receiving radiotherapy (RT), 30%-75% of patients undergoing chemotherapy and most patients undergoing conditioning regimens for hematopoietic stem cell transplant.

OM is caused by damage to the DNA in the basal epithelial cell lining of the mouth leading to decreased cell proliferation and cell death. Symptoms of OM vary from pain and discomfort to an inability to tolerate food or fluids, which can prevent patients from eating, swallowing and speaking. OM often necessitates hospitalization for re-hydration, opiate pain medication and total parenteral nutrition. Patients with damaged oral mucosa and reduced immunity resulting from chemo- and radiotherapy are also prone to infections in the mouth. Severe OM can even limit the dosing and frequency of treatment for cancer.

About episil oral liquid
episil oral liquid represents a unique and innovative concept for local treatment of pain associated with OM. Developed using the award-winning* Camurus proprietary technology FluidCrystal, episil is administered as a lipid-based liquid that spreads on the intra-oral mucosal surfaces and transforms to a strongly bioadhesive film that mechanically protects the sensitized and sore epithelium of the oral cavity. Clinically demonstrated, episil has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. episil oral liquid is supplied as a ready-to-use, pocket-sized device helping patients maintain their quality of life while undergoing cancer therapy. episil was first launched in Europe and is today commercially available in a number of countries. episil oral liquid is a CE-marked medical device class 1 in Europe and a 510k registered medical device in the US.

Sonidegib selectively inhibits smoothened protein, suppresses the growth of Hedgehog pathway-dependent tumors, and has recently been approved in the indication of locally advanced basal cell carcinoma. A comprehensive exposure-response analysis was conducted to further characterize the relationship of sonidegib exposure to efficacy and safety. Minimum observed plasma concentration at pre-dose (Cmin), peak concentration (Cmax), and area under the curve were used as exposure endpoints. Exposure-efficacy analyses included data from 190 patients who received sonidegib 200 mg or 800 mg once daily in the primary efficacy study. Objective response rate (ORR) (complete response [CR] or partial response [PR]), progression-free survival (PFS), and time to tumor response (TTR) were assessed by logistic regression, Cox regression and Kaplan-Meier analyses. Exposure-safety (creatine phosphokinase [CK] elevation) analyses included data from 336 patients pooled from four clinical trials and included doses across ranges of 100-3000 mg once daily and 250-750 mg twice daily. Similar plasma exposure was observed between responders and non-responders. The logistic regression model of Week 5 Cmin vs. ORR indicated no relationship between sonidegib exposure resulting from 200 mg or 800 mg doses and the probability of CR or PR. A similar conclusion of no exposure-efficacy relationship was drawn from the PFS and TTR analyses. Increased exposure was associated with a greater risk of Grade 3 or 4 CK elevation, with lower risk in females than in males when using Cmin in the model. These analyses support the sonidegib dose recommendation for registration and are consistent with clinical observations. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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